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CLIA Acceptable Test Performance Criteria

CLIA 88 has publisheded acceptable performance criteria for analytes that are graded in proficiency surveys. Some analytes have different performance criteria at different medical decision levels. When two criteria are given, which ever one is greater should be used. CLIA allowable error is calculated by multiplying CLIA acceptable performance criteria by the medical decision level.Fraser has independently published what he believes allowable error should be based on medical significance.

Routine Chemistry

CLIA Acceptable Performance

Medical Decision Level

CLIA Allowable Error

Medically Allowable Error

Albumin

+/-10%

3.5 g/dL

0.35 g/dL

0.24 g/dL

Bilirubin

+/-20% or 0.4 mg/dL

1.0 mg/dL

0.40 mg/dL

0.54 mg/dL

20 mg/dL

4.00 mg/dL

10.8 mg/dL

Calcium

+/-1.0 mg/dL

7.0 mg/dL

1.00 mg/dL

0.37 mg/dL

10.8 mg/dL

1.00 mg/dL

0.48 mg/dL

13.0 mg/dL

1.00 mg/dL

0.57 mg/dL

Chloride

+/-5%

90 meq/L

4.50 meq/L

2.97 meq/L

110 meq/L

5.50 meq/L

3.63 meq/L

Cholesterol

+/-10%

200 mg/dL

20.00 mg/dL

29.8 mg/dL

Creatinine

+/-0.3 mg/dL or +/-15%

1.0 mg/dL

0.30 mg/dL

0.11 mg/dL

3.0 mg/dL

0.45 mg/dL

0.36 mg/dL

Glucose

+/-6mg/dL or +/-10%

50 mg/dL

6.00 mg/dL

5.35 mg/dL

120 mg/dL

12.00 mg/dL

12.7 mg/dL

200 mg/dL

20.00 mg/dL

21.4 mg/dL

Iron

+/-20%

150 mg/dL

30.00 mg/dL

109.4 mg/dL

Magnesium

+/-25%

2.0 mg/dL

0.50 mg/dL

0.11 mg/dL

Phosphate

4.5 mg/dL

0.86 mg/dL

Potassium

+/-0.5 meq/L

3.0 meq/L

0.50 meq/L

0.33meq/L

6.0 meq/L

0.50 meq/L

0.66 meq/L

Protein, total

+/-10%

7.0 g/dL

0.70 g/dL

0.51 g/dL

Sodium

+/-4meq/L

130 meq/L

4.00 meq/L

1.78 meq/L

150 meq/L

4.00 meq/L

2.06 meq/L

Triglycerides

+/-25%

160 mg/dL

40.00 mg/dL

97.0 mg/dL

Urea nitrogen

+/-2 mg/dL or +/- 9%

27 mg/dL

2.40 mg/dL

8.2 mg/dL

Uric acid

+/-17%

6.0 mg/dL

1.0 mg/dL

1.25 mg/dL

Enzymes

CLIA Acceptable Performance

Medical Decision Level (U/L)

CLIA Allowable Error (U/L)

Medically Allowable Error (U/L)

Acid ptase

2

0.40

ALP

+/- 30%

150

45

30.0

ALT

+/- 20%

50

10

34.0

Amylase

+/- 30%

100

30

21.3

AST

+/- 20%

30

6

10.7

70

14

24.3

CK

+/- 30%

200

60

200.0

GGT

100

51.4

LD

+/- 20%

250

50

50.0

Hormones

CLIA Acceptable Performance

Medical Decision Level

CLIA Allowable Error

Medically Allowable Error

FSH

10 U/L

1.3 U/L

95 U/L

12.5 U/L

hCG

+/- 3 SD

25 IU/L

3 SD

LH

6 U/L

1.9 U/L

55 U/L

18.0 U/L

Prolactin

15 ug/L

4.0 ug/L

200 ug/L

58.0 ug/L

Testosterone

90 ng/dL

20.5 ng/L

1000 ng/dL

226.0 ng/L

Free T4

+/- 3 SD

2.3 ng/dL

3 SD

0.4 ng/dL

T3 Uptake

+/- 3 SD

25%

3 SD

0.0 %

T3

+/- 3 SD

100 ng/dL

3 SD

21.5 ng/dL

200 ng/dL

3 SD

43.0 ng/dL

TSH

+/- 3 SD

0.3 mIU/L

3 SD

0.1 mIU/L

5.0 mIU/L

3 SD

2.0 mIU/L

Thyroxine

+/-1 ug/dL or +/- 20%

3 ug/dL

1.0 ug/dL

0.5 ug/dL

13 ug/dL

2.6 ug/dL

2.3 ug/dL

Toxicology

CLIA Acceptable Performance

Medical Decision Level

CLIA Allowable Error

Medically Allowable Error

Alcohol, blood

+/- 25%

0.10 g/dL

0.025 g/dL

Blood lead

+/- 4 ug/dL or +/- 10%

10 ug/dL

4.0 ug/dL

40 ug/dL

4.0 ug/dL

Carbamazepine

+/- 25 %

8 mg/dL

2.0 mg/dL

2.2 mg/dL

12 mg/dL

3.0 mg/dL

3.5 mg/dL

Digoxin

+/- 0.2 ng/mL or +/- 20%

0.8 ug/L

0.2 ug/L

0.2 ug/L

2.0 ug/L

0.4 ug/L

0.5 ug/L

Ethosuximide

+/- 20%

40 mg/L

8.0 mg/L

8.0 mg/L

100 mg/L

20.0 mg/L

20.0 mg/L

Gentamicin

+/-25%

10 mg/L

2.5mg/L

Lithium

0.3 mmol/L or +/- 20%

0.5 mmol/L

0.3 mmol/L

0.2 mmol/L

1.5 mmol/L

0.3 mmol/L

0.7 mmol/L

Phenobarbital

+/- 20%

15 mg/L

3.0 mg/L

5.2 mg/L

40 mg/L

8.0 mg/L

14.4 mg/L

Phenytoin

+/- 25%

10 mg/L

2.5 mg/L

3.2 mg/L

20 mg/L

5.0 mg/L

6.0 mg/L

Primidone

+/- 25%

5 mg/L

1.2 mg/L

2.2 mg/L

12 mg/L

3.0 mg/L

5.4 mg/L

Procainamide

+/- 25%

4 mg/L

1.0 mg/L

20 mg/L

5.0 mg/L

Quinidine

+/- 25%

7 mg/L

1.8 mg/L

Theophylline

+/- 25%

10 mg/L

2.5 mg/L

3.3 mg/L

20 mg/L

5.0 mg/L

6.6 mg/L

Valproic acid

+/- 25%

100 mg/L

25mg/L

30.0 mg/L

Immunology

CLIA Acceptable Performance

Medical Decision Level

CLIA Allowable Error

Medically Allowable Error

Alpha -1 antitrypsin

+/- 3 SD

3 SD

AFP

+/- 3 SD

3 SD

ANA

+/- 2 titers or P/N

2 titers or P/N

ASO

+/- 2 titers or P/N

2 titers or P/N

Anti-HIV

Reactive/

Nonreactive

Reactive/

Nonreactive

CEA

5 ng/mL

1.7 ng/mL

C3

+/- 3 SD

3 SD

C4

+/- 3 SD

3 SD

HBsAg

Reactive/

Nonreactive

anti-HBc

Reactive/

Nonreactive

Reactive/Nonreactive

IgA

+/- 3 SD

500 mg/dL

3 SD

107 mg/dL

IgE

+/- 3 SD

200 IU/mL

3 SD

IgG

+/- 25%

2000 mg/dL

3 SD

252 mg/dL

IgM

+/- 3 SD

300 mg/dL

3 SD

66 mg/dL

Infectious mono

+/- 2 titers or P/N

2 titers or P/N

Rheumatoid factor

+/- 2 titers or P/N

2 titers or P/N

Rubella

+/- 2 titers or P/N or Immune/

nonimmune

2 titers or P/N

Transferrin

375 mg/dL

44.6 mg/dL

Hematology

CLIA Acceptable Performance

Medical Decision Level

CLIA Allowable Error

Medically Allowable Error

Hemoglobin

+/- 7%

16 g/dL

1.12 g/dL

1.00 g/dL

Hematocrit

+/- 6%

50%

3.00%

3.20%

RBC

+/- 6%

5.5*106/uL

0.33*106/uL

0.55*106/uL

Platelet count

+/- 25%

500,000/uL

125,000

102,000

MCV

100 fl

5.10 fl

MCH

33 pg

1.25 pg

MCHC

37%

1.10%

WBC

+/- 15%

11,400/uL

1700/uL

2950/uL

Neutrophils

+/- 3 SD

8300 cells/uL

3 SD

2200/uL

Lymphocytes

+/- 3 SD

3600 cells/uL

3 SD

975/uL

Monocytes

+/- 3 SD

99 cells, uL

3 SD

297/uL

Granulocytes

+/- 3 SD

500 cells/uL

3 SD

250/uL

Fibrinogen

+/- 20%

400 mg/dL

80 mg/dL

Protime

+/- 15%

15 sec

2.25 sec

APTT

+/- 15%

35 sec

5.25 sec

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