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MEDICAL LABORATORY E E V V A A L L U U A A T T I I O O N N Total Commitment to Education and Service Provided by ACP, Inc. Hematology, Coagulation, Blood Bank, Urinalysis, PPM MLE-M1 PARTICIPANT SUMMARY 2 • 0 • 1 • 4

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Page 1: M E D I C A L L A B O R A T O R Y E VVV AAA LLL UUU AA TTT ... · E M E D I C A L L A B O R A T O R Y E VVV AAA LLL UUU AA TTT III OOO NNN Total Commitment to Education and Service

M E D I C A L L A B O R A T O R Y

EEE VVV AAA LLL UUU AAA TTT III OOO NNN

Total Commitment to Education and Service

Provided by ACP, Inc.

Hematology, Coagulation,

Blood Bank, Urinalysis, PPM

MLE-M1

PARTICIPANT SUMMARY

2 • 0 • 1 • 4

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COPYRIGHT ACP, Inc. Single copies of all material subject to this copyright may be photocopied for the non-commercial use of scientific or educational advancement.

Table of Contents

Evaluation Criteria ....................................................................................................................... 5 Hematology

HemoCue .................................................................................................................................................................................. 6

Hemoglobin ......................................................................................................................................................................... 6

Glucose ............................................................................................................................................................................... 6

Sedimentation Rate .................................................................................................................................................................. 6

Hematology with 5-part Automated Differential (CL Samples)............................................................................................. 7

White Blood Cell Count ....................................................................................................................................................... 7

Red Blood Cell Count .......................................................................................................................................................... 7

Hemoglobin ......................................................................................................................................................................... 8

Hematocrit ........................................................................................................................................................................... 8

Platelet Count...................................................................................................................................................................... 9

Automated Differential ......................................................................................................................................................... 9

Sysmex Hematology with 3-part Automated Differential (SYX Samples) .......................................................................... 12

White Blood Cell Count ..................................................................................................................................................... 12

Red Blood Cell Count ........................................................................................................................................................ 12

Hemoglobin ....................................................................................................................................................................... 13

Hematocrit ......................................................................................................................................................................... 13

Platelet Count.................................................................................................................................................................... 14

Automated Differential ....................................................................................................................................................... 14

Basic Hematology with 3-part Automated Differential (HD Samples) ................................................................................ 16

White Blood Cell Count ..................................................................................................................................................... 16

Red Blood Cell Count ........................................................................................................................................................ 17

Hemoglobin ....................................................................................................................................................................... 19

Hematocrit ......................................................................................................................................................................... 20

Platelet Count.................................................................................................................................................................... 22

Automated Differential ....................................................................................................................................................... 23

Hematology with 5-part Automated Differential (DIF Samples).......................................................................................... 28

White Blood Cell Count ..................................................................................................................................................... 28

Red Blood Cell Count ........................................................................................................................................................ 28

Hemoglobin ....................................................................................................................................................................... 29

Hematocrit ......................................................................................................................................................................... 29

Platelet Count.................................................................................................................................................................... 30

Automated Differential ....................................................................................................................................................... 30

QBC Hematology (QBC Samples) ......................................................................................................................................... 33

Hematocrit ......................................................................................................................................................................... 33

Hemoglobin ....................................................................................................................................................................... 33

White Blood Cell Count ..................................................................................................................................................... 34

Platelet Count.................................................................................................................................................................... 34

Automated Differential ....................................................................................................................................................... 35

Reticulocyte Count ................................................................................................................................................................. 36

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2014 MLE-M1 Participant Summary/ 3

Table of Contents (cont’d)

Hematology (cont’d)

Hematology with 5-part Automated Differential (BCX Samples) ........................................................................................ 36

White Blood Cell Count ..................................................................................................................................................... 36

Red Blood Cell Count ....................................................................................................................................................... 37

Hemoglobin ....................................................................................................................................................................... 38

Hematocrit......................................................................................................................................................................... 39

Platelet Count ................................................................................................................................................................... 40

Automated Differential ...................................................................................................................................................... 41

Hematology with 5-part Automated Differential (MX Samples) .......................................................................................... 46

White Blood Cell Count ..................................................................................................................................................... 46

Red Blood Cell Count ....................................................................................................................................................... 46

Hemoglobin ....................................................................................................................................................................... 47

Hematocrit......................................................................................................................................................................... 47

Platelet Count ................................................................................................................................................................... 48

Automated Differential ...................................................................................................................................................... 48

Waived Hematology ............................................................................................................................................................... 63

Hemoglobin ....................................................................................................................................................................... 63

Hematocrit......................................................................................................................................................................... 63

Blood Cell Identification ........................................................................................................................................................ 51

Blood Bank

ABO Group ............................................................................................................................................................................. 55

Rh Factor (D Type) ................................................................................................................................................................. 55

Rh Factor (Slide Method) ....................................................................................................................................................... 59

Unexpected Antibody Detection ........................................................................................................................................... 55

Antibody Identification .......................................................................................................................................................... 56

Compatibility Testing ............................................................................................................................................................. 56

Coagulation

Prothrombin Time .................................................................................................................................................................. 57

International Normalized Ratio (INR) ................................................................................................................................ 58

Activated Partial Thromboplastin Time ................................................................................................................................ 59

Fibrinogen............................................................................................................................................................................... 59

CoaguChek XS Plus Prothrombin Time ............................................................................................................................... 60

International Normalized Ratio (INR) ................................................................................................................................ 60

ITC Protime Microcoagulation System Prothrombin Time ................................................................................................. 60

International Normalized Ratio (INR) ................................................................................................................................ 60

i-Stat Prothrombin Time ........................................................................................................................................................ 61

International Normalized Ratio (INR) ................................................................................................................................ 61

CoaguChek XS INR ................................................................................................................................................................ 65

Fluid Cell Count/Crystals ...................................................................................................................................................... 62

WBC Count ....................................................................................................................................................................... 62

RBC Count ........................................................................................................................................................................ 62

Crystal Identification .......................................................................................................................................................... 62

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4 / 2014 MLE-M1 Participant Summary

Table of Contents (cont’d) Urinalysis

Microalbumin, Urine ............................................................................................................................................................... 63

Dipstick ............................................................................................................................................................................. 63

Quantitative ....................................................................................................................................................................... 63

Creatinine, Urine..................................................................................................................................................................... 64

Dipstick ............................................................................................................................................................................. 64

Quantitative ....................................................................................................................................................................... 64

Urinalysis Dipstick ................................................................................................................................................................. 66

Specific Gravity ................................................................................................................................................................. 66

pH ..................................................................................................................................................................................... 67

Protein ............................................................................................................................................................................... 68

Glucose ............................................................................................................................................................................. 69

Ketones ............................................................................................................................................................................. 70

Bilirubin ............................................................................................................................................................................. 71

Urobilinogen ...................................................................................................................................................................... 72

Blood or Hemoglobin ......................................................................................................................................................... 73

Leukocyte Esterase ........................................................................................................................................................... 74

Nitrite ................................................................................................................................................................................. 75

Microalbumin (Dipstick Only)............................................................................................................................................. 76

Urine hCG ............................................................................................................................................................................... 77

Fecal Occult Blood ................................................................................................................................................................. 78

KOH Skin Preparation ............................................................................................................................................................ 65

Urine Sediment Identification ................................................................................................................................................ 78

Provider-Performed Microscopy (PPM)

Provider-Performed Microscopy (PPM) ................................................................................................................................ 80

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2014 MLE-M1 Participant Summary/ 5

EVALUATION CRITERIA The evaluation criteria used in the MLE Program is in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA ‘88) federal requirements for proficiency testing. The criteria are included below.

Qualitative For qualitative procedures, evaluation is based on participant or referee consensus. If participant consensus is not reached, CMS requirements call for grading by referee consensus. A minimum percentage of participants or referee laboratories must receive a passing score or the challenge is not evaluated due to lack of consensus. These percentages are listed below. Crystal Identification 80% Consensus

Blood Cell Identification 80% Consensus

Urine Dipstick 80% Consensus

Urine hCG 80% Consensus

Microalbumin (Semi-Quantitative) 80% Consensus

Fecal Occult Blood 80% Consensus

Urine Sediment Identification 80% Consensus

Provider-Performed Microscopy 80% Consensus

KOH Skin Preparation 80% Consensus

ABO Group 95% Consensus

Rh Factor (D Type) 95% Consensus

Unexpected Antibody Detection 95% Consensus

Antibody Identification 95% Consensus

Compatibility Testing 95% Consensus

Quantitative For quantitative procedures, a mean and standard deviation (SD) are calculated for each peer group consisting of 10 or more laboratories except for QBC Hematology and Coagulation (CG Specimens) which consist of peer groups of 5 or more

laboratories. Acceptable performance is established on a target value the intervals below. An explanation on how to calculate the range of acceptability based upon these limits is also provided in your MLE Program Guide on page 37 under the heading “Acceptable Ranges for Quantitative Results.” Hemoglobin 7%

Hemoglogin, Waived 7%

Hematocrit 6%

Hematocrit, Waived 6% or 2 SD*

White Blood Cell Count 15%

Red Blood Cell Count 6%

Platelet Count 25%

Automated Differential 3 SD

Body Fluid - White Cell Count 2 SD

Body Fluid - Red Cell Count 2 SD

Sedimentation Rate 3 SD

Prothrombin Time 15%

International Normalized Ratio (INR) 20%

Activated Partial Thromboplastin Time 15%

Fibrinogen 20%

Specific Gravity 0.010

Reticulocyte Count 3 SD

Whole Blood Glucose – HemoCue 12 mg/dL or 20%*

Microalbumin (Quantitative) 3 SD

Creatinine, Urine (Quantitative) 3 SD

*Whichever is greater

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6 / 2014 MLE-M1 Participant Summary

HEMOCUE HEMATOLOGYHEMOGLOBIN (g/dL)

Specimen HQ-1 Specimen HQ-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

HemoCue 41 5.57 0.24 4.4 5.6 5.1 - 6.0 41 15.69 0.47 3.0 15.6 14.5 - 16.8

HEMOCUE HEMATOLOGYGLUCOSE (mg/dL)

Specimen HQ-1 Specimen HQ-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 45 61.6 6.5 10.5 61 49 - 74 45 328.4 10.9 3.3 327 262 - 395 HemoCue Glucose 201/+ 43 61.8 6.4 10.4 61 49 - 75 43 328.4 10.7 3.3 327 262 - 395

SEDIMENTATION RATE (MM/HR)

Specimen ES-1 Specimen ES-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 186 6.0 2.2 37.4 6 0 - 13 189 47.8 13.6 28.5 45 6 - 89 All HiChem Methods 10 4.7 2.3 48.2 4 0 - 12 10 82.8 14.8 17.9 86 38 - 128 All Vital Diagnostics Methods 21 5.2 0.7 13.1 5 3 - 8 22 60.3 7.0 11.6 60 39 - 82 HiChem Mini-Ves 10 4.7 2.3 48.2 4 0 - 12 10 82.8 14.8 17.9 86 38 - 128 Polymedco Sedimat 13 3.7 1.6 43.4 4 0 - 9 12 48.0 7.0 14.7 46 26 - 70 Streck ESR-Auto Plus 13 9.1 1.7 18.2 9 4 - 15 13 65.5 7.1 10.9 65 44 - 87 Vital Diagnostics Excyte M/10 16 5.1 0.7 14.0 5 2 - 8 17 60.2 7.2 11.9 60 38 - 82 Westergren - diluted 106 5.9 2.0 34.3 6 0 - 12 110 41.9 8.4 20.1 40 16 - 68 Westergren - undiluted 14 8.9 6.1 68.9 8 0 - 28 14 44.1 13.0 29.4 43 5 - 84

SEDIMAT SEDIMENTATION RATE (MM/HR)

Specimen MAT-1 Specimen MAT-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range Polymedco Sedimat 15 15 1.5 0.7 48.5 2 0 - 4 14 63.7 7.2 11.3 64 42 - 86

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2014 MLE-M1 Participant Summary/ 7

HEMATOLOGY W/ 5-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x K/uL)

Specimen CL-1 Specimen CL-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 31 7.85 0.24 3.1 7.9 6.6 - 9.1 31 21.37 0.85 4.0 21.5 18.1 - 24.6 All Abbott Cell-Dyn Instruments 30 7.85 0.24 3.1 7.9 6.6 - 9.1 30 21.33 0.83 3.9 21.5 18.1 - 24.6 Abbott Cell-Dyn 3200 11 7.88 0.24 3.1 7.9 6.6 - 9.1 11 21.22 0.95 4.5 21.2 18.0 - 24.5 Abbott Cell-Dyn Ruby 13 7.81 0.23 3.0 7.9 6.6 - 9.0 13 21.40 0.77 3.6 21.6 18.1 - 24.7

Specimen CL-3 Specimen CL-4 All Method 30 3.26 0.19 5.8 3.3 2.7 - 3.8 31 7.82 0.30 3.8 7.8 6.6 - 9.0 All Abbott Cell-Dyn Instruments 29 3.26 0.19 5.9 3.3 2.7 - 3.8 30 7.82 0.30 3.8 7.8 6.6 - 9.0 Abbott Cell-Dyn 3200 11 3.07 0.41 13.3 3.1 2.6 - 3.6 11 7.96 0.33 4.1 7.9 6.7 - 9.2 Abbott Cell-Dyn Ruby 13 3.32 0.21 6.4 3.3 2.8 - 3.9 13 7.76 0.27 3.5 7.8 6.5 - 9.0

Specimen CL-5 All Method 31 21.40 0.82 3.8 21.6 18.1 - 24.7 All Abbott Cell-Dyn Instruments 30 21.37 0.81 3.8 21.6 18.1 - 24.6 Abbott Cell-Dyn 3200 11 21.15 0.75 3.5 21.1 17.9 - 24.4 Abbott Cell-Dyn Ruby 13 21.43 0.81 3.8 21.7 18.2 - 24.7

HEMATOLOGY W/ 5-PART DIFFERENTIALRED BLOOD CELL COUNT (x M/uL)

Specimen CL-1 Specimen CL-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 30 4.674 0.076 1.6 4.68 4.39 - 4.96 31 5.188 0.135 2.6 5.20 4.87 - 5.50 All Abbott Cell-Dyn Instruments 29 4.672 0.076 1.6 4.67 4.39 - 4.96 30 5.186 0.137 2.6 5.19 4.87 - 5.50 Abbott Cell-Dyn 3200 11 4.649 0.071 1.5 4.64 4.37 - 4.93 11 5.164 0.079 1.5 5.14 4.85 - 5.48 Abbott Cell-Dyn Ruby 13 4.714 0.059 1.2 4.71 4.43 - 5.00 13 5.263 0.128 2.4 5.28 4.94 - 5.58

Specimen CL-3 Specimen CL-4 All Method 31 2.147 0.054 2.5 2.14 2.01 - 2.28 31 4.647 0.159 3.4 4.66 4.36 - 4.93 All Abbott Cell-Dyn Instruments 30 2.146 0.055 2.6 2.14 2.01 - 2.28 30 4.645 0.161 3.5 4.66 4.36 - 4.93 Abbott Cell-Dyn 3200 11 2.154 0.059 2.7 2.14 2.02 - 2.29 11 4.627 0.181 3.9 4.64 4.34 - 4.91 Abbott Cell-Dyn Ruby 13 2.156 0.049 2.3 2.15 2.02 - 2.29 13 4.718 0.120 2.5 4.70 4.43 - 5.01

Specimen CL-5 All Method 31 5.204 0.147 2.8 5.20 4.89 - 5.52 All Abbott Cell-Dyn Instruments 30 5.201 0.149 2.9 5.20 4.88 - 5.52 Abbott Cell-Dyn 3200 11 5.155 0.141 2.7 5.16 4.84 - 5.47 Abbott Cell-Dyn Ruby 13 5.300 0.099 1.9 5.28 4.98 - 5.62

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8 / 2014 MLE-M1 Participant Summary

HEMATOLOGY W/ 5-PART DIFFERENTIALHEMOGLOBIN (g/dL)

Specimen CL-1 Specimen CL-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 31 13.69 0.32 2.3 13.7 12.7 - 14.7 31 16.58 0.47 2.8 16.6 15.4 - 17.8 All Abbott Cell-Dyn Instruments 30 13.69 0.33 2.4 13.8 12.7 - 14.7 30 16.59 0.47 2.9 16.6 15.4 - 17.8 Abbott Cell-Dyn 3200 11 13.58 0.40 3.0 13.7 12.6 - 14.6 11 16.34 0.44 2.7 16.5 15.1 - 17.5 Abbott Cell-Dyn Ruby 13 13.80 0.25 1.8 13.8 12.8 - 14.8 13 16.83 0.42 2.5 16.9 15.6 - 18.1

Specimen CL-3 Specimen CL-4 All Method 30 5.56 0.13 2.3 5.6 5.1 - 6.0 31 13.57 0.39 2.9 13.6 12.6 - 14.6 All Abbott Cell-Dyn Instruments 29 5.56 0.13 2.4 5.6 5.1 - 6.0 30 13.57 0.40 2.9 13.7 12.6 - 14.6 Abbott Cell-Dyn 3200 11 5.59 0.17 3.0 5.6 5.1 - 6.0 11 13.49 0.51 3.8 13.7 12.5 - 14.5 Abbott Cell-Dyn Ruby 13 5.49 0.18 3.4 5.5 5.1 - 5.9 13 13.65 0.34 2.5 13.7 12.6 - 14.7

Specimen CL-5 All Method 31 16.63 0.45 2.7 16.7 15.4 - 17.8 All Abbott Cell-Dyn Instruments 30 16.62 0.46 2.8 16.7 15.4 - 17.8 Abbott Cell-Dyn 3200 11 16.45 0.54 3.3 16.7 15.3 - 17.7 Abbott Cell-Dyn Ruby 13 16.80 0.38 2.3 16.8 15.6 - 18.0

HEMATOLOGY W/ 5-PART DIFFERENTIALHEMATOCRIT (percent)

Specimen CL-1 Specimen CL-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 31 39.03 2.28 5.8 37.8 36.6 - 41.4 31 44.88 2.92 6.5 43.9 42.1 - 47.6 All Abbott Cell-Dyn Instruments 23 37.78 0.67 1.8 37.7 35.5 - 40.1 24 43.47 1.23 2.8 43.5 40.8 - 46.1 Abbott Cell-Dyn 3200 11 37.63 0.63 1.7 37.6 35.3 - 39.9 11 43.08 1.06 2.5 43.1 40.4 - 45.7 Abbott Cell-Dyn Ruby 13 38.12 1.00 2.6 37.7 35.8 - 40.5 13 43.79 1.30 3.0 43.7 41.1 - 46.5

Specimen CL-3 Specimen CL-4 All Method 31 15.68 1.06 6.7 15.3 14.7 - 16.7 31 38.90 2.25 5.8 38.4 36.5 - 41.3 All Abbott Cell-Dyn Instruments 24 15.18 0.50 3.3 15.1 14.2 - 16.1 24 37.85 1.18 3.1 37.8 35.5 - 40.2 Abbott Cell-Dyn 3200 11 15.20 0.60 3.9 15.1 14.2 - 16.2 11 37.45 1.22 3.3 37.7 35.1 - 39.7 Abbott Cell-Dyn Ruby 13 15.15 0.42 2.8 15.0 14.2 - 16.1 13 38.18 1.08 2.8 37.9 35.8 - 40.5

Specimen CL-5 All Method 31 45.05 2.93 6.5 44.0 42.3 - 47.8 All Abbott Cell-Dyn Instruments 24 43.63 1.32 3.0 43.6 41.0 - 46.3 Abbott Cell-Dyn 3200 11 43.06 1.39 3.2 43.4 40.4 - 45.7 Abbott Cell-Dyn Ruby 13 44.12 1.10 2.5 44.0 41.4 - 46.8

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2014 MLE-M1 Participant Summary/ 9

HEMATOLOGY W/ 5-PART DIFFERENTIALPLATELET COUNT (x K/uL)

Specimen CL-1 Specimen CL-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 31 265.0 13.4 5.1 266 198 - 332 31 497.4 28.0 5.6 497 373 - 622 All Abbott Cell-Dyn Instruments 30 265.7 13.1 4.9 267 199 - 333 30 499.2 26.6 5.3 499 374 - 624 Abbott Cell-Dyn 3200 11 261.1 16.2 6.2 260 195 - 327 11 490.4 30.8 6.3 487 367 - 613 Abbott Cell-Dyn Ruby 13 267.8 11.2 4.2 267 200 - 335 13 505.7 23.1 4.6 500 379 - 633

Specimen CL-3 Specimen CL-4 All Method 30 80.9 6.1 7.6 80 60 - 102 31 259.8 19.1 7.3 263 194 - 325 All Abbott Cell-Dyn Instruments 29 80.7 6.1 7.6 80 60 - 101 30 261.2 17.8 6.8 264 195 - 327 Abbott Cell-Dyn 3200 11 80.7 9.3 11.5 80 60 - 101 11 261.5 19.4 7.4 268 196 - 327 Abbott Cell-Dyn Ruby 13 79.9 5.4 6.7 80 59 - 100 13 262.0 20.3 7.8 264 196 - 328

Specimen CL-5 All Method 31 499.8 27.1 5.4 503 374 - 625 All Abbott Cell-Dyn Instruments 30 501.2 26.3 5.3 505 375 - 627 Abbott Cell-Dyn 3200 11 491.7 31.0 6.3 498 368 - 615 Abbott Cell-Dyn Ruby 13 513.3 19.1 3.7 513 384 - 642

HEMATOLOGY W/ 5-PART DIFFERENTIALNEUTROPHILS (percent)

Specimen CL-1 Specimen CL-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 31 65.96 1.01 1.5 66.0 62.9 - 69.0 31 73.45 0.95 1.3 73.5 70.5 - 76.4 All Abbott Cell-Dyn Instruments 29 65.85 0.93 1.4 65.8 63.0 - 68.7 29 73.39 0.95 1.3 73.4 70.5 - 76.3 Abbott Cell-Dyn 3200 11 65.35 1.13 1.7 65.2 61.9 - 68.8 11 73.52 1.07 1.5 73.8 70.3 - 76.8 Abbott Cell-Dyn Ruby 13 66.08 0.71 1.1 66.1 63.9 - 68.3 13 73.30 1.03 1.4 73.4 70.2 - 76.4

Specimen CL-3 Specimen CL-4 All Method 30 52.45 2.36 4.5 52.2 45.3 - 59.6 31 66.15 1.05 1.6 66.1 63.0 - 69.3 All Abbott Cell-Dyn Instruments 28 52.05 1.86 3.6 52.1 46.4 - 57.7 29 66.02 0.95 1.4 66.0 63.1 - 68.9 Abbott Cell-Dyn 3200 11 53.79 10.63 19.8 50.5 21.8 - 85.7 11 65.83 1.17 1.8 65.8 62.3 - 69.4 Abbott Cell-Dyn Ruby 13 52.72 1.49 2.8 52.8 48.2 - 57.2 13 66.00 0.73 1.1 66.1 63.8 - 68.2

Specimen CL-5 All Method 31 73.42 1.02 1.4 73.1 70.3 - 76.5 All Abbott Cell-Dyn Instruments 29 73.33 0.99 1.4 73.1 70.3 - 76.4 Abbott Cell-Dyn 3200 11 73.72 0.98 1.3 73.6 70.7 - 76.7 Abbott Cell-Dyn Ruby 13 73.05 1.00 1.4 72.8 70.0 - 76.1

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10 / 2014 MLE-M1 Participant Summary

HEMATOLOGY W/ 5-PART DIFFERENTIALLYMPHOCYTES (percent)

Specimen CL-1 Specimen CL-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 30 27.53 1.07 3.9 27.5 24.3 - 30.8 31 15.40 0.96 6.2 15.5 12.5 - 18.3 All Abbott Cell-Dyn Instruments 29 27.59 1.04 3.8 27.5 24.4 - 30.8 30 15.44 0.95 6.2 15.5 12.5 - 18.3 Abbott Cell-Dyn 3200 11 28.14 1.15 4.1 28.4 24.6 - 31.6 11 15.20 1.06 7.0 15.3 12.0 - 18.4 Abbott Cell-Dyn Ruby 13 27.09 0.93 3.5 27.2 24.2 - 29.9 13 15.38 0.87 5.7 15.7 12.7 - 18.0

Specimen CL-3 Specimen CL-4 All Method 29 38.59 1.86 4.8 38.4 33.0 - 44.2 30 27.56 1.23 4.5 27.5 23.8 - 31.3 All Abbott Cell-Dyn Instruments 28 38.79 1.56 4.0 38.6 34.1 - 43.5 29 27.63 1.20 4.3 27.5 24.0 - 31.3 Abbott Cell-Dyn 3200 11 36.68 10.66 29.1 39.8 4.6 - 68.7 11 28.12 1.22 4.3 28.4 24.4 - 31.8 Abbott Cell-Dyn Ruby 13 38.21 1.26 3.3 38.1 34.4 - 42.0 13 27.28 1.07 3.9 27.4 24.0 - 30.6

Specimen CL-5 All Method 31 15.55 1.04 6.7 15.5 12.4 - 18.7 All Abbott Cell-Dyn Instruments 30 15.59 1.04 6.7 15.6 12.4 - 18.8 Abbott Cell-Dyn 3200 11 15.19 1.00 6.6 15.3 12.1 - 18.2 Abbott Cell-Dyn Ruby 13 15.76 0.93 5.9 15.9 12.9 - 18.6

HEMATOLOGY W/ 5-PART DIFFERENTIALMONOCYTES (percent)

Specimen CL-1 Specimen CL-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 30 3.78 0.62 16.4 3.8 1.9 - 5.7 30 3.80 0.35 9.1 3.8 2.7 - 4.9 All Abbott Cell-Dyn Instruments 29 3.79 0.63 16.5 3.8 1.9 - 5.7 29 3.80 0.35 9.2 3.7 2.7 - 4.9 Abbott Cell-Dyn 3200 11 3.73 0.67 18.0 3.7 1.7 - 5.8 11 3.83 0.40 10.5 3.8 2.6 - 5.1 Abbott Cell-Dyn Ruby 13 3.87 0.70 18.0 3.8 1.7 - 6.0 13 3.85 0.31 8.1 3.8 2.9 - 4.8

Specimen CL-3 Specimen CL-4 All Method 30 5.58 0.76 13.6 5.4 3.3 - 7.9 29 3.63 0.58 15.9 3.5 1.8 - 5.4 All Abbott Cell-Dyn Instruments 29 5.61 0.76 13.5 5.4 3.3 - 7.9 28 3.64 0.58 16.0 3.6 1.8 - 5.4 Abbott Cell-Dyn 3200 11 6.03 0.54 8.9 6.1 4.4 - 7.7 11 3.29 0.86 26.0 3.6 0.7 - 5.9 Abbott Cell-Dyn Ruby 13 5.38 0.64 11.9 5.2 3.4 - 7.4 13 3.79 0.66 17.4 3.7 1.8 - 5.8

Specimen CL-5 All Method 30 3.68 0.36 9.9 3.6 2.5 - 4.8 All Abbott Cell-Dyn Instruments 29 3.66 0.36 9.7 3.6 2.5 - 4.8 Abbott Cell-Dyn 3200 11 3.65 0.36 9.8 3.7 2.5 - 4.8 Abbott Cell-Dyn Ruby 13 3.58 0.25 6.9 3.5 2.8 - 4.4

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2014 MLE-M1 Participant Summary/ 11

HEMATOLOGY W/ 5-PART DIFFERENTIALEOSINOPHILS (percent)

Specimen CL-1 Specimen CL-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 30 2.36 0.23 9.7 2.4 1.6 - 3.1 30 6.82 0.25 3.7 6.8 6.0 - 7.6 All Abbott Cell-Dyn Instruments 29 2.36 0.23 9.9 2.4 1.6 - 3.1 29 6.81 0.25 3.7 6.8 6.0 - 7.6 Abbott Cell-Dyn 3200 11 2.35 0.22 9.2 2.4 1.7 - 3.1 11 6.82 0.25 3.7 6.8 6.0 - 7.6 Abbott Cell-Dyn Ruby 13 2.42 0.27 11.2 2.5 1.6 - 3.3 13 6.75 0.25 3.7 6.7 6.0 - 7.6

Specimen CL-3 Specimen CL-4 All Method 29 2.76 0.36 13.1 2.8 1.6 - 3.9 30 2.38 0.22 9.1 2.4 1.7 - 3.1 All Abbott Cell-Dyn Instruments 28 2.75 0.37 13.3 2.8 1.6 - 3.9 29 2.37 0.21 8.9 2.4 1.7 - 3.1 Abbott Cell-Dyn 3200 10 2.54 0.41 16.2 2.6 1.3 - 3.8 11 2.40 0.25 10.4 2.3 1.6 - 3.2 Abbott Cell-Dyn Ruby 13 2.86 0.31 10.7 2.8 1.9 - 3.8 13 2.35 0.21 8.8 2.4 1.7 - 3.0

Specimen CL-5 All Method 30 6.84 0.34 5.0 6.8 5.8 - 7.9 All Abbott Cell-Dyn Instruments 29 6.86 0.34 4.9 6.8 5.8 - 7.9 Abbott Cell-Dyn 3200 11 6.86 0.32 4.6 6.8 5.9 - 7.9 Abbott Cell-Dyn Ruby 13 6.88 0.35 5.1 6.9 5.8 - 8.0

HEMATOLOGY W/ 5-PART DIFFERENTIALBASOPHILS (percent)

Specimen CL-1 Specimen CL-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 26 0.45 0.16 35.4 0.4 0.0 - 1.0 30 0.61 0.18 29.7 0.6 0.0 - 1.2 All Abbott Cell-Dyn Instruments 26 0.45 0.16 35.4 0.4 0.0 - 1.0 29 0.62 0.17 28.1 0.6 0.0 - 1.2 Abbott Cell-Dyn 3200 10 0.47 0.19 41.4 0.4 0.0 - 1.1 11 0.62 0.13 20.2 0.6 0.2 - 1.0 Abbott Cell-Dyn Ruby 12 0.48 0.14 29.0 0.5 0.0 - 1.0 13 0.59 0.16 27.1 0.6 0.1 - 1.1

Specimen CL-3 Specimen CL-4 All Method 30 0.85 0.31 36.6 0.9 0.0 - 1.8 29 0.39 0.17 44.2 0.4 0.0 - 0.9 All Abbott Cell-Dyn Instruments 28 0.85 0.23 26.6 0.9 0.1 - 1.6 28 0.37 0.15 41.4 0.4 0.0 - 0.9 Abbott Cell-Dyn 3200 11 0.85 0.23 27.7 0.9 0.1 - 1.6 11 0.39 0.14 35.2 0.4 0.0 - 0.9 Abbott Cell-Dyn Ruby 13 0.82 0.23 28.7 0.8 0.1 - 1.6 13 0.46 0.27 57.7 0.4 0.0 - 1.3

Specimen CL-5 All Method 30 0.61 0.22 35.2 0.6 0.0 - 1.3 All Abbott Cell-Dyn Instruments 29 0.62 0.21 33.9 0.6 0.0 - 1.3 Abbott Cell-Dyn 3200 11 0.60 0.21 35.7 0.6 0.0 - 1.3 Abbott Cell-Dyn Ruby 13 0.58 0.15 26.6 0.6 0.1 - 1.1

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12 / 2014 MLE-M1 Participant Summary

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALWHITE BLOOD CELL COUNT (x 109/L)

Specimen SYX-1 Specimen SYX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 56 8.33 0.24 2.9 8.3 7.0 - 9.6 54 20.71 0.44 2.1 20.7 17.6 - 23.9 All Sysmex Instruments 55 8.34 0.24 2.9 8.3 7.0 - 9.6 54 20.71 0.44 2.1 20.7 17.6 - 23.9 Sysmex KX-21N & K - 800,1000,4500 31 8.25 0.20 2.4 8.2 7.0 - 9.5 32 20.71 0.43 2.1 20.7 17.6 - 23.9 Sysmex pocH-100i 18 8.40 0.24 2.9 8.4 7.1 - 9.7 17 20.57 0.41 2.0 20.5 17.4 - 23.7 Specimen SYX-3 Specimen SYX-4 All Method 56 2.96 0.10 3.3 3.0 2.5 - 3.5 56 8.31 0.23 2.8 8.3 7.0 - 9.6 All Sysmex Instruments 55 2.95 0.10 3.2 3.0 2.5 - 3.4 54 8.31 0.20 2.5 8.3 7.0 - 9.6 Sysmex KX-21N & K - 800,1000,4500 32 2.94 0.09 3.1 2.9 2.4 - 3.4 31 8.29 0.21 2.5 8.3 7.0 - 9.6 Sysmex pocH-100i 17 2.96 0.09 3.1 3.0 2.5 - 3.5 18 8.29 0.20 2.4 8.3 7.0 - 9.6 Specimen SYX-5 All Method 54 20.69 0.48 2.3 20.8 17.5 - 23.8 All Sysmex Instruments 54 20.69 0.48 2.3 20.8 17.5 - 23.8 Sysmex KX-21N & K - 800,1000,4500 32 20.75 0.44 2.1 20.9 17.6 - 23.9 Sysmex pocH-100i 17 20.44 0.47 2.3 20.5 17.3 - 23.6

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALRED BLOOD CELL COUNT (x 1012

/L)

Specimen SYX-1 Specimen SYX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 58 4.021 0.057 1.4 4.01 3.77 - 4.27 57 5.649 0.088 1.6 5.64 5.31 - 5.99 All Sysmex Instruments 57 4.022 0.057 1.4 4.01 3.78 - 4.27 56 5.648 0.088 1.6 5.64 5.30 - 5.99 Sysmex KX-21N & K - 800,1000,4500 32 3.996 0.034 0.9 4.00 3.75 - 4.24 32 5.618 0.064 1.1 5.63 5.28 - 5.96 Sysmex pocH-100i 19 4.066 0.063 1.5 4.07 3.82 - 4.32 18 5.713 0.097 1.7 5.73 5.37 - 6.06 Specimen SYX-3 Specimen SYX-4 All Method 56 2.479 0.037 1.5 2.47 2.32 - 2.63 58 4.008 0.060 1.5 4.00 3.76 - 4.25 All Sysmex Instruments 55 2.480 0.036 1.4 2.47 2.33 - 2.63 57 4.010 0.060 1.5 4.00 3.76 - 4.26 Sysmex KX-21N & K - 800,1000,4500 32 2.477 0.029 1.2 2.47 2.32 - 2.63 32 3.983 0.039 1.0 3.98 3.74 - 4.23 Sysmex pocH-100i 18 2.499 0.052 2.1 2.49 2.34 - 2.65 19 4.060 0.065 1.6 4.06 3.81 - 4.31 Specimen SYX-5 All Method 57 5.645 0.073 1.3 5.64 5.30 - 5.99 All Sysmex Instruments 56 5.644 0.073 1.3 5.64 5.30 - 5.99 Sysmex KX-21N & K - 800,1000,4500 32 5.624 0.053 0.9 5.62 5.28 - 5.97 Sysmex pocH-100i 18 5.689 0.087 1.5 5.68 5.34 - 6.04

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2014 MLE-M1 Participant Summary/ 13

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALHEMOGLOBIN (g/dL)

Specimen SYX-1 Specimen SYX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 58 12.02 0.20 1.6 12.0 11.1 - 12.9 56 18.02 0.31 1.7 18.1 16.7 - 19.3 All Sysmex Instruments 57 12.02 0.20 1.6 12.0 11.1 - 12.9 55 18.01 0.31 1.7 18.0 16.7 - 19.3 Sysmex KX-21N & K - 800,1000,4500 31 12.03 0.13 1.1 12.0 11.1 - 12.9 30 18.09 0.19 1.1 18.1 16.8 - 19.4 Sysmex pocH-100i 19 12.04 0.24 2.0 12.0 11.1 - 12.9 18 17.94 0.37 2.1 17.9 16.6 - 19.2 Specimen SYX-3 Specimen SYX-4 All Method 57 6.26 0.11 1.8 6.2 5.8 - 6.7 57 11.98 0.18 1.5 12.0 11.1 - 12.9 All Sysmex Instruments 56 6.25 0.11 1.8 6.2 5.8 - 6.7 56 11.98 0.18 1.5 12.0 11.1 - 12.9 Sysmex KX-21N & K - 800,1000,4500 32 6.29 0.09 1.5 6.3 5.8 - 6.8 31 12.05 0.13 1.1 12.0 11.2 - 12.9 Sysmex pocH-100i 18 6.23 0.11 1.8 6.2 5.7 - 6.7 19 11.85 0.18 1.5 11.8 11.0 - 12.7 Specimen SYX-5 All Method 56 18.05 0.25 1.4 18.1 16.7 - 19.4 All Sysmex Instruments 55 18.05 0.25 1.4 18.1 16.7 - 19.4 Sysmex KX-21N & K - 800,1000,4500 31 18.14 0.18 1.0 18.1 16.8 - 19.5 Sysmex pocH-100i 18 17.91 0.30 1.7 17.9 16.6 - 19.2

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALHEMATOCRIT (percent)

Specimen SYX-1 Specimen SYX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 58 32.66 1.10 3.4 32.3 30.7 - 34.7 57 49.35 1.42 2.9 49.0 46.3 - 52.4 All Sysmex Instruments 57 32.67 1.11 3.4 32.3 30.7 - 34.7 56 49.33 1.43 2.9 49.0 46.3 - 52.3 Sysmex KX-21N & K - 800,1000,4500 32 32.01 0.39 1.2 32.0 30.0 - 34.0 32 48.60 0.64 1.3 48.7 45.6 - 51.6 Sysmex pocH-100i 19 33.97 0.89 2.6 33.9 31.9 - 36.1 18 50.92 1.36 2.7 50.8 47.8 - 54.0 Specimen SYX-3 Specimen SYX-4 All Method 57 17.59 0.54 3.1 17.5 16.5 - 18.7 58 32.47 1.13 3.5 32.0 30.5 - 34.5 All Sysmex Instruments 56 17.60 0.54 3.0 17.5 16.5 - 18.7 57 32.49 1.13 3.5 32.0 30.5 - 34.5 Sysmex KX-21N & K - 800,1000,4500 32 17.33 0.25 1.4 17.4 16.2 - 18.4 32 31.80 0.38 1.2 31.9 29.8 - 33.8 Sysmex pocH-100i 18 18.21 0.48 2.6 18.3 17.1 - 19.3 19 33.86 0.85 2.5 34.1 31.8 - 35.9 Specimen SYX-5 All Method 57 49.42 1.18 2.4 49.0 46.4 - 52.4 All Sysmex Instruments 56 49.40 1.18 2.4 49.0 46.4 - 52.4 Sysmex KX-21N & K - 800,1000,4500 32 48.87 0.60 1.2 48.8 45.9 - 51.9 Sysmex pocH-100i 18 50.72 1.03 2.0 50.9 47.6 - 53.8

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14 / 2014 MLE-M1 Participant Summary

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALPLATELET COUNT (x109/L)

Specimen SYX-1 Specimen SYX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 58 182.2 9.4 5.2 182 136 - 228 58 371.7 22.7 6.1 372 278 - 465 All Sysmex Instruments 57 182.2 9.5 5.2 182 136 - 228 57 372.3 22.3 6.0 373 279 - 466 Sysmex KX-21N & K - 800,1000,4500 32 184.8 6.7 3.6 184 138 - 231 32 379.3 14.6 3.8 382 284 - 475 Sysmex pocH-100i 19 175.1 8.9 5.1 175 131 - 219 19 355.1 24.5 6.9 354 266 - 444 Specimen SYX-3 Specimen SYX-4 All Method 56 61.2 3.6 5.8 61 45 - 77 58 181.9 8.5 4.7 183 136 - 228 All Sysmex Instruments 56 61.4 3.9 6.3 61 46 - 77 56 182.7 7.4 4.1 183 137 - 229 Sysmex KX-21N & K - 800,1000,4500 32 61.2 3.3 5.4 61 45 - 77 32 184.3 7.7 4.2 184 138 - 231 Sysmex pocH-100i 18 61.0 4.8 7.8 61 45 - 77 19 178.1 7.8 4.4 180 133 - 223 Specimen SYX-5 All Method 57 369.9 22.7 6.1 377 277 - 463 All Sysmex Instruments 56 370.6 22.3 6.0 378 277 - 464 Sysmex KX-21N & K - 800,1000,4500 32 379.7 15.9 4.2 381 284 - 475 Sysmex pocH-100i 18 349.3 18.8 5.4 347 261 - 437

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALLYMPH W/SCR (percent)

Specimen SYX-1 Specimen SYX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 54 30.60 1.05 3.4 30.5 27.4 - 33.8 54 60.85 0.67 1.1 60.9 58.8 - 62.9 All Sysmex Instruments 53 30.58 1.05 3.4 30.5 27.4 - 33.8 53 60.86 0.68 1.1 60.9 58.8 - 62.9 Sysmex KX-21N & K - 800,1000,4500 30 31.04 0.92 3.0 30.9 28.2 - 33.8 30 60.93 0.70 1.1 61.0 58.8 - 63.1 Sysmex pocH-100i 18 29.84 0.75 2.5 29.8 27.6 - 32.1 18 60.83 0.56 0.9 60.9 59.1 - 62.6 Specimen SYX-3 Specimen SYX-4 All Method 52 12.04 1.10 9.1 12.2 8.7 - 15.4 54 30.78 0.85 2.7 30.9 28.2 - 33.4 All Sysmex Instruments 52 12.04 1.10 9.1 12.2 8.7 - 15.4 53 30.76 0.83 2.7 30.9 28.2 - 33.3 Sysmex KX-21N & K - 800,1000,4500 30 12.34 0.95 7.7 12.4 9.4 - 15.2 30 31.07 0.73 2.3 31.1 28.8 - 33.3 Sysmex pocH-100i 17 11.24 0.87 7.8 11.2 8.6 - 13.9 18 30.29 0.79 2.6 30.3 27.9 - 32.7 Specimen SYX-5 All Method 53 60.95 0.67 1.1 60.9 58.9 - 63.0 All Sysmex Instruments 52 60.97 0.66 1.1 60.9 58.9 - 63.0 Sysmex KX-21N & K - 800,1000,4500 30 61.12 0.70 1.1 61.3 59.0 - 63.3 Sysmex pocH-100i 17 60.71 0.56 0.9 60.8 59.0 - 62.4

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2014 MLE-M1 Participant Summary/ 15

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALMONO/MIXED W/MCR (percent)

Specimen SYX-1 Specimen SYX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 52 15.59 0.93 6.0 15.5 12.7 - 18.4 52 13.36 0.88 6.6 13.6 10.7 - 16.1 All Sysmex Instruments 52 15.59 0.93 6.0 15.5 12.7 - 18.4 52 13.36 0.88 6.6 13.6 10.7 - 16.1 Sysmex KX-21N & K - 800,1000,4500 29 15.96 0.75 4.7 16.0 13.7 - 18.3 29 13.84 0.62 4.5 13.9 11.9 - 15.7 Sysmex pocH-100i 18 14.84 0.75 5.1 15.1 12.5 - 17.2 18 12.42 0.34 2.7 12.3 11.4 - 13.5 Specimen SYX-3 Specimen SYX-4 All Method 51 17.74 1.45 8.2 17.6 13.3 - 22.1 52 15.51 1.20 7.7 15.7 11.9 - 19.2 All Sysmex Instruments 51 17.74 1.45 8.2 17.6 13.3 - 22.1 52 15.51 1.20 7.7 15.7 11.9 - 19.2 Sysmex KX-21N & K - 800,1000,4500 29 18.55 1.17 6.3 18.8 15.0 - 22.1 29 16.13 0.76 4.7 15.9 13.8 - 18.4 Sysmex pocH-100i 18 16.11 1.34 8.3 16.4 12.0 - 20.2 18 14.34 1.00 7.0 14.4 11.3 - 17.4 Specimen SYX-5 All Method 51 13.35 0.94 7.0 13.3 10.5 - 16.2 All Sysmex Instruments 51 13.35 0.94 7.0 13.3 10.5 - 16.2 Sysmex KX-21N & K - 800,1000,4500 29 13.83 0.79 5.7 13.9 11.4 - 16.3 Sysmex pocH-100i 17 12.50 0.59 4.7 12.4 10.7 - 14.3

SYSMEX HEMATOLOGY W/ AUTOMATED DIFFERENTIALNEUT W/LCR (percent)

Specimen SYX-1 Specimen SYX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 52 53.84 1.47 2.7 53.7 49.4 - 58.3 52 25.77 1.00 3.9 25.7 22.7 - 28.8 All Sysmex Instruments 52 53.84 1.47 2.7 53.7 49.4 - 58.3 52 25.77 1.00 3.9 25.7 22.7 - 28.8 Sysmex KX-21N & K - 800,1000,4500 29 53.00 1.08 2.0 53.3 49.7 - 56.3 29 25.20 0.76 3.0 25.2 22.9 - 27.5 Sysmex pocH-100i 18 55.32 0.86 1.6 55.6 52.7 - 58.0 18 26.74 0.65 2.4 26.8 24.7 - 28.7 Specimen SYX-3 Specimen SYX-4

All Method 51 70.23 2.08 3.0 70.0 64.0 - 76.5 52 53.75 1.66 3.1 53.7 48.7 - 58.8 All Sysmex Instruments 51 70.23 2.08 3.0 70.0 64.0 - 76.5 52 53.75 1.66 3.1 53.7 48.7 - 58.8 Sysmex KX-21N & K - 800,1000,4500 29 69.11 1.43 2.1 69.2 64.8 - 73.5 28 52.94 0.92 1.7 52.9 50.1 - 55.8 Sysmex pocH-100i 17 72.42 1.33 1.8 72.4 68.4 - 76.5 18 55.36 1.30 2.3 55.2 51.4 - 59.3 Specimen SYX-5 All Method 51 25.69 1.09 4.2 25.7 22.4 - 29.0 All Sysmex Instruments 51 25.69 1.09 4.2 25.7 22.4 - 29.0 Sysmex KX-21N & K - 800,1000,4500 29 25.06 0.85 3.4 25.1 22.5 - 27.7 Sysmex pocH-100i 17 26.79 0.53 2.0 26.7 25.2 - 28.4

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16 / 2014 MLE-M1 Participant Summary

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x 109/L)

Specimen HD-1 Specimen HD-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 748 3.29 0.23 7.0 3.3 2.7 - 3.8 744 6.70 0.31 4.7 6.7 5.6 - 7.8 All Abbott Cell-Dyn Instruments 271 3.30 0.18 5.6 3.3 2.8 - 3.8 272 6.70 0.31 4.6 6.7 5.6 - 7.8 All ABX Instruments 119 3.17 0.12 3.9 3.2 2.6 - 3.7 120 6.59 0.20 3.0 6.6 5.5 - 7.6 All COULTER Instruments 250 3.45 0.16 4.8 3.4 2.9 - 4.0 244 6.90 0.20 2.9 6.9 5.8 - 8.0 All Danam/Drew Scientific Instruments 11 3.20 0.12 3.7 3.2 2.7 - 3.7 11 6.45 0.15 2.3 6.5 5.4 - 7.5 Abbott Cell-Dyn 1700 25 3.39 0.29 8.4 3.4 2.8 - 3.9 26 6.98 0.53 7.6 7.0 5.9 - 8.1 Abbott Cell-Dyn 1800 126 3.28 0.17 5.0 3.3 2.7 - 3.8 127 6.77 0.27 4.0 6.8 5.7 - 7.8 Abbott Cell-Dyn Emerald 117 3.29 0.18 5.6 3.3 2.7 - 3.8 116 6.58 0.25 3.8 6.6 5.5 - 7.6 ABX Diagnostics Micros/45/60 119 3.17 0.12 3.9 3.2 2.6 - 3.7 120 6.59 0.20 3.0 6.6 5.5 - 7.6 Boule Medonic CA 620 12 3.28 0.14 4.1 3.3 2.7 - 3.8 12 6.82 0.17 2.5 6.9 5.7 - 7.9 Boule Medonic M series 79 2.91 0.15 5.0 2.9 2.4 - 3.4 80 6.25 0.20 3.1 6.3 5.3 - 7.2 COULTER AcT 8/10 13 3.44 0.24 6.9 3.4 2.9 - 4.0 13 6.95 0.27 3.8 7.0 5.9 - 8.0 COULTER AcT diff/diff 2 234 3.45 0.16 4.6 3.4 2.9 - 4.0 228 6.90 0.19 2.8 6.9 5.8 - 8.0 Drew Scientific D3 11 3.20 0.12 3.7 3.2 2.7 - 3.7 11 6.45 0.15 2.3 6.5 5.4 - 7.5

Specimen HD-3 Specimen HD-4 All Method 744 3.26 0.19 5.9 3.3 2.7 - 3.8 740 14.98 0.69 4.6 15.0 12.7 - 17.3 All Abbott Cell-Dyn Instruments 272 3.28 0.17 5.2 3.3 2.7 - 3.8 271 14.85 0.68 4.6 14.8 12.6 - 17.1 All ABX Instruments 118 3.16 0.11 3.4 3.2 2.6 - 3.7 118 14.81 0.39 2.6 14.8 12.5 - 17.1 All COULTER Instruments 246 3.39 0.13 3.8 3.4 2.8 - 4.0 244 15.49 0.42 2.7 15.5 13.1 - 17.9 All Danam/Drew Scientific Instruments 11 3.17 0.13 4.0 3.2 2.6 - 3.7 11 14.28 0.38 2.6 14.2 12.1 - 16.5 Abbott Cell-Dyn 1700 25 3.33 0.27 8.1 3.4 2.8 - 3.9 26 15.45 1.16 7.5 15.6 13.1 - 17.8 Abbott Cell-Dyn 1800 126 3.28 0.14 4.3 3.3 2.7 - 3.8 127 15.17 0.53 3.5 15.2 12.8 - 17.5 Abbott Cell-Dyn Emerald 117 3.26 0.16 5.0 3.3 2.7 - 3.8 115 14.38 0.43 3.0 14.4 12.2 - 16.6 ABX Diagnostics Micros/45/60 118 3.16 0.11 3.4 3.2 2.6 - 3.7 118 14.81 0.39 2.6 14.8 12.5 - 17.1 Boule Medonic CA 620 12 3.26 0.11 3.3 3.3 2.7 - 3.8 12 15.40 0.35 2.3 15.5 13.0 - 17.8 Boule Medonic M series 80 2.98 0.12 4.0 3.0 2.5 - 3.5 79 14.09 0.49 3.5 14.1 11.9 - 16.3 COULTER AcT 8/10 13 3.39 0.19 5.7 3.4 2.8 - 4.0 12 15.68 0.58 3.7 15.5 13.3 - 18.1 COULTER AcT diff/diff 2 228 3.39 0.12 3.5 3.4 2.8 - 4.0 228 15.48 0.40 2.6 15.5 13.1 - 17.9 Drew Scientific D3 11 3.17 0.13 4.0 3.2 2.6 - 3.7 11 14.28 0.38 2.6 14.2 12.1 - 16.5

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2014 MLE-M1 Participant Summary/ 17

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x 109/L) cont’d

Specimen HD-5 Instrument Labs Mean SD CV Median Range All Method 737 6.84 0.35 5.1 6.9 5.8 - 7.9 All Abbott Cell-Dyn Instruments 270 6.84 0.34 5.0 6.8 5.8 - 7.9 All ABX Instruments 119 6.78 0.24 3.5 6.8 5.7 - 7.9 All COULTER Instruments 242 7.06 0.22 3.2 7.1 6.0 - 8.2 All Danam/Drew Scientific Instruments 11 6.65 0.18 2.7 6.7 5.6 - 7.7 Abbott Cell-Dyn 1700 25 7.05 0.50 7.1 7.1 5.9 - 8.2 Abbott Cell-Dyn 1800 122 6.91 0.24 3.5 6.9 5.8 - 8.0 Abbott Cell-Dyn Emerald 119 6.68 0.34 5.1 6.7 5.6 - 7.7 ABX Diagnostics Micros/45/60 119 6.78 0.24 3.5 6.8 5.7 - 7.9 Boule Medonic CA 620 12 6.91 0.23 3.3 6.9 5.8 - 8.0 Boule Medonic M series 79 6.33 0.24 3.8 6.4 5.3 - 7.3 COULTER AcT 8/10 12 7.12 0.44 6.2 7.0 6.0 - 8.2 COULTER AcT diff/diff 2 227 7.07 0.21 3.0 7.1 6.0 - 8.2 Drew Scientific D3 11 6.65 0.18 2.7 6.7 5.6 - 7.7

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALRED BLOOD CELL COUNT (x 1012

/L)

Specimen HD-1 Specimen HD-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 741 3.222 0.099 3.1 3.22 3.02 - 3.42 740 5.416 0.126 2.3 5.42 5.09 - 5.75 All Abbott Cell-Dyn Instruments 272 3.275 0.099 3.0 3.28 3.07 - 3.48 274 5.392 0.128 2.4 5.40 5.06 - 5.72 All ABX Instruments 118 3.154 0.082 2.6 3.15 2.96 - 3.35 118 5.373 0.104 1.9 5.37 5.05 - 5.70 All COULTER Instruments 247 3.216 0.088 2.7 3.22 3.02 - 3.41 243 5.454 0.131 2.4 5.44 5.12 - 5.79 All Danam/Drew Scientific Instruments 11 3.199 0.086 2.7 3.19 3.00 - 3.40 11 5.399 0.125 2.3 5.41 5.07 - 5.73 Abbott Cell-Dyn 1700 25 3.268 0.082 2.5 3.25 3.07 - 3.47 26 5.451 0.127 2.3 5.47 5.12 - 5.78 Abbott Cell-Dyn 1800 127 3.326 0.081 2.4 3.33 3.12 - 3.53 126 5.399 0.119 2.2 5.40 5.07 - 5.73 Abbott Cell-Dyn Emerald 118 3.218 0.095 2.9 3.22 3.02 - 3.42 119 5.371 0.134 2.5 5.38 5.04 - 5.70 ABX Diagnostics Micros/45/60 118 3.154 0.082 2.6 3.15 2.96 - 3.35 118 5.373 0.104 1.9 5.37 5.05 - 5.70 Boule Medonic CA 620 12 3.209 0.060 1.9 3.22 3.01 - 3.41 12 5.434 0.089 1.6 5.42 5.10 - 5.77 Boule Medonic M series 78 3.177 0.052 1.6 3.19 2.98 - 3.37 79 5.459 0.094 1.7 5.46 5.13 - 5.79 COULTER AcT 8/10 13 3.198 0.058 1.8 3.22 3.00 - 3.39 13 5.492 0.094 1.7 5.46 5.16 - 5.83 COULTER AcT diff/diff 2 231 3.217 0.090 2.8 3.22 3.02 - 3.42 227 5.453 0.133 2.4 5.44 5.12 - 5.78 Drew Scientific D3 11 3.199 0.086 2.7 3.19 3.00 - 3.40 11 5.399 0.125 2.3 5.41 5.07 - 5.73

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18 / 2014 MLE-M1 Participant Summary

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALRED BLOOD CELL COUNT (x 1012

/L) cont’d

Specimen HD-3 Specimen HD-4 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 746 4.698 0.115 2.4 4.70 4.41 - 4.98 739 5.685 0.136 2.4 5.69 5.34 - 6.03 All Abbott Cell-Dyn Instruments 275 4.700 0.121 2.6 4.71 4.41 - 4.99 269 5.643 0.120 2.1 5.64 5.30 - 5.99 All ABX Instruments 119 4.634 0.094 2.0 4.63 4.35 - 4.92 119 5.652 0.111 2.0 5.64 5.31 - 6.00 All COULTER Instruments 248 4.721 0.115 2.4 4.72 4.43 - 5.01 244 5.722 0.144 2.5 5.73 5.37 - 6.07 All Danam/Drew Scientific Instruments 11 4.665 0.149 3.2 4.66 4.38 - 4.95 11 5.649 0.139 2.5 5.61 5.31 - 5.99 Abbott Cell-Dyn 1700 26 4.751 0.148 3.1 4.78 4.46 - 5.04 25 5.752 0.130 2.3 5.73 5.40 - 6.10 Abbott Cell-Dyn 1800 127 4.720 0.113 2.4 4.73 4.43 - 5.01 125 5.630 0.113 2.0 5.63 5.29 - 5.97 Abbott Cell-Dyn Emerald 119 4.668 0.117 2.5 4.67 4.38 - 4.95 117 5.635 0.121 2.1 5.64 5.29 - 5.98 ABX Diagnostics Micros/45/60 119 4.634 0.094 2.0 4.63 4.35 - 4.92 119 5.652 0.111 2.0 5.64 5.31 - 6.00 Boule Medonic CA 620 12 4.738 0.075 1.6 4.73 4.45 - 5.03 12 5.738 0.106 1.8 5.79 5.39 - 6.09 Boule Medonic M series 79 4.715 0.075 1.6 4.72 4.43 - 5.00 79 5.762 0.116 2.0 5.77 5.41 - 6.11 COULTER AcT 8/10 13 4.772 0.231 4.8 4.67 4.48 - 5.06 12 5.786 0.168 2.9 5.72 5.43 - 6.14 COULTER AcT diff/diff 2 233 4.723 0.113 2.4 4.72 4.43 - 5.01 230 5.722 0.145 2.5 5.73 5.37 - 6.07 Drew Scientific D3 11 4.665 0.149 3.2 4.66 4.38 - 4.95 11 5.649 0.139 2.5 5.61 5.31 - 5.99

Specimen HD-5 All Method 739 3.158 0.092 2.9 3.16 2.96 - 3.35 All Abbott Cell-Dyn Instruments 270 3.204 0.086 2.7 3.21 3.01 - 3.40 All ABX Instruments 120 3.073 0.073 2.4 3.07 2.88 - 3.26 All COULTER Instruments 245 3.159 0.081 2.6 3.16 2.96 - 3.35 All Danam/Drew Scientific Instruments 11 3.135 0.092 2.9 3.13 2.94 - 3.33 Abbott Cell-Dyn 1700 26 3.204 0.087 2.7 3.22 3.01 - 3.40 Abbott Cell-Dyn 1800 125 3.244 0.074 2.3 3.25 3.04 - 3.44 Abbott Cell-Dyn Emerald 118 3.157 0.086 2.7 3.16 2.96 - 3.35 ABX Diagnostics Micros/45/60 120 3.073 0.073 2.4 3.07 2.88 - 3.26 Boule Medonic CA 620 12 3.158 0.050 1.6 3.17 2.96 - 3.35 Boule Medonic M series 78 3.130 0.059 1.9 3.13 2.94 - 3.32 COULTER AcT 8/10 12 3.162 0.100 3.2 3.19 2.97 - 3.36 COULTER AcT diff/diff 2 230 3.158 0.081 2.6 3.16 2.96 - 3.35 Drew Scientific D3 11 3.135 0.092 2.9 3.13 2.94 - 3.33

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2014 MLE-M1 Participant Summary/ 19

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALHEMOGLOBIN (g/dL)

Specimen HD-1 Specimen HD-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 746 9.53 0.23 2.4 9.5 8.8 - 10.2 745 15.24 0.36 2.4 15.2 14.1 - 16.4 All Abbott Cell-Dyn Instruments 271 9.68 0.21 2.1 9.7 9.0 - 10.4 270 15.55 0.27 1.8 15.6 14.4 - 16.7 All ABX Instruments 118 9.46 0.16 1.7 9.5 8.7 - 10.2 120 14.97 0.23 1.5 15.0 13.9 - 16.1 All COULTER Instruments 248 9.40 0.21 2.3 9.4 8.7 - 10.1 241 15.06 0.27 1.8 15.0 14.0 - 16.2 All Danam/Drew Scientific Instruments 11 9.48 0.26 2.7 9.6 8.8 - 10.2 11 15.18 0.21 1.4 15.3 14.1 - 16.3 Abbott Cell-Dyn 1700 25 9.73 0.23 2.4 9.7 9.0 - 10.5 26 15.49 0.30 2.0 15.5 14.4 - 16.6 Abbott Cell-Dyn 1800 125 9.68 0.18 1.9 9.7 9.0 - 10.4 125 15.57 0.25 1.6 15.6 14.4 - 16.7 Abbott Cell-Dyn Emerald 118 9.68 0.23 2.3 9.7 8.9 - 10.4 119 15.52 0.32 2.1 15.5 14.4 - 16.7 ABX Diagnostics Micros/45/60 118 9.46 0.16 1.7 9.5 8.7 - 10.2 120 14.97 0.23 1.5 15.0 13.9 - 16.1 Boule Medonic CA 620 12 9.53 0.19 2.0 9.5 8.8 - 10.3 12 15.08 0.17 1.2 15.2 14.0 - 16.2 Boule Medonic M series 79 9.53 0.15 1.5 9.5 8.8 - 10.2 78 15.16 0.26 1.7 15.2 14.0 - 16.3 COULTER AcT 8/10 13 9.47 0.21 2.2 9.5 8.8 - 10.2 13 15.18 0.26 1.7 15.2 14.1 - 16.3 COULTER AcT diff/diff 2 232 9.39 0.21 2.2 9.4 8.7 - 10.1 226 15.05 0.27 1.8 15.0 13.9 - 16.2 Drew Scientific D3 11 9.48 0.26 2.7 9.6 8.8 - 10.2 11 15.18 0.21 1.4 15.3 14.1 - 16.3

Specimen HD-3 Specimen HD-4 All Method 744 13.68 0.32 2.4 13.6 12.7 - 14.7 751 17.65 0.47 2.6 17.6 16.4 - 18.9 All Abbott Cell-Dyn Instruments 269 13.95 0.24 1.7 14.0 12.9 - 15.0 272 18.08 0.30 1.7 18.1 16.8 - 19.4 All ABX Instruments 118 13.47 0.22 1.6 13.5 12.5 - 14.5 118 17.25 0.23 1.3 17.3 16.0 - 18.5 All COULTER Instruments 244 13.52 0.25 1.9 13.5 12.5 - 14.5 244 17.41 0.32 1.9 17.4 16.1 - 18.7 All Danam/Drew Scientific Instruments 11 13.58 0.33 2.4 13.6 12.6 - 14.6 11 17.46 0.27 1.5 17.5 16.2 - 18.7 Abbott Cell-Dyn 1700 26 13.90 0.34 2.5 14.0 12.9 - 14.9 25 18.06 0.24 1.3 18.1 16.7 - 19.4 Abbott Cell-Dyn 1800 123 13.98 0.21 1.5 14.0 13.0 - 15.0 125 18.13 0.26 1.5 18.1 16.8 - 19.4 Abbott Cell-Dyn Emerald 119 13.92 0.27 1.9 13.9 12.9 - 14.9 119 18.03 0.34 1.9 18.0 16.7 - 19.3 ABX Diagnostics Micros/45/60 118 13.47 0.22 1.6 13.5 12.5 - 14.5 118 17.25 0.23 1.3 17.3 16.0 - 18.5 Boule Medonic CA 620 12 13.62 0.20 1.5 13.6 12.6 - 14.6 12 17.36 0.28 1.6 17.4 16.1 - 18.6 Boule Medonic M series 78 13.57 0.19 1.4 13.6 12.6 - 14.6 79 17.66 0.35 2.0 17.7 16.4 - 18.9 COULTER AcT 8/10 13 13.74 0.64 4.6 13.7 12.7 - 14.8 12 17.60 0.45 2.6 17.6 16.3 - 18.9 COULTER AcT diff/diff 2 231 13.52 0.25 1.9 13.5 12.5 - 14.5 229 17.40 0.31 1.8 17.4 16.1 - 18.7 Drew Scientific D3 11 13.58 0.33 2.4 13.6 12.6 - 14.6 11 17.46 0.27 1.5 17.5 16.2 - 18.7

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20 / 2014 MLE-M1 Participant Summary

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALHEMOGLOBIN (g/dL) cont’d

Specimen HD-5 Instrument Labs Mean SD CV Median Range All Method 746 9.02 0.24 2.6 9.0 8.3 - 9.7 All Abbott Cell-Dyn Instruments 271 9.22 0.19 2.1 9.2 8.5 - 9.9 All ABX Instruments 119 8.87 0.14 1.6 8.9 8.2 - 9.5 All COULTER Instruments 244 8.90 0.18 2.0 8.9 8.2 - 9.6 All Danam/Drew Scientific Instruments 11 8.91 0.20 2.3 8.9 8.2 - 9.6 Abbott Cell-Dyn 1700 26 9.28 0.21 2.3 9.3 8.6 - 10.0 Abbott Cell-Dyn 1800 127 9.24 0.19 2.1 9.2 8.5 - 9.9 Abbott Cell-Dyn Emerald 116 9.16 0.19 2.1 9.1 8.5 - 9.9 ABX Diagnostics Micros/45/60 119 8.87 0.14 1.6 8.9 8.2 - 9.5 Boule Medonic CA 620 12 9.02 0.14 1.6 9.1 8.3 - 9.7 Boule Medonic M series 77 9.04 0.16 1.8 9.0 8.4 - 9.7 COULTER AcT 8/10 12 8.98 0.19 2.1 9.0 8.3 - 9.7 COULTER AcT diff/diff 2 230 8.89 0.18 2.0 8.9 8.2 - 9.6 Drew Scientific D3 11 8.91 0.20 2.3 8.9 8.2 - 9.6

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALHEMATOCRIT (percent)

Specimen HD-1 Specimen HD-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 726 34.08 2.93 8.6 34.7 32.0 - 36.2 748 54.58 2.73 5.0 54.4 51.3 - 57.9 All Abbott Cell-Dyn Instruments 262 36.70 1.52 4.1 36.8 34.4 - 39.0 271 57.13 1.76 3.1 57.1 53.7 - 60.6 All ABX Instruments 117 30.98 0.85 2.7 31.0 29.1 - 32.9 118 51.37 1.13 2.2 51.4 48.2 - 54.5 All COULTER Instruments 239 34.57 1.05 3.0 34.6 32.4 - 36.7 243 54.27 1.50 2.8 54.2 51.0 - 57.6 All Danam/Drew Scientific Instruments 11 34.65 2.97 8.6 35.5 32.5 - 36.8 11 55.13 1.15 2.1 55.8 51.8 - 58.5 Abbott Cell-Dyn 1700 22 35.70 1.14 3.2 35.5 33.5 - 37.9 25 57.35 1.79 3.1 57.2 53.9 - 60.8 Abbott Cell-Dyn 1800 125 37.58 1.10 2.9 37.6 35.3 - 39.9 127 57.46 1.69 2.9 57.7 54.0 - 61.0 Abbott Cell-Dyn Emerald 111 35.86 1.44 4.0 36.0 33.7 - 38.1 116 56.67 1.83 3.2 56.7 53.2 - 60.1 ABX Diagnostics Micros/45/60 117 30.98 0.85 2.7 31.0 29.1 - 32.9 118 51.37 1.13 2.2 51.4 48.2 - 54.5 Boule Medonic CA 620 11 29.44 0.95 3.2 29.6 27.6 - 31.3 12 51.38 1.05 2.0 51.6 48.3 - 54.5 Boule Medonic M series 76 29.49 0.73 2.5 29.5 27.7 - 31.3 80 52.49 1.51 2.9 52.8 49.3 - 55.7 COULTER AcT 8/10 13 33.75 1.02 3.0 33.9 31.7 - 35.8 13 54.23 1.45 2.7 54.2 50.9 - 57.5 COULTER AcT diff/diff 2 223 34.64 1.03 3.0 34.7 32.5 - 36.8 228 54.32 1.52 2.8 54.3 51.0 - 57.6 Drew Scientific D3 11 34.65 2.97 8.6 35.5 32.5 - 36.8 11 55.13 1.15 2.1 55.8 51.8 - 58.5

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2014 MLE-M1 Participant Summary/ 21

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALHEMATOCRIT (percent) cont’d

Specimen HD-3 Specimen HD-4 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 746 51.56 3.04 5.9 51.8 48.4 - 54.7 745 57.73 2.41 4.2 57.6 54.2 - 61.2 All Abbott Cell-Dyn Instruments 272 54.44 1.73 3.2 54.6 51.1 - 57.8 272 60.02 1.63 2.7 59.9 56.4 - 63.7 All ABX Instruments 118 47.76 1.01 2.1 47.7 44.8 - 50.7 119 55.45 1.23 2.2 55.4 52.1 - 58.8 All COULTER Instruments 247 51.54 1.45 2.8 51.6 48.4 - 54.7 243 56.96 1.53 2.7 57.0 53.5 - 60.4 All Danam/Drew Scientific Instruments 11 52.66 1.35 2.6 53.0 49.5 - 55.9 11 57.83 1.04 1.8 57.7 54.3 - 61.3 Abbott Cell-Dyn 1700 25 54.53 1.81 3.3 54.4 51.2 - 57.9 24 60.30 1.78 2.9 60.2 56.6 - 64.0 Abbott Cell-Dyn 1800 126 54.98 1.49 2.7 55.1 51.6 - 58.3 125 59.69 1.40 2.3 59.7 56.1 - 63.3 Abbott Cell-Dyn Emerald 117 53.85 1.80 3.3 53.7 50.6 - 57.1 119 60.33 1.75 2.9 60.4 56.7 - 64.0 ABX Diagnostics Micros/45/60 118 47.76 1.01 2.1 47.7 44.8 - 50.7 119 55.45 1.23 2.2 55.4 52.1 - 58.8 Boule Medonic CA 620 12 47.54 1.09 2.3 47.4 44.6 - 50.4 12 54.64 1.36 2.5 54.4 51.3 - 58.0 Boule Medonic M series 79 48.08 1.27 2.6 48.1 45.1 - 51.0 79 56.51 1.72 3.0 56.5 53.1 - 59.9 COULTER AcT 8/10 13 51.23 2.13 4.2 50.8 48.1 - 54.4 12 57.28 1.42 2.5 57.3 53.8 - 60.8 COULTER AcT diff/diff 2 231 51.64 1.36 2.6 51.7 48.5 - 54.8 228 56.95 1.54 2.7 57.0 53.5 - 60.4 Drew Scientific D3 11 52.66 1.35 2.6 53.0 49.5 - 55.9 11 57.83 1.04 1.8 57.7 54.3 - 61.3

Specimen HD-5 All Method 740 35.26 2.97 8.4 36.0 33.1 - 37.4 All Abbott Cell-Dyn Instruments 268 37.93 1.30 3.4 38.0 35.6 - 40.3 All ABX Instruments 117 31.74 0.77 2.4 31.8 29.8 - 33.7 All COULTER Instruments 240 35.81 1.06 3.0 35.9 33.6 - 38.0 All Danam/Drew Scientific Instruments 11 36.91 1.04 2.8 36.6 34.6 - 39.2 Abbott Cell-Dyn 1700 24 36.95 1.21 3.3 37.1 34.7 - 39.2 Abbott Cell-Dyn 1800 126 38.49 1.04 2.7 38.5 36.1 - 40.8 Abbott Cell-Dyn Emerald 115 37.51 1.35 3.6 37.6 35.2 - 39.8 ABX Diagnostics Micros/45/60 117 31.74 0.77 2.4 31.8 29.8 - 33.7 Boule Medonic CA 620 12 30.48 0.48 1.6 30.7 28.6 - 32.4 Boule Medonic M series 76 31.02 0.79 2.6 31.1 29.1 - 32.9 COULTER AcT 8/10 12 35.09 1.15 3.3 35.1 32.9 - 37.2 COULTER AcT diff/diff 2 225 35.88 1.01 2.8 35.9 33.7 - 38.1 Drew Scientific D3 11 36.91 1.04 2.8 36.6 34.6 - 39.2

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22 / 2014 MLE-M1 Participant Summary

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALPLATELET COUNT (x 109/L)

Specimen HD-1 Specimen HD-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 740 130.0 18.9 14.6 129 97 - 163 744 270.3 37.4 13.8 276 202 - 338 All Abbott Cell-Dyn Instruments 271 139.9 16.3 11.6 138 104 - 175 268 300.0 19.7 6.6 298 225 - 376 All ABX Instruments 119 142.9 11.1 7.8 142 107 - 179 118 285.9 16.1 5.6 283 214 - 358 All COULTER Instruments 240 116.2 13.6 11.7 115 87 - 146 235 226.7 15.9 7.0 226 170 - 284 All Danam/Drew Scientific Instruments 11 146.6 16.9 11.5 146 109 - 184 10 289.7 10.8 3.7 288 217 - 363 Abbott Cell-Dyn 1700 26 128.6 14.2 11.0 131 96 - 161 24 290.0 23.0 7.9 287 217 - 363 Abbott Cell-Dyn 1800 126 130.6 10.2 7.8 129 97 - 164 127 308.6 19.1 6.2 305 231 - 386 Abbott Cell-Dyn Emerald 116 152.9 13.2 8.6 151 114 - 192 115 293.2 16.9 5.8 292 219 - 367 ABX Diagnostics Micros/45/60 119 142.9 11.1 7.8 142 107 - 179 118 285.9 16.1 5.6 283 214 - 358 Boule Medonic CA 620 12 117.5 14.7 12.5 113 88 - 147 12 262.9 15.2 5.8 260 197 - 329 Boule Medonic M series 77 114.5 7.8 6.8 114 85 - 144 79 260.0 16.6 6.4 259 194 - 325 COULTER AcT 8/10 13 106.3 9.4 8.8 106 79 - 133 12 214.6 7.7 3.6 215 160 - 269 COULTER AcT diff/diff 2 225 116.8 13.9 11.9 116 87 - 147 220 227.1 16.0 7.0 226 170 - 284 Drew Scientific D3 11 146.6 16.9 11.5 146 109 - 184 10 289.7 10.8 3.7 288 217 - 363

Specimen HD-3 Specimen HD-4 All Method 749 134.0 18.0 13.4 136 100 - 168 748 518.0 73.3 14.2 534 388 - 648 All Abbott Cell-Dyn Instruments 271 146.5 11.2 7.6 147 109 - 184 272 580.7 33.1 5.7 581 435 - 726 All ABX Instruments 120 143.3 10.9 7.6 142 107 - 180 117 546.6 24.6 4.5 546 409 - 684 All COULTER Instruments 244 115.9 10.0 8.7 115 86 - 145 242 427.7 30.3 7.1 424 320 - 535 All Danam/Drew Scientific Instruments 11 149.9 10.1 6.7 149 112 - 188 11 563.5 29.1 5.2 561 422 - 705 Abbott Cell-Dyn 1700 26 137.0 13.9 10.1 139 102 - 172 25 575.4 42.1 7.3 574 431 - 720 Abbott Cell-Dyn 1800 124 143.6 8.3 5.8 143 107 - 180 125 599.9 25.4 4.2 600 449 - 750 Abbott Cell-Dyn Emerald 117 151.4 10.7 7.1 151 113 - 190 117 559.2 24.3 4.3 558 419 - 700 ABX Diagnostics Micros/45/60 120 143.3 10.9 7.6 142 107 - 180 117 546.6 24.6 4.5 546 409 - 684 Boule Medonic CA 620 12 130.8 12.5 9.5 133 98 - 164 12 518.6 22.1 4.3 517 388 - 649 Boule Medonic M series 79 126.5 11.2 8.9 125 94 - 159 79 519.2 24.8 4.8 521 389 - 649 COULTER AcT 8/10 13 111.1 12.2 11.0 108 83 - 139 12 408.4 15.4 3.8 410 306 - 511 COULTER AcT diff/diff 2 227 116.0 9.7 8.4 115 86 - 145 228 428.7 31.0 7.2 425 321 - 536 Drew Scientific D3 11 149.9 10.1 6.7 149 112 - 188 11 563.5 29.1 5.2 561 422 - 705

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2014 MLE-M1 Participant Summary/ 23

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALPLATELET COUNT (x 109/L) cont’d

Specimen HD-5 Instrument Labs Mean SD CV Median Range All Method 746 454.1 83.2 18.3 482 340 - 568 All Abbott Cell-Dyn Instruments 267 517.2 35.0 6.8 517 387 - 647 All ABX Instruments 120 528.7 23.4 4.4 529 396 - 661 All COULTER Instruments 233 353.6 27.4 7.8 353 265 - 442 All Danam/Drew Scientific Instruments 11 542.2 28.4 5.2 538 406 - 678 Abbott Cell-Dyn 1700 24 453.3 42.5 9.4 455 339 - 567 Abbott Cell-Dyn 1800 125 500.6 21.0 4.2 500 375 - 626 Abbott Cell-Dyn Emerald 118 541.3 27.5 5.1 543 405 - 677 ABX Diagnostics Micros/45/60 120 528.7 23.4 4.4 529 396 - 661 Boule Medonic CA 620 12 406.2 37.1 9.1 407 304 - 508 Boule Medonic M series 79 410.8 30.6 7.4 410 308 - 514 COULTER AcT 8/10 12 341.0 24.4 7.2 338 255 - 427 COULTER AcT diff/diff 2 220 354.6 28.8 8.1 353 265 - 444 Drew Scientific D3 11 542.2 28.4 5.2 538 406 - 678

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALLYMPHOCYTES (percent)

Specimen HD-1 Specimen HD-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 709 48.05 3.11 6.5 48.4 38.7 - 57.4 708 34.74 2.69 7.7 35.2 26.6 - 42.8 All Abbott Cell-Dyn Instruments 256 46.72 2.95 6.3 47.3 37.8 - 55.6 255 33.83 2.76 8.2 34.4 25.5 - 42.2 All ABX Instruments 115 48.14 1.66 3.5 47.8 43.1 - 53.2 113 34.23 1.38 4.0 33.9 30.1 - 38.4 All COULTER Instruments 227 50.68 1.73 3.4 50.7 45.5 - 55.9 226 37.02 1.42 3.8 37.0 32.7 - 41.3 All Danam/Drew Scientific Instruments 11 49.18 1.92 3.9 48.3 43.4 - 55.0 11 35.60 1.70 4.8 35.2 30.4 - 40.8 Abbott Cell-Dyn 1700 23 50.56 1.77 3.5 50.3 45.2 - 55.9 22 37.03 1.35 3.7 37.0 32.9 - 41.1 Abbott Cell-Dyn 1800 119 48.48 1.61 3.3 48.4 43.6 - 53.4 117 35.52 1.17 3.3 35.5 32.0 - 39.1 Abbott Cell-Dyn Emerald 110 43.98 1.63 3.7 43.9 39.0 - 48.9 106 30.96 1.00 3.2 30.8 27.9 - 34.0 ABX Diagnostics Micros/45/60 115 48.14 1.66 3.5 47.8 43.1 - 53.2 113 34.23 1.38 4.0 33.9 30.1 - 38.4 Boule Medonic CA 620 12 48.87 1.97 4.0 48.8 42.9 - 54.8 12 34.98 1.32 3.8 35.4 31.0 - 39.0 Boule Medonic M series 77 44.64 1.96 4.4 44.4 38.7 - 50.6 78 31.80 1.17 3.7 31.7 28.2 - 35.4 COULTER AcT diff/diff 2 221 50.76 1.63 3.2 50.8 45.8 - 55.7 220 37.03 1.33 3.6 37.0 33.0 - 41.1 Drew Scientific D3 11 49.18 1.92 3.9 48.3 43.4 - 55.0 11 35.60 1.70 4.8 35.2 30.4 - 40.8

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24 / 2014 MLE-M1 Participant Summary

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALLYMPHOCYTES (percent) cont’d

Specimen HD-3 Specimen HD-4 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 706 37.77 2.97 7.9 38.1 28.8 - 46.7 705 47.15 2.46 5.2 47.4 39.7 - 54.6 All Abbott Cell-Dyn Instruments 255 36.44 3.25 8.9 37.2 26.6 - 46.2 255 45.86 2.44 5.3 46.3 38.5 - 53.2 All ABX Instruments 114 37.37 1.89 5.1 37.1 31.7 - 43.1 117 46.86 1.44 3.1 46.6 42.5 - 51.2 All COULTER Instruments 229 39.99 1.89 4.7 39.9 34.3 - 45.7 223 49.45 1.13 2.3 49.4 46.0 - 52.9 All Danam/Drew Scientific Instruments 11 38.94 1.94 5.0 38.9 33.1 - 44.8 11 48.10 1.67 3.5 47.6 43.0 - 53.2 Abbott Cell-Dyn 1700 23 40.95 2.28 5.6 40.2 34.1 - 47.8 22 49.21 1.47 3.0 49.5 44.8 - 53.7 Abbott Cell-Dyn 1800 119 38.50 1.46 3.8 38.4 34.1 - 42.9 119 47.43 1.11 2.3 47.5 44.0 - 50.8 Abbott Cell-Dyn Emerald 109 33.23 1.44 4.3 33.1 28.8 - 37.6 110 43.38 0.70 1.6 43.3 41.2 - 45.5 ABX Diagnostics Micros/45/60 114 37.37 1.89 5.1 37.1 31.7 - 43.1 117 46.86 1.44 3.1 46.6 42.5 - 51.2 Boule Medonic CA 620 12 38.91 0.98 2.5 39.1 35.9 - 41.9 11 48.30 0.75 1.5 48.2 46.0 - 50.6 Boule Medonic M series 78 35.95 1.68 4.7 36.1 30.9 - 41.0 78 45.41 1.24 2.7 45.2 41.6 - 49.2 COULTER AcT diff/diff 2 220 40.08 1.70 4.2 40.0 34.9 - 45.2 219 49.46 1.08 2.2 49.4 46.2 - 52.8 Drew Scientific D3 11 38.94 1.94 5.0 38.9 33.1 - 44.8 11 48.10 1.67 3.5 47.6 43.0 - 53.2

Specimen HD-5 All Method 704 32.31 2.82 8.7 32.8 23.8 - 40.8 All Abbott Cell-Dyn Instruments 253 31.06 2.85 9.2 31.4 22.5 - 39.7 All ABX Instruments 116 32.96 1.76 5.3 32.8 27.6 - 38.3 All COULTER Instruments 224 34.44 1.36 3.9 34.6 30.3 - 38.6 All Danam/Drew Scientific Instruments 11 33.96 1.21 3.6 34.1 30.3 - 37.6 Abbott Cell-Dyn 1700 22 34.77 1.30 3.7 34.8 30.8 - 38.7 Abbott Cell-Dyn 1800 115 32.54 1.27 3.9 32.5 28.7 - 36.4 Abbott Cell-Dyn Emerald 107 28.28 1.23 4.4 27.8 24.5 - 32.0 ABX Diagnostics Micros/45/60 116 32.96 1.76 5.3 32.8 27.6 - 38.3 Boule Medonic CA 620 12 32.90 1.06 3.2 32.6 29.7 - 36.1 Boule Medonic M series 77 28.95 1.31 4.5 29.0 25.0 - 32.9 COULTER AcT diff/diff 2 220 34.45 1.33 3.9 34.6 30.4 - 38.5 Drew Scientific D3 11 33.96 1.21 3.6 34.1 30.3 - 37.6

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2014 MLE-M1 Participant Summary/ 25

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALMONO/MID/MIXED/MCR (percent)

Specimen HD-1 Specimen HD-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 692 7.50 2.10 28.0 7.4 1.2 - 13.8 693 6.90 2.49 36.1 6.8 0.0 - 14.4 All Abbott Cell-Dyn Instruments 253 8.82 2.13 24.2 8.9 2.4 - 15.3 253 8.60 2.21 25.7 8.5 1.9 - 15.3 All ABX Instruments 112 8.20 1.08 13.2 8.4 4.9 - 11.5 110 8.29 0.94 11.3 8.5 5.4 - 11.1 All COULTER Instruments 225 5.69 1.24 21.8 5.7 1.9 - 9.5 227 4.40 1.50 34.2 4.4 0.0 - 9.0 All Danam/Drew Scientific Instruments 11 6.46 1.04 16.0 6.3 3.3 - 9.6 11 6.25 1.55 24.7 6.4 1.6 - 10.9 Abbott Cell-Dyn 1700 24 5.66 1.01 17.8 5.5 2.6 - 8.7 24 5.55 0.73 13.2 5.6 3.3 - 7.8 Abbott Cell-Dyn 1800 115 7.56 1.12 14.8 7.7 4.2 - 11.0 117 7.18 1.08 15.0 7.0 3.9 - 10.5 Abbott Cell-Dyn Emerald 109 10.87 0.61 5.6 11.0 9.0 - 12.7 109 10.87 0.52 4.8 10.9 9.2 - 12.5 ABX Diagnostics Micros/45/60 112 8.20 1.08 13.2 8.4 4.9 - 11.5 110 8.29 0.94 11.3 8.5 5.4 - 11.1 Boule Medonic CA 620 12 6.75 1.18 17.5 6.8 3.2 - 10.3 12 7.79 0.82 10.5 7.6 5.3 - 10.3 Boule Medonic M series 78 7.69 1.31 17.0 7.8 3.7 - 11.7 77 6.77 0.76 11.2 6.7 4.4 - 9.1 COULTER AcT diff/diff 2 222 5.69 1.25 21.9 5.7 1.9 - 9.5 224 4.40 1.51 34.4 4.4 0.0 - 9.0 Drew Scientific D3 11 6.46 1.04 16.0 6.3 3.3 - 9.6 11 6.25 1.55 24.7 6.4 1.6 - 10.9

Specimen HD-3 Specimen HD-4 All Method 687 8.42 2.50 29.8 8.0 0.9 - 16.0 693 6.83 1.62 23.7 6.6 1.9 - 11.7 All Abbott Cell-Dyn Instruments 251 10.08 2.56 25.4 10.0 2.3 - 17.8 253 7.70 1.90 24.7 7.5 1.9 - 13.5 All ABX Instruments 107 9.70 0.92 9.5 9.8 6.9 - 12.5 110 7.42 0.84 11.3 7.6 4.8 - 10.0 All COULTER Instruments 225 6.31 1.50 23.7 6.3 1.8 - 10.9 226 5.75 1.05 18.3 5.7 2.5 - 9.0 All Danam/Drew Scientific Instruments 11 7.33 1.77 24.2 7.5 2.0 - 12.7 11 5.59 1.48 26.4 6.1 1.1 - 10.1 Abbott Cell-Dyn 1700 23 6.26 1.10 17.6 6.3 2.9 - 9.6 24 4.99 0.95 19.0 5.0 2.1 - 7.9 Abbott Cell-Dyn 1800 115 8.53 1.15 13.5 8.4 5.0 - 12.0 117 6.49 0.89 13.7 6.4 3.8 - 9.2 Abbott Cell-Dyn Emerald 107 12.68 0.62 4.9 12.7 10.8 - 14.6 110 9.64 0.32 3.3 9.7 8.6 - 10.6 ABX Diagnostics Micros/45/60 107 9.70 0.92 9.5 9.8 6.9 - 12.5 110 7.42 0.84 11.3 7.6 4.8 - 10.0 Boule Medonic CA 620 12 8.21 1.51 18.4 8.1 3.6 - 12.8 12 7.20 0.60 8.3 7.1 5.4 - 9.0 Boule Medonic M series 78 7.62 1.04 13.6 7.7 4.5 - 10.8 78 6.49 0.58 9.0 6.4 4.7 - 8.3 COULTER AcT diff/diff 2 222 6.31 1.50 23.8 6.3 1.8 - 10.9 223 5.76 1.06 18.3 5.7 2.5 - 9.0 Drew Scientific D3 11 7.33 1.77 24.2 7.5 2.0 - 12.7 11 5.59 1.48 26.4 6.1 1.1 - 10.1

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26 / 2014 MLE-M1 Participant Summary

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALMONO/MID/MIXED/MCR (percent) cont’d

Specimen HD-5 Instrument Labs Mean SD CV Median Range All Method 687 6.63 2.60 39.2 6.5 0.0 - 14.5 All Abbott Cell-Dyn Instruments 252 8.58 2.29 26.7 8.3 1.6 - 15.5 All ABX Instruments 110 7.82 0.91 11.6 8.1 5.0 - 10.6 All COULTER Instruments 223 3.93 1.36 34.5 3.8 0.0 - 8.1 All Danam/Drew Scientific Instruments 11 5.89 0.85 14.4 5.8 3.3 - 8.5 Abbott Cell-Dyn 1700 24 5.30 0.78 14.7 5.2 2.9 - 7.7 Abbott Cell-Dyn 1800 116 7.15 0.98 13.7 7.2 4.2 - 10.1 Abbott Cell-Dyn Emerald 109 10.95 0.50 4.5 11.0 9.4 - 12.5 ABX Diagnostics Micros/45/60 110 7.82 0.91 11.6 8.1 5.0 - 10.6 Boule Medonic CA 620 12 7.13 0.87 12.2 7.2 4.5 - 9.8 Boule Medonic M series 76 6.41 0.73 11.3 6.4 4.2 - 8.6 COULTER AcT diff/diff 2 220 3.94 1.36 34.6 3.8 0.0 - 8.1 Drew Scientific D3 11 5.89 0.85 14.4 5.8 3.3 - 8.5

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALGRANULOCYTES/NEUT (percent)

Specimen HD-1 Specimen HD-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 678 44.28 1.68 3.8 44.1 39.2 - 49.4 686 58.24 1.49 2.6 58.1 53.7 - 62.8 All Abbott Cell-Dyn Instruments 254 44.51 1.59 3.6 44.6 39.7 - 49.3 251 57.60 1.09 1.9 57.6 54.3 - 60.9 All ABX Instruments 114 43.77 1.10 2.5 43.7 40.4 - 47.1 116 57.44 0.92 1.6 57.6 54.6 - 60.2 All COULTER Instruments 224 43.56 1.07 2.4 43.7 40.3 - 46.8 225 58.54 0.93 1.6 58.5 55.7 - 61.4 All Danam/Drew Scientific Instruments 11 44.33 1.48 3.3 44.9 39.8 - 48.8 11 58.16 0.65 1.1 58.2 56.2 - 60.2 Abbott Cell-Dyn 1700 23 43.86 1.66 3.8 44.0 38.8 - 48.9 22 57.25 1.19 2.1 57.0 53.6 - 60.9 Abbott Cell-Dyn 1800 118 44.03 1.29 2.9 44.1 40.1 - 48.0 116 57.29 0.85 1.5 57.3 54.7 - 59.9 Abbott Cell-Dyn Emerald 111 45.11 1.64 3.6 45.4 40.1 - 50.1 109 58.07 1.08 1.9 58.3 54.8 - 61.4 ABX Diagnostics Micros/45/60 114 43.77 1.10 2.5 43.7 40.4 - 47.1 116 57.44 0.92 1.6 57.6 54.6 - 60.2 Boule Medonic CA 620 12 44.38 2.33 5.2 44.3 37.4 - 51.4 12 57.23 1.24 2.2 57.1 53.5 - 61.0 Boule Medonic M series 77 47.75 2.32 4.9 47.7 40.7 - 54.8 75 61.51 1.21 2.0 61.6 57.8 - 65.2 COULTER AcT diff/diff 2 221 43.55 1.07 2.5 43.7 40.3 - 46.8 222 58.55 0.92 1.6 58.5 55.7 - 61.4 Drew Scientific D3 11 44.33 1.48 3.3 44.9 39.8 - 48.8 11 58.16 0.65 1.1 58.2 56.2 - 60.2

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2014 MLE-M1 Participant Summary/ 27

BASIC HEMATOLOGY W/ 3-PART DIFFERENTIALGRANULOCYTES/NEUT (percent) cont’d

Specimen HD-3 Specimen HD-4 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 685 53.72 1.56 2.9 53.7 49.0 - 58.5 691 45.93 1.33 2.9 45.8 41.9 - 50.0 All Abbott Cell-Dyn Instruments 251 53.51 1.44 2.7 53.5 49.1 - 57.9 251 46.48 0.84 1.8 46.5 43.9 - 49.0 All ABX Instruments 114 53.06 1.23 2.3 53.3 49.3 - 56.8 115 45.85 0.73 1.6 46.0 43.6 - 48.1 All COULTER Instruments 226 53.62 1.06 2.0 53.6 50.4 - 56.9 224 44.77 0.64 1.4 44.8 42.8 - 46.7 All Danam/Drew Scientific Instruments 11 53.74 0.70 1.3 53.7 51.6 - 55.9 11 46.33 0.57 1.2 46.2 44.6 - 48.1 Abbott Cell-Dyn 1700 22 53.15 1.64 3.1 53.4 48.2 - 58.1 22 45.87 1.27 2.8 45.8 42.0 - 49.7 Abbott Cell-Dyn 1800 118 53.07 1.21 2.3 53.0 49.4 - 56.8 117 46.11 0.67 1.5 46.2 44.0 - 48.2 Abbott Cell-Dyn Emerald 108 54.11 1.40 2.6 54.1 49.9 - 58.4 110 46.97 0.69 1.5 47.0 44.9 - 49.1 ABX Diagnostics Micros/45/60 114 53.06 1.23 2.3 53.3 49.3 - 56.8 115 45.85 0.73 1.6 46.0 43.6 - 48.1 Boule Medonic CA 620 12 52.88 1.84 3.5 53.0 47.3 - 58.5 11 44.62 0.73 1.6 44.9 42.4 - 46.8 Boule Medonic M series 78 56.50 1.95 3.5 56.6 50.6 - 62.4 78 48.10 1.46 3.0 48.3 43.7 - 52.5 COULTER AcT diff/diff 2 223 53.63 1.06 2.0 53.6 50.4 - 56.9 221 44.78 0.64 1.4 44.8 42.8 - 46.7 Drew Scientific D3 11 53.74 0.70 1.3 53.7 51.6 - 55.9 11 46.33 0.57 1.2 46.2 44.6 - 48.1

Specimen HD-5 All Method 680 60.97 1.76 2.9 61.0 55.6 - 66.3 All Abbott Cell-Dyn Instruments 246 60.47 1.12 1.9 60.6 57.1 - 63.9 All ABX Instruments 116 59.30 1.25 2.1 59.3 55.5 - 63.1 All COULTER Instruments 220 61.57 0.80 1.3 61.6 59.1 - 64.0 All Danam/Drew Scientific Instruments 11 60.18 0.97 1.6 60.1 57.2 - 63.1 Abbott Cell-Dyn 1700 22 59.97 1.27 2.1 60.0 56.1 - 63.8 Abbott Cell-Dyn 1800 114 60.32 1.01 1.7 60.4 57.3 - 63.4 Abbott Cell-Dyn Emerald 107 60.76 1.09 1.8 61.1 57.4 - 64.1 ABX Diagnostics Micros/45/60 116 59.30 1.25 2.1 59.3 55.5 - 63.1 Boule Medonic CA 620 12 59.98 0.90 1.5 60.2 57.2 - 62.7 Boule Medonic M series 75 64.62 1.70 2.6 64.5 59.5 - 69.8 COULTER AcT diff/diff 2 217 61.57 0.80 1.3 61.6 59.1 - 64.0 Drew Scientific D3 11 60.18 0.97 1.6 60.1 57.2 - 63.1

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28 / 2014 MLE-M1 Participant Summary

HEMATOLOGY W/ 5-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x 109/L)

Specimen DIF-1 Specimen DIF-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 19 10.02 0.31 3.1 10.0 8.5 - 11.6 19 22.32 0.57 2.5 22.3 18.9 - 25.7 All COULTER Instruments 18 10.06 0.28 2.8 10.1 8.5 - 11.6 18 22.41 0.44 2.0 22.4 19.0 - 25.8

Specimen DIF-3 Specimen DIF-4 All Method 18 4.22 0.13 3.2 4.2 3.5 - 4.9 19 9.93 0.27 2.8 10.0 8.4 - 11.5 All COULTER Instruments 18 4.22 0.13 3.2 4.2 3.5 - 4.9 18 9.97 0.22 2.2 10.0 8.4 - 11.5

Specimen DIF-5 All Method 19 22.25 0.59 2.7 22.3 18.9 - 25.6 All COULTER Instruments 18 22.30 0.57 2.6 22.4 18.9 - 25.7

HEMATOLOGY W/ 5-PART DIFFERENTIALRED BLOOD CELL COUNT (x 1012

/L)

Specimen DIF-1 Specimen DIF-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 19 4.042 0.088 2.2 4.02 3.79 - 4.29 19 5.445 0.107 2.0 5.47 5.11 - 5.78 All COULTER Instruments 18 4.046 0.088 2.2 4.04 3.80 - 4.29 18 5.446 0.110 2.0 5.48 5.11 - 5.78

Specimen DIF-3 Specimen DIF-4 All Method 19 2.624 0.052 2.0 2.63 2.46 - 2.79 19 4.036 0.073 1.8 4.02 3.79 - 4.28 All COULTER Instruments 18 2.619 0.049 1.9 2.62 2.46 - 2.78 18 4.041 0.072 1.8 4.03 3.79 - 4.29

Specimen DIF-5 All Method 19 5.454 0.098 1.8 5.45 5.12 - 5.79 All COULTER Instruments 18 5.456 0.101 1.8 5.46 5.12 - 5.79

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2014 MLE-M1 Participant Summary/ 29

HEMATOLOGY W/ 5-PART DIFFERENTIALHEMOGLOBIN (g/dL)

Specimen DIF-1 Specimen DIF-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 19 11.64 0.12 1.0 11.6 10.8 - 12.5 19 17.35 0.23 1.3 17.3 16.1 - 18.6 All COULTER Instruments 18 11.64 0.12 1.1 11.6 10.8 - 12.5 18 17.36 0.23 1.3 17.4 16.1 - 18.6

Specimen DIF-3 Specimen DIF-4 All Method 19 6.62 0.10 1.4 6.6 6.1 - 7.1 19 11.55 0.14 1.2 11.6 10.7 - 12.4 All COULTER Instruments 18 6.61 0.10 1.5 6.6 6.1 - 7.1 18 11.55 0.14 1.2 11.6 10.7 - 12.4

Specimen DIF-5 All Method 19 17.38 0.23 1.3 17.4 16.1 - 18.7 All COULTER Instruments 18 17.41 0.22 1.3 17.4 16.1 - 18.7

HEMATOLOGY W/ 5-PART DIFFERENTIALHEMATOCRIT (percent)

Specimen DIF-1 Specimen DIF-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 19 36.49 1.22 3.3 36.7 34.3 - 38.7 19 54.61 1.69 3.1 54.9 51.3 - 57.9 All COULTER Instruments 18 36.69 0.90 2.5 36.8 34.4 - 38.9 18 54.86 1.30 2.4 55.1 51.5 - 58.2

Specimen DIF-3 Specimen DIF-4 All Method 19 20.43 0.53 2.6 20.4 19.2 - 21.7 18 36.63 0.72 2.0 36.6 34.4 - 38.9 All COULTER Instruments 18 20.49 0.47 2.3 20.5 19.2 - 21.8 18 36.63 0.72 2.0 36.6 34.4 - 38.9

Specimen DIF-5 All Method 18 55.06 1.00 1.8 55.4 51.7 - 58.4 All COULTER Instruments 18 55.06 1.00 1.8 55.4 51.7 - 58.4

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30 / 2014 MLE-M1 Participant Summary

HEMATOLOGY W/ 5-PART DIFFERENTIALPLATELET COUNT (x 109/L)

Specimen DIF-1 Specimen DIF-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 18 234.5 11.6 5.0 234 175 - 294 18 471.1 19.3 4.1 465 353 - 589 All COULTER Instruments 18 234.5 11.6 5.0 234 175 - 294 18 471.1 19.3 4.1 465 353 - 589

Specimen DIF-3 Specimen DIF-4 All Method 18 75.7 4.3 5.6 77 56 - 95 18 233.5 12.3 5.3 235 175 - 292 All COULTER Instruments 18 75.7 4.3 5.6 77 56 - 95 18 233.5 12.3 5.3 235 175 - 292

Specimen DIF-5 All Method 18 469.4 20.0 4.3 466 352 - 587 All COULTER Instruments 18 469.4 20.0 4.3 466 352 - 587

HEMATOLOGY W/ 5-PART DIFFERENTIALNEUTROPHILS (percent)

Specimen DIF-1 Specimen DIF-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 18 59.69 3.28 5.5 59.5 49.8 - 69.6 18 63.29 2.63 4.2 62.9 55.3 - 71.2 All COULTER Instruments 18 59.69 3.28 5.5 59.5 49.8 - 69.6 18 63.29 2.63 4.2 62.9 55.3 - 71.2

Specimen DIF-3 Specimen DIF-4 All Method 17 50.79 0.78 1.5 50.7 48.4 - 53.2 18 58.69 2.18 3.7 58.3 52.1 - 65.3 All COULTER Instruments 17 50.79 0.78 1.5 50.7 48.4 - 53.2 18 58.69 2.18 3.7 58.3 52.1 - 65.3

Specimen DIF-5 All Method 18 63.57 1.73 2.7 63.9 58.3 - 68.8 All COULTER Instruments 18 63.57 1.73 2.7 63.9 58.3 - 68.8

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2014 MLE-M1 Participant Summary/ 31

HEMATOLOGY W/ 5-PART DIFFERENTIAL LYMPHOCYTES (percent)

Specimen DIF-1 Specimen DIF-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 17 29.40 0.99 3.4 29.4 26.4 - 32.4 18 21.52 0.95 4.4 21.5 18.6 - 24.4 All COULTER Instruments 17 29.40 0.99 3.4 29.4 26.4 - 32.4 18 21.52 0.95 4.4 21.5 18.6 - 24.4

Specimen DIF-3 Specimen DIF-4 All Method 17 40.65 0.99 2.4 40.8 37.6 - 43.7 18 29.23 1.08 3.7 29.3 26.0 - 32.5 All COULTER Instruments 17 40.65 0.99 2.4 40.8 37.6 - 43.7 18 29.23 1.08 3.7 29.3 26.0 - 32.5

Specimen DIF-5 All Method 19 21.10 2.16 10.2 21.2 14.6 - 27.6 All COULTER Instruments 18 21.34 1.95 9.1 21.3 15.5 - 27.2

HEMATOLOGY W/ 5-PART DIFFERENTIAL MONOCYTES (percent)

Specimen DIF-1 Specimen DIF-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 18 4.28 2.12 49.6 4.0 0.0 - 10.7 18 9.98 2.24 22.4 10.0 3.2 - 16.7 All COULTER Instruments 18 4.28 2.12 49.6 4.0 0.0 - 10.7 18 9.98 2.24 22.4 10.0 3.2 - 16.7

Specimen DIF-3 Specimen DIF-4

All Method 18 0.52 0.44 84.3 0.3 0.0 - 1.9 18 4.83 1.50 31.0 4.7 0.3 - 9.4 All COULTER Instruments 18 0.52 0.44 84.3 0.3 0.0 - 1.9 18 4.83 1.50 31.0 4.7 0.3 - 9.4

Specimen DIF-5 All Method 18 9.12 2.57 28.2 9.2 1.4 - 16.9 All COULTER Instruments 18 9.12 2.57 28.2 9.2 1.4 - 16.9

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HEMATOLOGY W/ 5-PART DIFFERENTIAL EOSINOPHILS (percent)

Specimen DIF-1 Specimen DIF-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 17 6.68 0.44 6.5 6.8 5.3 - 8.0 18 4.62 0.49 10.6 4.5 3.1 - 6.1 All COULTER Instruments 17 6.68 0.44 6.5 6.8 5.3 - 8.0 18 4.62 0.49 10.6 4.5 3.1 - 6.1

Specimen DIF-3 Specimen DIF-4 All Method 18 7.91 0.41 5.2 7.9 6.6 - 9.2 18 6.75 0.35 5.2 6.8 5.6 - 7.9 All COULTER Instruments 18 7.91 0.41 5.2 7.9 6.6 - 9.2 18 6.75 0.35 5.2 6.8 5.6 - 7.9

Specimen DIF-5 All Method 18 4.63 0.43 9.3 4.6 3.3 - 6.0 All COULTER Instruments 18 4.63 0.43 9.3 4.6 3.3 - 6.0

HEMATOLOGY W/ 5-PART DIFFERENTIAL BASOPHILS (percent)

Specimen DIF-1 Specimen DIF-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 18 0.44 0.38 85.7 0.3 0.0 - 1.6 17 0.52 0.38 72.7 0.4 0.0 - 1.7 All COULTER Instruments 18 0.44 0.38 85.7 0.3 0.0 - 1.6 17 0.52 0.38 72.7 0.4 0.0 - 1.7

Specimen DIF-3 Specimen DIF-4 All Method 18 0.14 0.13 89.6 0.2 0.0 - 0.6 17 0.40 0.40 99.6 0.2 0.0 - 1.6 All COULTER Instruments 18 0.14 0.13 89.6 0.2 0.0 - 0.6 17 0.40 0.40 99.6 0.2 0.0 - 1.6

Specimen DIF-5 All Method 17 0.63 0.50 80.0 0.5 0.0 - 2.2 All COULTER Instruments 17 0.63 0.50 80.0 0.5 0.0 - 2.2

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QBC HEMATOLOGYHEMATOCRIT (percent)

Specimen QBC-1 Specimen QBC-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 7 35.51 0.54 1.5 35.5 33.3 - 37.7 7 33.06 0.72 2.2 33.0 31.0 - 35.1

Specimen QBC-3 Specimen QBC-4 All Method 7 20.91 0.53 2.5 20.9 19.6 - 22.2 7 20.86 0.64 3.1 21.2 19.6 - 22.2

Specimen QBC-5 All Method 7 28.16 0.59 2.1 28.0 26.4 - 29.9

QBC HEMATOLOGYHEMOGLOBIN (g/dL)

Specimen QBC-1 Specimen QBC-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 7 12.01 0.23 1.9 12.0 11.1 - 12.9 7 11.19 0.32 2.8 11.1 10.4 - 12.0

Specimen QBC-3 Specimen QBC-4 All Method 7 7.19 0.21 2.9 7.2 6.6 - 7.7 7 7.20 0.33 4.5 7.0 6.6 - 7.8

Specimen QBC-5

All Method 7 9.60 0.31 3.2 9.6 8.9 - 10.3

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QBC HEMATOLOGYWHITE BLOOD CELL COUNT (x 109/L)

Specimen QBC-1 Specimen QBC-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 6 25.40 2.44 9.6 25.7 21.5 - 29.3 5 17.98 3.46 19.2 17.0 15.2 - 20.7

Specimen QBC-3 Specimen QBC-4 All Method 6 9.25 1.41 15.2 8.8 7.8 - 10.7 6 8.42 1.38 16.4 8.9 7.1 - 9.7

Specimen QBC-5 All Method 6 10.45 1.09 10.4 10.3 8.8 - 12.1

QBC HEMATOLOGYPLATELET COUNT (x 109/L)

Specimen QBC-1 Specimen QBC-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 7 176.1 32.6 18.5 185 132 - 221 7 163.7 28.2 17.2 174 122 - 205

Specimen QBC-3 Specimen QBC-4 All Method 7 682.3 65.7 9.6 708 511 - 853 7 671.7 84.4 12.6 691 503 - 840

Specimen QBC-5 All Method 7 378.3 57.3 15.2 383 283 - 473

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QBC HEMATOLOGYGRANULOCYTES (x 109/L)

Specimen QBC-1 Specimen QBC-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 7 11.67 4.09 35.0 11.3 0.0 - 24.0 7 10.23 3.65 35.7 9.9 0.0 - 21.2

Specimen QBC-3 Specimen QBC-4 All Method 7 5.71 2.18 38.2 5.0 0.0 - 12.3 7 5.13 1.87 36.5 5.0 0.0 - 10.8

Specimen QBC-5 All Method 6 6.57 1.53 23.2 6.1 1.9 - 11.2

QBC HEMATOLOGYLYMPHS/MONO (x 109/L)

Specimen QBC-1 Specimen QBC-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 7 12.27 2.22 18.1 13.5 5.6 - 19.0 7 8.80 0.63 7.2 8.8 6.9 - 10.7

Specimen QBC-3 Specimen QBC-4 All Method 7 3.07 0.79 25.8 3.6 0.6 - 5.5 7 2.99 0.82 27.3 3.3 0.5 - 5.5

Specimen QBC-5 All Method 6 3.57 0.39 11.0 3.7 2.3 - 4.8

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RETICULOCYTE COUNT (percent)

Specimen RT-1 Specimen RT-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 33 8.10 1.51 18.6 8.4 3.5 - 12.7 32 3.41 0.70 20.6 3.5 1.3 - 5.6 All Automated Methods 20 7.88 1.24 15.7 8.4 4.1 - 11.6 19 3.24 0.60 18.7 3.4 1.4 - 5.1 All Manual Methods 15 9.29 2.82 30.4 8.6 0.8 - 17.8 15 4.31 1.87 43.4 3.8 0.0 - 10.0 Manual-New Methylen Blue Stain 11 9.61 3.27 34.0 9.0 0.0 - 19.5 11 4.65 2.10 45.2 4.0 0.0 - 11.0

HEMATOLOGY W/ 5-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x 109/L)

Specimen BCX-1 Specimen BCX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 70 3.91 0.12 3.2 3.9 3.3 - 4.5 70 18.14 0.50 2.7 18.2 15.4 - 20.9 All ABX Instruments 30 3.94 0.11 2.7 3.9 3.3 - 4.6 30 18.25 0.43 2.4 18.2 15.5 - 21.0 All COULTER Instruments 40 3.89 0.13 3.4 3.9 3.3 - 4.5 40 18.06 0.53 3.0 18.1 15.3 - 20.8 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 3.93 0.13 3.3 3.9 3.3 - 4.6 17 18.35 0.37 2.0 18.3 15.6 - 21.2 ABX Diagnostics Pentra 80 / XL 80 13 3.95 0.07 1.7 3.9 3.3 - 4.6 13 18.11 0.48 2.7 18.1 15.3 - 20.9 COULTER AcT 5diff (version 2.01) 38 3.88 0.13 3.5 3.9 3.3 - 4.5 40 18.05 0.72 4.0 18.0 15.3 - 20.8

Specimen BCX-3 Specimen BCX-4 All Method 71 4.72 0.14 2.9 4.7 4.0 - 5.5 70 15.53 0.38 2.5 15.5 13.2 - 17.9 All ABX Instruments 30 4.73 0.10 2.2 4.7 4.0 - 5.5 30 15.56 0.30 1.9 15.6 13.2 - 17.9 All COULTER Instruments 41 4.71 0.16 3.3 4.7 4.0 - 5.5 40 15.52 0.44 2.8 15.5 13.1 - 17.9 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 4.73 0.12 2.6 4.7 4.0 - 5.5 17 15.63 0.30 1.9 15.6 13.2 - 18.0 ABX Diagnostics Pentra 80 / XL 80 13 4.74 0.08 1.6 4.7 4.0 - 5.5 13 15.46 0.27 1.8 15.4 13.1 - 17.8 COULTER AcT 5diff (version 2.01) 39 4.70 0.16 3.3 4.7 3.9 - 5.5 38 15.52 0.45 2.9 15.5 13.1 - 17.9

Specimen BCX-5 All Method 69 24.02 0.67 2.8 24.0 20.4 - 27.7 All ABX Instruments 29 24.14 0.56 2.3 24.0 20.5 - 27.8 All COULTER Instruments 41 23.99 0.81 3.4 24.0 20.3 - 27.6 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 24.24 0.63 2.6 24.0 20.6 - 27.9

ABX Diagnostics Pentra 80 / XL 80 13 24.01 0.46 1.9 24.0 20.4 - 27.7 COULTER AcT 5diff (version 2.01) 39 23.99 0.83 3.5 24.0 20.3 - 27.6

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HEMATOLOGY W/ 5-PART DIFFERENTIALRED BLOOD CELL COUNT (x 1012

/L)

Specimen BCX-1 Specimen BCX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 70 3.857 0.071 1.8 3.86 3.62 - 4.09 70 4.982 0.093 1.9 4.98 4.68 - 5.29 All ABX Instruments 30 3.831 0.051 1.3 3.83 3.60 - 4.07 30 4.961 0.079 1.6 4.97 4.66 - 5.26 All COULTER Instruments 41 3.882 0.083 2.1 3.89 3.64 - 4.12 41 5.005 0.109 2.2 5.00 4.70 - 5.31 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 3.820 0.056 1.5 3.81 3.59 - 4.05 17 4.943 0.075 1.5 4.95 4.64 - 5.24 ABX Diagnostics Pentra 80 / XL 80 13 3.845 0.042 1.1 3.85 3.61 - 4.08 13 4.985 0.080 1.6 4.98 4.68 - 5.29 COULTER AcT 5diff (version 2.01) 39 3.881 0.084 2.2 3.88 3.64 - 4.12 39 5.003 0.109 2.2 5.00 4.70 - 5.31

Specimen BCX-3 Specimen BCX-4 All Method 71 4.988 0.094 1.9 5.00 4.68 - 5.29 70 4.307 0.073 1.7 4.30 4.04 - 4.57 All ABX Instruments 30 4.965 0.086 1.7 4.98 4.66 - 5.27 30 4.277 0.055 1.3 4.27 4.02 - 4.54 All COULTER Instruments 42 5.012 0.107 2.1 5.03 4.71 - 5.32 40 4.329 0.077 1.8 4.33 4.06 - 4.59 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 4.944 0.083 1.7 4.93 4.64 - 5.25 17 4.272 0.058 1.4 4.27 4.01 - 4.53 ABX Diagnostics Pentra 80 / XL 80 13 4.992 0.085 1.7 5.02 4.69 - 5.30 13 4.282 0.054 1.3 4.27 4.02 - 4.54 COULTER AcT 5diff (version 2.01) 40 5.010 0.108 2.2 5.03 4.70 - 5.32 38 4.324 0.074 1.7 4.33 4.06 - 4.59

Specimen BCX-5

All Method 70 5.942 0.109 1.8 5.95 5.58 - 6.30 All ABX Instruments 30 5.936 0.098 1.6 5.95 5.58 - 6.30 All COULTER Instruments 40 5.947 0.117 2.0 5.95 5.58 - 6.31 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 5.897 0.100 1.7 5.86 5.54 - 6.26 ABX Diagnostics Pentra 80 / XL 80 13 5.988 0.069 1.2 5.97 5.62 - 6.35 COULTER AcT 5diff (version 2.01) 38 5.936 0.111 1.9 5.94 5.58 - 6.30

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HEMATOLOGY W/ 5-PART DIFFERENTIALHEMOGLOBIN (g/dL)

Specimen BCX-1 Specimen BCX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 71 9.47 0.16 1.7 9.5 8.8 - 10.2 71 15.85 0.25 1.6 15.9 14.7 - 17.0 All ABX Instruments 30 9.39 0.15 1.6 9.4 8.7 - 10.1 30 15.91 0.28 1.8 15.9 14.7 - 17.1 All COULTER Instruments 41 9.53 0.15 1.6 9.5 8.8 - 10.2 41 15.81 0.22 1.4 15.8 14.7 - 17.0 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 9.41 0.16 1.7 9.4 8.7 - 10.1 17 15.94 0.29 1.8 15.9 14.8 - 17.1 ABX Diagnostics Pentra 80 / XL 80 13 9.37 0.13 1.4 9.4 8.7 - 10.1 13 15.86 0.28 1.8 16.0 14.7 - 17.0 COULTER AcT 5diff (version 2.01) 39 9.53 0.15 1.6 9.5 8.8 - 10.2 39 15.81 0.23 1.4 15.8 14.7 - 17.0

Specimen BCX-3 Specimen BCX-4 All Method 72 14.58 0.22 1.5 14.6 13.5 - 15.7 71 10.31 0.16 1.5 10.3 9.5 - 11.1 All ABX Instruments 30 14.59 0.24 1.6 14.6 13.5 - 15.7 30 10.26 0.15 1.5 10.3 9.5 - 11.0 All COULTER Instruments 42 14.57 0.22 1.5 14.6 13.5 - 15.6 41 10.35 0.15 1.5 10.3 9.6 - 11.1 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 14.64 0.24 1.7 14.6 13.6 - 15.7 17 10.31 0.17 1.6 10.3 9.5 - 11.1 ABX Diagnostics Pentra 80 / XL 80 13 14.53 0.23 1.5 14.6 13.5 - 15.6 13 10.21 0.10 1.0 10.2 9.4 - 11.0 COULTER AcT 5diff (version 2.01) 40 14.58 0.22 1.5 14.6 13.5 - 15.6 39 10.35 0.16 1.5 10.3 9.6 - 11.1

Specimen BCX-5 All Method 71 17.43 0.26 1.5 17.4 16.2 - 18.7 All ABX Instruments 30 17.55 0.24 1.4 17.5 16.3 - 18.8 All COULTER Instruments 40 17.33 0.22 1.3 17.4 16.1 - 18.6 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 17.59 0.26 1.5 17.6 16.3 - 18.9 ABX Diagnostics Pentra 80 / XL 80 13 17.49 0.20 1.1 17.5 16.2 - 18.8 COULTER AcT 5diff (version 2.01) 39 17.34 0.26 1.5 17.4 16.1 - 18.6

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HEMATOLOGY W/ 5-PART DIFFERENTIALHEMATOCRIT (percent)

Specimen BCX-1 Specimen BCX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 71 27.81 0.63 2.3 27.8 26.1 - 29.5 71 44.98 0.99 2.2 44.9 42.2 - 47.7 All ABX Instruments 30 27.78 0.51 1.9 27.8 26.1 - 29.5 30 44.87 0.87 1.9 44.8 42.1 - 47.6 All COULTER Instruments 41 27.83 0.71 2.6 27.9 26.1 - 29.6 41 45.07 1.07 2.4 45.2 42.3 - 47.8 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 27.50 0.47 1.7 27.3 25.8 - 29.2 17 44.79 0.92 2.0 44.4 42.1 - 47.5 ABX Diagnostics Pentra 80 / XL 80 13 28.15 0.29 1.0 28.3 26.4 - 29.9 13 44.96 0.83 1.8 44.8 42.2 - 47.7 COULTER AcT 5diff (version 2.01) 39 27.79 0.71 2.5 27.8 26.1 - 29.5 39 45.05 1.05 2.3 45.2 42.3 - 47.8

Specimen BCX-3 Specimen BCX-4 All Method 71 41.81 0.96 2.3 41.8 39.2 - 44.4 70 30.70 0.66 2.2 30.7 28.8 - 32.6 All ABX Instruments 29 41.66 0.83 2.0 41.7 39.1 - 44.2 30 30.62 0.51 1.7 30.7 28.7 - 32.5 All COULTER Instruments 42 41.91 1.03 2.5 42.0 39.3 - 44.5 40 30.75 0.76 2.5 30.7 28.9 - 32.6 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 41.54 0.85 2.1 41.6 39.0 - 44.1 17 30.46 0.54 1.8 30.4 28.6 - 32.3 ABX Diagnostics Pentra 80 / XL 80 12 41.83 0.81 1.9 42.1 39.3 - 44.4 13 30.83 0.41 1.3 30.8 28.9 - 32.7 COULTER AcT 5diff (version 2.01) 40 41.89 1.03 2.5 42.0 39.3 - 44.5 38 30.71 0.73 2.4 30.7 28.8 - 32.6

Specimen BCX-5 All Method 68 50.14 0.95 1.9 50.0 47.1 - 53.2 All ABX Instruments 28 49.89 0.69 1.4 49.9 46.8 - 52.9 All COULTER Instruments 41 50.27 1.26 2.5 50.1 47.2 - 53.3 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 50.03 1.00 2.0 49.8 47.0 - 53.1 ABX Diagnostics Pentra 80 / XL 80 13 49.92 0.63 1.3 50.0 46.9 - 53.0 COULTER AcT 5diff (version 2.01) 39 50.22 1.26 2.5 50.1 47.2 - 53.3

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HEMATOLOGY W/ 5-PART DIFFERENTIALPLATELET COUNT (x 109/L)

Specimen BCX-1 Specimen BCX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 70 109.8 6.0 5.5 110 82 - 138 71 500.2 17.5 3.5 500 375 - 626 All ABX Instruments 30 107.6 5.6 5.2 108 80 - 135 30 501.9 17.0 3.4 499 376 - 628 All COULTER Instruments 40 111.6 5.9 5.3 112 83 - 140 41 499.0 17.9 3.6 500 374 - 624 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 108.6 5.2 4.8 109 81 - 136 17 493.6 12.4 2.5 493 370 - 618 ABX Diagnostics Pentra 80 / XL 80 13 106.2 5.9 5.5 105 79 - 133 13 512.8 16.4 3.2 511 384 - 641 COULTER AcT 5diff (version 2.01) 38 111.6 5.6 5.0 112 83 - 140 39 498.8 18.2 3.7 500 374 - 624

Specimen BCX-3 Specimen BCX-4 All Method 70 149.5 7.5 5.0 150 112 - 187 71 216.5 7.2 3.3 216 162 - 271 All ABX Instruments 28 147.6 6.3 4.3 148 110 - 185 30 216.5 6.9 3.2 215 162 - 271 All COULTER Instruments 42 150.8 8.0 5.3 150 113 - 189 41 216.5 7.5 3.4 217 162 - 271 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 17 149.0 9.2 6.2 146 111 - 187 17 217.2 7.6 3.5 216 162 - 272 ABX Diagnostics Pentra 80 / XL 80 12 148.0 6.7 4.5 150 111 - 185 13 215.6 6.0 2.8 214 161 - 270 COULTER AcT 5diff (version 2.01) 40 150.6 7.8 5.2 150 112 - 189 39 216.3 7.5 3.5 217 162 - 271

Specimen BCX-5 All Method 71 502.8 20.2 4.0 500 377 - 629 All ABX Instruments 30 504.6 18.2 3.6 503 378 - 631 All COULTER Instruments 41 501.4 21.7 4.3 498 376 - 627 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 495.6 9.4 1.9 496 371 - 620

ABX Diagnostics Pentra 80 / XL 80 13 512.4 18.7 3.7 510 384 - 641 COULTER AcT 5diff (version 2.01) 39 500.3 21.7 4.3 496 375 - 626

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HEMATOLOGY W/ 5-PART DIFFERENTIALNEUTROPHILS (percent)

Specimen BCX-1 Specimen BCX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 71 59.91 6.18 10.3 60.1 41.3 - 78.5 69 69.17 5.50 8.0 68.4 52.6 - 85.7 All ABX Instruments 29 62.22 5.45 8.8 64.2 45.8 - 78.6 29 73.30 5.03 6.9 74.5 58.2 - 88.4 All COULTER Instruments 42 58.32 6.20 10.6 59.5 39.7 - 77.0 40 66.18 3.58 5.4 66.8 55.4 - 77.0 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 64.53 3.88 6.0 65.8 52.8 - 76.2 16 75.78 3.91 5.2 76.7 64.0 - 87.6 ABX Diagnostics Pentra 80 / XL 80 13 59.38 5.88 9.9 57.3 41.7 - 77.1 13 70.25 4.64 6.6 69.0 56.3 - 84.2 COULTER AcT 5diff (version 2.01) 38 59.82 4.17 7.0 60.0 47.3 - 72.4 38 66.44 3.38 5.1 67.2 56.2 - 76.6

Specimen BCX-3 Specimen BCX-4 All Method 71 45.58 3.30 7.2 46.4 35.6 - 55.5 71 68.24 4.82 7.1 68.1 53.7 - 82.7 All ABX Instruments 29 45.57 3.85 8.4 46.4 34.0 - 57.2 29 71.92 4.39 6.1 72.9 58.7 - 85.1 All COULTER Instruments 42 45.58 2.91 6.4 46.5 36.8 - 54.4 42 65.70 3.21 4.9 66.7 56.0 - 75.4 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 47.21 2.62 5.5 46.6 39.3 - 55.1 16 74.24 3.45 4.6 74.5 63.8 - 84.6 ABX Diagnostics Pentra 80 / XL 80 13 43.55 4.24 9.7 43.0 30.8 - 56.3 13 69.07 3.76 5.5 68.7 57.7 - 80.4 COULTER AcT 5diff (version 2.01) 40 45.70 2.87 6.3 46.5 37.0 - 54.4 40 65.92 3.08 4.7 66.8 56.6 - 75.2

Specimen BCX-5 All Method 71 46.01 4.59 10.0 45.9 32.2 - 59.8 All ABX Instruments 29 47.35 4.84 10.2 47.9 32.8 - 61.9 All COULTER Instruments 42 45.08 4.21 9.3 45.6 32.4 - 57.8 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 49.99 3.17 6.3 50.2 40.4 - 59.6 ABX Diagnostics Pentra 80 / XL 80 13 44.10 4.62 10.5 42.5 30.2 - 58.0 COULTER AcT 5diff (version 2.01) 40 45.28 4.17 9.2 45.7 32.7 - 57.8

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HEMATOLOGY W/ 5-PART DIFFERENTIALLYMPHOCYTES (percent)

Specimen BCX-1 Specimen BCX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 69 26.03 4.89 18.8 25.4 11.3 - 40.7 71 18.53 4.59 24.8 17.3 4.7 - 32.4 All ABX Instruments 29 28.82 4.48 15.5 27.3 15.3 - 42.3 29 20.25 4.87 24.1 18.9 5.6 - 34.9 All COULTER Instruments 39 23.61 3.37 14.3 22.8 13.4 - 33.8 42 17.34 4.03 23.3 16.3 5.2 - 29.5 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 26.42 2.75 10.4 25.5 18.1 - 34.7 16 17.59 3.69 21.0 16.8 6.5 - 28.7 ABX Diagnostics Pentra 80 / XL 80 13 31.78 4.49 14.1 32.5 18.3 - 45.3 13 23.52 4.17 17.7 23.8 11.0 - 36.1 COULTER AcT 5diff (version 2.01) 38 23.44 3.25 13.9 22.6 13.6 - 33.2 40 17.02 3.71 21.8 16.1 5.8 - 28.2

Specimen BCX-3 Specimen BCX-4 All Method 70 42.13 3.87 9.2 41.6 30.5 - 53.8 71 19.35 3.95 20.4 18.3 7.4 - 31.2 All ABX Instruments 29 44.53 4.61 10.4 44.1 30.7 - 58.4 29 21.54 4.39 20.4 20.0 8.3 - 34.8 All COULTER Instruments 42 40.78 2.97 7.3 40.3 31.8 - 49.7 42 17.83 2.77 15.5 17.1 9.5 - 26.2 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 41.79 2.40 5.7 42.0 34.5 - 49.0 15 18.50 1.78 9.6 18.7 13.1 - 23.9 ABX Diagnostics Pentra 80 / XL 80 13 47.92 4.47 9.3 47.3 34.5 - 61.4 13 24.39 3.84 15.7 24.1 12.8 - 35.9 COULTER AcT 5diff (version 2.01) 40 40.53 2.75 6.8 40.2 32.2 - 48.8 40 17.55 2.47 14.1 17.1 10.1 - 25.0

Specimen BCX-5 All Method 70 42.84 4.58 10.7 41.5 29.1 - 56.6 All ABX Instruments 29 45.46 5.12 11.3 44.7 30.1 - 60.9 All COULTER Instruments 41 40.98 3.05 7.4 40.6 31.8 - 50.2 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 42.35 2.92 6.9 41.5 33.5 - 51.2 ABX Diagnostics Pentra 80 / XL 80 13 49.28 4.66 9.5 50.0 35.3 - 63.3 COULTER AcT 5diff (version 2.01) 39 40.71 2.81 6.9 40.5 32.2 - 49.2

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HEMATOLOGY W/ 5-PART DIFFERENTIALMONOCYTES (percent)

Specimen BCX-1 Specimen BCX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 69 1.48 1.19 80.4 1.0 0.0 - 5.1 68 1.83 1.50 81.5 1.5 0.0 - 6.4 All ABX Instruments 29 1.62 1.23 76.0 1.3 0.0 - 5.4 29 1.78 1.42 79.9 1.4 0.0 - 6.1 All COULTER Instruments 40 1.37 1.16 84.5 1.0 0.0 - 4.9 41 2.15 1.97 91.6 1.6 0.0 - 8.1 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 1.38 1.08 78.4 1.1 0.0 - 4.7 16 1.79 1.59 88.4 1.2 0.0 - 6.6 ABX Diagnostics Pentra 80 / XL 80 13 1.92 1.38 71.9 1.8 0.0 - 6.1 13 1.76 1.25 71.2 1.4 0.0 - 5.6 COULTER AcT 5diff (version 2.01) 38 1.30 1.05 81.0 1.0 0.0 - 4.5 39 2.21 2.01 90.9 1.6 0.0 - 8.3

Specimen BCX-3 Specimen BCX-4 All Method 67 1.02 0.67 65.5 0.9 0.0 - 3.1 68 1.26 0.92 73.3 1.0 0.0 - 4.1 All ABX Instruments 28 0.95 0.55 57.5 0.9 0.0 - 2.6 29 1.22 0.77 62.8 1.0 0.0 - 3.6 All COULTER Instruments 40 1.13 0.83 73.6 1.0 0.0 - 3.7 41 1.47 1.31 89.3 1.0 0.0 - 5.5 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 15 0.87 0.51 59.1 0.9 0.0 - 2.5 16 1.29 0.94 72.9 0.9 0.0 - 4.2 ABX Diagnostics Pentra 80 / XL 80 13 1.05 0.59 56.2 0.8 0.0 - 2.9 13 1.14 0.50 44.3 1.1 0.0 - 2.7 COULTER AcT 5diff (version 2.01) 38 1.17 0.83 70.7 1.0 0.0 - 3.7 39 1.51 1.33 88.0 1.1 0.0 - 5.6

Specimen BCX-5 All Method 69 1.63 1.07 65.6 1.4 0.0 - 4.9 All ABX Instruments 29 1.62 0.91 56.1 1.4 0.0 - 4.4 All COULTER Instruments 41 1.72 1.31 75.7 1.4 0.0 - 5.7 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 1.68 1.01 60.3 1.5 0.0 - 4.8

ABX Diagnostics Pentra 80 / XL 80 13 1.54 0.79 51.5 1.3 0.0 - 4.0 COULTER AcT 5diff (version 2.01) 39 1.78 1.31 73.7 1.4 0.0 - 5.8

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HEMATOLOGY W/ 5-PART DIFFERENTIAL EOSINOPHILS (percent)

Specimen BCX-1 Specimen BCX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 70 6.95 1.41 20.3 7.1 2.7 - 11.2 71 4.16 0.56 13.4 4.2 2.4 - 5.9 All ABX Instruments 29 7.03 1.32 18.8 7.1 3.0 - 11.0 29 4.10 0.60 14.6 4.2 2.3 - 5.9 All COULTER Instruments 41 6.89 1.49 21.6 7.2 2.4 - 11.4 42 4.21 0.53 12.7 4.2 2.6 - 5.9 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 7.52 1.01 13.4 7.2 4.4 - 10.6 16 4.29 0.46 10.7 4.2 2.9 - 5.7 ABX Diagnostics Pentra 80 / XL 80 13 6.43 1.45 22.5 6.4 2.0 - 10.8 13 3.86 0.68 17.5 3.6 1.8 - 5.9 COULTER AcT 5diff (version 2.01) 40 6.95 1.47 21.1 7.2 2.5 - 11.4 40 4.24 0.53 12.4 4.3 2.6 - 5.9

Specimen BCX-3 Specimen BCX-4 All Method 71 8.05 1.74 21.5 7.9 2.8 - 13.3 71 4.78 0.64 13.4 4.8 2.8 - 6.8 All ABX Instruments 29 8.55 1.90 22.2 8.4 2.8 - 14.3 29 4.82 0.74 15.3 5.1 2.6 - 7.1 All COULTER Instruments 41 7.60 1.37 18.1 7.6 3.4 - 11.8 42 4.76 0.57 12.0 4.8 3.0 - 6.5 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 9.56 1.69 17.7 9.3 4.4 - 14.7 16 4.74 0.81 17.1 4.9 2.3 - 7.2 ABX Diagnostics Pentra 80 / XL 80 13 7.31 1.35 18.4 7.3 3.2 - 11.4 13 4.92 0.66 13.4 5.3 2.9 - 6.9 COULTER AcT 5diff (version 2.01) 39 7.68 1.35 17.5 7.7 3.6 - 11.8 40 4.77 0.58 12.1 4.8 3.0 - 6.6

Specimen BCX-5 All Method 71 5.14 0.68 13.2 5.2 3.1 - 7.2 All ABX Instruments 29 5.21 0.79 15.2 5.3 2.8 - 7.6 All COULTER Instruments 42 5.10 0.60 11.7 5.2 3.3 - 6.9 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 5.59 0.74 13.3 5.9 3.3 - 7.9

ABX Diagnostics Pentra 80 / XL 80 13 4.74 0.59 12.4 4.6 2.9 - 6.6 COULTER AcT 5diff (version 2.01) 40 5.11 0.61 11.9 5.2 3.2 - 7.0

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HEMATOLOGY W/ 5-PART DIFFERENTIAL BASOPHILS (percent)

Specimen BCX-1 Specimen BCX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range

All Method 71 5.00 3.91 78.1 7.5 0.0 - 16.8 71 6.58 5.09 77.4 10.3 0.0 - 21.9 All ABX Instruments 27 0.40 0.00 0.0 0.4 0.4 - 0.4 28 0.56 0.05 9.0 0.6 0.4 - 0.8 All COULTER Instruments 41 8.06 0.52 6.4 8.1 6.5 - 9.7 40 10.89 0.47 4.4 10.9 9.4 - 12.4 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 15 0.40 0.00 0.0 0.4 0.4 - 0.4 16 0.54 0.08 15.0 0.6 0.2 - 0.8 ABX Diagnostics Pentra 80 / XL 80 12 0.40 0.00 0.0 0.4 0.4 - 0.4 13 0.55 0.05 9.4 0.6 0.3 - 0.8 COULTER AcT 5diff (version 2.01) 39 8.03 0.51 6.3 8.1 6.5 - 9.6 38 10.92 0.45 4.1 10.9 9.5 - 12.3

Specimen BCX-3 Specimen BCX-4 All Method 71 2.90 2.26 78.2 4.5 0.0 - 9.7 71 6.17 4.76 77.1 9.7 0.0 - 20.5 All ABX Instruments 27 0.20 0.00 0.0 0.2 0.2 - 0.2 29 0.50 0.00 0.0 0.5 0.5 - 0.5 All COULTER Instruments 42 4.75 0.31 6.6 4.7 3.8 - 5.7 40 10.11 0.26 2.6 10.2 9.3 - 10.9 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 15 0.20 0.00 0.0 0.2 0.2 - 0.2 16 0.50 0.00 0.0 0.5 0.5 - 0.5 ABX Diagnostics Pentra 80 / XL 80 12 0.20 0.00 0.0 0.2 0.2 - 0.2 13 0.50 0.00 0.0 0.5 0.5 - 0.5 COULTER AcT 5diff (version 2.01) 40 4.75 0.32 6.8 4.7 3.7 - 5.8 38 10.11 0.25 2.5 10.2 9.3 - 10.9

Specimen BCX-5 All Method 71 4.45 3.41 76.7 7.0 0.0 - 14.7 All ABX Instruments 29 0.39 0.04 9.1 0.4 0.2 - 0.5 All COULTER Instruments 41 7.22 0.28 3.9 7.3 6.3 - 8.1 ABX Diagnostics Pentra 60C+ (version 2.21 and up) 16 0.38 0.04 10.6 0.4 0.2 - 0.6 ABX Diagnostics Pentra 80 / XL 80 12 0.40 0.00 0.0 0.4 0.4 - 0.4 COULTER AcT 5diff (version 2.01) 39 7.23 0.28 3.9 7.3 6.3 - 8.1

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HEMATOLOGY W/ 5-PART DIFFERENTIALWHITE BLOOD CELL COUNT (x 109/L)

Specimen MX-1 Specimen MX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 43 7.49 0.30 4.0 7.6 6.3 - 8.7 43 19.27 0.93 4.8 19.2 16.3 - 22.2 All Sysmex Instruments 43 7.49 0.30 4.0 7.6 6.3 - 8.7 43 19.27 0.93 4.8 19.2 16.3 - 22.2 Sysmex XS-1000i 27 7.64 0.19 2.5 7.6 6.4 - 8.8 27 19.65 0.82 4.2 19.5 16.7 - 22.6

Specimen MX-3 Specimen MX-4 All Method 41 3.94 0.12 2.9 4.0 3.3 - 4.6 43 7.50 0.29 3.9 7.5 6.3 - 8.7 All Sysmex Instruments 41 3.94 0.12 2.9 4.0 3.3 - 4.6 43 7.50 0.29 3.9 7.5 6.3 - 8.7 Sysmex XS-1000i 27 3.99 0.09 2.3 4.0 3.3 - 4.6 27 7.65 0.20 2.7 7.7 6.5 - 8.8

Specimen MX-5 All Method 43 19.19 0.94 4.9 19.0 16.3 - 22.1 All Sysmex Instruments 43 19.19 0.94 4.9 19.0 16.3 - 22.1 Sysmex XS-1000i 27 19.57 0.83 4.2 19.5 16.6 - 22.6

HEMATOLOGY W/ 5-PART DIFFERENTIALRED BLOOD CELL COUNT (x 1012

/L)

Specimen MX-1 Specimen MX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 43 4.680 0.064 1.4 4.68 4.39 - 4.97 43 5.361 0.075 1.4 5.36 5.03 - 5.69 All Sysmex Instruments 43 4.680 0.064 1.4 4.68 4.39 - 4.97 43 5.361 0.075 1.4 5.36 5.03 - 5.69 Sysmex XS-1000i 27 4.669 0.054 1.1 4.67 4.38 - 4.95 27 5.373 0.047 0.9 5.37 5.05 - 5.70

Specimen MX-3 Specimen MX-4 All Method 43 2.405 0.053 2.2 2.40 2.26 - 2.55 43 4.697 0.078 1.7 4.68 4.41 - 4.98 All Sysmex Instruments 43 2.405 0.053 2.2 2.40 2.26 - 2.55 43 4.697 0.078 1.7 4.68 4.41 - 4.98 Sysmex XS-1000i 27 2.379 0.035 1.5 2.38 2.23 - 2.53 27 4.680 0.057 1.2 4.67 4.39 - 4.97

Specimen MX-5 All Method 43 5.351 0.077 1.4 5.36 5.02 - 5.68 All Sysmex Instruments 43 5.351 0.077 1.4 5.36 5.02 - 5.68 Sysmex XS-1000i 27 5.364 0.055 1.0 5.36 5.04 - 5.69

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HEMATOLOGY W/ 5-PART DIFFERENTIALHEMOGLOBIN (g/dL)

Specimen MX-1 Specimen MX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 43 13.36 0.14 1.0 13.4 12.4 - 14.3 43 17.47 0.21 1.2 17.5 16.2 - 18.7 All Sysmex Instruments 43 13.36 0.14 1.0 13.4 12.4 - 14.3 43 17.47 0.21 1.2 17.5 16.2 - 18.7 Sysmex XS-1000i 27 13.36 0.13 1.0 13.3 12.4 - 14.3 27 17.56 0.16 0.9 17.6 16.3 - 18.8

Specimen MX-3 Specimen MX-4 All Method 43 5.93 0.09 1.5 5.9 5.5 - 6.4 43 13.37 0.13 1.0 13.4 12.4 - 14.4 All Sysmex Instruments 43 5.93 0.09 1.5 5.9 5.5 - 6.4 43 13.37 0.13 1.0 13.4 12.4 - 14.4 Sysmex XS-1000i 27 5.91 0.09 1.5 5.9 5.4 - 6.4 27 13.36 0.12 0.9 13.4 12.4 - 14.3

Specimen MX-5 All Method 43 17.47 0.24 1.4 17.5 16.2 - 18.7 All Sysmex Instruments 43 17.47 0.24 1.4 17.5 16.2 - 18.7 Sysmex XS-1000i 27 17.56 0.18 1.0 17.6 16.3 - 18.8

HEMATOLOGY W/ 5-PART DIFFERENTIAL – HEMATOCRIT (percent)

Specimen MX-1 Specimen MX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 43 39.37 0.68 1.7 39.3 37.0 - 41.8 43 50.67 0.97 1.9 50.6 47.6 - 53.8 All Sysmex Instruments 43 39.37 0.68 1.7 39.3 37.0 - 41.8 43 50.67 0.97 1.9 50.6 47.6 - 53.8 Sysmex XS-1000i 27 39.24 0.66 1.7 39.3 36.8 - 41.6 27 50.62 1.02 2.0 50.7 47.5 - 53.7

Specimen MX-3 Specimen MX-4 All Method 43 18.29 0.38 2.1 18.3 17.1 - 19.4 43 39.49 0.73 1.9 39.5 37.1 - 41.9 All Sysmex Instruments 43 18.29 0.38 2.1 18.3 17.1 - 19.4 43 39.49 0.73 1.9 39.5 37.1 - 41.9 Sysmex XS-1000i 27 18.14 0.33 1.8 18.2 17.0 - 19.3 27 39.34 0.72 1.8 39.3 36.9 - 41.7

Specimen MX-5 All Method 43 50.57 1.07 2.1 50.5 47.5 - 53.7 All Sysmex Instruments 43 50.57 1.07 2.1 50.5 47.5 - 53.7 Sysmex XS-1000i 27 50.53 1.16 2.3 50.6 47.4 - 53.6

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HEMATOLOGY W/ 5-PART DIFFERENTIALPLATELET COUNT (x 109/L)

Specimen MX-1 Specimen MX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 43 220.7 7.0 3.2 221 165 - 276 43 424.5 17.6 4.1 425 318 - 531 All Sysmex Instruments 43 220.7 7.0 3.2 221 165 - 276 43 424.5 17.6 4.1 425 318 - 531 Sysmex XS-1000i 27 222.4 4.9 2.2 222 166 - 278 27 429.6 12.6 2.9 427 322 - 538

Specimen MX-3 Specimen MX-4 All Method 43 61.1 4.2 6.8 61 45 - 77 43 221.7 7.6 3.4 222 166 - 278 All Sysmex Instruments 43 61.1 4.2 6.8 61 45 - 77 43 221.7 7.6 3.4 222 166 - 278 Sysmex XS-1000i 27 60.3 3.4 5.6 60 45 - 76 27 223.1 5.9 2.6 224 167 - 279

Specimen MX-5 All Method 43 424.9 18.6 4.4 422 318 - 532 All Sysmex Instruments 43 424.9 18.6 4.4 422 318 - 532 Sysmex XS-1000i 27 428.8 11.2 2.6 427 321 - 537

HEMATOLOGY W/ 5-PART DIFFERENTIAL – NEUTROPHILS (percent)

Specimen MX-1 Specimen MX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 43 54.45 3.60 6.6 56.1 43.6 - 65.3 43 60.67 6.21 10.2 61.9 42.0 - 79.4 All Sysmex Instruments 43 54.45 3.60 6.6 56.1 43.6 - 65.3 43 60.67 6.21 10.2 61.9 42.0 - 79.4 Sysmex XS-1000i 27 52.69 3.22 6.1 50.7 43.0 - 62.4 27 59.87 7.75 12.9 54.3 36.6 - 83.2

Specimen MX-3 Specimen MX-4 All Method 43 62.88 3.69 5.9 63.3 51.7 - 74.0 43 54.37 3.52 6.5 56.4 43.8 - 65.0 All Sysmex Instruments 43 62.88 3.69 5.9 63.3 51.7 - 74.0 43 54.37 3.52 6.5 56.4 43.8 - 65.0 Sysmex XS-1000i 27 60.99 3.08 5.1 59.4 51.7 - 70.3 27 52.58 3.24 6.2 51.0 42.8 - 62.3

Specimen MX-5 All Method 43 60.89 6.09 10.0 62.0 42.6 - 79.2 All Sysmex Instruments 43 60.89 6.09 10.0 62.0 42.6 - 79.2 Sysmex XS-1000i 27 60.04 7.55 12.6 54.8 37.3 - 82.7

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2014 MLE-M1 Participant Summary/ 49

HEMATOLOGY W/ 5-PART DIFFERENTIAL – LYMPHOCYTES (percent)

Specimen MX-1 Specimen MX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 43 23.13 3.41 14.8 24.1 12.8 - 33.4 43 18.95 3.16 16.7 19.5 9.4 - 28.5 All Sysmex Instruments 43 23.13 3.41 14.8 24.1 12.8 - 33.4 43 18.95 3.16 16.7 19.5 9.4 - 28.5 Sysmex XS-1000i 27 22.50 4.05 18.0 23.9 10.3 - 34.7 27 18.63 3.73 20.0 21.3 7.4 - 29.9

Specimen MX-3 Specimen MX-4 All Method 43 15.71 2.11 13.4 16.4 9.3 - 22.1 43 22.79 3.68 16.1 24.4 11.7 - 33.9 All Sysmex Instruments 43 15.71 2.11 13.4 16.4 9.3 - 22.1 43 22.79 3.68 16.1 24.4 11.7 - 33.9 Sysmex XS-1000i 27 15.14 2.13 14.1 16.3 8.7 - 21.6 27 22.40 4.22 18.8 24.8 9.7 - 35.1

Specimen MX-5 All Method 43 18.74 3.20 17.1 19.3 9.1 - 28.4 All Sysmex Instruments 43 18.74 3.20 17.1 19.3 9.1 - 28.4 Sysmex XS-1000i 27 18.56 3.82 20.6 21.4 7.0 - 30.1

HEMATOLOGY W/ 5-PART DIFFERENTIAL – MONOCYTES (percent)

Specimen MX-1 Specimen MX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 43 5.45 2.48 45.5 5.4 0.0 - 12.9 43 4.58 2.01 43.9 4.2 0.0 - 10.7 All Sysmex Instruments 43 5.45 2.48 45.5 5.4 0.0 - 12.9 43 4.58 2.01 43.9 4.2 0.0 - 10.7 Sysmex XS-1000i 27 5.70 2.99 52.5 3.6 0.0 - 14.7 27 4.62 2.41 52.1 2.8 0.0 - 11.9

Specimen MX-3 Specimen MX-4 All Method 42 1.55 1.41 90.4 1.1 0.0 - 5.8 43 5.77 2.97 51.5 5.3 0.0 - 14.7 All Sysmex Instruments 42 1.55 1.41 90.4 1.1 0.0 - 5.8 43 5.77 2.97 51.5 5.3 0.0 - 14.7 Sysmex XS-1000i 27 1.72 1.88 108.9 0.5 0.0 - 7.4 27 5.81 3.23 55.6 3.6 0.0 - 15.6

Specimen MX-5 All Method 43 4.66 2.09 44.8 4.6 0.0 - 11.0 All Sysmex Instruments 43 4.66 2.09 44.8 4.6 0.0 - 11.0 Sysmex XS-1000i 27 4.65 2.48 53.3 2.9 0.0 - 12.1

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HEMATOLOGY W/ 5-PART DIFFERENTIAL – EOSINOPHILS (percent)

Specimen MX-1 Specimen MX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 42 14.45 1.42 9.8 13.8 10.2 - 18.8 42 12.61 2.09 16.5 13.5 6.3 - 18.9 All Sysmex Instruments 42 14.45 1.42 9.8 13.8 10.2 - 18.8 42 12.61 2.09 16.5 13.5 6.3 - 18.9 Sysmex XS-1000i 27 14.91 1.59 10.7 14.0 10.1 - 19.7 27 11.90 2.28 19.2 13.2 5.0 - 18.8

Specimen MX-3 Specimen MX-4 All Method 42 16.55 1.71 10.3 15.7 11.4 - 21.7 42 14.48 1.44 10.0 13.8 10.1 - 18.9 All Sysmex Instruments 42 16.55 1.71 10.3 15.7 11.4 - 21.7 42 14.48 1.44 10.0 13.8 10.1 - 18.9 Sysmex XS-1000i 27 17.08 1.93 11.3 16.1 11.3 - 22.9 27 14.89 1.66 11.2 13.9 9.9 - 19.9

Specimen MX-5 All Method 42 12.61 1.99 15.8 13.5 6.6 - 18.6 All Sysmex Instruments 42 12.61 1.99 15.8 13.5 6.6 - 18.6 Sysmex XS-1000i 27 11.78 2.03 17.2 12.8 5.6 - 17.9

HEMATOLOGY W/ 5-PART DIFFERENTIAL – BASOPHILS (percent)

Specimen MX-1 Specimen MX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 14 73.22 0.87 1.2 7.1 70.6 - 75.9 15 81.66 2.22 2.7 8.8 74.9 - 88.4 All Sysmex XS/XN Instruments 28 4.04 3.65 90.4 6.4 0.0 - 15.0 28 4.66 4.31 92.4 7.7 0.0 - 17.6 All Sysmex XT/XE Instruments 14 73.22 0.87 1.2 73.4 70.6 - 75.9 15 81.66 2.22 2.7 81.5 74.9 - 88.4 Sysmex XS-1000i 27 4.17 3.65 87.5 6.5 0.0 - 15.2 27 4.83 4.30 88.9 7.9 0.0 - 17.8

Specimen MX-3 Specimen MX-4 All Method 15 85.10 5.12 6.0 9.2 69.7 - 100.5 15 73.43 1.56 2.1 7.4 68.7 - 78.1 All Sysmex XS/XN Instruments 28 4.81 4.41 91.6 7.8 0.0 - 18.1 28 4.11 3.72 90.3 6.7 0.0 - 15.3 All Sysmex XT/XE Instruments 15 85.10 5.12 6.0 83.5 69.7 - 100.5 15 73.43 1.56 2.1 73.0 68.7 - 78.1 Sysmex XS-1000i 27 4.98 4.40 88.4 7.8 0.0 - 18.2 27 4.26 3.70 86.8 6.7 0.0 - 15.4

Specimen MX-5 All Method 15 81.51 2.31 2.8 8.5 74.5 - 88.5 All Sysmex XS/XN Instruments 28 4.64 4.27 91.9 7.7 0.0 - 17.5 All Sysmex XT/XE Instruments 15 81.51 2.31 2.8 81.6 74.5 - 88.5 Sysmex XS-1000i 27 4.81 4.25 88.5 7.8 0.0 - 17.6

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2014 M1 Specimens BC-1 through BC-6

Case History: A 26-year-old male presented for his first physical. He reported that he recently began an exercise program to overcome his life-long feelings of weakness and chronic fatigue. However, he was unable to make any progress toward his goal of physical fitness due to having dizzy spells whenever he tried to exert himself. Upon examination, the patient appeared pale, his pulse was elevated, and the physician heard a slight heart murmur. A CBC was performed, and the results appear below.

Test Results Reference Range

WBC 8.5 x 109/L 4.5 - 15.0 x 10

9/L

RBC 4.84 x 1012

/L 4.6 - 6.0 x 1012

/L

HGB 10.4 g/dL 14.0 - 18.0 g/dL

HCT 35.0 % 40 - 54 %

PLT 360 x 109/L 150 - 450 x 10

9/L

MCV 72 fL 80 - 94 fL

MCH 21 pg 26 - 32 pg

MCHC 30 g/dL 32 - 36 g/dL

RDW 16 % 11.5 - 14.5 %

This patient was diagnosed with hereditary sideroblastic anemia. Sideroblastic anemias are a group of hereditary and acquired disorders of heme synthesis. Heme is the red, iron-

containing portion of the hemoglobin molecule that carries oxygen. In the hereditary form, a genetic mutation disrupts the insertion of iron into developing heme molecules, which prevents red blood cells from making enough hemoglobin. This leads to a buildup of iron that would normally have been incorporated into hemoglobin. The body attempts to compensate for the low hemoglobin by absorbing even more iron from the diet. Serum iron and transferrin levels increase. Over time, severe complications such as heart disease and liver damage can evolve from the buildup of excess iron deposits in these organs. Signs and symptoms of hereditary sideroblastic anemia tend to appear in young adulthood, and result from a combination of low hemoglobin and iron overload. They include fatigue, dizziness, rapid heartbeat, pale skin, and enlarged liver and spleen. Disorders of iron metabolism often cause microcytic, hypochromic anemias. The peripheral smear of a patient with sideroblastic anemia may include distorted red blood cells, schistocytes, target cells, spherocytes, and basophilic stippling. A diagnostic feature of this disease is the presence of ringed sideroblasts (red cells containing iron deposits) on bone marrow smears stained with Prussian Blue.

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BLOOD CELL IDENTIFICATION Specimen BC-1

Identification Labs Percent Performance Basophilic stippling 252 98.82%

Acceptable

The arrows in this photograph point to erythrocytes with basophilic stippling. These immature red blood cells have expelled their nuclei but still contain some residual RNA. The RNA is aggregated into small granular clumps that stain dark blue-purple. The clumps are evenly distributed throughout the cell, and may appear fine (smaller) or coarse (larger). Basophilic stippling is associated with increased RBC production, defective heme synthesis, anemia, thalassemia, and lead poisoning. These cells would be called reticulocytes only when examined with a supravital stain such as New Methylene Blue. To view another photo of basophilic stippling, see 2012 M3 Specimen BC-17.

Specimen BC-2

Identification Labs Percent Performance Lymphocyte, reactive 194 76.08% Acceptable

Immature/abnormal cell – refer 24 9.41% Acceptable

Monocyte 22 8.63%

Lymphocyte 15 5.88%

The arrow in this photograph points to a reactive lymphocyte. Reactive lymphs appear in a wide variety of forms, sizes and shapes. These large atypical lymphocytes are reacting to immune stimuli in the body. They are often increased in viral infections such as infectious mononucleosis. The cytoplasm is light blue, with peripheral basophilia- a deeper blue color at the extreme border. The edges of the cytoplasm tend to flow around the adjacent red blood cells. The nucleus is large, appearing slightly elongated or stretched. Some participants incorrectly identified this cell as a monocyte. Monocytes often appear to push away adjacent red cells with their cytoplasm, and lack the dark blue periphery that is typical of lymphocytes. To view another photo of a reactive lymphocyte, see 2013 M3 Specimen BC-14. To view a monocyte, see 2013 M1 Specimen BC-3. .

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BLOOD CELL IDENTIFICATION

Specimen BC-3

Identification Labs Percent Performance

Hypochromic red cell 249 97.27% Acceptable

Macrocyte 5 1.95%

The arrows in this photograph point to hypochromic erythrocytes. A red blood cell is considered hypochromic when the zone of central pallor covers more than one-third of the diameter of the cell (or >3μm.)

In normochromic (normal-colored) RBCs, the zone of central pallor comprises one-third or less of the total diameter of the cell. Hypochromic cells have more central pallor than a normal RBC due to lower concentration of hemoglobin. A decreased MCHC value is often associated with marked hypochromia. Specimen BC-4

Identification Labs Percent Performance

Neutrophil-Segmented or band 247 96.86% Acceptable

Hypersegmented neutrophil 5 1.96%

The arrow in this photograph points to a segmented neutrophil. The cytoplasm of these normal cells is pale pink and filled with fine, violet-pink granules. The nucleus of the cell is divided into two to five segments, or lobes, connected by a thin thread-like filament. This filament connecting the segments must be visible to classify the cell as segmented. To view another photo of a normal “seg,” see 2013 M1 Specimen BC-1.

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BLOOD CELL IDENTIFICATION Specimen BC-5

Identification Labs Percent Performance

Microcyte 227 89.02% Acceptable

Erythrocyte, normal 22 8.63%

The arrows in this photograph point to microcytes. These small red blood cells have the same color, morphology, and central pallor as the normal RBCs in the field, but are simply smaller in size. The nucleus of a mature, resting lymphocyte such as the one in this photo is a good reference for estimating the size of red blood cells. A normal RBC will be approximately the same size as the lymph’s nucleus. To view another photo of microcytes, see 2011 M3 BC-17. To view normal erythrocytes, see 2013 M1 specimen BC-2. Specimen BC-6

Identification Labs Percent Performance

Pappenheimer body 197 77.56% Not graded – Educational Challenge

Howell-Jolly body 23 9.06%

Immature/abnormal cell – refer 17 6.69%

Heinz body 12 4.72%

The arrows in this ungraded educational challenge point to erythrocytes containing Pappenheimer bodies. Any condition that disturbs hemoglobin synthesis can cause Pappenheimer bodies. These red cell inclusions are small, blue, angular, irregular in size and shape, and tend to aggregate in small clusters near the edge of the cell. The cells would be called siderocytes when viewed with Prussian Blue staining, which would confirm that these particles contain iron. Howell-Jolly bodies are spherical and larger than Pappenheimer bodies. Heinz bodies are not visible in Wright-stained smears. To view another photo of Pappenheimer bodies, see 2009 M2 Specimen BC-11.

References: Carr, J.H., Rodak, B.F.: Clinical Hematology Atlas, 3

rd ed. Saunders, St. Louis, 2009.

Henderson, L. H.: The POL Microscopy Atlas. 2

nd ed. American Academy of Family Physicians, Leawood KS, 2003.

O’Connor, B. H.: A Color Atlas and Instruction Manual of Peripheral Blood Cell Morphology. Williams & Wilkins, Baltimore MD, 1984. Rodak, B. F.: Hematology: Clinical Principles and Applications. 3

rd ed. W. B. Saunders, Philadelphia, 2007.

Schrier, S. L. “Anemia: Production Defects.” ACP Medicine. Ed. D. C. Dale. New York: WebMD, Inc., 2004. 1087. “X-linked Sideroblastic Anemia.” (Reviewed April 2009) Genetics Home Reference. US National Library of Medicine. Web. Accessed Jan. 23, 2014. Available at: http://ghr.nlm.nih.gov/condition/x-linked-sideroblastic-anemia.

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BLOOD BANK ABO GROUP

Specimen Results Labs Percent Performance

BB-1 Group B 7 100% Acceptable

BB-2 Group AB 7 100% Acceptable

BB-3 Group A 7 100% Acceptable

BB-4 Group A 7 100% Acceptable

BB-5 Group O 7 100% Acceptable

RH FACTOR (D TYPE)

Specimen Results Labs Percent Performance

BB-1 Rh Negative 11 100% Acceptable

BB-2 Rh Positive 11 100% Acceptable

BB-3 Rh Positive 11 100% Acceptable

BB-4 Rh Negative 11 100% Acceptable

BB-5 Rh Positive 11 100% Acceptable

UNEXPECTED ANTIBODY DETECTION

Specimen Results Labs Percent Performance

AB-1 Unexpected antibody detected 7 100% Acceptable

AB-2 Unexpected antibody detected 7 100% Acceptable AB-3 No unexpected antibody detected 7 100% Acceptable AB-4 No unexpected antibody detected 7 100% Acceptable AB-5 No unexpected antibody detected 7 100% Acceptable

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BLOOD BANK

ANTIBODY IDENTIFICATION

Specimen Results Labs Percent Performance

AB-1 Anti-Fya 1 100% Acceptable

AB-2 Anti-k 1 100% Acceptable

AB-3 No antibody detected 1 100% Acceptable AB-4 No antibody detected 1 100% Acceptable

AB-5 No antibody detected 1 100% Acceptable

COMPATIBILITY TESTING

Specimen Results Labs Percent Performance

AB-1 Not Compatible 5 100% Acceptable

AB-2 Compatible 5 100% Acceptable AB-3 Compatible 5 100% Acceptable AB-4 Compatible 5 100% Acceptable AB-5 Compatible 5 100% Acceptable

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PROTHROMBIN TIME (seconds)

Specimen CG-1 Specimen CG-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 66 40.78 8.72 21.4 43.5 34.6 - 46.9 65 10.74 0.77 7.2 10.7 9.1 - 12.4 Dade Innovin Dade Behring BFT II 5 47.86 2.63 5.5 46.8 40.6 - 55.1 5 9.26 0.35 3.8 9.2 7.8 - 10.7 Other Instrument Specified 5 42.58 3.92 9.2 44.4 36.1 - 49.0 5 10.36 0.09 0.9 10.4 8.8 - 12.0 Sysmex CA-500/600 series 25 44.31 2.91 6.6 44.4 37.6 - 51.0 24 10.49 0.32 3.1 10.5 8.9 - 12.1 All Coagulation Instruments 37 44.71 3.29 7.4 44.7 38.0 - 51.5 36 10.28 0.52 5.1 10.4 8.7 - 11.9 IL TEST PT Fibrinogen IL ACL, all models 13 30.16 2.11 7.0 29.3 25.6 - 34.7 13 11.19 0.38 3.4 11.1 9.5 - 12.9 PH/CMS Thromboplastin-D All Coagulation Instruments 5 29.48 3.50 11.9 29.9 25.0 - 34.0 5 10.88 0.80 7.4 11.1 9.2 - 12.6

Specimen CG-3 Specimen CG-4 All Method 63 13.32 0.54 4.1 13.3 11.3 - 15.4 66 11.04 0.80 7.3 11.0 9.3 - 12.7 Dade Innovin Dade Behring BFT II 5 12.76 0.71 5.5 12.6 10.8 - 14.7 5 9.56 0.40 4.2 9.7 8.1 - 11.0 Other Instrument Specified 5 12.94 0.61 4.7 13.1 10.9 - 14.9 5 10.60 0.12 1.2 10.6 9.0 - 12.2 Sysmex CA-500/600 series 24 13.30 0.36 2.7 13.3 11.3 - 15.3 25 10.80 0.37 3.4 10.9 9.1 - 12.5 All Coagulation Instruments 36 13.15 0.48 3.7 13.2 11.1 - 15.2 37 10.57 0.56 5.3 10.6 8.9 - 12.2 IL TEST PT Fibrinogen IL ACL, all models 13 13.65 0.44 3.2 13.7 11.6 - 15.8 13 11.77 0.40 3.4 11.7 10.0 - 13.6 PH/CMS Thromboplastin-D All Coagulation Instruments 5 13.08 0.78 6.0 13.1 11.1 - 15.1 5 11.04 0.86 7.8 11.5 9.3 - 12.7

Specimen CG-5 All Method 65 24.40 3.43 14.0 25.4 20.7 - 28.1 Dade Innovin Dade Behring BFT II 5 26.50 0.95 3.6 26.5 22.5 - 30.5 Other Instrument Specified 5 25.28 2.01 7.9 26.2 21.4 - 29.1 Sysmex CA-500/600 series 24 25.85 1.12 4.4 25.8 21.9 - 29.8 All Coagulation Instruments 35 26.00 1.12 4.3 26.0 22.1 - 29.9 IL TEST PT Fibrinogen IL ACL, all models 13 20.39 1.01 4.9 20.2 17.3 - 23.5 PH/CMS Thromboplastin-D All Coagulation Instruments 5 19.84 1.39 7.0 20.2 16.8 - 22.9

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PROTHROMBIN TIMEINTERNATIONAL NORMALIZED RATIO (INR)

Specimen CG-1 Specimen CG-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 66 5.02 1.20 23.9 4.6 4.0 - 6.1 65 1.00 0.05 5.5 1.0 0.7 - 1.2 Dade Innovin Dade Behring BFT II 5 4.08 0.31 7.6 4.0 3.2 - 4.9 5 1.00 0.00 0.0 1.0 0.8 - 1.2 Other Instrument Specified 5 3.90 0.38 9.8 4.0 3.1 - 4.7 5 1.00 0.00 0.0 1.0 0.8 - 1.2 Sysmex CA-500/600 series 25 4.21 0.36 8.4 4.2 3.3 - 5.1 24 1.01 0.05 5.0 1.0 0.8 - 1.3 All Coagulation Instruments 37 4.17 0.36 8.7 4.2 3.3 - 5.1 36 1.01 0.05 4.6 1.0 0.8 - 1.3 IL TEST PT Fibrinogen IL ACL, all models 13 6.28 0.62 9.9 6.3 5.0 - 7.6 13 0.99 0.05 5.0 1.0 0.7 - 1.2 PH/CMS Thromboplastin-D All Coagulation Instruments 5 7.82 1.70 21.8 8.2 6.2 - 9.4 5 0.94 0.05 5.8 0.9 0.7 - 1.2

Specimen CG-3 Specimen CG-4 All Method 67 1.31 0.11 8.4 1.3 1.0 - 1.6 66 1.03 0.06 6.2 1.0 0.8 - 1.3 Dade Innovin Dade Behring BFT II 5 1.32 0.08 6.3 1.3 1.0 - 1.6 5 1.04 0.05 5.3 1.0 0.8 - 1.3 Other Instrument Specified 5 1.26 0.05 4.3 1.3 1.0 - 1.6 5 1.00 0.00 0.0 1.0 0.8 - 1.2 Sysmex CA-500/600 series 25 1.27 0.09 7.1 1.3 1.0 - 1.6 25 1.04 0.06 5.6 1.0 0.8 - 1.3 All Coagulation Instruments 36 1.29 0.07 5.6 1.3 1.0 - 1.6 37 1.04 0.06 5.3 1.0 0.8 - 1.3 IL TEST PT Fibrinogen IL ACL, all models 13 1.44 0.07 4.5 1.4 1.1 - 1.8 13 1.07 0.06 5.9 1.1 0.8 - 1.3 PH/CMS Thromboplastin-D All Coagulation Instruments 5 1.36 0.17 12.3 1.4 1.0 - 1.7 5 0.94 0.09 9.5 1.0 0.7 - 1.2

Specimen CG-5 All Method 62 2.68 0.32 11.9 2.6 2.1 - 3.3 Dade Innovin Dade Behring BFT II 5 2.46 0.19 7.9 2.4 1.9 - 3.0 Other Instrument Specified 5 2.38 0.16 6.9 2.4 1.9 - 2.9 Sysmex CA-500/600 series 22 2.48 0.16 6.6 2.5 1.9 - 3.0 All Coagulation Instruments 34 2.47 0.17 6.7 2.5 1.9 - 3.0 IL TEST PT Fibrinogen IL ACL, all models 13 3.01 0.22 7.2 3.0 2.4 - 3.7 PH/CMS Thromboplastin-D All Coagulation Instruments 5 3.44 0.63 18.3 3.2 2.7 - 4.2

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ACTIVATED PARTIAL THROMBOPLASTIN (seconds)

Specimen CG-1 Specimen CG-2 Reagent/Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 28 74.1 10.6 14.2 71 62 - 86 27 28.3 1.4 4.9 28 24 - 33 Dade Actin FSL Sysmex CA-500/600 series 14 69.5 4.3 6.2 69 59 - 80 14 27.9 1.1 3.8 28 23 - 33 All Coagulation Instruments 16 69.6 4.0 5.7 70 59 - 80 16 27.8 1.0 3.8 28 23 - 32 IL TEST APTT-SP IL ACL, all models 7 69.9 5.6 8.1 70 59 - 81 7 28.7 1.7 5.9 28 24 - 34

Specimen CG-3 Specimen CG-4 All Method 28 36.7 6.3 17.1 34 31 - 43 27 26.3 1.1 4.3 26 22 - 31 Dade Actin FSL Sysmex CA-500/600 series 14 32.0 1.9 5.9 32 27 - 37 14 25.9 0.9 3.7 26 21 - 30 All Coagulation Instruments 16 31.9 1.8 5.6 32 27 - 37 16 25.9 0.9 3.4 26 21 - 30 IL TEST APTT-SP IL ACL, all models 7 42.7 2.5 5.8 42 36 - 50 7 26.4 1.0 3.7 26 22 - 31

Specimen CG-5 All Method 28 49.8 7.1 14.3 48 42 - 58 Dade Actin FSL Sysmex CA-500/600 series 14 46.1 3.6 7.9 46 39 - 54 All Coagulation Instruments 16 46.2 3.4 7.3 46 39 - 54 IL TEST APTT-SP IL ACL, all models 7 48.3 2.1 4.4 48 41 - 56

Fibrinogen (mg/dL)

One participant reported Fibrinogen. The vendor assay values for specimens CG-1 through CG-5 are: 262 mg/dL, 595 mg/dL, 95 mg/dL, 320 mg/dL and 293 mg/dL respectively.

RH FACTOR (Slide Method)

Specimen Results Labs Percent Performance

RH-1 Rh Negative 2 100% Acceptable

RH-2 Rh Positive 2 100% Acceptable

RH-3 Rh Positive 2 100% Acceptable

RH-4 Rh Negative 2 100% Acceptable

RH-5 Rh Negative 2 100% Acceptable

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COAGUCHEK XS PLUS PROTHROMBIN TIME (seconds)

Specimen XS-1 Specimen XS-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 20 15.20 2.50 16.4 14.4 12.9 - 17.5 20 24.24 2.18 9.0 23.8 20.6 - 27.9 Roche CoaguChek XS Plus 20 15.20 2.50 16.4 14.4 12.9 - 17.5 20 24.24 2.18 9.0 23.8 20.6 - 27.9

Specimen XS-3 Specimen XS-4 All Method 20 31.85 0.69 2.2 31.9 27.0 - 36.7 20 22.92 0.59 2.6 22.8 19.4 - 26.4 Roche CoaguChek XS Plus 20 31.85 0.69 2.2 31.9 27.0 - 36.7 20 22.92 0.59 2.6 22.8 19.4 - 26.4

Specimen XS-5 All Method 20 22.92 0.76 3.3 23.0 19.4 - 26.4 Roche CoaguChek XS Plus 20 22.92 0.76 3.3 23.0 19.4 - 26.4

COAGUCHEK XS PLUS PROTHROMBIN TIMEINTERNATIONAL NORMALIZED RATIO (INR)

Specimen XS-1 Specimen XS-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 24 1.20 0.00 0.0 1.2 0.9 - 1.5 24 1.94 0.05 2.6 1.9 1.5 - 2.4 Roche CoaguChek XS Plus 20 1.20 0.00 0.0 1.2 0.9 - 1.5 20 1.93 0.05 2.5 1.9 1.5 - 2.4

Specimen XS-3 Specimen XS-4 All Method 22 2.67 0.09 3.2 2.7 2.1 - 3.3 22 1.94 0.05 2.7 1.9 1.5 - 2.4 Roche CoaguChek XS Plus 20 2.67 0.05 1.9 2.7 2.1 - 3.3 20 1.95 0.05 2.8 2.0 1.5 - 2.4

Specimen XS-5 All Method 22 1.92 0.07 3.5 1.9 1.5 - 2.4 Roche CoaguChek XS Plus 20 1.93 0.08 4.2 2.0 1.5 - 2.4

ITC PROTIME MICROCOAGULATION SYSTEM PROTHROMBIN TIME (seconds)

Specimen IT-1 Specimen IT-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 1 - - - 20.9 Not graded 1 - - - 39.2 Not graded

ITC PROTIME MICROCOAGULATION SYSTEM INTERNATIONAL NORMALIZED RATIO (INR)

Specimen IT-1 Specimen IT-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 2 - - - 1.7 Not graded 3 - - - 3.0 Not graded

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i-Stat PROTHROMBIN TIME (seconds)

Specimen PTI-1 Specimen PTI-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range i-Stat Prothrombin Time 11 15.66 0.65 4.1 15.6 13.3 - 18.1 11 15.52 1.08 7.0 15.1 13.1 - 17.9

Specimen PTI-3 Specimen PTI-4 i-Stat Prothrombin Time 11 23.40 1.00 4.3 23.4 19.8 - 27.0 11 23.96 1.15 4.8 24.0 20.3 - 27.6

Specimen PTI-5 i-Stat Prothrombin Time 11 16.12 1.31 8.1 15.7 13.7 - 18.6

i-Stat PROTHROMBIN TIME - INTERNATIONAL NORMALIZED RATIO (INR)

Specimen PTI-1 Specimen PTI-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range i-Stat Prothrombin Time 11 1.30 0.07 5.4 1.3 1.0 - 1.6 11 1.32 0.11 8.3 1.3 1.0 - 1.6

Specimen PTI-3 Specimen PTI-4 i-Stat Prothrombin Time 11 2.02 0.08 4.1 2.0 1.6 - 2.5 11 2.06 0.11 5.5 2.1 1.6 - 2.5

Specimen PTI-5 i-Stat Prothrombin Time 11 1.36 0.13 9.9 1.3 1.0 - 1.7

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FLUID CELL COUNT/CRYSTALS WHITE BLOOD CELL COUNT (uL)

Specimen BF-1 Specimen BF-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 6 0.0 0.0 0.0 0 0 - 0 6 1620.8 223.9 13.8 1628 1172 - 2069

FLUID CELL COUNT/CRYSTALS RED BLOOD CELL COUNT (uL)

Specimen BF-1 Specimen BF-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 6 0.0 0.0 0.0 0 0 - 0 6 631.8 136.4 21.6 641 359 - 905

FLUID CELL COUNT/CRYSTALS CRYSTAL IDENTIFCATION

Specimen Identification Labs Percent Performance

BF-1 CPPD Crystals 7 58.33% Ungraded

Other, not listed 2 16.67%

Cholesterol crystals 1 8.33%

No crystals observed 1 8.33%

Calcium Oxalate crystals 1 8.33%

BF-1 is an ungraded challenge due to no referee group found.

BF-2 MSU (Monosodium Urate) 11 91.67% Acceptable CPPD Crystals 1 8.33%

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MICROALBUMIN, DIPSTICK

Specimen UM-1 Participant Results

Method Labs Negative 10 mg/L(Pos) 20/30 mg/L 50 mg/L (+) 80 mg/L 100 mg/L (++) 150 mg/L

ALL METHODS 40 - 2 1 3 25 4 5

Bayer Clinitek Microalbumin 33 - 2 1 - 25 - 5

Roche Micral - 1 minute 7 - - - 3 - 4 -

CREATININE, DIPSTICK

Specimen UM-1

Participant Results

Method Labs Negative 10 mg/dL 30 mg/dL 50 mg/dL 100 mg/dL 200 mg/dL 300 mg/dL

ALL METHODS 34 - - 1 6 16 9 2

Bayer Clinitek Microalbumin 31 - - 1 5 16 8 1

Bayer Multistix Pro 3 - - - 1 - 1 1

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WAIVED HEMATOLOGYHEMOGLOBIN (g/dL)

Specimen HD-1 Specimen HD-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 92 9.59 0.24 2.5 9.6 8.9 - 10.3 90 15.10 0.50 3.3 15.2 14.0 - 16.2 All Stanbio Methods 29 9.79 0.15 1.5 9.8 9.1 - 10.5 31 15.37 0.54 3.5 15.4 14.2 - 16.5 HemoCue 61 9.51 0.18 1.9 9.5 8.8 - 10.2 58 14.92 0.35 2.4 15.0 13.8 - 16.0 Stanbio HemoPoint H2 27 9.79 0.09 0.9 9.8 9.1 - 10.5 28 15.33 0.52 3.4 15.4 14.2 - 16.5

WAIVED HEMATOLOGYHEMATOCRIT (percent)

Specimen HD-1 Specimen HD-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range All Method 11 28.97 1.01 3.9 29.0 26.9 - 31.0 16 47.73 2.73 5.7 46.5 42.2 - 53.2

MICROALBUMIN, QUANTITATIVE

Specimen UM-1 Method Labs Mean SD CV Median Range All Method 83 102.7 7.1 6.9 102 81 - 125 Axis-Shield Afinion AS100 11 103.6 8.1 7.9 102 79 - 129 Beckman AU 13 97.6 5.7 5.9 97 80 - 115 Siemens DCA Vantage 14 101.1 4.9 4.8 102 86 - 116 Siemens Dimension/AR/ES/RxL/Xpand 24 108.2 9.8 9.1 106 78 - 138

CREATININE, URINE (mg/dL)

Specimen UM-1 Method Labs Mean SD CV Median Range All Method 83 63.2 3.6 5.6 63 52 - 74 Axis-Shield Afinion AS100 11 61.8 4.2 6.9 62 49 - 75 Beckman AU 12 64.0 4.5 7.0 64 50 - 78 Siemens DCA Vantage 14 66.5 1.6 2.3 67 61 - 72 Siemens Dimension/AR/ES/RxL/Xpand 19 61.2 2.3 3.8 61 54 - 69

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KOH SKIN PREPARATION Specimen Identification Labs Percent Performance K-1 Yeast/fungal elements absent 148 88.62% Acceptable Yeast/fungal elements present 19 11.38% Organism present in specimen K-1: Staphylococcus epidermidis. K-2 Yeast/fungal elements present 162 97.01% Acceptable Yeast/fungal elements absent 5 2.99% Organism present in specimen K-2: Microsporum gypsum.

COAGUCHECK XS - INTERNATIONAL NORMALIZED RATIO (INR)

Specimen INX-1 Specimen INX-2 Instrument Labs Mean SD CV Median Range Labs Mean SD CV Median Range Roche CoaguChek XS 111 1.20 0.04 3.6 1.2 0.9 - 1.5 107 2.56 0.12 4.6 2.5 2.0 - 3.1

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URINALYSIS DIPSTICKSPECIFIC GRAVITY

Specimen UA-1 Method Labs Mean SD CV Median Range All Method 907 1.0166 0.0042 0.4 1.015 1.006 - 1.027 All Bayer Instruments 442 1.0183 0.0032 0.3 1.020 1.008 - 1.029 All Roche Instruments 66 1.0130 0.0032 0.3 1.015 1.002 - 1.023 Bayer Clinitek 10 / 100 14 1.0186 0.0041 0.4 1.020 1.008 - 1.029 Bayer Clinitek 50 56 1.0137 0.0026 0.3 1.015 1.003 - 1.024 Bayer Clinitek 500 13 1.0150 0.0000 0.0 1.015 1.005 - 1.025 Bayer Clinitek Advantus 21 1.0150 0.0027 0.3 1.015 1.005 - 1.025 Bayer Clinitek Status / Status+ 328 1.0194 0.0021 0.2 1.020 1.009 - 1.030 Bayer Reagent Strips 239 1.0148 0.0041 0.4 1.015 1.004 - 1.025 Consult Diagnostics Urine Analyzer 13 1.0169 0.0048 0.5 1.015 1.006 - 1.027 CTMI CT-120 Urine Analyzer 10 1.0195 0.0043 0.4 1.020 1.009 - 1.030 Diagnostic Test Group Clarity Urocheck 120 12 1.0192 0.0047 0.5 1.018 1.009 - 1.030

Other Dipstick Method 16 1.0196 0.0032 0.3 1.020 1.009 - 1.030 Roche Chemstrip 101 12 1.0121 0.0026 0.3 1.010 1.002 - 1.023 Roche Chemstrips 48 1.0123 0.0030 0.3 1.015 1.002 - 1.023 Roche Criterion Analyzer 15 1.0120 0.0032 0.3 1.010 1.002 - 1.022 Roche Urisys 34 1.0137 0.0034 0.3 1.015 1.003 - 1.024

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URINALYSIS DIPSTICKpH

Specimen UA-1 Participant Results

Method Labs 3.5 or less

4.0 4.5 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0

ALL METHODS 934 - - - 19 9 151 380 374 1 - - -

Arkray DiaScreen 4 - - - - - - 4 - - - - -

Arkray DiaScreen 50 3 - - - - - 1 2 - - - - -

Bayer Clinitek 10 / 100 14 - - - - 1 3 8 2 - - - -

Bayer Clinitek 200/200+ 1 - - - - - 1 - - - - - -

Bayer Clinitek 2000 2 - - - - 1 - - 1 - - - -

Bayer Clinitek 50 59 - - - - - 5 52 2 - - - -

Bayer Clinitek 500 16 - - - - - 2 13 1 - - - -

Bayer Clinitek Advantus 21 - - - - - 2 18 1 - - - -

Bayer Clinitek Atlas 5 - - - - - - 4 1 - - - -

Bayer Clinitek Status / Status+ 333 - - - 2 1 6 79 245 - - - -

Bayer Hemacombistix 1 - - - - - 1 - - - - - -

Bayer Reagent Strips 249 - - - 7 3 24 123 91 1 - - -

Bayer Uristix 1 - - - - - - 1 - - - - -

Consult Diagnostics Urine Analyzer 13 - - - - 2 8 3 - - - - -

CTMI CT-120 Urine Analyzer 10 - - - - - 9 1 - - - - -

Diagnostic Test Group Clarity Urocheck 7 - - - - - 3 3 1 - - - - Diagnostic Test Group Clarity Urocheck 120 12 - - - - - 9 3 - - - - -

Germaine Laboratories AimStrip 5 - - - 1 - 4 - - - - - -

McKesson 10SG Reagent Strips 9 - - - 1 - 4 4 - - - - -

Other Analyzer Method 8 - - - - - 5 3 - - - - -

Other Dipstick Method 17 - - - 3 1 5 3 5 - - - -

pH Paper 1 - - - - - - 1 - - - - -

PSS Select Reagent Strips 7 - - - - - 2 1 4 - - - -

PSS Select Urine Analyzer 1 - - - - - 1 - - - - - -

Roche Chemstrip 101 12 - - - - - 4 5 3 - - - -

Roche Chemstrips 51 - - - 2 - 40 - 9 - - - -

Roche cobas u 411 3 - - - - - 1 2 - - - - -

Roche Criterion Analyzer 15 - - - 2 - - 12 1 - - - -

Roche SuperUA/ChemstripUA 2 - - - - - 2 - - - - - -

Roche Urisys 34 - - - 1 - 5 25 3 - - - -

Schein Urispec 8 - - - - - - 7 1 - - - -

UriScan Reagent Strips 1 - - - - - 1 - - - - - -

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URINALYSIS DIPSTICKPROTEIN QUALITATIVE

Specimen UA-1

Participant Results

Method Labs Negative Trace 30 mg/dL

(1+)

100 mg/dL

(2+)

300-500 mg/dL (3+)

>300 mg/dL

>1000 mg/dL

(4+)

ALL METHODS 969 941 25 1 1 1 - -

Arkray DiaScreen 9 6 3 - - - - -

Arkray DiaScreen 50 3 3 - - - - - -

Bayer Albustix 1 1 - - - - - -

Bayer Clinitek 10 / 100 14 14 - - - - - -

Bayer Clinitek 200/200+ 1 1 - - - - - -

Bayer Clinitek 2000 2 2 - - - - - -

Bayer Clinitek 50 59 59 - - - - - -

Bayer Clinitek 500 16 16 - - - - - -

Bayer Clinitek Advantus 21 21 - - - - - -

Bayer Clinitek Atlas 5 5 - - - - - -

Bayer Clinitek Status / Status+ 330 330 - - - - - -

Bayer Hemacombistix 1 1 - - - - - -

Bayer Reagent Strips 246 237 9 - - - - -

Bayer Uristix 17 16 1 - - - - -

Consult Diagnostics Urine Analyzer 13 13 - - - - - -

CTMI CT-120 Urine Analyzer 10 10 - - - - - -

Diagnostic Test Group Clarity Urocheck 6 5 1 - - - - - Diagnostic Test Group Clarity Urocheck 120 12 12 - - - - - -

Germaine Laboratories AimStrip 5 4 1 - - - - -

McKesson 10SG Reagent Strips 9 5 2 1 1 - - -

Other Analyzer Method 8 8 - - - - - -

Other Dipstick Method 17 15 2 - - - - -

PSS Select Reagent Strips 8 7 1 - - - - -

PSS Select Urine Analyzer 1 1 - - - - - -

Roche Chemstrip 101 12 12 - - - - - -

Roche Chemstrips 69 64 4 - - 1 - -

Roche cobas u 411 3 3 - - - - - -

Roche Criterion Analyzer 15 14 1 - - - - -

Roche SuperUA/ChemstripUA 2 2 - - - - - -

Roche Urisys 33 33 - - - - - -

Schein Urispec 8 8 - - - - - -

Sulfosalicylic Acid 2 2 - - - - - -

UriScan Reagent Strips 1 1 - - - - - -

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URINALYSIS DIPSTICKGLUCOSE

Specimen UA-1 Participant Results Method

Labs

Negative

50-100 mg/dL (Trace)

150

mg/dL

250

mg/dL

500

mg/dL

1000

mg/dL

>1000 mg/dL

>2000 mg/dL

ALL METHODS 907 12 19 21 420 296 70 61 8

Arkray DiaScreen 4 - 1 - 2 - 1 - -

Arkray DiaScreen 50 3 - - - 2 1 - - -

Bayer Clinitek 10 / 100 11 - - 1 6 4 - - -

Bayer Clinitek 200/200+ 1 - - - - 1 - - -

Bayer Clinitek 2000 2 - - - 1 1 - - -

Bayer Clinitek 50 57 - - - 12 35 - 10 -

Bayer Clinitek 500 16 1 - - 7 8 - - -

Bayer Clinitek Advantus 20 - 1 - 7 12 - - -

Bayer Clinitek Atlas 5 - - - - 1 - 4 -

Bayer Clinitek Status / Status+ 333 5 5 13 232 72 1 2 3

Bayer Clinitest, 5 drop 1 - - - - 1 - - -

Bayer Hemacombistix 1 - - - - 1 - - -

Bayer Reagent Strips 228 2 5 4 97 116 21 2 2

Bayer Uristix 6 - - - 3 2 - - 1

Consult Diagnostics Urine Analyzer 13 - - - 4 7 1 1 -

CTMI CT-120 Urine Analyzer 9 - - - 9 - - - -

Diagnostic Test Group Clarity Urocheck 7 1 2 - 4 - - - -

Diagnostic Test Group Clarity Urocheck 120 12 1 - - 11 - - - -

Germaine Laboratories AimStrip 5 - 1 1 3 - - - -

McKesson 10SG Reagent Strips 9 - 2 1 4 2 - - -

Micro-Bumintest 1 - - - - - - 1 -

Other Analyzer Method 8 1 - 1 1 5 - - -

Other Dipstick Method 17 - 2 - 7 5 3 - -

PSS Select Reagent Strips 8 - - - 1 5 2 - -

PSS Select Urine Analyzer 1 - - - - - 1 - -

Roche Chemstrip 101 9 - - - - 1 - 8 -

Roche Chemstrips 51 - - - - 5 45 - 1

Roche cobas u 411 3 - - - - - 1 2 -

Roche Criterion Analyzer 14 - - - 1 - 13 - -

Roche SuperUA/ChemstripUA 2 - - - - - 2 - -

Roche Urisys 32 1 - - - 3 - 28 -

Schein Urispec 8 - - - - 6 - 1 1

UriScan Reagent Strips 1 - - - - 1 - - -

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URINALYSIS DIPSTICKKETONES

Specimen UA-1

Participant Results

Method

Labs

Negative

Trace (5 mg/dL)

Small (1+, 15 mg/dL)

Moderate (2+, 40 mg/dL)

Large (3+, 80 mg/dL)

150 mg/dL ≥ 160 mg/dL

ALL METHODS 930 1 - 1 12 345 54 517

Arkray DiaScreen 4 - - - - - - 4

Arkray DiaScreen 50 3 - - - 1 - - 2

Bayer Acetest 1 - - - - 1 - -

Bayer Clinitek 10 / 100 13 - - - - 7 - 6

Bayer Clinitek 200/200+ 1 - - - - - - 1

Bayer Clinitek 2000 2 - - - - 1 - 1

Bayer Clinitek 50 57 - - - - 55 - 2

Bayer Clinitek 500 15 - - - - 15 - -

Bayer Clinitek Advantus 21 - - - - 21 - -

Bayer Clinitek Atlas 5 - - - - 4 - 1

Bayer Clinitek Status / Status+ 333 - - - - 42 8 283

Bayer Ketostix 1 - - - - 1 - -

Bayer Reagent Strips 247 1 - - - 54 7 185

Consult Diagnostics Urine Analyzer 13 - - 1 5 7 - -

CTMI CT-120 Urine Analyzer 10 - - - - 10 - -

Diagnostic Test Group Clarity Urocheck 7 - - - - 2 - 5 Diagnostic Test Group Clarity Urocheck 120 12 - - - - 12 - -

Germaine Laboratories AimStrip 5 - - - - 4 - 1

McKesson 10SG Reagent Strips 9 - - - - 2 - 7

Other Analyzer Method 8 - - - - 6 - 2

Other Dipstick Method 17 - - - 1 9 - 7

PSS Select Reagent Strips 6 - - - 1 4 - 1

PSS Select Urine Analyzer 1 - - - - 1 - -

Roche Chemstrip 101 12 - - - - 7 5 -

Roche Chemstrips 55 - - - - 55 - -

Roche cobas u 411 3 - - - - 2 1 -

Roche Criterion Analyzer 15 - - - 1 4 10 -

Roche SuperUA/ChemstripUA 2 - - - - 2 - -

Roche Urisys 34 - - - 3 8 23 -

Schein Urispec 8 - - - - 2 - 6

UriScan Reagent Strips 1 - - - - 1 - -

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URINALYSIS DIPSTICKBILIRUBIN

Specimen UA-1

Participant Results

Method

Labs

Negative

Small (1+)

Moderate (2+)

Large (3+)

ALL METHODS 906 903 - 2 1

Arkray DiaScreen 4 4 - - -

Arkray DiaScreen 50 3 3 - - -

Bayer Clinitek 10 / 100 13 13 - - -

Bayer Clinitek 200/200+ 1 1 - - -

Bayer Clinitek 2000 2 2 - - -

Bayer Clinitek 50 57 57 - - -

Bayer Clinitek 500 15 15 - - -

Bayer Clinitek Advantus 20 20 - - -

Bayer Clinitek Atlas 5 5 - - -

Bayer Clinitek Status / Status+ 320 320 - - -

Bayer Reagent Strips 238 237 - 1 -

Consult Diagnostics Urine Analyzer 13 13 - - -

CTMI CT-120 Urine Analyzer 10 10 - - -

Diagnostic Test Group Clarity Urocheck 7 7 - - - Diagnostic Test Group Clarity Urocheck 120 12 12 - - -

Germaine Laboratories AimStrip 5 5 - - -

McKesson 10SG Reagent Strips 9 8 - - 1

Other Analyzer Method 8 8 - - -

Other Dipstick Method 17 17 - - -

PSS Select Reagent Strips 6 6 - - -

PSS Select Urine Analyzer 1 1 - - -

Roche Chemstrip 101 12 12 - - -

Roche Chemstrips 53 53 - - -

Roche cobas u 411 3 3 - - -

Roche Criterion Analyzer 15 15 - - -

Roche SuperUA/ChemstripUA 2 1 - 1 -

Roche Urisys 34 34 - - -

Schein Urispec 8 8 - - -

UriScan Reagent Strips 1 1 - - -

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URINALYSIS DIPSTICKUROBILINOGEN Specimen UA-1 Participant Results

Method

Labs

0.2/Normal mg/dL

1.0 mg/dL

2.0 mg/dL

4.0 mg/dL

>8.0 mg/dL

ALL METHODS 889 877 3 4 2 3

Arkray DiaScreen 4 4 - - - -

Arkray DiaScreen 50 3 3 - - - -

Bayer Clinitek 10 / 100 13 13 - - - -

Bayer Clinitek 200/200+ 1 1 - - - -

Bayer Clinitek 2000 2 2 - - - -

Bayer Clinitek 50 57 57 - - - -

Bayer Clinitek 500 9 9 - - - -

Bayer Clinitek Advantus 20 20 - - - -

Bayer Clinitek Atlas 3 3 - - - -

Bayer Clinitek Status / Status+ 321 320 - 1 - -

Bayer Reagent Strips 234 232 - 1 - 1

Consult Diagnostics Urine Analyzer 13 13 - - - -

CTMI CT-120 Urine Analyzer 10 9 - - 1 -

Diagnostic Test Group Clarity Urocheck 7 6 1 - - - Diagnostic Test Group Clarity Urocheck 120 11 11 - - - -

Germaine Laboratories AimStrip 5 4 - - 1 -

McKesson 10SG Reagent Strips 9 7 - 1 - 1

Other Analyzer Method 7 7 - - - -

Other Dipstick Method 17 15 1 1 - -

PSS Select Reagent Strips 6 6 - - - -

PSS Select Urine Analyzer 1 1 - - - -

Roche Chemstrip 101 12 12 - - - -

Roche Chemstrips 52 51 - - - 1

Roche cobas u 411 3 3 - - - -

Roche Criterion Analyzer 15 15 - - - -

Roche SuperUA/ChemstripUA 2 1 1 - - -

Roche Urisys 34 34 - - - - Schein Urispec 8 8 - - - - UriScan Reagent Strips 1 1 - - - -

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URINALYSIS DIPSTICKBLOOD/HEMOGLOBIN

Specimen UA-1

Participant Results

Method

Labs

Negative

Trace

Small (5-10 RBC/µL, 1+)

Moderate (50 RBC/µL, 2+)

Large (250 RBC/µL, 3+)

ALL METHODS 943 905 34 3 1 -

Arkray DiaScreen 4 4 - - - -

Arkray DiaScreen 50 3 3 - - - -

Bayer Clinitek 10 / 100 14 14 - - - -

Bayer Clinitek 200/200+ 1 1 - - - -

Bayer Clinitek 2000 2 1 1 - - -

Bayer Clinitek 50 59 57 1 1 - -

Bayer Clinitek 500 16 16 - - - -

Bayer Clinitek Advantus 21 21 - - - -

Bayer Clinitek Atlas 5 5 - - - -

Bayer Clinitek Status / Status+ 332 317 15 - - -

Bayer Hemacombistix 1 1 - - - -

Bayer Reagent Strips 247 234 13 - - -

Consult Diagnostics Urine Analyzer 13 13 - - - -

CTMI CT-120 Urine Analyzer 9 9 - - - -

Diagnostic Test Group Clarity Urocheck 7 7 - - - - Diagnostic Test Group Clarity Urocheck 120 12 12 - - - -

Germaine Laboratories AimStrip 5 5 - - - -

McKesson 10SG Reagent Strips 9 9 - - - -

Other Analyzer Method 8 8 - - - -

Other Dipstick Method 17 17 - - - -

PSS Select Reagent Strips 7 7 - - - -

PSS Select Urine Analyzer 1 1 - - - -

Roche Chemstrip 101 12 11 1 - - -

Roche Chemstrips 66 64 2 - - -

Roche cobas u 411 3 3 - - - -

Roche Criterion Analyzer 15 15 - - - -

Roche SuperUA/ChemstripUA 2 2 - - - -

Roche Urisys 34 34 - - - -

Schein Urispec 8 6 - 1 1 -

UriScan Reagent Strips 1 1 - - - -

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URINALYSIS DIPSTICKLEUKOCYTE ESTERASE

Specimen UA-1

Participant Results

Method

Labs

Negative

Trace

Small (1+)

Moderate (2+)

Large (3+)

ALL METHODS 956 4 19 191 528 214

Arkray DiaScreen 9 - - - 1 8

Arkray DiaScreen 50 3 - - - 1 2

Bayer Clinitek 10 / 100 13 - - 3 10 -

Bayer Clinitek 200/200+ 1 - - - 1 -

Bayer Clinitek 2000 2 - - 1 1 -

Bayer Clinitek 50 59 - 1 28 24 6

Bayer Clinitek 500 16 - - - 15 1

Bayer Clinitek Advantus 21 - - 1 20 -

Bayer Clinitek Atlas 5 - - - - 5

Bayer Clinitek Status / Status+ 333 2 15 136 114 66

Bayer Reagent Strips 242 - 1 18 194 29

Bayer Uristix 14 - - 1 12 1

Consult Diagnostics Urine Analyzer 13 - - - 3 10

CTMI CT-120 Urine Analyzer 10 1 - - 6 3

Diagnostic Test Group Clarity Urocheck 7 - - - 4 3

Diagnostic Test Group Clarity Urocheck 120 12 - - - 9 3

Germaine Laboratories AimStrip 5 - - 1 2 2

McKesson 10SG Reagent Strips 9 - - - 6 3

Other Analyzer Method 8 - - - - 8

Other Dipstick Method 17 - - 1 6 10

PSS Select Reagent Strips 7 - - - 2 5

PSS Select Urine Analyzer 1 - - - - 1

Roche Chemstrip 101 12 - - - 7 5

Roche Chemstrips 65 - - - 58 7

Roche cobas u 411 3 - - - 1 2

Roche Criterion Analyzer 15 - - - 10 5

Roche SuperUA/ChemstripUA 2 1 - - 1 -

Roche Urisys 34 - - - 18 16

Schein Urispec 7 - - - - 7

UriScan Reagent Strips 1 - - - - 1

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URINALYSIS DIPSTICKNITRITE

Specimen UA-1

Participant Results

Method Labs Positive Negative

ALL METHODS 954 949 5

Arkray DiaScreen 9 9 -

Arkray DiaScreen 50 3 3 -

Bayer Clinitek 10 / 100 13 13 -

Bayer Clinitek 200/200+ 1 1 -

Bayer Clinitek 2000 2 2 -

Bayer Clinitek 50 59 59 -

Bayer Clinitek 500 16 16 -

Bayer Clinitek Advantus 21 21 -

Bayer Clinitek Atlas 5 5 -

Bayer Clinitek Status / Status+ 330 329 1

Bayer Ictotest 1 1 -

Bayer Reagent Strips 239 237 2

Bayer Uristix 14 14 -

Consult Diagnostics Urine Analyzer 13 13 -

CTMI CT-120 Urine Analyzer 10 10 -

Diagnostic Test Group Clarity Urocheck 7 7 - Diagnostic Test Group Clarity Urocheck 120 12 12 -

Germaine Laboratories AimStrip 5 5 -

McKesson 10SG Reagent Strips 9 9 -

Other Analyzer Method 8 8 -

Other Dipstick Method 17 17 -

PSS Select Reagent Strips 7 7 -

PSS Select Urine Analyzer 1 1 -

Roche Chemstrip 101 12 12 -

Roche Chemstrips 66 65 1

Roche cobas u 411 3 3 -

Roche Criterion Analyzer 15 15 -

Roche SuperUA/ChemstripUA 2 2 -

Roche Urisys 33 33 -

Schein Urispec 8 8 -

UriScan Reagent Strips 1 1 -

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URINALYSIS MICROALBUMIN (dipstick only)

Specimen UA-1

Participant Results

Method Labs Negative 10 mg/L(Pos) 20/30 mg/L 50 mg/L (+) 80 mg/L 100 mg/L (++) 150 mg/L

ALL METHODS 66 25 30 7 - 3 - 1

Bayer Clinitek Microalbumin 35 1 30 1 - 2 - 1

DCL ImmunoDip 1 1 - - - - - -

Micro-Bumintest 2 2 - - - - - -

Roche Micral - 1 minute 26 20 - 6 - - - -

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URINALYSIS URINE hCG Specimen UA-1 Participant Results

Method Labs Positive Negative

ALL METHODS 527 2 525

AimStep Combo Pregnancy 2 - 2

Alfa Scientific Instant View 4 - 4

Bayer Bili-Labstix 1 - 1

Bayer Clinitek Status / Status+ 1 - 1

Beckman Coulter ICON 25 hCG 33 - 33

Beckman Coulter ICON II/20 HCG 2 - 2

Cardinal Health SP Brand combo 25 - 25

Cardinal Hlth SPBrand-cassette 7 - 7

CONSULT diagnostics hCG Cassette 48 1 47

CONSULT diagnostics hCG Combo 21 - 21

CONSULT diagnostics hCG Dipstick 15 - 15

Diagnostic Test Group Clarity hCG strip/cassette 6 - 6

Henry Schein One Step 51 - 51

Immunostics Cept-D 1 - 1

Immunostics Detector Combi 1 - 1

Immunostics hCG Detector-urine 11 - 11

Inverness Acceva hCG-Urine 5 - 5

Inverness Clearview 25 hCG Combo 1 - 1

Inverness Clearview hCG Cassette 2 - 2

McKesson hCG Combo Cassette 13 - 13

McKesson hCG Urine Cassette 20 - 20

McKesson urine hCG-all 20 mIU kits 4 - 4

NDC Pro Advantage 4 - 4

PEP (Lab Supply) HCG 2 - 2

Polymedco Poly stat hCG 9 - 9

PSS Select hCG Cassette 2 - 2

Quidel QuickVue One-Step Combo 29 - 29

Quidel QuickVue One-Step Urine 73 1 72

Quidel QuickVue+ One-Step Combo 12 - 12

Sekisui OSOM - Urine Test 6 - 6

Sekisui OSOM Card Pregnancy 6 - 6

Sekisui OSOM hCG Combo Test 19 - 19

Sekisui Signify-Urine/Serum 1 - 1

Stanbio QuPID 7 - 7

Stanbio QuPID Plus 1 - 1

Stanbio QuStick 1 - 1

Stanbio TRUE hCG 6 - 6

Sure-Vue hCG - 25mIU 4 - 4

Sure-Vue hCG-STAT 5 - 5

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FECAL OCCULT BLOOD

Specimen OC-1 Specimen OC-2

Method Labs Positive Negative Labs Positive Negative

ALL METHODS 435 2 433 432 430 2

Alfa Scientific Instant View 2 - 2 2 2 -

Beckman Coulter Hemoccult ICT 46 1 45 46 45 1

Guaiac (slide) Test 276 - 276 273 273 -

Hemosure IFOB 47 - 47 47 47 -

Inverness Clearview iFOBT Complete 1 - 1 1 1 -

Other Immunochemical FOB kit 21 - 21 21 21 -

Polymedco OC Auto Micro 80 6 - 6 6 6 -

Polymedco OC-Light iFOB 15 - 15 15 15 -

Quidel QuickVue iFOB 10 - 10 10 10 -

2014 M1 Urine Sediment ID Specimens US-1 and US-2 CASE HISTORY US-1 and US-2: A 40-year-old pregnant female presented to her OB/GYN for a routine prenatal examination. A urine specimen was collected and refrigerated in the laboratory until urinalysis testing could be performed. Results appear below. Color = Pink Appearance = Turbid Dipstick results:

Specific Gravity = 1.025 pH = 5.5 Protein = Negative Glucose = Negative Ketones = Negative Bilirubin = Negative Urobilinogen = Normal/0.2 mg/dL Blood = Negative Leukocyte Esterase = Negative Nitrite = Negative

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Specimen US-1

Identification Labs Percent Performance

Amorph urate/phosphate crystal 554 86.29% Acceptable

Granular cast 23 3.58%

Identification Unknown – Refer 14 2.18%

Yeast/fungi 9 1.40%

Bacteria 8 1.25%

White blood cell(WBC) 6 0.93% Fiber/fecal contamination 5 0.78%

RBC/blood/hgb cast 5 0.78%

The arrows in this photo point to amorphous urate crystals. Amorphous means without shape or form. Amorphous urate crystals are normal, nonpathologic crystals commonly seen in

acidic, concentrated specimens that have been refrigerated. The specimen cup often contains a fluffy red precipitate described as “brick dust.” Microscopically, these small, formless urate crystals are identical to amorphous phosphate crystals, which are found in alkaline urines and form a white or colorless precipitate. To view another photo of amorphous crystals, see 2009 M1 Specimen US-2. Technical tip: Amorphous crystals can be so numerous that they obstruct the view of any other elements in the sediment. The crystals can be dissolved by washing the sediment with

warm saline or heating a tube of the urine or sediment in a hot water bath. Specimen US-2

Identification Labs Percent Performance

Hyaline cast 587 91.58% Acceptable

Waxy cast 27 4.21%

Granular cast 9 1.40%

Fiber/fecal contamination 8 1.25%

The arrow in this photo points to a hyaline cast. Hyaline casts are the most commonly seen casts in the urine. They are colorless and smooth, with a finely wrinkled surface and no

granules. The sides are parallel and the ends are blunt and rounded. Hyaline casts are normal, and frequently seen in the urine sediment of healthy people in small numbers (less than two per low-power field.) They may be increased after strenuous exercise or in other conditions, including renal disease. Waxy casts are more broad and square, with cracks and blunt ends. Granular casts have much more prominent granularity. To view a photo of a waxy cast, see 2006 M1 Specimen US-1. To view a granular cast, see 2008 M2 Specimen US-3. Technical tip: Hyaline casts have a low refractive index, which makes them hard to see if the microscope’s illumination is not set correctly. Use subdued lighting to examine urine

sediment, with the sub-stage condenser raised all the way up, and the condenser iris diaphragm approximately 70% closed / 30% open. Do not lower the condenser to decrease brightness. This reduces the resolution and sharpness of the image, which could cause you to miss important elements like casts. References: Moore, M.C.: Troubleshooting Clinical Microscopes. Microscopy USA, Pottstown, PA, 2008. Mundt, L.A, Shanahan, K.: Graff’s Textbook of Routine Urinalysis and Body Fluids, 2

nd ed. Philadelphia, Lippincott Williams & Wilkins, 2011.

Ringsrud, K. M., Linné, J. J.: Urinalysis and Body Fluids/ A ColorText and Atlas. St. Louis: Mosby, 1995. .

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PROVIDER-PERFORMED MICROSCOPY (PPM) Wet Mount Preparation

Specimen PPM-1

Identification Labs Percent Performance

White blood cell (WBC) 507 88.17% Acceptable

Red blood cell (RBC) 38 6.61%

Starch (Talc) granules 6 1.04%

Yeast/fungi 5 0.87%

The arrows in this photograph of a vaginal wet mount point to white blood cells. The nuclei within the cells give them a granular appearance. Presence of a large number of white blood cells is associated with infection such as Candidia, herpes, trichomonas, gonorrhea, or chlamydia. Red blood cells are smaller in size and appear hollow, sometimes resembling donuts or inner tubes. To view a photo of red blood cells in a wet mount, see 2011 M1 Specimen PPM-1. KOH Preparation Specimen PPM-2

Identification Labs Percent Performance

Yeast/fungal elements absent 494 89.66% Acceptable

Yeast/fungal elements present 57 10.34%

Yeast and fungal elements are absent in this photograph of a KOH vaginal wet mount. The numerous small objects in this photograph are bacteria. To view a photo of yeast in a KOH prep, see 2013 M1 Specimen PPM-2.

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PROVIDER-PERFORMED MICROSCOPY (PPM) Sperm Identification Specimen PPM-3

Identification Labs Percent Performance

Sperm present 556 99.82% Acceptable

Sperm absent 1 0.18%

Three sperm are present in this photograph of a vaginal wet mount preparation. Nasal Smear Specimen PPM-4

Identification Labs Percent Performance

Eosinophils absent 136 74.32% Acceptable

Eosinophils present 47 25.68%

Eosinophils are absent in this photograph of Wright-stained nasal mucus. The purpose of examining the leukocytes in stained nasal secretions is to differentiate allergic conditions from infections. Eosinophils are a specific type of leukocyte (white blood cell) that is increased in allergic conditions. The cells shown in this photo are not eosinophils. They indicate infection rather than allergy. “Eos” have a unique red-orange color that makes them easy to spot and identify. The cytoplasm of an eosinophil is filled with large, round, orange-staining granules that surround the purple nucleus but do not obscure it from view. The orange color comes from the dye eosin, which is a component of Wright stain. To view a photo of eosinophils, see 2013 M2 Specimen PPM-10. Specimen PPM-4 is graded by 100% referee consensus.

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PROVIDER-PERFORMED MICROSCOPY (PPM) PINWORM PREPARATION Specimen PPM-5

Identification Labs Percent Performance

Pinworms are present 246 99.60% Acceptable

Pinworms are absent 1 0.40%

Three pinworm eggs are present in this photograph of a perianal skin prep. . Vaginal Fluid Preparation Specimen PPM-6

Identification Labs Percent Performance

Ferning absent 263 98.87% Acceptable

Ferning present 3 1.13%

Ferning is absent in this photograph of air-dried vaginal secretions. References: Fischer, P. M.: The Office Laboratory. Norwalk, Conn.: Appleton-Century-Crofts, 1983. Mundt, L.A, Shanahan, K.: Graff’s Textbook of Routine Urinalysis and Body Fluids, 2

nd ed. Philadelphia: Lippincott Williams & Wilkins, 2011.

Ringsrud, K. M., Linné, J. J.: Urinalysis and Body Fluids/ A ColorText and Atlas. St. Louis: Mosby, 1995.

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