RECOMMENDED

TOTAL ALLOWABLE ERROR LIMITS

Sun Diagnostics has compiled this list of Total Allowable Error limits for a variety of laboratory
tests as defined by CLIA or other industry standards. This list is intended as a reference only.
Laboratories are responsible for setting their own performance criteria.
Chemistry Analyte
Albumin (ALB)
Alkaline Phosphatase (ALP)
Alanine Aminotransferase (ALT)
Amylase (AMY)
Aspartate Aminotransferase (AST)
Bilirubin, Total (TBILI)
Calcium (CA)
Cholesterol, Total (CHOL)
HDL Cholesterol (HDL-C)
LDL Cholesterol (LDL-C)
Chloride (CL)
Creatine Kinase (CK)
Creatinine (CREA)

Glucose (GLU)
Hemoglobin A1c (HbA1c)
IRON (FE)
Lactate Dehydrogenase (LDH)
Magnesium (MG)
PCO2
pH
PO2
Potassium (K)
Protein, Total (TP)
Sodium (NA)
Triglycerides (TRIG)
Urea (UREA)
Uric Acid (UA)

Limit
10%
30%
20%
30%
20%
0.4 mg/dL or 20% (greater)
1.0 mg/dL
10%
9%
30%
13%
12%
5%
30%
0.3 mg/dL or 15% (greater)
7.6% (desirable), 11.4%
(minimum)
6 mg/dL or 10% (greater)
6%
20%
20%
25%
5 mmHg or 8% (greater)
0.04
3 SD
0.5 mmol/L
10%
4 mmol/L
25%
15%
2 mg/dL or 9% (greater)
17%

Source
CLIA
CLIA
CLIA
CLIA
CLIA
CLIA
CLIA
CLIA
NCEP
CLIA
NCEP
NCEP
CLIA
CLIA
CLIA
NKDEP
CLIA
NGSP
CLIA
CLIA
CLIA
CLIA
CLIA
CLIA
CLIA
CLIA
CLIA
CLIA
NCEP
CLIA
CLIA

60 PINELAND DRIVE
AUBURN HALL SUITE 305
NEW GLOUCESTER, ME 04260
PHONE: 207-926-1125 TOLL FREE: 1-877-786-3424 FAX: 207-926-1126
www.sundiagnostics.us
TAE Limits Table rev20120725

RECOMMENDED
TOTAL ALLOWABLE ERROR LIMITS

Therapeutic Drugs and Drugs of Abuse

Ethanol
Acetaminophen
Carbamazepine
Digoxin
Gentamicin
Lithium
NAPA
Phenobarbital
Phenytoin
Primidome
Procainamide
Quinidine
Theophylline
Tobramycin
Valproic acid
Vancomycin

Limit
25%
10%
15%
25%
15%
0.2 ng/mL or 20% (greater)
0.2 ng/mL or 15% (greater)
25%
15%
0.3 mmol/L or 20% (greater)
0.3 mmol/L or 15% (greater)
25%
20%
15%
25%
15%
25%
15%
25%
25%
15%
25%
15%
25%
15%
25%
15%
15%

Source
CLIA
NYS
NYS
CLIA
NYS
CLIA
NYS
CLIA
NYS
CLIA
NYS
NYS
CLIA
NYS
CLIA
NYS
CLIA
NYS
CLIA
CLIA
NYS
CLIA
NYS
CLIA
NYS
CLIA
NYS
NYS

60 PINELAND DRIVE
AUBURN HALL SUITE 305
NEW GLOUCESTER, ME 04260
PHONE: 207-926-1125 TOLL FREE: 1-877-786-3424 FAX: 207-926-1126
www.sundiagnostics.us
TAE Limits Table rev20120725

RECOMMENDED
TOTAL ALLOWABLE ERROR LIMITS

Endocrinology and Immunology Analytes

IgG
Cortisol
Free Thyroxine (FT4)
Human Chorionic Gonadotropin (HCG)
Triiodothyronine (T3)
T3 Uptake
Thyroxine (T4)
Thyroid Stimulating Hormone (TSH)
Free Triiodothyronine (FT3)
Vitamin B12
Folic Acid
Insulin
Free Estriol
Estradiol
Testosterone
Progesterone
Dehydroepiandrosterone sulfate (DHEA-S)
Luteinizing Hormone (LH)
Follicle Stimulating Hormone (FSH)
Prolactin
25-OH Vitamin D
Parathyroid Hormone, Intact (PTH)

Limit
25%
25%
3 SD
3 SD
3 SD
3 SD
1.0 g/dL or 20% (greater)
3 SD
0.5 pg/mL or 25% (greater)
25%
2.0 ng/mL or 30% (greater)
3.0 U/mL or 25% (greater)
3.0 ng/mL or 25% (greater)
15 pg/mL or 25% (greater)
20 ng/mL or 25% (greater)
1.0 ng/mL or 25% (greater)
15 g/dL or 25% (greater)
1.5 mIU/mL or 25% (greater)
2.0 mIU/mL or 25% (greater)
2.0 g/dL or 25% (greater)
3.0 ng/mL or 25% (greater)
10 pg/mL or 30% (greater)

Source
CLIA
CLIA
CLIA
CLIA
CLIA
CLIA
CLIA
CLIA
NYS
NYS
NYS
NYS
NYS
NYS
NYS
NYS
NYS
NYS
NYS
NYS
NYS
NYS

Hematology Analytes
Activated Partial Thromboplastin Time (APTT)
Erythrocyte Count (RBC)
Fibrinogen
Hematocrit (HCT)
Hemoglobin (HGB)
Platelet Count (PLT)
Prothrombin Time (PT)
Leukocyte Count (WBC)

Limit
15%
6%
20%
6%
7%
25%
15%
15%

Source
CLIA
CLIA
CLIA
CLIA
CLIA
CLIA
CLIA
CLIA

60 PINELAND DRIVE
AUBURN HALL SUITE 305
NEW GLOUCESTER, ME 04260
PHONE: 207-926-1125 TOLL FREE: 1-877-786-3424 FAX: 207-926-1126
www.sundiagnostics.us
TAE Limits Table rev20120725

RECOMMENDED
TOTAL ALLOWABLE ERROR LIMITS

Note: Sources are not listed if they agree with CLIA.

SOURCES:
1. CLIA, CFR Part 439
a. Routine Chemistry: http://wwwn.cdc.gov/clia/regs/subpart_i.aspx
b. Toxicology: http://wwwn.cdc.gov/clia/regs/subpart_i.aspx
2. New York State Dept. of Health (NYSDOH) Clinical Laboratory Evaluation Program.
a. Clinical Chemistry: http://www.wadsworth.org/chemheme/chem/gencc/ccpt.htm
b. Therapeutic Substances: http://www.wadsworth.org/chemheme/chem/tsm/tsmpt.htm
c. Endocrinology: http://www.wadsworth.org/chemheme/chem/endo/endo.htm
2. National Cholesterol Education Program: Recommendations for improving cholesterol
measurement. a report from the Laboratory Standardization Panel of the National Cholesterol
Education Program. NIH Publication No. 90-2964, Bethesda, Maryland, February, 1990.
3. Bachorik PS, Ross JW, for the NCEP Working Group on Lipoprotein Measurement. National
Cholesterol Education Program recommendations for measurement of low-density lipoprotein
cholesterol: executive summary. Clin Chem 1995;41:1414-20.
4. Stein EA, Myers GL, for the NCEP Working Group on Lipoprotein Measurement. National
Cholesterol Education Program recommendations for triglyceride measurement: executive
summary. Clin Chem 1995;41:1421-6.
5. Warnick GR, Wood PD, for the NCEP Working Group on Lipoprotein Measurement. National
Cholesterol Education Program recommendations for measurement of high-density lipoprotein
cholesterol: executive summary. Clin Chem 1995;41:1427-33.
6. National Glycohemoglobin Standardization Program (NGSP), www.ngsp.org.
7. Myers GL, Miller WG, Coresh J, Fleming J, Greenberg N, Greene T, et al. Recommendations for
improving serum creatinine measurement: a report from the Laboratory Working Group of the
National Kidney Disease Education Program. Clin Chem 2006; 52: 5-18.

60 PINELAND DRIVE
AUBURN HALL SUITE 305
NEW GLOUCESTER, ME 04260
PHONE: 207-926-1125 TOLL FREE: 1-877-786-3424 FAX: 207-926-1126
www.sundiagnostics.us
TAE Limits Table rev20120725