Acceptable Performance Criteria, CLIA 88

Gravimetric Units

Acceptable Desirable Allowable Maximum Desirable

Performance Allowable Error Decision Level Error SD, CLIA SD (Ricos,
ANALYTE Criteria (CLIA 88) (Ricos, Fraser)a XCb CLIA '88c '88d Fraser)a
Routine Chemistry
Alanine aminotransferase ±20% ±27.48% 50 U/L 10 1.7 3.00
Albumin ±10% ±4.07% 3.5 g/dL 0.35 0.06 0.06
Alkaline phosphatase ±30% ±12.04% 150 U/L 45 7.5 4.80
Amylase ±30% ±14.6% 100 U/L 30 5.0 4.40
Aspartate aminotransferase ±20% ±16.69% 30 U/L 6.0 1.0 1.85
70 U/L 14 2.3 4.31
Bicarbonate ±4.86% 20 mmol/L 0.40
30 mmol/L 0.50
Bilirubin, total ±0.4 mg/dl or ±26.94% 1.0 mg/dL 0.40 0.07 0.11
±20% 20 mg/dL 4.0 0.7 2.18
Bilirubin, direct ±44.5% 0.5 mg/dL 0.09
5.0 mg/dL 0.92
Calcium ±1.0 mg/dL ±2.55% 7.0 mg/dL 1.0 0.17 0.07
10.8 mg/dL 1.0 0.17 0.11
Chloride ±5% ±1.5% 90 mmol/L 4.5 0.8 0.54
110 mmol/L 5.5 0.9 0.66
Cholesterol, total ±10% ±9.01% 200 mg/dL 20 3.3 5.96
Cholesterol, HDL ±30% ±11.63% 35 mg/dL 10.5 1.8 1.28
65 mg/dL 19.5 3.3 2.37
Creatine kinase ±30% ±30.3% 200 U/L 60 10 22.80
Creatine kinase, MB ±3 SD ±16.5% 13 µg/L 3 SD 0.5 SD 0.46
Creatinine ±0.3 mg/dL or ±8.87% 1.0 mg/dL 0.30 0.05 0.03
±15% 3.0 mg/dL 0.45 0.08 0.09
Glucose ±6 mg/dL or ±6.96% 50 mg/dL 6 1.0 1.15
±10% 126 mg/dL 12.6 2.1 2.90
200 mg/dL 20 3.3 4.60
HbA1c ±3% 7.00% 0.28%e 0.06
Iron ±20% ±30.7% 150 mg/dL 30 5 19.95
Lactate ±30.4% 2.0 mmol/L 0.27
Lactate dehydrogenase ±20% ±11.4% 300 U/L 60 10 12.90
Lipase ±37.88% 100 U/L 30 5.0 16.10
Magnesium ±25% ±4.8% 2.0 mg/dL 0.5 0.08 0.04
Phosphate ±10.11% 4.5 mg/dL 0.18
pH ±0.04 ±3.9% 7.35 0.04 0.007 0.13
±3.9% 7.45 0.04 0.007 0.13
PCO2 ±5 mm Hg or ±5.7% 35 mm Hg 5.0 0.8 0.84
±8% 30 mm Hg 5.0 0.8 0.72
PO2 ±3 SD 30 mm Hg 3 SD 0.5 SD
80 mm Hg 3 SD 0.5 SD
Potassium ±0.5 mmol/L ±5.61% 3.0 mmol/L 0.5 0.08 0.07
6.0 mmol/L 0.5 0.08 0.14
Protein, total ±10% ±3.63% 7.0 g/dL 0.7 0.12 0.10
Sodium ±4 mmol/L ±0.73% 130 mmol/L 4.0 0.7 0.39
150 mmol/L 4.0 0.7 0.45
Triglycerides ±25% ±25.99% 160 mg/dL 40 7 15.92
Troponin I or T ±27.91% 99th %ile of CV < 10%f
Norm Pop
Urea nitrogen ±2 mg/dL or ±15.55% 27.0 mg/dL 2.4 0.4 1.63
±9%
 Acceptable Performance Criteria, CLIA 88
Gravimetric Units

Acceptable Desirable Allowable Maximum Desirable

Performance Allowable Error Decision Level Error SD, CLIA SD (Ricos,
ANALYTE Criteria (CLIA 88) (Ricos, Fraser)a XCb CLIA '88c '88d Fraser)a
Uric acid ±17% ±11.97% 6.0 mg/dL 1.02 0.17 0.26
 Acceptable Performance Criteria, CLIA 88
Gravimetric Units

Acceptable Desirable Allowable Maximum Desirable

Performance Allowable Error Decision Level Error SD, CLIA SD (Ricos,
ANALYTE Criteria (CLIA 88) (Ricos, Fraser)a XCb CLIA '88c '88d Fraser)a

Endocrinology and Various Markers

17-OH Progesterone ±29.7% 0.5 ug/L 0.05
3.0 ug/L 0.29
Aldosterone ±36.7% 15 ng/dL 2.21
30 ng/dL 4.41
Androstenedione ±23.51% 260 ng/dL 20.54
N-terminal (NT)-proBNP ±13% males: 60 ng/L 3.00
females: 150 ng/L 7.5
CA 15-3 ±20.8% 25 U/mL 0.78
CA 125 ±35.4% 35 U/mL 4.34
CEA ±24.7% 5 ng/mL 0.32
Cortisol ±25% ±22.8% 5 µg/dL 1.25 0.21 0.38
30 µg/dL 7.5 1.25 2.28
C-peptide ±20.8% 37 µg/L 3.07
DHEA-S ±13.08% 2000 µg/L 64
4500 µg/L 143
Estradiol ±26.86% 60 ng/L 6.75
450 ng/L 51
FSH ±21.19% 10 U/L 0.55
95 U/L 5.23
HCG ±3 SD or 25 IU/L 3 SD 0.5 SD
+/- 10000 IU/L 3 SD 0.5 SD
LH ±27.92% 6 U/L 0.69
55 U/L 6.33
Prolactin ±29.4% 15 µg/L 1.73
200 µg/L 23.00
PSA ±33.6% 2 µg/L 0.18
PTH ±30.2% 65 ng/L 8.45
150 ng/L 19.50
T3 uptake ± 3 SD 25% 3 SD 0.5 SD
Testosterone ±13.61% 90 ng/dL 4.17
1000 ng/dL 46
Thyroxine (T4) ± 1.0 µg/dL or ±7% 3 µg/dL 1 0.17 0.08
±20% 13 µg/dL 2.6 0.43 0.33
Thyroxine, free (FT4) ±3 SD ±8% 0.8 ng/dL 3 SD 0.5 SD 0.02
4.0 ng/dL 3 SD 0.5 SD 0.12
Transferrin ±3.8% 375 mg/dL 5.63
Triiodothyronine (T3) ±3 SD ±9.22% 80 ng/dL 3 SD 0.5 SD 2.76
200 ng/dL 3 SD 0.5 SD 6.90
TSH ±3 SD ±23.7% 0.3 mIU/L 3 SD 0.5 SD 0.03
5.0 mIU/L 3 SD 0.5 SD 0.49
TDM & Toxicology
Alcohol, blood ±25% 0.10 g/dL 0.025 0.004
Carbamazepine ±25% 8 mg/L 2 0.3
12 mg/L 3 0.5
Digoxin ±0.2 ng/mL or 0.8 µg/L 0.2 0.03
±20% 2.0 µg/L 0.4 0.07
Ethosuximide ±20% 40 mg/L 8 1.3
100 mg/L 20 3.3
 Acceptable Performance Criteria, CLIA 88
Gravimetric Units

Acceptable Desirable Allowable Maximum Desirable

Performance Allowable Error Decision Level Error SD, CLIA SD (Ricos,
ANALYTE Criteria (CLIA 88) (Ricos, Fraser)a XCb CLIA '88c '88d Fraser)a
Gentamicin ±25% 10 mg/L 2.5 0.4
 Acceptable Performance Criteria, CLIA 88
Gravimetric Units

Acceptable Desirable Allowable Maximum Desirable

Performance Allowable Error Decision Level Error SD, CLIA SD (Ricos,
ANALYTE Criteria (CLIA 88) (Ricos, Fraser)a XCb CLIA '88c '88d Fraser)a
Lead, blood ±4 µg/dL or 10 µg/dL 4 0.7
±10% 40 µg/dL 4 0.7
Lithium ±0.3 mmol/L or 0.5 mmol/L 0.3 0.05
±20% 1.5 mmol/L 0.3 0.05
Phenobarbital ±20% 15 mg/L 3 0.5
40 mg/L 8 1.3
Phenytoin ±25% 10 mg/L 2.5 0.4
20 mg/L 5 0.8
Primidone ±25% 5 mg/L 1.25 0.21
12 mg/L 3 0.5
Procainamide ±25% 4 mg/L 1 0.17
20 mg/L 5 0.83
Quinidine ±25% 7 mg/L 1.8 0.3
Theophylline ±25% 10 mg/L 2.5 0.4
20 mg/L 5 0.8
Valproic acid ±25% 50 mg/L 12.5 2.1
100 mg/L 25 4.2

Hematology
Cell identification 90% consensus
Erythrocyte count ±6% ±4.4% 4.5 M/µL 0.27 0.05 0.07
5.9 M/µL 0.35 0.06 0.09
Fibrinogen ±20% ±13.6% 150 mg/dL 30 5.0 8.10
Hematocrit ±6% ±3.97% 35% 2.10% 0.35% 0.47
50% 3.00% 0.50% 0.68
Hemoglobin ±7% ±4.19% 12 g/dL 0.84 0.14 0.17
17 g/dL 1.19 0.2 0.24
Leukocyte count ±15% ±15.49% 3.5 K/µL 0.52 0.09 0.20
11 K/µL 1.65 0.28 0.63
Platelet count ±25% ±13.4% 50 K/µL 12.5 2.1 2.30
1000 K/µL 250 42 46
PTT ±15% ±4.5% 40 sec. 6.0 1.0 0.56
PT ±15% ±5.3% INR 3.6 INR 0.54 INR 0.09
25 sec. 3.8 0.6
White cell differentiation ±3 SD

Immunology
A1AT ±3 SD ±9.2% 80 mg/dL 3 SD 0.5 SD 2.40
AFP ±3 SD ±21.9% 10 µg/L 3 SD 0.5 SD 0.61
Antinuclear antibody 2 titers or +/- 1 titer
Antistreptolysin O 2 titers or +/- 1 titer
Anti-HIV react/nonreact R/N
Complement C3 ±3 SD ±8.4% 100 mg/dL 3 SD 0.5 SD 2.60
Complement C4 ±3 SD ±16.0% 20 mg/dL 3 SD 0.5 SD 0.90
IgG ±25% ±8.0% 500 mg/dL 125 21 12
2000 mg/dL 500 83 46
IgA ±3 SD ±13.5% 400 mg/dL 3 SD 0.5 SD 11
IgM ±3 SD ±16.8% 300 mg/dL 3 SD 0.5 SD 9
IgE ±3 SD 100 IU/mL 3 SD 0.5 SD
Infectious mono. 2 titers or +/- 1 titer
 Acceptable Performance Criteria, CLIA 88
Gravimetric Units

Acceptable Desirable Allowable Maximum Desirable

Performance Allowable Error Decision Level Error SD, CLIA SD (Ricos,
ANALYTE Criteria (CLIA 88) (Ricos, Fraser)a XCb CLIA '88c '88d Fraser)a
Rheumatoid factor 2 titers or +/- ±13.5% 1 titer
Rubella 2 titers or +/- 1 titer

a
Desirable specifications for allowable total error and imprecision from Ricos et al's 2012 biologic variation database
update, (http:www.westgard.com/biodatabase1.htm - accessed March 21, 2012)
b
Medical decision level, many of which are based on Barnett, RN: Am J Clin Pathol 50:671-676, 1968
c
Allowable error based on CLIA 88 performance requirements at the respective medical decision level.
d
Maximum internal SD based on criteria that 6 x SD < allowable error.
e
This performance goal is from the US National Glycohemoglobin Standardization Program (NGSP) and the
specification for allowable error is 1% GHB units
f
Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial
Infarction. Universal definition of myocardial infarction. J Am Coll Cardiol 2007; 50:2173-95
Acceptable Performance Criteria, CLIA 88
Gravimetric Units
 Acceptable Performance Criteria, CLIA 88
SI Units

Acceptable Desirable Allowable Maximum Desirable SD

Performance Criteria Allowable Error Decision Level Error SD, CLIA (Ricos,
ANALYTE (CLIA '88) (Ricos, Fraser)a XCb CLIA 88c '88d Fraser)a
Routine Chemistry
Alanine aminotransferase ±20% ±27.48% 50 U/L 10 1.7 3.00
Albumin ±10% ±4.07% 35 g/L 3.5 0.6 0.56
Alkaline phosphatase ±30% ±12.04% 150 U/L 45 7.5 4.80
Amylase ±30% ±14.6% 100 U/L 30 5.0 4.40
Aspartate aminotransferase ±20% ±15.2% 30 U/L 6.0 1.0 1.85
70 U/L 14 2.3 4.31
Bicarbonate ±4.86% 20 mmol/L 0.40
30 mmol/L 0.50
Bilirubin, total ±6.8 µmol/L or ±26.94% 17.1 µmol/L 6.8 1.1 1.86
±20% 340 µmol/L 68 11 37.06
Bilirubin, direct ±44.5% 8.55 µmol/L 1.57
85.5 µmol/L 15.73
Calcium ±0.25 mmol/L ±2.55% 1.75 mmol/L 0.25 0.04 1.84
2.7 mmol/L 0.25 0.04 2.84
Chloride ±5% ±1.5% 90 mmol/L 4.5 0.8 0.54
110 mmol/L 5.5 0.9 0.66
Cholesterol, total ±10% ±9.01% 5.2 mmol/L 0.52 0.09 0.15
Cholesterol, HDL ±30% ±11.63% 0.9 mmol/L 0.27 0.05 0.03
1.7 mmol/L 0.51 0.08 0.06
Creatine kinase ±30% ±30.3% 200 U/L 60 10 22.80
Creatine kinase, MB ±3 SD ±16.5% 13 µg/L 3 SD 0.5 SD 0.46
Creatinine ±27 µmol/L or ±8.87% 88 µmol/L 27 4.4 2.62
±15% 265 µmol/L 40 6.6 7.90
Glucose ±0.33 mmol/L or ±6.96% 2.8 mmol/L 0.33 0.06 0.06
±10% 7.0 mmol/L 0.70 0.12 0.16
11 mmol/L 1.11 0.19 0.25
HbA1c ±3% 7.00% 0.28%e 0.12
Iron ±20% ±30.7% 27µmol/L 5.37 0.9 3.59
Lactate ±30.4% 2.0 mmol/L 0.27
Lactate dehydrogenase ±20% ±11.4% 300 U/L 60 10 12.90
Lipase ±37.88% 100 U/L 30 5 16.10
Magnesium ±25% ±4.8% 0.8 mmol/L 0.2 0.03 0.01
Phosphate ±10.11% 1.45 mmol/L 0.06
pH ±0.04 ±3.9% 7.35 0.04 0.007 0.13
±3.9% 7.45 0.04 0.007 0.13
PCO2 ±5 mm Hg or ±5.7% 35 mm Hg 5.0 0.8 0.84
±8% 30 mm Hg 5.0 0.8 0.72
PO2 ±3 SD 30 mm Hg 3 SD 0.5 SD
80 mm Hg 3 SD 0.5 SD
Potassium ±0.5 mmol/L ±5.61% 3.0 mmol/L 0.5 0.08 0.07
6.0 mmol/L 0.5 0.08 0.14
Protein, total ±10% ±3.63% 70 g/L 7.0 1.2 0.97
Sodium ±4 mmol/L ±0.73% 130 mmol/L 4.0 0.7 0.39
150 mmol/L 4.0 0.7 0.45
Triglycerides ±25% ±25.99% 1.8 mmol/L 0.5 0.08 0.18
Troponin I or T ±27.91% 99th %ile of CV < 10%f
Nor Pop
 Acceptable Performance Criteria, CLIA 88
SI Units

Acceptable Desirable Allowable Maximum Desirable SD

Performance Criteria Allowable Error Decision Level Error SD, CLIA (Ricos,
ANALYTE (CLIA '88) (Ricos, Fraser)a XCb CLIA 88c '88d Fraser)a
Urea nitrogen ±0.71 mmol/L or ±15.55% 9.6 mmol/L 0.9 0.14 0.58
±9%
Uric acid ±17% ±11.97% 357 µmol/L 61 10 15.35
 Acceptable Performance Criteria, CLIA 88
SI Units

Acceptable Desirable Allowable Maximum Desirable SD

Performance Criteria Allowable Error Decision Level Error SD, CLIA (Ricos,
ANALYTE (CLIA '88) (Ricos, Fraser)a XCb CLIA 88c '88d Fraser)a
Endocrinology and Various Markers
17-OH Progesterone ±29.7% 1.5 nmol/L 0.15
9.1 nmol/L 0.89
Aldosterone ±36.7% 415 pmol/L 61
830 pmol/L 122
Androstenedione ±23.51% 9 nmol/L 0.71
N-terminal (NT)-proBNP ±13% males: 60 ng/L 3.00
females: 150 ng/L 7.5
CA 15-3 ±20.8% 25 U/mL 0.78
CA 125 ±35.4% 35 kU/L 4.34
CEA ±24.7% 5 ng/mL 0.32
Cortisol ±25% ±22.8% 140 nmol/L 34 5.8 10.64
830 nmol/L 207 34 63.08
C-peptide ±20.8% 12 nmol/L 1.00
DHEA-S ±13.08% 5.4 µmol/L 0.17
12 µmol/L 0.38
Estradiol ±26.86% 220 pmol/L 25
1650 pmol/L 186
FSH ±21.19% 10 U/L 0.55
95 U/L 5.23
HCG ±3 SD or 25 U/L 3 SD 0.5 SD
positive/negative 10000 U/L 3 SD 0.5 SD
LH ±27.92% 6 U/L 0.69
55 U/L 6.33
Prolactin ±29.4% 15 µg/L 1.73
200 µg/L 23.00
PSA ±33.6% 2 µg/L 0.18
PTH ±30.2% 65 ng/L 8.45
150 ng/L 19.50
T3 uptake ± 3 SD 25% 3 SD 0.5 SD
Testosterone ±13.61% 3.1 nmol/L 0.14
35 nmol/L 1.62
Thyroxine (T4) ± 12.9 nmol/L or ±7% 39 nmol/L 12.9 2.2 0.98
±20% 168 nmol/L 33.5 5.6 4.20
Thyroxine, free (FT4) ±3 SD ±8% 10 pmol/L 3 SD 0.5 SD 0.29
52 pmol/L 3 SD 0.5 SD 1.51
Transferrin ±3.8% 3.75 g/L 0.06
Triiodothyronine (T3) ±3 SD ±9.22% 1.2 nmol/L 3 SD 0.5 SD 0.04
3.1 nmol/L 3 SD 0.5 SD 0.11
TSH ±3 SD ±23.7% 0.3 mU/L 3 SD 0.5 SD 0.03
5.0 mU/L 3 SD 0.5 SD 0.49
TDM & Toxicology
Alcohol, blood ±25% 22 nmol/L 5.4 0.9
Carbamazepine ±25% 34 µmol/L 8.5 1.4
51 µmol/L 12.7 2.1
Digoxin ±0.26 nmol/L or 1.0 nmol/L 0.26 0.04
±20% 2.6 nmol/L 0.51 0.09
Ethosuximide ±20% 283 µmol/L 57 9.4
 Acceptable Performance Criteria, CLIA 88
SI Units

Acceptable Desirable Allowable Maximum Desirable SD

Performance Criteria Allowable Error Decision Level Error SD, CLIA (Ricos,
ANALYTE (CLIA '88) (Ricos, Fraser)a XCb CLIA 88c '88d Fraser)a
708 µmol/L 142 24
Gentamicin ±25% 20.9 µmol/L 5.2 0.9
 Acceptable Performance Criteria, CLIA 88
SI Units

Acceptable Desirable Allowable Maximum Desirable SD

Performance Criteria Allowable Error Decision Level Error SD, CLIA (Ricos,
ANALYTE (CLIA '88) (Ricos, Fraser)a XCb CLIA 88c '88d Fraser)a
Lead, blood ±0.19 µmol/L or 0.48 µmol/L 0.19 0.03
±10% 1.93 µmol/L 0.19 0.03
Lithium ±0.3 mmol/L or 0.5 mmol/L 0.3 0.05
±20% 1.5 mmol/L 0.3 0.05
Phenobarbital ±20% 65 umol/L 12.9 2.2
172 umol/L 34.4 5.7
Phenytoin ±25% 39.6 µmol/L 9.9 1.6
79.2 µmol/L 19.8 3.3
Primidone ±25% 23 µmol/L 5.7 1.0
55 µmol/L 13.7 2.3
Procainamide ±25% 17 µmol/L 4.2 0.7
85 µmol/L 21.2 3.5
Quinidine ±25% 3.9 umol/L 5.5 0.9
Theophylline ±25% 56 µmol/L 14 2.3
111 µmol/L 28 4.6
Valproic acid ±25% 347 µmol/L 87 14
693 µmol/L 173 29
Hematology
Cell identification 90% consensus
Erythrocyte count ±6% ±4.4% 4.5 M/µL 0.27 0.05 0.07
5.9 M/µL 0.35 0.06 0.09
Fibrinogen ±20% ±13.6% 150 mg/dL 30 5.0 8.10
Hematocrit ±6% ±3.97% 35% 2.1% 0.4% 0.47
50% 3.0% 0.5% 0.68
Hemoglobin ±7% ±4.19% 12 g/dL 0.8 0.14 0.17
17 g/dL 1.2 0.20 0.24
Leukocyte count ±15% ±15.49% 3.5 K/µL 0.52 0.09 0.20
11 K/µL 1.65 0.28 0.63
Platelet count ±25% ±13.4% 50 K/µL 12.5 2.1 2.3
1000 K/µL 250 42 46
PTT ±15% ±4.5% 40 sec. 6.0 1.0 0.56
PT ±15% ±5.3% INR 3.6 INR 0.54 INR 0.09
25 sec. 3.8 0.6
White cell differentiation ±3 SD
Immunology
A1AT ±3 SD ±9.2% 0.8 g/L 3 SD 0.5 SD 0.02
AFP ±3 SD ±21.8% 8.3 kU/L 3 SD 0.5 SD 0.51
Antinuclear antibody 2 titers or +/- 1 titer
Antistreptolysin O 2 titers or +/- 1 titer
Anti-HIV reactive/nonreactive R/N
Complement C3 ±3 SD ±8.4% 1 g/L 3 SD 0.5 SD 0.03
Complement C4 ±3 SD ±16% 0.2 g/L 3 SD 0.5 SD 0.01
IgG ±25% ±8.0% 5 g/L 1.25 0.2 0.12
20 g/L 5 0.8 0.46
IgA ±3 SD ±13.5% 4 g/L 3 SD 0.5 SD 0.11
IgM ±3 SD ±16.8% 3 g/L 3 SD 0.5 SD 0.09
IgE ±3 SD 100 ku/L 3 SD 0.5 SD
Infectious mono. 2 titers or +/- 1 titer
 Acceptable Performance Criteria, CLIA 88
SI Units

Acceptable Desirable Allowable Maximum Desirable SD

Performance Criteria Allowable Error Decision Level Error SD, CLIA (Ricos,
ANALYTE (CLIA '88) (Ricos, Fraser)a XCb CLIA 88c '88d Fraser)a
Rheumatoid factor 2 titers or +/- ±13.5% koc 1 titer
Rubella 2 titers or +/- 1 titer
 Acceptable Performance Criteria, CLIA 88
SI Units

Acceptable Desirable Allowable Maximum Desirable SD

Performance Criteria Allowable Error Decision Level Error SD, CLIA (Ricos,
ANALYTE (CLIA '88) (Ricos, Fraser)a XCb CLIA 88c '88d Fraser)a

a
Desirable specifications for allowable total error and imprecision from Ricos et al's 2010 biologic variation database
update, (http:www.westgard.com/biodatabase1.htm - accessed May 24, 2011)
b
Medical decision level, many of which are based on Barnett, RN: Am J Clin Pathol 50:671-676, 1968
c
Allowable error based on CLIA 88 performance requirements at the respective medical decision level.
d
Maximum internal SD based on criteria that 6 x SD < allowable error.
e
This performance goal is from the US National Glycohemoglobin Standardization Program (NGSP) and the
specification for allowable error is 1% GHB units
f
Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction.
Universal definition of myocardial infarction. J Am Coll Cardiol 2007; 50:2173-95