blood sciences uncertainty of results

Barnsley/Rotherham Integrated Laboratories Department: Blood Sciences

Filename : Blood Sciences Uncertainty of Results QMS No : SOP-BS-30

Version : 5 of 33

Author : S. Dean Approved by : N. Cuthbert/E. Lees

Active Date : 16/04/2015 Review due : 16/04/2016

Title: Blood Sciences Uncertainty of Results

No.of copies : 2

Location of copies : 1. QPulse

2. Website

3.

Table of contents

1. Introduction .................................................................................................. 2

2. Uncertainty of laboratory results ................................................................... 2

2.1 Qualitative tests ............................................................................................ 2

2.2 Quantitative tests .......................................................................................... 2

3. Measurement Uncertainty for Biochemistry Assays ....................................... 3

4. Measurement Uncertainty for Haematology Assays ..................................... 14

5. Appendix 1 .................................................................................................. 32

6. Appendix 2 .................................................................................................. 32

7. Summary of revisions .................................................................................. 33



Version : 5 of 33



1. Introduction

The laboratory strives to maintain a high standard of performance. Good laboratory practice and

effective quality control procedures are invaluable at maintaining this position. However it should

be understood that there is an inherent degree of uncertainty in any laboratory investigation. The

level of uncertainty is a combination of three factors; pre-analytical influences, analytical variation

and biological variation. This ‘uncertainty’ means that if a series of samples are taken from one

individual, for any particular laboratory test, then the results will not be exactly the same.

Although some of the uncertainty can be controlled by the laboratory it is important for users to

recognise the effect of pre-analytical and biological variation when they interpret laboratory tests

and to understand the changes in values that must occur before they can be regarded as significant.

2. Uncertainty of laboratory results

All assays carry an inevitable degree of uncertainty. The Uncertainty Policy in Pathology (QU-COM-D-

32) identifies the risks/uncertainties with all the steps in the pre-examination, examination and post

examination phase and the control measures that are used to ensure that variation and possibilities

for error are minimised. These factors are well recognised but some occur by random error alone. A

random error is associated with the fact that when a measurement is repeated it will generally

provide a measured value that is different from the previous value. It is random in that the next

measured value cannot be predicted exactly from previous such values.

Within the laboratory we monitor analytical imprecision by a variety of methods:

2.1 Qualitative tests

Some laboratory results require ‘intrepretative’ assessments i.e. Positive or Negative or subjective

analysis e.g.. microcytic ++. There is an inevitable degree of observer bias in these assessments.

However, internal quality schemes are designed to minimise this variability but observer bias will

always be a factor.

Not only should users bear in mind these uncertainties when interpreting any laboratory value, but

they should also be cautious when attempting comparisons between different laboratories.

Specific information for qualitative tests can be found in the individual test SOPs.

2.2 Quantitative tests

Analytical variation can be divided into random error (precision) and systematic error (bias). For the

monitoring of a patients’ condition both most be controlled and maintained at an acceptable level.

This level may vary from analyte to analyte due to the nature of the assay but can be controlled by

the laboratory.

The Blood Sciences Quality Control Procedure (SOP-BS-076) outlines how it utilizes both Internal QC

and External QA schemes within procedures to monitor performance.

Regular review of External QA samples offers reassurance that accuracy and consistency are being

maintained through peer group analysis.



Version : 5 of 33



Day to day assurance is provided by repeated analysis of internal quality control material. This

analysis occurs at timed intervals. The time period will between analysers or specific tests due to

manufacturers guidelines or the experience; backed up by statistical data; of the laboratory staff.

This data is reviewed regularly for trends and required action.

Using a basic interpretation of method mean and Standard Deviation cut off at + and – 2 intervals

(see figure 1, below), we are able to access bias and uncertainty for parameters run on these

analysers. Additional Westgard statistical rules may also be applied to aid the laboratory to spot

biases and trends.

Figure 1; Typical normal distribution around a mean with cut off points at + and – 2 standard

deviations

All staff members are trained in Quality Control procedures to recognise a deterioration in

performance of an assay (for more information please see Qpulse reference HR-TR-CB-TUT-043;

Quality Control Tutorial) and have procedures to follow in case more guidance is required (e.g.

Qpulse reference SOP-CB-D-1; Biochemistry Quality Control Review and Interpretation).

Senior staff review this data regulaly for trends in performance.

As a laboratory generally employs a measurement procedure for long periods of time, the

uncertainty of measurement information most relevant to interpreting its test results against fixed

reference values is the imprecision of the test results across as many routine operating conditions as

possible (for example; multiple calibrator and reagent batches, multiple operators, equipment

maintenance, summer/winter etc). With the caveat that quality control materials may not totally

reflect the analytical behaviour of patient specimens, this imprecision is most easily derived from

long-term internal quality control (QC) data, calculated as standard deviation (SD) or coefficient of

variation (CV%). For the purpose of recording estimates of uncertainty of measurement the

imprecision should be documented as the 95% confidence interval (± 1.96 SD; or ± 1.96 CV%).

2.2.1 Measurement Uncertainty for Biochemistry Assays

The following table lists numeric Biochemisty assays perfomed by the Barnsley Blood

Sciences Laboratory.

The range refers to the quoted normal range unless otherwise stated.

+2sd -2sd



Version : 5 of 33



The table lists the QC with the target closest to these ranges and its CV. The effect that

1.96% of the CV would have on these ranges is the listed.

Please see Appendix 1 for the QC lot informationand date range used for calculating the CV.

Please note these values are for serum samples unless stated otherwise.

Biochemistry Reference Range Uncertainty

Assay Sex Age Category Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

AFP Upper Limit 10 9.7 7.9 8 12

ALBUMIN

Lower Limit 35 24.5 1.1 34 36

Upper Limit 50 43.0 1.7 48 52

ALKALINE

PHOSPHATASE

1 month

Lower Limit 70 70.5 3.3 65 75

Upper Limit 380 260.0 1.8 367 393

16 years

Lower Limit 60 70.5 3.3 56 64

Upper Limit 425 260.0 1.8 410 440

> 16 years

Lower Limit 30 22.0 3.3 28 32

Upper Limit 130 260 1.8 125 135

ALT Upper Limit 40 39.0 2.1 38 42

AMMONIA

Lower Limit 17 72.4 1.1 17 17

Upper Limit 48 72.4 1.1 47 49

AMPHETAMINE Positive 1000 770 5.2 898 1102

AMYLASE

Lower Limit 20 49.0 1.1 20 20

Upper Limit 100 146.0 1.3 97 103

AMYLASE (urine) Upper Limit 750 194 1.5 728 772

AST Upper Limit 40 48.5 1.8 39 41

B12

Lower Limit 211 184 16.2 144 278

Upper Limit 911 1260 6.4 797 1025

BENZODIAZEPINE Positive 200 162.0 6.3 175 225

BHCG (Pregnancy) Upper Limit 25 21.9 10 20 30

BHCG (Tumour) Upper Limit 5 5.9 10.4 4 6

BILIRUBIN (Total) Upper Limit 21 22.5 3 20 22

BILIRUBIN

(Conjugated)

<1 month Upper Limit 10 12.0 4.1 9 11

>1 month Upper Limit 7 12.0 4.1 6 8

BNP (Plasma)

Heart failure

probable 100 47.9 5.8 89 111



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Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

Heart failure

very

probable

500 484.0 5.7 444 556

CA125 Upper Limit 35 24.8 5.3 31 39

CA199 Upper Limit 35 24.7 11.4 27 43

CALCIUM (Adjusted

Serum)

Lower Limit 2.1 2.29 1.3 2.0 2.2

Upper Limit 2.6 2.29 1.3 2.5 2.7

CALCIUM (Urine 24

hour)

Lower Limit 2.5 2.72 1.6 2.4 2.6

Upper Limit 7.5 2.72 1.6 7.3 7.7

CALCIUM (Ionized)

Lower Limit 0.95 0.81 2.7 0.9 1.0

Upper Limit 1.5 1.59 2.7 1.4 1.6

CANNABINOIDS

Positive Cut

Off 50 35.0 9.8 40 60

CARBAMAZEPINE

(Theraputic Range)

Lower Limit 4 5.0 8.7 3 5

Upper Limit 25 13.6 5.5 22 28

CARBOXY

HAEMAGLOBIN Upper Limit 1.5 3.5 1.5 1.5 1.5

CEA Upper Limit 5 4.37 5.2 4 6

CHLORIDE (Serum)

Lower Limit 95 89.0 0.7 94 96

Upper Limit 108 103.0 0.75 106 110

CHLORIDE (Whole

Blood)

Lower Limit 95 112 2.2 91 99

Upper Limit 108 112 2.2 103 113

CHLORIDE (Urine 24

Hour)

Lower Limit 170 181.1 0.8 167 173

Upper Limit 250 181.1 0.8 246 254

CHOLESTEROL Upper Limit 5 5.27 1.6 5 5

COCAINE Positive 300 225.0 4.5 274 326

CREATINE KINASE

Neonates Upper limit 900 560.0 0.9 884.1 915.9

Infants

Lower Limit 100 61.0 2 96 104

Upper Limit 480 560.0 0.9 472 488

M Adult Lower Limit 40 61.0 2 38 42

Upper Limit 320 271.1 1 314 326

F

Adult

Lower Limit 25 61.0 2 24 26

Upper Limit 200 271.1 1 196 204

CREATININE (Serum) M

Lower Limit 66

49.0

2 63 69



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Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

Upper Limit 118 127.0 1.9 114 122

F

Lower Limit 51 49.0 2 49 53

Upper Limit 96 127.0 1.9 92 100

CREATINE (24 hour

urine)

Lower Limit 9 6.74 3.4 8 10

Upper Limit 17 16.3 3.2 16 18

CRP Upper Limit 10 4.6 2.4 10 10

CSF GLUCOSE

Lower Limit 2.5 3.5 1.6 2.4 2.6

Upper Limit 5 7.4 0.8 5 5

CSF LACTATE

Lower Limit 0.9 1.71 5.4 0.8 1.0

Upper Limit 1.8 1.71 5.4 1.6 2.0

CSF PROTEIN

<1year

Lower Limit 0.1 0.14 4.7 0.1 0.1

Upper Limit 1.2 0.74 2.3 1.1 1.3

> 1 year

Lower Limit 0.1 0.14 4.7 0.1 0.1

Upper Limit 0.4 0.74 2.3 0.4 0.4

CORTISOL (Morning)

Lower Limit 140

175

7 121 159

Upper Limit 500 578 6.9 432 568

DIGOXIN (Theraputic)

Lower Limit 0.5 0.76 9.1 0.4 0.6

Upper Limit 2 2.53 4.9 2 2

ETHANOL

Detection

limit 10 40.0 2.5 10 10

FERRITIN

Lower Limit 22 15.3 8.1 19 25

Upper Limit 322 312.4 6.7 280 364

FOLATE

Lower Limit 3.4 9.2 9.3 2.8 4.0

Upper Limit 15.8 18.0 9.9 12.7 18.9

FREE T3

<1 year

Lower Limit 3.3 4.95 3.1 3.1 3.5

Upper Limit 7.8 4.95 3.3 7.3 8.3

> 1 year

Lower Limit 3.5 4.95 3.1 3.3 3.7

Upper Limit 6.5 4.95 3.3 6.1 6.9

FREE T4

<1 month

Lower Limit 6.2 10.8 7.8 5.3 7.1

Upper Limit 29.9 28.5 5.3 26.8 33.0

< 1 year

Lower Limit 9.8 10.8 7.8 8.3 11.3

Upper Limit 25.8 28.5 5.3 23.1 28.5

< 16 year Lower Limit 9.8 10.8 7.8 8.3 11.3



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Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

Upper Limit 19.5 28.5 5.3 17.5 21.5

> 16 year

Lower Limit 10 10.8 7.8 8 12

Upper Limit 18.7 28.5 5.3 16.8 20.6

FSH (Follicular levels) F

Lower Limit 3.0 5.5 7.3 2.6 3.4

Upper Limit 20.0 34.3 7.2 17.2 22.8

FSH (Peak levels) F

Lower Limit 9.0 5.5 7.3 7.7 10.3

Upper Limit 26.0 34.3 7.2 22.3 29.7

FSH (Luteal) F

Lower Limit 1.0 5.5 7.3 0.9 1.1

Upper Limit 12.0 5.5 7.3 10.3 13.7

FSH (Post

Menopausall)

F

Lower Limit 18.0 5.5 7.2 15.5 20.5

Upper Limit 153.0 77.95 7.2 131.4 174.6

FSH M

Lower Limit 1.0 5.5 7.3 0.9 1.1

Upper Limit 12.0 5.5 7.3 10.3 13.7

FASTING GLUCOSE

(Serum)

Indicative of

Diabetes

Mellitus

7.0 7.40 0.8 6.9 7.1

GGT F Upper Limit 30.0 33.0 3.5 27.9 32.1

M Upper Limit 50.0 77.5 1.7 48.3 51.7

GENTAMICIN Upper Limit 10.0 5.1 7.1 8.6 11.4

HDL- Cholesterol Lower Limit 1.0 1.24 2.7 0.9 1.1

HbA1c

Increased

risk of

Diabetes

38.8 33.3 1.8 37.4 40.2

IgA

< 13 days Lower Limit 0.01 1.19 1.6 0.01 0.01

Upper Limit 0.08 1.19 1.6 0.08 0.08

13 - 28 days Lower Limit 0.02 1.19 1.6 0.02 0.02

Upper Limit 0.15 1.19 1.6 0.15 0.15

28 days – 2

months

Lower Limit 0.05 1.19 1.6 0.05 0.05

Upper Limit 0.4 1.19 1.6 0.4 0.4

2 months –

5 months

Lower Limit 0.1 1.19 1.6 0.1 0.1

Upper Limit 0.5 1.19 1.6 0.5 0.5

5 months –

8 months

Lower Limit 0.15 1.19 1.6 0.15 0.15

Upper Limit 0.7 1.19 1.6 0.7 0.7

8 months – Lower Limit 0.2 1.19 1.6 0.2 0.2



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Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

11 months Upper Limit 0.7 1.19 1.6 0.7 0.7

11 months –

1 year

Lower Limit 0.3 1.19 1.6 0.3 0.3

Upper Limit 1.2 1.19 1.6 1.2 1.2

1 year – 2

years

Lower Limit 0.3 1.19 1.6 0.3 0.3

Upper Limit 1.3 1.19 1.6 1.3 1.3

2 years – 5

years

Lower Limit 0.2 1.19 1.6 0.2 0.2


5 years – 8

years

Lower Limit 0.5 1.19 1.6 0.5 0.5

Upper Limit 2.4 2.6 1.4 2.3 2.5

8 years- 11

years

Lower Limit 0.7 1.19 1.6 0.7 0.7

Upper Limit 2.5 2.6 1.4 2.4 2.6

11 years –

44 years

Lower Limit 0.8 1.19 1.6 0.8 0.8

Upper Limit 2.8 2.6 1.4 2.7 2.9

> 44 years Lower Limit 0.8 1.19 1.6 0.8 0.8


IgG

< 13 days Lower Limit 5 6.98 1.3 5 5

Upper Limit 17 15.7 1.2 17 17

13 - 28 days Lower Limit 3.9 6.98 1.3 3.8 4.0

Upper Limit 13 11.54 1 12.7 13.3

28 days – 2

months

Lower Limit 2.1 6.98 1.3 2.0 2.2

Upper Limit 7.7 6.98 1.3 7.5 7.9

2 months –

5 months

Lower Limit 2.4 6.98 1.3 2.3 2.5

Upper Limit 8.8 6.98 1.3 8.6 9.0

5 months –

8 months

Lower Limit 3 6.98 1.3 3 3

Upper Limit 9 6.98 1.3 9 9

8 months –

11 months

Lower Limit 3 6.98 1.3 3 3

Upper Limit 10.9 11.54 1 10.7 11.1

11 months –

1 year

Lower Limit 3.1 6.98 1.3 3.0 3.2

Upper Limit 13.8 11.54 1 13.5 14.1

1 year – 2

years

Lower Limit 3.7 6.98 1.3 3.6 3.8

Upper Limit 15.8 15.7 1.2 15.4 16.2

2 years – 5

years

Lower Limit 4.9 6.98 1.3 4.8 5.0

Upper Limit 16.1 15.7 1.2 15.7 16.5

5 years – 14 Lower Limit 5.4 6.98 1.3 5.3 5.5



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Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

years Upper Limit 16.1 15.7 1.2 15.7 16.5

> 14 years Lower Limit 6 6.98 1.3 6 6

Upper Limit 16 15.7 1.2 16 16

IgM

< 13 days Lower Limit 0.05 0.48 3.5 0.05 0.05


13 - 28 days Lower Limit 0.08 0.48 3.5 0.07 0.09

Upper Limit 0.4 0.48 3.5 0.4 0.4

28 days – 2

months

Lower Limit 0.17 0.48 3.5 0.16 0.18

Upper Limit 0.7 0.48 3.5 0.7 0.7

2 months –

5 months

Lower Limit 0.2 0.48 3.5 0.2 0.2

Upper Limit 1 1.08 1.8 1 1

5 months –

8 months

Lower Limit 0.4 0.48 3.5 0.4 0.4

Upper Limit 1.6 1.2 1.6 1.5 1.7

8 months –

11 months

Lower Limit 0.6 0.48 3.5 0.6 0.6

Upper Limit 2.1 1.2 1.6 2.0 2.2

11 months –

2 year

Lower Limit 0.5 0.48 3.5 0.5 0.5

Upper Limit 2.2 1.2 1.6 2.1 2.3

2 year – 5

years

Lower Limit 0.5 0.48 3.5 0.5 0.5


5 years – 11

years

Lower Limit 0.5 0.48 3.5 0.5 0.5

Upper Limit 1.8 1.2 1.6 1.7 1.9

11 years –

44 years

Lower Limit 0.5 0.48 3.5 0.5 0.5

Upper Limit 1.9 1.2 1.6 1.8 2.0



IRON

M

Lower Limit 12 15.5 1.4 12 12

Upper Limit 31 39.0 1.1 30 32

F

Lower Limit 9 15.5 1.4 9 9

Upper Limit 30 39.0 1.1 29 31

LACTATE (whole

blood)

Lower Limit 0.67 1.71 5.4 0.60 0.74

Upper Limit 2.47 1.71 5.4 2.21 2.73

LACTATE

DEHYDROGENASE

Lower Limit 208 295 1.6 201 215

Upper Limit 378 295 1.6 366 390

LH (Follicular levels) F Lower Limit 2 3.68 5.3 2 2



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Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

Upper Limit 15 3.68 5.3 13 17

LH (Peak levels) F

Lower Limit 22 38.4 4.8 20 24

Upper Limit 105 61.1 5.4 94 116

LH (Luteal) F Lower Limit 0.6 3.68 5.3 1 1

Upper Limit 19 3.68 5.3 17 21

LH (Post

Menopausall)

F

Lower Limit 16 3.68 5.3 14 18

Upper Limit 64 61.1 5.4 57 71

LH M

Lower Limit 2 3.68 5.3 2 2

Upper Limit 12 3.68 5.3 11 13

LITHIUM (Theraputic

Range)

Lower Limit 0.4 0.64 0.9 0.4 0.4

Upper Limit 1.0 1.15 2.7 0.9 1.1

MAGNESIUM Blood)

Lower Limit 0.7 0.57 5.5 0.6 0.8

Upper Limit 1 1.06 2.4 1 1

MAGNESIUM (24

hour urine)

Lower Limit 2.4 1.74 2.4 2.3 2.5

Upper Limit 6.5 1.74 2.4 6.2 6.8

METHADONE Positive 300 215.0 2.2 287 313

METHAEMAGLOBIN

Lower Limit 0.4 3.9 0.4 0.4 0.4

Upper Limit 1.5 3.9 0.4 1.5 1.5

MICROALBUMIN Upper Limit 30 63.6 4.1 28 32

OESTRADIOL

< 2 months Upper Limit 177 226.0 11 139 215

2 months –

14 years Upper Limit 44 226.0 11 35 53

> 14 years Upper Limit 146 226.0 11 115 177

OPIATES Positive 300 235.0 8.3 251 349

OSMOLALITY (Serum)

Lower Limit 275 311 1 267 280

Upper Limit 295 311 1 289 301

OSMOLALITY (Urine)

Lower Limit 50 451 0.4 50 50

Upper Limit 1200 877 0.4 1191 1209

PARACETAMOL

4 hours 100 164 3 94 106

12 hours 25 17.0 3.8 23 27

pCO2

Lower Limit 4.5 2.0 6.9 3.9 5.1

Upper Limit 6.1 9.9 4.7 5.5 6.7

pH

Lower Limit 7.35 7.55 0.2 7.32 7.38

Upper Limit 7.45 7.55 0.2 7.42 7.48



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Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

PHENOBARBITONE

(Theraputic Range)

Lower Limit 10 7.86 5.5 9 11

Upper Limit 40 28.4 5.8 35 45

PHENYTOIN

(Theraputic Range)

Lower Limit 5 7.8 6.5 4 6

Upper Limit 20 20.5 5.5 18 22

pO2

Lower Limit 12 18.2 8.1 10 14

Upper Limit 15 18.2 8.1 13 17

POTASSIUM (Serum)

Lower Limit 3.5 4.05 0.7 3.5 3.5

Upper Limit 5.3 5.87 0.7 5.2 5.4

POTASSIUM (Whole

blood)

Lower Limit 3.5 3.3 1 3.4 3.6

Upper Limit 5.1 3.3 1 5.0 5.2

POTASSIUM (Urine)

Lower Limit 40 30.0 0.8 39 41

Upper Limit 120 83.3 1 118 122

PHOSPHATE (Serum) < 1 month Lower Limit 1.4 1.44 2.2 1.3 1.5

Upper Limit 3.1 2.22 2.4 3.0 3.2

1 month - 1

year

Lower Limit 1 1.44 2.2 1 1

Upper Limit 2.6 2.22 2.4 2.5 2.7

1 year- 16

years

Lower Limit 1.2 1.44 2.2 1.1 1.3

Upper Limit 2.3 2.22 2.4 2.2 2.4


Upper Limit 1.5 1.44 2.4 1.4 1.6

PHOSPHATE (Urine) Lower Limit 15 15.9 2.8 14 16

Upper Limit 50 15.9 2.8 47 53

PROGESTERONE

(Follicular levels)

F

Lower Limit 24.7 25.1 7.3 21.2 28.2

Upper Limit 85.9 90.94 5.9 76.0 95.8

PROGESTERONE

(Luteal)

F

Lower Limit 24.7 25.1 7.3 21.2 28.2

Upper Limit 85.9 90.94 5.9 76.0 95.8

PROGESTERONE (Mid

Luteal)

F

Lower Limit 30.8 25.1 7.3 26.4 35.2

Upper Limit 36.8 25.1 7.3 31.5 42.1

PROGESTERONE

(Post Menopausal)

F

Lower Limit 0.6 2.67 15.5 0.4 0.8

Upper Limit 1.6 2.67 15.5 1.1 2.1

PROLACTIN M Upper Limit 373 497.0 6.2 328 418

F Upper Limit 646 794.3 5.7 574 718

PROTEIN (Serum)

Lower Limit 60 72 2.1 58 62

Upper Limit 80 91 2 77 83



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Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

PROTEIN (24 Hour

Urine)

Detection

limit 0.15 0.14 4.7 0.14 0.16

PROTEIN (URINE) Detection

limit 0.1 0.14 4.1 0.1 0.1

PSA

M <60 years Upper Limit 3 1.71 5.6 3 3

60-70 years Upper Limit 4 1.71 5.6 4 4

>60 years Upper Limit 5 1.71 5.6 4 6

RF Positive cut

off 13 12.7 12.3 10 16

SALICYLATE

Theraputic

upper limit 250 132.0 3.2 234 266

Severe

toxicity 500 531.0 1.6 484 516

SODIUM (Serum)

Lower Limit 136 140.0 0.5 135 137

Upper Limit 145 140.0 0.5 144 146

SODIUM (Whole

Blood)

Lower Limit 136 126 0.8 134 138

Upper Limit 145 150 0.8 143 147

SODIUM (Urine 24

hour)

Lower Limit 100 73.7 0.6 99 101

Upper Limit 250 166.3 0.7 247 253

SHBG

M Lower Limit 17 16.55 5.2 15 19

Upper Limit 66 52.8 5.6 59 73

F

Lower Limit 28 16.55 5.2 25 31

Upper Limit 146 52.8 5.6 130 162

TESTOSTERONE

M

Lower Limit 8.4 12.0 8.8 7.0 9.8

Upper Limit 28.7 28.1 7.7 24.4 33.0

F

Lower Limit 0.5 1.16 27 0.2 0.8

Upper Limit 2.6 1.16 27 1.2 4.0

THEOPHYLLINE

(Theraputic Range)

Lower Limit 12 11.8 5.4 11 13

Upper Limit 20 30.7 7.9 17 23

TROPONIN I

Detectable

cardiac

damage

40 10 11.5 31 49

TRANSFERRIN

Lower Limit 2.0 1.3 1.3 1.9 2.1

Upper Limit 3.2 3.3 1.9 3.1 3.3

TRIGLYCERIDES Lower Limit 0.45 1.53 3.9 0.42 0.48



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Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

Upper Limit 1.88 1.53 3.9 1.74 2.02

TSH

Lower Limit 0.35 0.107 5.2 0.31 0.39

Upper Limit 5.5 2.24 3.8 5.1 5.9

UREA

Lower Limit 0.8 3.1 2.7 0.8 0.8

Upper Limit 7.8 10.3 1.9 7.5 8.1

UREA (Urine)

Lower Limit 250 277.0 2.7 237 263

Upper Limit 600 277.0 2.7 568 632

URIC ACID

M

Lower Limit 200 166.0 2.7 189 211

Upper Limit 430 271.0 1.8 415 445

F

Lower Limit 140 166.0 2.7 133 147

Upper Limit 360 530.0 1.7 348 372

URIC ACID (Urine) Lower Limit 1.5 0.87 3.8 1.4 1.6

URIC ACID (Urine) Upper Limit 4.5 0.87 3.8 4.2 4.8

VALPROATE

(Theraputic Range)

Lower Limit 50 43.0 3.2 47 53

Upper Limit 100 84.0 2.8 95 105

TOTAL VIT D

Deficiency 25 49.7 17.8 16 34

Mild

deficiency 50 49.7 17.8 33 67

Toxic 150 102.0 7.2 129 171



Version : 5 of 33



2.2.2 Measurement Uncertainty for Haematology Assays

The following table lists numeric Haematology assays perfomed by the Barnsley Blood

Sciences Laboratory.

The range refers to the quoted normal range unless otherwise stated.

The table lists the QC with the target closest to these ranges and its CV. The effect that

1.96% of the CV would have on these ranges is the listed.

Please see Appendix 2 for the QC lot informationand date range used for calculating the

CV.

Assay Reference Range Uncertainty

Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

FBC (whole blood)

Platelets 0 - 3 days lower 125 17.1 5.28 112 138

upper 450 234 3.27 421 479

3 - 7 days lower 150 234 3.27 140 160

upper 450 234 3.27 421 479

7 - 30 days lower 150 234 3.27 140 160

upper 475 234 3.27 445 505

1 - 2 months lower 180 234 3.27 168 192

upper 550 234 3.27 515 585

1 - 3 months lower 210 234 3.27 197 223

upper 650 234 3.27 608 692

3 -6 months lower 210 234 3.27 197 223

upper 600 234 3.27 562 638

6 months - 1 year lower 190 234 3.27 178 202

upper 530 234 3.27 496 564

1 - 3 years lower 190 234 3.27 178 202

upper 500 234 3.27 468 532

3 - 6 years lower 190 234 3.27 178 202

upper 490 234 3.27 459 521

6 -8 years lower 190 234 3.27 178 202

upper 440 234 3.27 412 468

8 - 10 years lower 185 234 3.27 173 197

upper 245 234 3.27 229 261



Version : 5 of 33




Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

Platelets

10 - 12 years lower 180 234 3.27 168 192

upper 405 234 3.27 379 431

12 - 14 years lower 180 234 3.27 168 192

upper 400 234 3.27 374 426

14 - 19 years lower 170 234 3.27 159 181

upper 400 234 3.27 374 426

19 years and

above lower 150 234 3.27 140 160

upper 400 234 3.27 374 426

Red Blood Cells 0 -3 days lower 3.85 4.32 1.44 3.74 3.96

upper 6.5 4.32 1.44 6.3 6.7

3 - 7 days lower 3.85 4.32 1.44 3.74 3.96

upper 6.4 4.32 1.44 6.2 6.6

7-14 days lower 3.53 4.32 1.44 3.43 3.63

upper 6.2 4.32 1.44 6.0 6.4

14 - 30 days lower 3.1 4.32 1.44 3.0 3.2

upper 5.2 4.32 1.44 5.1 5.3

30 - 60 days lower 2.9 4.32 1.44 2.8 3.0

upper 4.6 4.32 1.44 4.5 4.7

60 - 90 days lower 3.1 4.32 1.44 3.0 3.2

upper 4.65 4.32 1.44 4.52 4.78

90 - 120 days lower 3.2 4.32 1.44 3.1 3.3

upper 5 4.32 1.44 4.9 5.1

120 days- 6

months lower 3.4 4.32 1.44 3.3 3.5

upper 5.1 4.32 1.44 5.0 5.2

6 months - 1 year lower 3.7 4.32 1.44 3.6 3.8

upper 5.1 4.32 1.44 5.0 5.2

1 - 2 years lower 3.8 4.32 1.44 3.7 3.9

F 12 - 15 years lower 4.04 4.32 1.44 3.93 4.15



Version : 5 of 33




Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

Red Blood Cells upper 5.1 4.32 1.44 5.0 5.2

M 15 - 18 years lower 4.42 4.32 1.44 4.30 4.54

upper 5.6 4.32 1.44 5.4 5.8

F 15 - 18 years lower 4.0 4.32 1.44 3.9 4.1

upper 5.1 4.32 1.44 5.0 5.2

M over 21 years lower 4.33 4.32 1.44 4.21 4.45

upper 5.6 4.32 1.44 5.4 5.8

F over 21 years lower 3.85 4.32 1.44 3.74 3.96

upper 4.9 4.32 1.44 4.8 5.0

Haemoglobin 0 -3 days lower 145 113 1.37 141 149

upper 230 113 1.37 224 236

3 - 7 days lower 140 113 1.37 136 144

upper 222 113 1.37 216 228

7-14 days lower 130 113 1.37 127 133

upper 195 113 1.37 190 200

14 - 30 days lower 115 113 1.37 112 118

upper 167 113 1.37 163 171

30 - 60 days lower 94 113 1.37 91 97

upper 132 113 1.37 128 136

60 - 90 days lower 98 113 1.37 95 101

upper 132 113 1.37 128 136

90 - 120 days lower 102 113 1.37 99 105

upper 137 113 1.37 133 141

120 days- 6

months lower 103 113 1.37 100 106

upper 137 113 1.37 133 141

6 months - 1 year lower 105 113 1.37 102 108

upper 137 113 1.37 133 141

1 - 2 years lower 107 113 1.37 104 110

upper 134 113 1.37 130 138

2 - 3 years lower 110 113 1.37 107 113

upper 135 113 1.37 131 139

3 - 5 years lower 110 113 1.37 107 113

upper 136 113 1.37 132 140



Version : 5 of 33




Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

Haemoglobin 5 - 6 years lower 111 113 1.37 108 114

upper 138 113 1.37 134 142

6 - 7 years lower 113 113 1.37 110 116

upper 142 113 1.37 138 146

7 - 8 years lower 115 113 1.37 112 118

upper 142 113 1.37 138 146

8 - 10 years lower 117 113 1.37 114 120

upper 145 113 1.37 141 149

10 - 11 years lower 118 113 1.37 115 121

upper 145 113 1.37 141 149

11 - 12 years lower 120 113 1.37 117 123

upper 147 113 1.37 143 151

M 12 - 14 years lower 124 113 1.37 121 127

upper 156 113 1.37 152 160

F 12 - 14 years lower 119 113 1.37 116 122

upper 146 113 1.37 142 150

M 14 - 16 years lower 131 113 1.37 127 135

upper 163 113 1.37 159 167

F 14 - 16 years lower 117 113 1.37 114 120

upper 156 113 1.37 152 160

M 16 - 18 years lower 129 113 1.37 126 132

upper 165 113 1.37 161 169

F 16 - 18 years lower 117 113 1.37 114 120

upper 157 113 1.37 153 161

M Over 21 years lower 132 113 1.37 128 136

upper 169 113 1.37 164 174

F Over 21 years lower 119 113 1.37 116 122

upper 149 113 1.37 145 153

Haematocrit 0 -7 days lower 0.44 0.339 2.22 0.42 0.46

upper 0.70 0.339 2.22 0.67 0.73

7-14 days lower 0.41 0.339 2.22 0.39 0.43

upper 0.65 0.339 2.22 0.62 0.68

14 - 30 days lower 0.34 0.339 2.22 0.33 0.35

upper 0.55 0.339 2.22 0.53 0.57



Version : 5 of 33




Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

Haematocrit 30 - 60 days lower 0.29 0.339 2.22 0.28 0.30

upper 0.47 0.339 2.22 0.45 0.49

60 - 90 days lower 0.29 0.339 2.22 0.28 0.30

upper 0.41 0.339 2.22 0.39 0.43

90 days - 6

months lower 0.30 0.339 2.22 0.29 0.31

upper 0.41 0.339 2.22 0.39 0.43

6 months - 2

years lower 0.31 0.339 2.22 0.30 0.32

upper 0.41 0.339 2.22 0.39 0.43

2 - 3 years lower 0.32 0.339 2.22 0.31 0.33

upper 0.41 0.339 2.22 0.39 0.43

3 - 5 years lower 0.33 0.339 2.22 0.32 0.34

upper 0.41 0.339 2.22 0.39 0.43

5 - 7 years lower 0.33 0.339 2.22 0.32 0.34

upper 0.42 0.339 2.22 0.40 0.44

7 - 8 years lower 0.34 0.339 2.22 0.33 0.35

upper 0.44 0.339 2.22 0.42 0.46

8 - 12 years lower 0.35 0.339 2.22 0.33 0.37

upper 0.44 0.339 2.22 0.42 0.46

M 12 - 14 years lower 0.35 0.339 2.22 0.33 0.37

upper 0.47 0.339 2.22 0.45 0.49

F 12 - 14 years lower 0.35 0.339 2.22 0.33 0.37

upper 0.45 0.339 2.22 0.43 0.47

M 14 - 16 years lower 0.37 0.339 2.22 0.35 0.39

upper 0.49 0.339 2.22 0.47 0.51

F 14 - 16 years lower 0.35 0.339 2.22 0.33 0.37

upper 0.45 0.339 2.22 0.43 0.47

M Over 16 years lower 0.39 0.339 2.22 0.37 0.41

upper 0.49 0.339 2.22 0.47 0.51

F Over 16 years lower 0.35 0.339 2.22 0.33 0.37

upper 0.46 0.339 2.22 0.44 0.48

MCV 0 -3 days lower 100 78.5 1.49 97 103

upper 127 78.5 1.49 123 131



Version : 5 of 33




Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

7 - 14 days lower 94 78.5 1.49 91 97

upper 126 78.5 1.49 122 130

14 - 30 days lower 90 78.5 1.49 87 93

upper 116 78.5 1.49 113 119

30 - 60 days lower 82 78.5 1.49 80 84

upper 99 78.5 1.49 96 102

60 - 90 days lower 75 78.5 1.49 73 77

upper 95 78.5 1.49 92 98

90 days - 6

months lower 70 78.5 1.47 68 72

upper 88 78.5 1.49 85 91

6 months - 1 year lower 71 78.5 1.47 69 73

upper 84 78.5 1.49 82 86

1 year - 2 years lower 73 78.5 1.47 71 75

upper 84 78.5 1.49 82 86

2 years - 3 years lower 73 78.5 1.47 71 75

upper 85 78.5 1.49 83 87


upper 86 78.5 1.49 83 89

MCV 6 years - 8 years lower 75 78.5 1.49 73 77

upper 89 78.5 1.49 86 92


upper 90 78.5 1.49 87 93

10 years - 12

years lower 77 78.5 1.49 75 79

upper 90 78.5 1.49 87 93

12 years - 14

years lower 78 78.5 1.49 76 80

upper 93 78.5 1.49 90 96

14 years - 16

years lower 79 78.5 1.49 77 81

upper 95 78.5 1.49 92 98

Over 16 years lower 82 78.5 1.49 80 84

upper 100 78.5 1.49 97 103

MCH 0 -7 days lower 31 26.2 1.70 30 32



Version : 5 of 33




Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

MCH upper 39 26.2 1.70 38 40

7 -14 days lower 30.5 26.2 1.70 29.5 31.5

upper 37.5 26.2 1.70 36.3 38.7

14 -30 days lower 28.5 26.2 1.70 27.6 29.4

upper 35.5 26.2 1.70 34.3 36.7

30 -60 days lower 26 26.2 1.70 25.1 26.9

upper 33 26.2 1.70 31.9 34.1

60 -90 days lower 24.5 26.2 2.15 23.5 25.5

upper 30 26.2 1.70 29.0 31.0

90 days - 6

months lower 24 26.2 2.15 23.0 25.0

upper 29 26.2 1.70 28.0 30.0

6 months - 6

years lower 24.5 26.2 2.15 23.5 25.5

upper 30 26.2 1.70 29.0 31.0

6 years - 8 years lower 25.2 26.2 1.70 24.4 26.0

upper 31.7 26.2 1.70 30.6 32.8


upper 31.7 26.2 1.70 30.6 32.8

10 years - 12

years lower 26 26.2 1.70 25.1 26.9

upper 31.7 26.2 1.70 30.6 32.8

12 years - 14

years lower 26.9 26.2 1.70 26.0 27.8

upper 32.3 26.2 1.70 31.2 33.4

14 years - 16

years lower 26.9 26.2 1.70 26.0 27.8

upper 32.5 26.2 1.70 31.4 33.6

Over 16 years lower 27 26.2 1.70 26.1 27.9

upper 32.5 26.2 1.70 31.4 33.6

MCHC 0 -3 days lower 308 26.2 2.66 292 324

upper 365 26.2 2.44 348 382

3 -7 days lower 303 26.2 2.66 287 319

upper 368 26.2 2.44 350 386

7 -14 days lower 298 26.2 2.66 282 314



Version : 5 of 33




Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

MCHC upper 373 26.2 2.44 355 391

14 -30 days lower 303 26.2 2.66 287 319

upper 368 26.2 2.44 350 386

60 -90 days lower 300 26.2 2.66 284 316

upper 365 26.2 2.44 348 382

90 days - 1 year lower 308 26.2 2.66 292 324

upper 365 26.2 2.44 348 382

1 year - 2 years lower 315 26.2 2.44 300 330

upper 365 26.2 2.44 348 382

Over 2 years lower 316 26.2 2.44 301 331

upper 365 26.2 2.44 348 382

RDW lower 12.2 15.9 1.52 11.8 12.6

upper 15.4 15.9 1.52 14.9 15.9

White Blood Cells 0 -3 days lower 10 7.02 2.87 9.4 10.6

upper 26 7.02 2.87 24.5 27.5

5 - 7 days lower 8.5 7.02 2.87 8.0 9.0

upper 24.5 7.02 2.87 23.1 25.9

7 - 30 days lower 6 7.02 2.87 5.7 6.3

upper 19.2 7.02 2.87 18.1 20.3

30 - 60 days lower 5.1 7.02 2.87 4.8 5.4

upper 17.3 7.02 2.87 16.3 18.3

60 - 90 days lower 5.5 7.02 2.87 5.2 5.8

upper 15.3 7.02 2.87 14.4 16.2

90 - 120 days lower 5.5 7.02 2.87 5.2 5.8

upper 16 7.02 2.87 15.1 16.9

120 days - 6

months lower 5 7.02 2.87 4.7 5.3

upper 15 7.02 2.87 14.2 15.8


upper 15 7.02 2.87 14.2 15.8

1 year - 2 years lower 5.3 7.02 2.87 5.0 5.6

upper 14 7.02 2.87 13.2 14.8


upper 14 7.02 2.87 13.2 14.8



Version : 5 of 33




Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range


upper 13.3 7.02 2.87 12.6 14.0

White Blood Cells 5 years - 6 years lower 4.8 7.02 3.29 4.5 5.1

upper 12 7.02 2.87 11.3 12.7


upper 11.8 7.02 2.87 11.1 12.5


upper 10.6 7.02 2.87 10.0 11.2

10 years - 11

years lower 4.3 7.02 3.29 4.0 4.6

upper 10.6 7.02 2.87 10.0 11.2

11 years - 13

years lower 4.2 7.02 3.29 3.9 4.5

upper 10.6 7.02 2.87 10.0 11.2

13 years - 14

years lower 4.2 7.02 3.29 3.9 4.5

upper 10.6 7.02 2.87 10.0 11.2

14 years - 18

years lower 4 7.02 3.29 3.7 4.3

upper 10 7.02 2.87 9.4 10.6

Over 18 years lower 3.7 7.02 3.29 3.5 3.9

upper 10 7.02 2.87 9.4 10.6

Automated

Neutrophils 0 -1 day lower 2.8 2.08 5.37 2.5 3.1

upper 15 4.39 2.18 14.4 15.6

1 -2 day lower 2.8 2.08 5.37 2.5 3.1

upper 15 4.39 2.18 14.4 15.6

2 -8 days lower 2.8 2.08 5.37 2.5 3.1

upper 12 4.39 2.18 11.5 12.5

8 - 14 days lower 1.8 2.08 5.37 1.6 2.0

upper 7.8 4.39 2.18 7.5 8.1

14 - 30 days lower 1.8 2.08 5.37 1.6 2.0

upper 6.8 4.39 2.18 6.5 7.1

30 - 60 days lower 1 2.08 5.37 0.9 1.1

upper 6 4.39 2.18 5.7 6.3



Version : 5 of 33




Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

60 - 90 days lower 0.8 2.08 5.37 0.7 0.9

upper 5.5 4.39 2.18 5.3 5.7

90 days - 6

months lower 1 2.08 5.37 0.9 1.1

upper 5.5 4.39 2.18 5.3 5.7

6 months - I year lower 1.3 2.08 5.37 1.2 1.4

upper 7 4.39 2.18 6.7 7.3

1 year - 2 years lower 1.4 2.08 5.37 1.3 1.5

upper 7.5 4.39 2.18 7.2 7.8


upper 7.5 4.39 2.18 7.2 7.8

Automated 3 years - 4 years lower 1.6 2.08 5.37 1.4 1.8

Neutrophils upper 7.7 4.39 2.18 7.4 8.0


upper 7.8 4.39 2.18 7.5 8.1


upper 7.4 4.39 2.18 7.1 7.7


upper 7.1 4.39 2.18 6.8 7.4


upper 7.2 4.39 2.18 6.9 7.5


upper 6.7 4.39 2.18 6.4 7.0

Over 11 years lower 1.7 2.08 5.37 1.5 1.9

upper 6.6 4.39 2.18 6.3 6.9

Automated 0 -1 day lower 2 1.49 4.36 1.8 2.2

Lymphocytes upper 8.8 1.49 4.36 8.0 9.6

1 -2 day lower 2 1.49 4.36 1.8 2.2

upper 7.7 1.49 4.36 7.0 8.4

2 - 3 days lower 2 1.49 4.36 1.8 2.2

upper 7.5 1.49 4.36 6.9 8.1

3 - 5 days lower 2 1.49 4.36 1.8 2.2

upper 7.3 1.49 4.36 6.7 7.9

5 - 14 days lower 2.9 1.49 4.36 2.7 3.1



Version : 5 of 33




Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

upper 9 1.49 4.36 8.2 9.8

14 - 30 days lower 2.9 1.49 4.36 2.7 3.1

upper 9.1 1.49 4.36 8.3 9.9

30 - 60 days lower 3.3 1.49 4.36 3.0 3.6

upper 10 1.49 4.36 9.1 10.9

60 - 90 days lower 3.3 1.49 4.36 3.0 3.6

upper 10.6 1.49 4.36 9.7 11.5

90 days - 1 year lower 3.2 1.49 4.36 2.9 3.5

upper 9.6 1.49 4.36 8.8 10.4

1 - 2 years lower 2.5 1.49 4.36 2.3 2.7

upper 7.5 1.49 4.36 6.9 8.1

2 - 3 years lower 2.5 1.49 4.36 2.3 2.7

upper 6.5 1.49 4.36 5.9 7.1

4 - 5 years lower 1.7 1.49 4.36 1.6 1.8

upper 4.5 1.49 4.36 4.1 4.9

5 - 6 years lower 1.6 1.49 4.36 1.5 1.7

Automated upper 4.5 1.49 4.36 4.1 4.9

Lymphocytes 6 - 7 years lower 1.8 1.49 4.36 1.6 2.0

upper 4.5 1.49 4.36 4.1 4.9

7 - 9 years lower 1.5 1.49 4.36 1.4 1.6

upper 4.2 1.49 4.36 3.8 4.6

9 - 12 years lower 1.4 1.49 4.36 1.3 1.5

upper 4.1 1.49 4.36 3.7 4.5

12 - 13 years lower 1.4 1.49 4.36 1.3 1.5

upper 3.7 1.49 4.36 3.4 4.0

13 - 15 years lower 1.3 1.49 4.36 1.2 1.4

upper 3.6 1.49 4.36 3.3 3.9

15 - 18 years lower 1.2 1.49 4.36 1.1 1.3

upper 3.5 1.49 4.36 3.2 3.8

Over 18 years lower 1 1.49 5.67 0.9 1.1

upper 3 1.49 4.36 2.7 3.3

Automated 0 -1 day lower 0.2 0.27 10.77 0.2 0.2

Monocytes upper 2.3 0.65 7.85 1.9 2.7

1 -2 day lower 0.2 0.27 10.77 0.2 0.2



Version : 5 of 33




Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

Automated upper 1.8 0.65 7.85 1.5 2.1

Monocytes 1 -30 day lower 0.2 0.27 10.77 0.2 0.2

upper 1.5 0.65 7.85 1.3 1.7

30 days - 6

months lower 0.3 0.27 10.77 0.2 0.4

upper 1.2 0.65 7.85 1.0 1.4


upper 1.2 0.65 7.85 1.0 1.4

1 year - 3 years lower 0.2 0.27 10.77 0.2 0.2

upper 1 0.65 7.85 0.8 1.2


upper 1.2 0.65 7.85 1.0 1.4


upper 1 0.65 7.85 0.8 1.2

Over 16 years lower 0.2 0.27 10.77 0.2 0.2

upper 0.8 0.65 7.85 0.7 0.9

Automated 0 -3 days lower 0.05 0.07 15.12 0.04 0.06

Eosinophils upper 1.23 0.15 11.02 0.96 1.50

3 -14 days lower 0.05 0.07 15.12 0.04 0.06

upper 1 0.15 11.02 0.78 1.22

14 days -10 years lower 0.05 0.07 15.12 0.04 0.06

upper 0.88 0.15 11.02 0.69 1.07

10 years -11

years lower 0.05 0.07 15.12 0.04 0.06

upper 0.8 0.15 11.02 0.63 0.97

11 years -15

years lower 0.05 0.07 15.12 0.04 0.06

upper 0.7 0.15 11.02 0.55 0.85

15 years -16

years lower 0.05 0.07 15.12 0.04 0.06

upper 0.6 0.15 11.02 0.47 0.73

Over 16 years lower 0.05 0.07 15.12 0.04 0.06

upper 0.45 0.15 11.02 0.35 0.55

Automated 0 -14 days upper 0.2 0.17 33.85 0.07 0.33

Basophils 14 -16 days upper 0.17 0.17 33.85 0.06 0.28



Version : 5 of 33




Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

16 days -1 year upper 0.16 0.17 33.85 0.05 0.27

1 - 12 years upper 0.12 0.17 33.85 0.04 0.20

Over 12 years upper 0.12 0.17 33.85 0.04 0.20

Manual 0 -1 day lower 2.8 2.6 19.8 2.4 3.2

Neutrophils** upper 15 14.8 4.2 14.9 15.1

1 -2 day lower 2.8 2.6 19.8 2.4 3.2

upper 15 14.8 4.2 14.9 15.1

2 -8 days lower 2.8 2.6 19.8 2.4 3.2

upper 12 14.8 4.2 11.9 12.1

8 - 14 days lower 1.8 2.3 12.9 1.5 2.1

upper 7.8 7 4.8 7.7 7.9

14 - 30 days lower 1.8 2.3 12.9 1.5 2.1

upper 6.8 7 4.8 6.7 6.9

30 - 60 days lower 1 2.3 12.9 0.7 1.3

upper 6 7 4.8 5.9 6.1

60 - 90 days lower 0.8 2.3 12.9 0.5 1.1

upper 5.5 5.2 5.8 5.4 5.6

90 days - 6

months lower 1 2.3 12.9 0.7 1.3

upper 5.5 5.2 5.8 5.4 5.6

6 months - I year lower 1.3 2.3 5.8 1.2 1.4

upper 7 7 4.8 6.9 7.1

1 year - 2 years lower 1.4 2.3 5.8 1.3 1.5

upper 7.5 7 4.8 7.4 7.6


upper 7.5 7 4.8 7.4 7.6


upper 7.7 7 4.8 7.6 7.8


upper 7.8 7 4.8 7.7 7.9


upper 7.4 7 4.8 7.3 7.5


upper 7.1 7 4.8 7.0 7.2



Version : 5 of 33




Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

Manual 8 years - 9 years lower 1.7 2.3 5.8 1.6 1.8

Neutrophil** upper 7.2 7 4.8 7.1 7.3


upper 6.7 7 4.8 6.6 6.8

Over 11 years lower 1.7 2.3 5.8 1.6 1.8

upper 6.6 7 4.8 6.5 6.7

0 -1 day lower 2 2.1 14.5 1.7 2.3

upper 8.8 6.1 14.7 8.5 9.1

1 -2 day lower 2 2.1 14.5 1.7 2.3

upper 7.7 6.1 14.7 7.4 8.0

2 - 3 days lower 2 2.1 14.5 1.7 2.3

upper 7.5 6.1 14.7 7.2 7.8

3 - 5 days lower 2 2.1 14.5 1.7 2.3

upper 7.3 6.1 14.7 7.0 7.6

Manual 5 - 14 days lower 2.9 2.1 14.5 2.6 3.2

Lymphocytes** upper 9 6.1 14.7 8.7 9.3

14 - 30 days lower 2.9 2.1 14.5 2.6 3.2

upper 9.1 6.1 14.7 8.8 9.4

30 - 60 days lower 3.3 2.1 14.5 3.0 3.6

upper 10 6.1 14.7 9.7 10.3

60 - 90 days lower 3.3 2.1 14.5 3.0 3.6

upper 10.6 6.1 14.7 10.3 10.9

90 days - 1 year lower 3.2 2.1 14.5 2.9 3.5

upper 9.6 6.1 14.7 9.3 9.9

1 - 2 years lower 2.5 2.1 14.5 2.2 2.8

upper 7.5 6.1 14.7 7.2 7.8

2 - 3 years lower 2.5 2.1 14.5 2.2 2.8

upper 6.5 6.1 14.7 6.2 6.8

4 - 5 years lower 1.7 1.8 12.7 1.5 1.9

upper 4.5 4 30.2 3.9 5.1

5 - 6 years lower 1.6 1.8 12.7 1.4 1.8

upper 4.5 4 30.2 3.9 5.1

6 - 7 years lower 1.8 1.8 12.7 1.6 2.0

upper 4.5 4 30.2 3.9 5.1



Version : 5 of 33




Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

7 - 9 years lower 1.5 1.3 14.7 1.2 1.8

Manual upper 4.2 4 30.2 3.6 4.8

Lymphocytes** 9 - 12 years lower 1.4 1.3 14.7 1.1 1.7

upper 4.1 4 30.2 3.5 4.7

12 - 13 years lower 1.4 1.3 14.7 1.1 1.7

upper 3.7 4 30.2 3.1 4.3

13 - 15 years lower 1.3 1.3 14.7 1.0 1.6

upper 3.6 4 30.2 3.0 4.2

15 - 18 years lower 1.2 1.2 22.3 0.8 1.6

upper 3.5 4 30.2 2.9 4.1

Over 18 years lower 1 1.2 22.3 0.6 1.4

upper 3 4 30.2 2.4 3.6

0 -1 day lower 0.2 0.2 61.5 -1.0 1.4

upper 2.3 3 43.1 1.5 3.1

1 -2 day lower 0.2 0.2 61.5 -1.0 1.4

upper 1.8 3 43.1 1.0 2.6

1 -30 day lower 0.2 0.2 61.5 -1.0 1.4

upper 1.5 3 43.1 0.7 2.3

30 days - 6

months lower 0.3 0.3 37.5 -0.4 1.0

Manual upper 1.2 0.5 24 0.7 1.7

Monocytes** 6 months - 1 year lower 0.2 0.2 61.5 -1.0 1.4

upper 1.2 0.5 24 0.7 1.7

1 year - 3 years lower 0.2 0.2 61.5 -1.0 1.4

upper 1 0.5 24 0.5 1.5

3 years - 8 years lower 0.2 0.2 61.5 -1.0 1.4

upper 1.2 0.5 24 0.7 1.7

8 years - 16 years lower 0.2 0.2 61.5 -1.0 1.4

upper 1 0.5 24 0.5 1.5

Over 16 years lower 0.2 0.2 61.5 -1.0 1.4

upper 0.8 0.5 24 0.3 1.3

Manual 0 -3 days lower 0.05 0.1 68.2 -1.3 1.4

Eosinophils** upper 1.23 1.27 77 -0.3 2.7

3 -14 days lower 0.05 0.1 68.2 -1.3 1.4



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Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

upper 1 1.27 77 -0.5 2.5

14 days -10 years lower 0.05 0.1 68.2 -1.3 1.4

Manual upper 0.88 1.27 77 -0.6 2.4

Eosinophils**

10 years -11

years lower 0.05 0.1 68.2 -1.3 1.4

upper 0.8 1.27 77 -0.7 2.3

11 years -15

years lower 0.05 0.1 68.2 -1.3 1.4

upper 0.7 1.27 77 -0.8 2.2

15 years -16

years lower 0.05 0.1 68.2 -1.3 1.4

upper 0.6 1.27 77 -0.9 2.1

Over 16 years lower 0.05 0.1 68.2 -1.3 1.4

upper 0.45 1.27 77 -1.1 2.0

Manual 0 -14 days upper 0.2 0.1 37 -0.5 0.9

Basophils** 14 -16 days upper 0.17 0.1 37 -0.6 0.9

16 days -1 year upper 0.16 0.1 37 -0.6 0.9

1 - 12 years upper 0.12 0.1 37 -0.6 0.8

Over 12 years upper 0.12 0.1 37 -0.6 0.8

Myelocytes*** upper 0

Metamyelocytes**** upper 0

Promyelocytes*** upper 0

Blasts*** upper 0

Coagulation (plasma)

Prothrombin Time 0 -1 days lower 14.4 15.0 1.98 13.8 15.0

upper 16.4 15.0 1.98 15.8 17.0

1 - 3 days lower 13.5 15.0 1.98 13.0 14.0

upper 16.4 15.0 1.98 15.8 17.0

3 days - 1 year lower 11.5 15.0 1.98 11.1 11.9

upper 15.3 15.0 1.98 14.7 15.9

Over 1 year lower 11.3 15.0 1.98 10.9 11.7

upper 16.1 15.0 1.98 15.5 16.7

APTT 0 -1 days lower 34.9 29 1.86 33.6 36.2

upper 47.4 29 1.86 45.7 49.1



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Sex Age Categor

y

Range QC

Value

Used

Assay

CV (%)

applied

to

range

Lower

Range

Upper

Range

1 - 3 days lower 31.2 29 1.86 30.1 32.3

upper 44 29 1.86 42.4 45.6

3 days - 1 year lower 29.1 29 1.86 28.0 30.2

upper 35.5 29 1.86 34.2 36.8

Over 1 year lower 22 29 1.86 21.2 22.8

upper 34 29 1.86 32.8 35.2

Fibrinogen 0 -1 days lower 1.92 1.45 4.53 1.75 2.09

upper 3.74 2.95 5.77 3.32 4.16

1 - 3 days lower 2.83 2.95 5.77 2.51 3.15

upper 4.01 2.95 5.77 3.56 4.46

3 days - 1 year lower 0.82 1.45 4.53 0.75 0.89

upper 3.83 2.95 5.77 3.40 4.26

Over 1 year lower 1.9 1.45 4.53 1.73 2.07

upper 4.1 2.95 5.77 3.64 4.56

D Dimer 0 -1 days lower 0.41 0.3 23.83 0.22 0.60

upper 2.47 2.35 4.41 2.26 2.68

1 - 3 days lower 0.58 0.3 23.83 0.31 0.85

upper 2.74 2.35 4.41 2.50 2.98

3 days - 1 year lower 0.11 0.3 23.83 0.06 0.16

upper 0.42 0.3 23.83 0.22 0.62

Over 1 year lower 0.05 0.3 23.83 0.03 0.07

upper 0.5 0.3 23.83 0.27 0.73

Other

ESR

0-70 years

lower 1 35 3.87 1 1

upper 15 35 3.87 14 16

>70 years

lower 1 35 3.87 1 1

upper 30 35 3.87 28 32

Manual ESR* 0-70 years lower 1 2 50.5 1 1

upper 15 16 7.7 14 16

>70 years lower 1 2 50.5 0.5 1.5

upper 30 25 8.4 27.5 32.5

*In the case of Manual ESR the CV is calculated from the results of a minimum of 6 BMS

staff manually reading two ESR samples with a result on the automated analyser close to

the decision point and not from QC data.



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** For manual differential results the CV is calculated from the results of a minimum of 9

BMS staff reading a blood film

*** These cells would not be expected to be found in a blood film from a patient with

full blood count results within normal limits. Of the 9 BMS staff reading 5 ‘normal’films

none reported seeing these cells. Details can be found in QU-EV-HAE-REC-D-68.

**** These cells would not be expected to be found in a blood film from a patient with

full blood count result within normal limits. Of the 9 BMS staff reading 5 ‘normal’films

only one reported seeing these cells. Details can be found in QU-EV-HAE-REC-D-68.



Version : 5 of 33



3. Appendix 1

The CV was calculated using the data available for the lot of QC in use at the time.

IQC Used Lot Date Range Analyser

Randox Liquid

Chemistry 1 178UL 16/9/14-22/10/14 CAD 1 and 2

CAD3 for

Lithium

Randox Liquid

Chemistry 2 945UN 16/9/14-22/10/14 CAD 1 and 2

CAD3 for

Lithium

Randox Liquid

Chemistry 3 617UE 11/8/14-22/10/14 CAD 1 and 2

CAD3 for

Lithium

and RF

Randox Urine 2 676UC 11/8/14-22/10/14 CAD2

Osmomet

er

Randox Urine 3 677UC 11/8/14-22/10/14 CAD2

Osmomet

er

Randox Human Assay 2 911UN 9/3/2015-9/4/2015 Osmometer

Biorad Urine Toxicology

S1 71800 11/8/14-22/10/14 CAD2

Biorad Urine Toxicology

S2 71840 11/8/14-22/10/14 CAD2

Randox Immunoassay 1 1299 20/4/14-20/10/14 Centaur 1-3



CVP 1 177

October/November

2014 GEM 4000

CVP 2 286

October/November

2014 GEM 4000

Where the assay is used on more than one platform the mean of the selected systems is used

4. Appendix 2

IQC Used Lot Date Range Analyser

Normal 2105 21/10/14-08/12/14

HAD1, HAD2,

HAD3

Abnormal 1105 21/10/14-08/12/14

HAD1, HAD2,

HAD3

Normal/Abnormal (DD) 112144 November 2014

Stago 1,

Stago2

Normal/Abnormal (other

coag) 111035 November 2014

Stago 1,

Stago2

Sed Check 1120313 2013-14

Where the assay is used on more than one platform the mean of the selected systems is used



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5. Summary of revisions

Version Summary of change

1 Not applicable – first issue.

2 1. Changed to include full range of Chemistry assays

2. Changed to reflect measurement of uncertainty

3 Further information on the calculation of results

Addition of manual ESR

4 Addition of serum osmolality range and QC details

5 Addition of uncertainty for manual differential.

Inclusion of IQC review information.

blood sciences uncertainty of results

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