Table 1

All test analyzed, their control values and further data used for estimation of the beta error.

Test

Abbreviation

QC target value

unit

n

mean

SD

CV

Maximal error (CLIA)

lowest measured value

highest measured value

Range Ratio

estimated beta-error smaller than

Federal Register

Qualab

Clinical estimate


Albumin

Alb

47

g/L

16

47.44

0.81

1.71

3.65

25

48

1.92

<10%

± 10%

± 15%


Alb

30.9

g/L

18

31.71

0.71

2.28


Alcaline Phosphatase

AP

71.9

U/L

18

70.56

1.04

1.47

67.80

36

416

11.56

<5%

± 30%

± 21%


AP

210

U/L

13

207.53

3.39

1.63


Alanin aminotransferase

ALTL

45.5

U/L

17

45.65

0.49

1.07

36.10

7

354

50.57

<5%

± 20%

± 21%


ALTL

126

U/L

19

126.47

1.58

1.25


Amikacin

Amik

7.83

umol/L

9

8.822

1.057

11.98

0.28

0

2.8

UD!

<10%

10%


Amik

23.1

umol/L

9

23.828

1.341

5.63


Amik

46.3

umol/L

11

48.225

2.994

6.2


Pancreatic Amylase

Amy-P

40

U/L

18

39.83

0.71

1.78

19.88

2

157

78.50

<5%

± 25%


Amy-P

107

U/L

19

107.11

1.05

0.98


Amylase

Amyl

79.5

U/L

16

79.31

0.79

1

29.25

13

182

14.00

<5%

± 30%

± 30%


Amyl

198

U/L

12

195.56

1.42

0.73


Aspartate aminotransferase

ASTL

47.3

U/L

17

46.59

1.18

2.53

25.40

10

244

24.40

<5%

± 20%

± 21%


ASTL

152

U/L

19

15.063

3.18

2.11


Bili-D

28.1

umol/L

19

28.326

1.125

3.97

22.20

1.1

220.9

200.82

20%


Total Bilirubin

Bili-T

16.5

umol/L

17

16.888

0.376

2.23

6.84

2.8

213.9

76.39

<5%

± 6.84 umol/L or ± 20%

± 20%


Bili-T

76.3

umol/L

19

75.421

5.257

6.97


Calcium

Ca

2.13

mmol/L

18

2.1233

0.0406

1.91

0.25

1.87

2.71

1.45

<10%

± 0.25 umol/L

± 12%


Ca

3.41

mmol/L

21

3.3681

0.0515

1.53


Carbamazepine

Carb

13.6

umol/L

9

11.6

1.773

15.28

0.13

0

1

UD

<5%

± 25%


Carb

37.9

umol/L

10

330.46

3.45

10.31


Carb

60.9

umol/L

11

54.955

4.377

7.96


Cholinesterase

CHE

5400

U/L

16

5232.13

98.07

1.87

1216.80

2877

9291

3.23

<5%

20%


CHE

1340

U/L

18

1313.78

26.47

2.01


Cholesterol

Chol

2.65

mmol/L

17

2.718

0.039

1.43

0.51

2.3

7.8

3.39

<10%

± 10%

± 10%


Cholesterol

Chol

5.27

mmol/L

18

5.117

0.051

1


Creatinin Kinase

CK

152

U/L

18

148.78

1.7

1.14

69.60

12

452

37.67

<5%

± 30%

± 30%


CK

499

U/L

18

494.56

6.29

1.27


CK, iso-enzyme MB

CKMB

5.13

ng/mL

9

5.43

0.063

1.16

1.45

0.9

21.2

23.56

?

± 3 SD


CKMB

56.7

ng/mL

7

55.62

0.903

1.62


Bicarbonate

CO2

18.1

mmol/L

17

18.575

0.331

1.78

2.08

10.3

31.3

3.04

<10%

10%


CO2

31.6

mmol/L

17

31.292

0.63

2.01


Cortisol

Cort

300

nmol/L

16

312.6

10.22

3.27

190.83

110.6

1416

12.80

<5%

± 25%

± 20%


Cort

723

nmol/L

13

733.3

12.22

1.67


Creatinine

Crea

89.1

umol/L

18

91.06

3.28

3.6

37.13

40

455

11.38

<5%

± 26.5 umol/L or ± 15%


Crea

346

umol/L

18

345.61

6.98

2.02


C-reactive Protein

CRP

9.7

mg/L

15

9.653

0.223

2.31

16.26

0.3

216.5

721.67

<5%

± 21%


CRP

53.2

mg/L

16

52.706

2.088

3.96


Chloride

Cl

84.8

mmol/L

28

83.709

2.623

3.13

5.15

87.9

118.1

1.34

>30%

± 5%

± 9%


Cl

118

mmol/L

28

114.967

2.066

1.8


Digoxin

Digo

1.382/1.48

nmol/L

10

0.048

1.4

0.41

0.192

3.09

16.09

<5%

± 25%

± 24% (<1 nmol/L: ± 0.24%)


Digo

3.699

nmol/L

7

3.66

0.084

2.30


Aethyl-ethanol

ETOH

11.3

mmol/L

15

11.253

0.767

6.82

0.16

-0.4

1.7

-4.25

<5%

± 25%


ETOH

33.2

mmol/L

14

33.35

2.69

8.07


Ferritin

Ferri

12.5

ug/L

10

13.95

0.333

2.39

216.84

8.7

1726

198.39

<5%

± 25%


Ferri

416

ug/L

10

412.4

13.21

3.2


Ferri

1330

ug/L

12

1283

61.71

4.81


Folic acid

Fol

6.765/7.08

nmol/L

11

0.639

9.35

5.48

9.44

45.4

4.81

<5%

± 20%


Fol

16.91

nmol/L

11

17.381

0.604

3.48


Fol

34.731

nmol/L

12

35.185

2.26

6.42


Free Tri-iodo thyronine

FT3

6.1/6.33

pmol/L

17

0.157

2.52

0.84

1.63

6.78

4.16

<5%

20%


FT3

25.6/26.0

pmol/L

15

0.6588

2.658


Free Thyroxine

FT4

14.3

pmol/L

16

15.82

0.54

3.41

3.84

11.27

27.13

2.41

<5%

± 3 SD

± 20%


FT4

51.6

pmol/L

16

55.69

2.42

4.35


Gentamycine

Gent

3.68

umol/L

9

3.189

0.586

18.38

1.33

0

10.6

UD

<5%

± 25%


Gent

9.38

umol/L

10

9.02

0.944

10.47


Gent

15.8

umol/L

11

15.891

0.879

5.53


-glutamyl transpeptidase

GGT

46.4

U/L

17

45.65

0.61

1.34

195.30

9

1851

205.67

<5%

± 21%


GGT

206

U/L

18

205.89

2.85

1.38


Glucose

Gluc

5.09

mmol/L

19

5.07

0.092

1.81

0.86

4.6

12.6

2.74

<10%

± 0.333 mmol/L or ± 10%

± 10%


Gluc

13.2

mmol/L

18

13.232

0.273

2.06


Anti-Hepatitis A IgG

HAV

18.5/18.7/20.5

IU/L

13

0.505

2.57

6.30

3

60

20.00

<5%

20%


HAV

32.1/33.5/37.1

IU/L

15

0.778

2.39


Human chorionic gonadotropin, Subunit

HCG-beta

9.52

mIU/mL

17

9.278

0.21

2.26

2.90

0.1

23.1

231.00

<5%

± 3 SD

± 25%


HCG-beta

38.1

mIU/mL

16

36.654

1.018

2.78


High-density lipoprotein

HDL

1.2

mmol/L

17

1.15

0.0278

2.42

0.41

0.12

2.63

21.92

<5%

± 30%


HDL

0.74

mmol/L

18

0.6461

0.0154

2.38


Iron

Iron

20

umol/L

18

20.131

0.304

1.51

2.89

1.9

27

14.21

<5%

± 20%

± 20%


Iron

29.5

umol/L

19

29.684

0.332

1.12


Potassium

K

3.41

mmol/L

27

3.3661

0.08

2.38

0.50

2.3

5.11

2.22

<10%

± 0.5 mmol/L

± 9%


K

6.26

mmol/L

28

6.1757

0.0916

1.48


Lactate Dehydrogenase

LDH

318

U/L

16

321.38

3.74

1.16

143.10

232

1199

5.17

<5%

± 20%

± 21%


LDH

497

U/L

17

501.82

4.52

0.9


Low-density lipoprotein

LDL

2.87

mmol/L

16

2.7144

0.0669

2.46

1.03

0.89

5.97

6.71

<5%

30%


LDL

5.17

mmol/L

18

4.7817

0.0932

1.95


Lipase

Lipe

55.4

U/L

18

54.28

0.67

1.23

97.68

6

808

134.67

<5%

± 24%


Lipe

89.9

U/L

18

88.33

1.88

2.13


Magnesium

Mg

0.892

mmol/L

17

0.868

0.0268

3.09

0.26

0.51

1.56

3.06

<5%

± 25%

± 20%


Mg

1.68

mmol/L

17

1.7065

0.0611

3.58


Myoglobin

Myo

85.2

ng/mL

11

80.107

2.025

2.53

28.68

21

170.2

8.10

<5%

± 30%


Myo

1080

ng/mL

11

1003.3

43.704

4.36


Sodium

Na

121

mmol/L

27

119.79

2.92

2.44

12.69

129

153

1.19

± 4 mmol/L

± 9%


Na

145

mmol/L

28

142.69

2.26

1.58


Pheno-barbital

Phno

39.9

umol/L

10

39.9

1.91

4.79

0.80

0

8

UD

<5%

± 20%


Phno

105

umol/L

11

97.55

2.46

2.52


Phno

215

umol/L

10

198.2

5.2

2.62


Phosphate

Phos

1.29

mmol/L

17

1.3047

0.0194

1.49

0.20

0.62

2.06

3.32

<5%

± 15%


Phos

2.01

mmol/L

18

2.0472

0.0321

1.57


N-terminal Brain natriuretic peptide

Pro-BNP

131

pg/mL

12

134

5.85

4.37

1837.05

5

24489

4897.80

<5%

± 15%


Pro-BNP

4360

pg/mL

11

4944

135.5

2.74


Parathyroid-hormone

PTH

5.7982

pmol/L

7

5.47

0.165

3.01

5.13

2.12

40.61

19.16

<5%

± 24%


PTH

20.246

pmol/L

5

19.94

0.278

1.4


PTH

86.39

pmol/L

6

87.06

1.23

1.42


Anti-Rubella IgG

RubG

3.57/3.96

IU/mL

13

0.186

4.99

50.02

0.17

500

2941.18

(1)


RubG

69.3

IU/mL

12

70.85

4.68

6.61


Anti-Rubella IgM

RubM

0.23

COI

13

0.224

0.008

3.57

UD

(1)


RubM

2

COI

13

1.816

0.128

7.05


Salicylate

Sali

0.29

mmol/L

9

0.2667

0.0324

12.15

-0.02

-0.22

0.05

-0.23

<5%

20%


Sali

1.14

mmol/L

10

1.1335

0.0362

3.19


Sali

3.12

mmol/L

11

3.3218

0.0795

2.39


Triiodo-thyronine

T3

2.46

nmol/L

16

2.34

0.179

7.66

0.30

0.541

2.47

4.57

<5%

± 3 SD

20%


T3

5.59

nmol/L

16

5.48

0.383

7


Theophyllin

Theo

30.1

umol/L

9

30.44

1.88

6.18

1.38

0

11

UD

<5%

± 25%


Theo

82.7

umol/L

10

83.1

2.51

3.02


Theo

171

umol/L

11

166.64

5.26

3.16


Troponin T

TN-T

0.071

ug/L

13

0.073

0.003

4.11

0.31

0.01

2.54

254.00

<5%

± 24%


TN-T

2.24

ug/L

11

2.213

0.037

1.67


High-sensitivity TNT

TNT-hs

0.0302

ug/L

11

0.032

0.001

3.13

0.26

0.003

2.19

730.00

<5%

± 24%


TNT-hs

2.45

ug/L

11

2.488

0.054

2.17


Tobramycin

Tobr

1.79

ug/mL

9

1.8

0.071

3.94

0.03

0

0.2

UD

<5%

± 25%


Tobr

4.01

ug/mL

10

3.94

0.07

1.78


Tobr

8.17

ug/mL

11

7.9

0.261

3.30


Anti-Toxo-plasma IgG

ToxoG

0.84

IU/mL

13

0.899

0.051

5.67

77.25

0.13

617.9

4753.08

<5%

20%


ToxoG

48.1

IU/mL

13

50.549

2.93

5.80


Anti-Toxo-plasma IgM

ToxoM

0.18

COI

13

0.14

0.015

10.71

-1

-1

1.00


ToxoM

1.78

COI

13

1.86

0.057

3.06


Total Protein

TP

64.6

g/L

14

65.786

1.122

1.71

7.00

50

90

1.80

<10%

± 10%

± 15%


TP

102

g/L

15

105.23

1.05

1.00


TP

66.8

g/L

17

66.88

0.86

1.29


TP

50.1

g/L

19

50.11

0.74

1.48


Triglycerides

Trigl

1.22

mmol/L

17

1.2371

0.0126

1.02

0.74

0.67

5.21

7.78

<5%

± 25%

± 20%


Trigl

2.37

mmol/L

18

2.3711

0.0345

1.46


Transferrin

Trfe

33

umol/L

13

33.154

0.689

2.08

6.30

16

47

2.94

<5%

20%


Trfe

48.9

umol/L

15

48.23

0.68

1.41


Trfe

25.1

umol/L

17

25.41

0.51

2.01


Thyroid-stimulating hormone

TSH

1.65

uIU/mL

16

1.57

0.019

1.21

0.62

0.05

6.14

122.80

<5%

± 3 SD

± 20%


TSH

9.09

uIU/mL

15

8.57

0.114

1.33


Uric Acid

UA

275

umol/L

17

276.12

2.71

0.98

75.00

93

907

9.75

<5%

± 17%

± 15%


UA

579

umol/L

18

575.11

10.53

1.83


Urea

Ureal

6.84

mmol/L

17

6.9

0.094

1.36

4.15

2

39.5

19.75

<5%

± 20%


Ureal

24.4

mmol/L

18

23.967

0.387

1.61


Valproate

Valp

238

umol/L

9

233.44

29.75

12.74

3.88

0

31

UD

<5%

± 25%


Valp

519

umol/L

10

549

47.71

8.69


Valp

811

umol/L

11

857.45

69.14

8.06


Vanco-mycin

Vanc

4.22

umol/L

10

4.59

0.468

10.2

0.18

0

1.8

UD

<5%

20%


Vanc

13.5

umol/L

10

15.52

0.914

5.89


Vanc

19.6

umol/L

12

22.083

0.997

4.51


Vitamin B12

VitB12

177.858/194.8

pmol/L

11

9.546

5.24

123.35

109.5

1124

10.26

<5%

± 20%


VitB12

392.616/408.9

pmol/L

11

11.8

2.99


VitB12

856.08

pmol/L

12

859.636

20.04

2.33


Vitamin D

VitD

55

nmol/L

6

48.36

6.93

14.33

14.71

17.78

129.3

7.27

<5%

± 20%


VitD

83.75

nmol/L

4

72.95

6.92

9.49


VitD

115.5

nmol/L

6

106.5

10.31

9.68


(1) Target value ± 2 dilutions or immune or nonimmune or positive or negative, UD = undetermined

All analyses were listed including their abbreviations used in the further tables. Their standard deviations (SD) and coefficient of variations (CV) of the controls (QC) are given. The target values of the QC material of different analytes, as well as the measurement units, the number of QC repetitions (n), the mean, SD and CV of the QC materials are displayed. The beta error was estimated [12] using the range ratio and the allowable biases as defined by the federal registry, the Qualab or the clinical estimate. The values used for the evaluations are displayed in bold.

Minder et al. BMC Clinical Pathology 2011 11:6   doi:10.1186/1472-6890-11-6

Open Data