CLIA Acceptable Test Performance Criteria

Last Update On : 2013-02-22

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 CLIA Acceptable Medical Decision CLIA Allowable Medically
Chemistry Performance Level Error 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
Medically
CLIA Acceptable Medical Decision CLIA Allowable
Enzymes Allowable Error
Performance Level (U/L) Error (U/L)
(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
CLIA Acceptable Medical Decision CLIA Allowable Medically
Hormones
Performance Level Error Allowable Error
FSH 10 U/L 1.3 U/L
95 U/L 12.5 U/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
CLIA Acceptable Medical Decision CLIA Allowable Medically
Immunology
Performance Level Error Allowable Error
ASO +/- 2 titers or P/N 2 titers or P/N
Anti-HIV Reactive/ Reactive/
Nonreactive Nonreactive
C3 +/- 3 SD 3 SD
C4 +/- 3 SD 3 SD
HBsAg Reactive/
 Nonreactive
Rheumatoid +/- 2 titers or P/N 2 titers or P/N
factor
Transferrin 375 mg/dL 44.6 mg/dL
CLIA Acceptable Medical Decision CLIA Allowable Medically
Hematology
Performance Level Error 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