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 |
