cbc-3k - rndheme.com · cbc-3k hematology controls ... manual / semi-automated ... notes: cbc-3k...

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AS029-020 Rev. 05/18 CBC-3K HEMATOLOGY CONTROLS ASSAY VALUES AND EXPECTED RANGES Instrument Parameter Low Normal High + KK084H CELL-DYN ® Sapphire TM WBC 10 9 /L 3.00 ± 0.40 7.90 ± 0.80 19.6 ± 2.20 NEU 10 9 /L 1.44 ± 0.60 5.17 ± 1.40 14.9 ± 3.60 NEU % 48.0 ± 12.0 65.5 ± 10.0 76.0 ± 9.00 LYM 10 9 /L 1.08 ± 0.55 1.70 ± 0.95 2.84 ± 2.07 LYM % 36.0 ± 12.0 21.5 ± 9.00 14.5 ± 8.00 MONO 10 9 /L 0.27 ± 0.27 0.40 ± 0.40 1.08 ± 1.08 MONO % 9.00 ± 9.00 5.00 ± 5.00 5.50 ± 5.50 EOS 10 9 /L 0.15 ± 0.15 0.47 ± 0.47 0.49 ± 0.49 EOS % 5.00 ± 5.00 6.00 ± 6.00 2.50 ± 2.50 BASO 10 9 /L 0.06 ± 0.06 0.16 ± 0.16 0.29 ± 0.29 BASO % 2.00 ± 2.00 2.00 ± 2.00 1.50 ± 1.50 RBC 10 12 /L 2.20 ± 0.18 4.84 ± 0.20 5.34 ± 0.24 RBCo 10 12 /L 2.20 ± 0.18 4.82 ± 0.20 5.27 ± 0.24 HGB g/dL 5.80 ± 0.30 13.6 ± 0.50 16.1 ± 0.70 HGB g/L 58.0 ± 3.00 136 ± 5.00 161 ± 7.00 HGB mmol/L 3.60 ± 0.20 8.43 ± 0.30 9.98 ± 0.50 HCT % 16.7 ± 1.80 40.9 ± 2.40 48.1 ± 3.00 HCT L/L 0.17 ± 0.02 0.41 ± 0.02 0.48 ± 0.03 MCV fL 76.0 ± 5.00 84.5 ± 5.00 90.0 ± 5.00 MCH pg 26.4 ± 2.80 28.1 ± 2.00 30.1 ± 2.00 MCH fmol 1.63 ± 0.18 1.74 ± 0.16 1.87 ± 0.16 MCHC g/dL 34.7 ± 3.60 33.3 ± 2.80 33.5 ± 2.80 MCHC g/L 347 ± 36.0 333 ± 28.0 335 ± 28.0 MCHC mmol/L 21.5 ± 2.30 20.6 ± 1.80 20.8 ± 1.80 RDW % 16.2 ± 3.00 15.4 ± 3.00 13.7 ± 3.00 NRBC 10 9 /L* .001 ± .001 .001 ± .001 2.15 ± 1.80 NRBC/100WBC* .001 ± .001 .001 ± .001 11.0 ± 9.20 PLT 10 9 /L 85.0 ± 22.0 232 ± 50.0 457 ± 70.0 PLTi 10 9 /L 94.0 ± 22.0 246 ± 50.0 474 ± 70.0 MPV fL 9.50 ± 3.00 8.40 ± 3.00 9.40 ± 3.00 PCT % ** 0.08 ± 0.03 0.19 ± 0.04 0.41 ± 0.08 PCT mL/L ** 0.80 ± 0.30 1.90 ± 0.40 4.10 ± 0.80 PDW** 16.5 ± 3.00 16.7 ± 2.50 17.4 ± 2.50 MANUAL / SEMI-AUTOMATED WBC 10 9 /L 3.1 ± 0.6 7.9 ± 1.2 22.0 ± 2.6 RBC 10 12 /L 2.10 ± 0.18 4.74 ± 0.22 5.24 ± 0.25 HGB g/dL 5.9 ± 0.4 13.9 ± 0.5 16.6 ± 0.8 HGB g/L 59 ± 4 139 ± 5 166 ± 8 HGB mmol/L 3.7 ± 0.2 8.6 ± 0.3 10.3 ± 0.5 Spun HCT % 15.5 ± 2.5 36.5 ± 3.0 44.5 ± 4.0 Spun HCT L/L 0.155 ± 0.025 0.365 ± 0.030 0.445 ± 0.040 PLT 10 9 /L 80 ± 20 240 ± 40 477 ± 70 Before using, refer to the instruction sheet for mixing directions. For technical assistance in the USA and Canada call Technical Service at (800) 523-3395. All brands and products are trademarks or registered trademarks of their respective companies. NOTES: CBC-3K may yield specimen status alert messages on the Cell-Dyn Sapphire instrument. PIC/POC errors may occur. Verify that the control is performing within assay range. * The assay value of .001 and mean range of +/- .001 for NRBC and NRBC/100WBC is entered for the Low level and Normal level controls since the instrument will not accept a value of zero. The NRBC concentration for the Low and Normal levels is below the detectable level of the instrument and such serves as the NRBC negative control. ** Clinical significance has not been established for these parameters. They are provided for laboratory use only. R&D Systems, Inc. 614 McKinley Place NE Minneapolis, MN 55413 USA AS029-020 Rev. 05/18 KK084 2018-09-05 QCP DATA MONTHS: JULY, AUGUST KK084N KK084L LOT LOT LOT CONTROL LOT Coulter Counter® F, FN, Z series Cyanmethemoglobin (manual) Centrifuged microhematocrit Hemocytometer Plt and WBC count

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Page 1: CBC-3K - rndheme.com · CBC-3K HEMATOLOGY CONTROLS ... MANUAL / SEMI-AUTOMATED ... NOTES: CBC-3K may yield specimen status alert messages on the Cell-Dyn 3200 …

AS029-020 Rev. 05/18

CBC-3KHEMATOLOGY CONTROLS

ASSAY VALUES AND EXPECTED RANGES

Instrument Parameter Low Normal High +KK084H

CELL-DYN® SapphireTM WBC 109/L 3.00 ± 0.40 7.90 ± 0.80 19.6 ± 2.20 NEU 109/L 1.44 ± 0.60 5.17 ± 1.40 14.9 ± 3.60 NEU % 48.0 ± 12.0 65.5 ± 10.0 76.0 ± 9.00 LYM 109/L 1.08 ± 0.55 1.70 ± 0.95 2.84 ± 2.07 LYM % 36.0 ± 12.0 21.5 ± 9.00 14.5 ± 8.00 MONO 109/L 0.27 ± 0.27 0.40 ± 0.40 1.08 ± 1.08 MONO % 9.00 ± 9.00 5.00 ± 5.00 5.50 ± 5.50 EOS 109/L 0.15 ± 0.15 0.47 ± 0.47 0.49 ± 0.49 EOS % 5.00 ± 5.00 6.00 ± 6.00 2.50 ± 2.50 BASO 109/L 0.06 ± 0.06 0.16 ± 0.16 0.29 ± 0.29 BASO % 2.00 ± 2.00 2.00 ± 2.00 1.50 ± 1.50RBC 1012/L 2.20 ± 0.18 4.84 ± 0.20 5.34 ± 0.24RBCo 1012/L 2.20 ± 0.18 4.82 ± 0.20 5.27 ± 0.24HGB g/dL 5.80 ± 0.30 13.6 ± 0.50 16.1 ± 0.70HGB g/L 58.0 ± 3.00 136 ± 5.00 161 ± 7.00HGB mmol/L 3.60 ± 0.20 8.43 ± 0.30 9.98 ± 0.50HCT % 16.7 ± 1.80 40.9 ± 2.40 48.1 ± 3.00HCT L/L 0.17 ± 0.02 0.41 ± 0.02 0.48 ± 0.03MCV fL 76.0 ± 5.00 84.5 ± 5.00 90.0 ± 5.00MCH pg 26.4 ± 2.80 28.1 ± 2.00 30.1 ± 2.00MCH fmol 1.63 ± 0.18 1.74 ± 0.16 1.87 ± 0.16MCHC g/dL 34.7 ± 3.60 33.3 ± 2.80 33.5 ± 2.80MCHC g/L 347 ± 36.0 333 ± 28.0 335 ± 28.0MCHC mmol/L 21.5 ± 2.30 20.6 ± 1.80 20.8 ± 1.80RDW % 16.2 ± 3.00 15.4 ± 3.00 13.7 ± 3.00NRBC 109/L* .001 ± .001 .001 ± .001 2.15 ± 1.80NRBC/100WBC* .001 ± .001 .001 ± .001 11.0 ± 9.20PLT 109/L 85.0 ± 22.0 232 ± 50.0 457 ± 70.0PLTi 109/L 94.0 ± 22.0 246 ± 50.0 474 ± 70.0MPV fL 9.50 ± 3.00 8.40 ± 3.00 9.40 ± 3.00PCT % ** 0.08 ± 0.03 0.19 ± 0.04 0.41 ± 0.08PCT mL/L ** 0.80 ± 0.30 1.90 ± 0.40 4.10 ± 0.80PDW** 16.5 ± 3.00 16.7 ± 2.50 17.4 ± 2.50

MANUAL / SEMI-AUTOMATEDWBC 109/L 3.1 ± 0.6 7.9 ± 1.2 22.0 ± 2.6RBC 1012/L 2.10 ± 0.18 4.74 ± 0.22 5.24 ± 0.25HGB g/dL 5.9 ± 0.4 13.9 ± 0.5 16.6 ± 0.8HGB g/L 59 ± 4 139 ± 5 166 ± 8HGB mmol/L 3.7 ± 0.2 8.6 ± 0.3 10.3 ± 0.5Spun HCT % 15.5 ± 2.5 36.5 ± 3.0 44.5 ± 4.0Spun HCT L/L 0.155 ± 0.025 0.365 ± 0.030 0.445 ± 0.040PLT 109/L 80 ± 20 240 ± 40 477 ± 70

Before using, refer to the instruction sheet for mixing directions. For technical assistance in the USA and Canada call Technical Service at (800) 523-3395.All brands and products are trademarks or registered trademarks of their respective companies.

NOTES: CBC-3K may yield specimen status alert messages on the Cell-Dyn Sapphire instrument. PIC/POC errors may occur. Verify that the control is performing within assay range.* The assay value of .001 and mean range of +/- .001 for NRBC and NRBC/100WBC is entered for the Low level and Normal level controls since the instrument will not accept a value of zero. The NRBC concentration for the Low and Normal levels is below the detectable level of the instrument and such serves as the NRBC negative control.** Clinical significance has not been established for these parameters. They are provided for laboratory use only.

R&D Systems, Inc.614 McKinley Place NE

Minneapolis, MN 55413 USAAS029-020 Rev. 05/18

KK084

2018-09-05QCP DATA MONTHS: JULY, AUGUST

KK084NKK084L LOTLOTLOT

CONTROL

LOT

Coulter Counter® F, FN, Z seriesCyanmethemoglobin (manual)Centrifuged microhematocritHemocytometer Plt and WBC count

Page 2: CBC-3K - rndheme.com · CBC-3K HEMATOLOGY CONTROLS ... MANUAL / SEMI-AUTOMATED ... NOTES: CBC-3K may yield specimen status alert messages on the Cell-Dyn 3200 …

AS029-020 Rev. 05/18

CBC-3KHEMATOLOGY CONTROLS

ASSAY VALUES AND EXPECTED RANGES KK084

2018-09-05QCP DATA MONTHS: JULY, AUGUST

CONTROL

LOT

Instrument Parameter Low Normal High ++KK084H

CELL-DYN 3200 WBC (WOC) K/µL 2.8 ± 0.4 7.5 ± 1.0 19.2 ± 2.5WBC (NOC) K/µL 3.0 ± 0.4 7.9 ± 1.0 21.6 ± 2.5

Software Version 1.8 or higher NEU K/µL 1.3 ± 0.6 5.0 ± 1.6 14.6 ± 4.1NEU % 48.0 ± 11.0 67.0 ± 10.0 76.0 ± 10.0LYM K/µL 1.1 ± 0.5 1.5 ± 1.1 3.1 ± 2.4LYM % 37.5 ± 11.0 20.0 ± 10.0 16.0 ± 9.0

Assay values established MONO K/µL 0.2 ± 0.2 0.4 ± 0.4 0.8 ± 0.8in QC file. MONO % 8.0 ± 8.0 5.0 ± 5.0 4.0 ± 4.0

EOS K/µL 0.1 ± 0.1 0.5 ± 0.5 0.5 ± 0.5EOS % 5.0 ± 5.0 6.5 ± 6.5 2.5 ± 2.5BASO K/µL 0.1 ± 0.1 0.1 ± 0.1 0.3 ± 0.3BASO % 1.5 ± 1.5 1.5 ± 1.5 1.5 ± 1.5RBC M/µL 2.16 ± 0.18 4.80 ± 0.24 5.32 ± 0.28HGB g/dL 5.6 ± 0.4 13.6 ± 0.6 16.4 ± 0.8HGB g/L 56 ± 4 136 ± 6 164 ± 8HGB mmol/L 3.5 ± 0.3 8.4 ± 0.4 10.2 ± 0.5HCT % 15.7 ± 1.8 38.4 ± 2.5 44.7 ± 3.5HCT L/L 0.157 ± 0.018 0.384 ± 0.025 0.447 ± 0.035MCV fL 72.5 ± 5.0 80.0 ± 5.0 84.0 ± 5.0MCH pg 25.9 ± 2.8 28.3 ± 2.4 30.8 ± 2.4MCH fmol 1.61 ± 0.18 1.76 ± 0.16 1.91 ± 0.16MCHC g/dL 35.8 ± 3.6 35.4 ± 3.0 36.7 ± 3.0MCHC g/L 358 ± 36 354 ± 30 367 ± 30MCHC mmol/L 22.2 ± 2.3 22.0 ± 1.8 22.8 ± 1.8RDW % 13.9 ± 3.0 12.8 ± 3.0 10.7 ± 3.0PLT K/µL 85 ± 22 250 ± 45 485 ± 70MPV fL 5.5 ± 3.0 5.5 ± 3.0 6.0 ± 3.0

CELL-DYN RubyTM WBC (WOC) K/µL 2.8 ± 0.4 7.5 ± 1.0 19.2 ± 2.5WBC (NOC) K/µL 3.0 ± 0.4 7.9 ± 1.0 21.6 ± 2.5NEU K/µL 1.3 ± 0.6 5.0 ± 1.6 14.6 ± 4.1NEU % 48.0 ± 11.0 67.0 ± 10.0 76.0 ± 10.0LYM K/µL 1.1 ± 0.5 1.5 ± 1.1 3.1 ± 2.4LYM % 37.5 ± 11.0 20.0 ± 10.0 16.0 ± 9.0

Assay values established MONO K/µL 0.2 ± 0.2 0.4 ± 0.4 0.8 ± 0.8in QC file. MONO % 8.0 ± 8.0 5.0 ± 5.0 4.0 ± 4.0

EOS K/µL 0.1 ± 0.1 0.5 ± 0.5 0.5 ± 0.5EOS % 5.0 ± 5.0 6.5 ± 6.5 2.5 ± 2.5BASO K/µL 0.1 ± 0.1 0.1 ± 0.1 0.3 ± 0.3BASO % 1.5 ± 1.5 1.5 ± 1.5 1.5 ± 1.5RBC M/µL 2.16 ± 0.18 4.80 ± 0.24 5.32 ± 0.28HGB g/dL 5.6 ± 0.4 13.6 ± 0.6 16.4 ± 0.8HGB g/L 56 ± 4 136 ± 6 164 ± 8HGB mmol/l 3.5 ± 0.3 8.4 ± 0.4 10.2 ± 0.5HCT % 15.7 ± 1.8 38.4 ± 2.5 44.7 ± 3.5HCT L/L 0.157 ± 0.018 0.384 ± 0.025 0.447 ± 0.035MCV fL 72.5 ± 5.0 80.0 ± 5.0 84.0 ± 5.0MCH pg 25.9 ± 2.8 28.3 ± 2.4 30.8 ± 2.4MCH fmol 1.61 ± 0.18 1.76 ± 0.16 1.91 ± 0.16MCHC g/dL 35.8 ± 3.6 35.4 ± 3.0 36.7 ± 3.0MCHC g/L 358 ± 36 354 ± 30 367 ± 30MCHC mmol/L 22.2 ± 2.3 22.0 ± 1.8 22.8 ± 1.8RDW % 13.9 ± 3.0 12.8 ± 3.0 10.7 ± 3.0PLT K/µL 85 ± 22 250 ± 45 485 ± 70MPV fL 5.5 ± 3.0 5.5 ± 3.0 6.0 ± 3.0

Before using, refer to the instruction sheet for mixing directions. For technical assistance in the USA and Canada call Technical Service at (800) 523-3395.All brands and products are trademarks or registered trademarks of their respective companies.

NOTES: CBC-3K may yield specimen status alert messages on the Cell-Dyn 3200 and Ruby instruments. Occasionally leukocyte cell populations are incorrectly identified. If this occurs, please rerun the sample. Neut/Eos flips may occur after Reticulocyte analysis. Please prime analyzer with whole blood to avoid.

R&D Systems, Inc.614 McKinley Place NE

Minneapolis, MN 55413 USAAS029-020 Rev. 05/18

KK084L KK084NLOT LOTLOT

Page 3: CBC-3K - rndheme.com · CBC-3K HEMATOLOGY CONTROLS ... MANUAL / SEMI-AUTOMATED ... NOTES: CBC-3K may yield specimen status alert messages on the Cell-Dyn 3200 …

AS029-020 Rev. 05/18

CBC-3KHEMATOLOGY CONTROLS

ASSAY VALUES AND EXPECTED RANGES KK084

2018-09-05QCP DATA MONTHS: JULY, AUGUST

CONTROL

LOT

Instrument Parameter Low Normal High +++KK084H

CELL-DYN 3500 WBC (WOC) K/µL 2.8 ± 0.4 7.4 ± 1.0 18.8 ± 2.5WIC K/µL 3.1 ± 0.4 8.1 ± 1.0 22.4 ± 2.5

CELL-DYN 3700 NEU K/µL 1.3 ± 0.6 5.0 ± 1.5 14.5 ± 4.0 NEU % 47.0 ± 12.0 67.5 ± 10.0 77.0 ± 10.0 LYM K/µL 1.1 ± 0.6 1.5 ± 1.0 2.9 ± 2.1 LYM % 40.0 ± 12.0 20.0 ± 10.0 15.5 ± 8.0 MONO K/µL 0.2 ± 0.2 0.4 ± 0.4 0.8 ± 0.8 MONO % 6.5 ± 6.5 5.0 ± 5.0 4.0 ± 4.0 EOS K/µL 0.2 ± 0.2 0.4 ± 0.4 0.5 ± 0.5 EOS % 5.5 ± 5.5 6.0 ± 6.0 2.5 ± 2.5 BASO K/µL 0.1 ± 0.1 0.1 ± 0.1 0.2 ± 0.2 BASO % 1.0 ± 1.0 1.5 ± 1.5 1.0 ± 1.0RBC M/µL 2.25 ± 0.18 4.81 ± 0.24 5.20 ± 0.28HGB g/dL 5.8 ± 0.4 13.6 ± 0.6 16.3 ± 0.8HGB g/L 58 ± 4 136 ± 6 163 ± 8HGB mmol/L 3.6 ± 0.3 8.4 ± 0.4 10.1 ± 0.5HCT % 18.5 ± 1.8 43.8 ± 2.5 50.4 ± 3.5HCT L/L 0.185 ± 0.018 0.438 ± 0.025 0.504 ± 0.035MCV fL 82.0 ± 5.0 91.0 ± 5.0 97.0 ± 5.0MCH pg 25.8 ± 2.8 28.3 ± 2.4 31.3 ± 2.4MCH fmol 1.60 ± 0.18 1.75 ± 0.16 1.94 ± 0.16MCHC g/dL 31.4 ± 3.6 31.1 ± 3.0 32.3 ± 3.0MCHC g/L 314 ± 36 311 ± 30 323 ± 30MCHC mmol/L 19.5 ± 2.3 19.3 ± 1.8 20.0 ± 1.8RDW % 17.0 ± 3.0 16.5 ± 3.0 16.0 ± 3.0PLT K/µL 85 ± 22 240 ± 45 475 ± 70MPV fL 7.5 ± 3.0 7.0 ± 3.0 8.5 ± 3.0

Before using, refer to the instruction sheet for mixing directions.

For technical assistance in the USA and Canada call Technical Service at (800) 523-3395.

All brands and products are trademarks or registered trademarks of their respective companies.

NOTES: CBC-3K may yield specimen status alert messages on the Cell-Dyn 3500 and 3700 instruments.

Occasionally leukocyte cell populations are incorrectly identified. If this occurs, please rerun the sample.

Neut/Eos flips may occur after Reticulocyte analysis. Please prime analyzer with whole blood to avoid.

R&D Systems, Inc.614 McKinley Place NE

Minneapolis, MN 55413 USAAS029-020 Rev. 05/18

KK084L KK084NLOT LOTLOT