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2019 CLIA Proposed Acceptance Limits for Proficiency Testing

CLIA has posted a proposed set of new quality requirements for proficiency testing. Here's what was listed in the Federal Register for public comment.

Chemistry

Routine Chemistry CLIA 2019    
Analyte or Test NEW Criteria for AP OLD AP
Alanine aminotransferase (ALT/SGPT) TV ± 15% TV ± 20%
Albumin TV ± 8% TV ± 10%
Alkaline Phosphatase TV ± 20% TV ± 30%
Amylase TV ± 10% TV ± 30%
Bilirubin, total TV ±20% TV  ± 20% or 0.4 mg/dL (greater)
Blood gas pCO2 TV ± 5mm Hg or ± 8% (greater) Same
Blood gas pO2 TV ± 15 mm Hg or ± 15% (greater) TV ± 3SD
Blood gas pH TV ± 0.04 Same
B-natriuretic peptide (BNP) TV ± 30% None
Pro B-natriuetic peptide (proBNP) TV ± 30% None
Calcium, total TV ± 1.0 mg/dL Same
Carbon dioxide TV ± 20% None
Chloride TV ± 5% Same
Cholesterol, total TV ± 10% Same
Cholesterol, high density liprotein TV ± 20% TV ± 30%
Cholesterol, low density lipoprotein (direct) TV ± 20% None
Creatine kinase (CK) TV ± 20% TV ± 30%
CK-MB isoenzymes MB elevated (presence or absence) Same
  or TV ± 25% (greater) or TV ± 3SD
Creatinine TV ± 0.2 mg/dL or ± 10% (greater) TV ± 0.2 mg/dL or ± 15% (greater)
Ferritin TV ± 20% None
Gamma glutamyl transferase TV ± 5 U/L or ±15% (greater) None
Glucose (excluding FDA home use) TV ± 8% TV ± 6 mg/dL or ± 10% (greater)
Hemoglobin A1c TV ± 10% None
Iron, total TV ± 15% TV ± 20%
Lactate dehydrogenase (LDH) TV ± 15% TV ± 20%
Magnesium TV ± 15% TV ± 25%
Phosphorus TV ± 0.3 mg/dL or 10% (greater) None
Potassium TV ± 0.3 mmol/L TV ± 0.5 mmol/L
Prostate Specific Antigen, total TV ± 0.2 ng/dL or 20% (greater) None
Sodium TV ± 4 mmol/L Same
Total Iron Binding Capacity (direct) TV ± 20% None
Total Protein TV ± 8% TV ± 10%
Triglycerides TV ± 15% TV ± 25%
Troponin I TV ± 0.9 ng/mL or 30% (greater) None
Troponin T TV ± 0.2 ng/ML or 30% (greater) None
Urea Nitrogen TV ± 2 mg/dL or ± 9% (greater) Same
Uric Acid TV ± 10% TV ± 17%

Immunology

Immunology CLIA 2019    
Analyte or Test NEW Criteria for AP OLD AP
Alpha-1 antitrypsin TV ± 20% or positive or negative TV ± 3 SD
Alpha-fetoprotein (tumor marker) TV ± 20% or positive or negative TV ± 3 SD
Antinuclear antibody TV ± 3 SD or positive or negative TV ± 2 dilutions or pos or neg
Antistreptolysin O TV ± 3 SD or positive or negative TV ± 2 dilutions or pos or neg
Anti-Human Immunodeficiency virus (HIV) Reactive (pos) or nonreactive (neg) Same
Complement C3 TV ± 15% or positive or negative TV ± 3 SD
Complement C4 TV ± 5 mg/dL or ± 20% (greater) TV ± 3 SD
C-reactive protein (HS) TV ± 1 mg/dL or ±  30% (greater) None
HBsAg Reactive (pos) or nonreactive (neg) Reactive (pos) or nonreactive (neg)
anti-HBc Reactive (pos) or nonreactive (neg) Reactive (pos) or nonreactive (neg)
HB3Ag Reactive (pos) or nonreactive (neg) Reactive (pos) or nonreactive (neg)
Anti-HBs Reactive (pos) or nonreactive (neg) Reactive (pos) or nonreactive (neg)
Anti-HCV Reactive (pos) or nonreactive (neg) Reactive (pos) or nonreactive (neg)
IgA TV ± 15% TV ± 3SD
IgE TV ± 20% TV ± 3SD
IgG TV ± 20% TV ± 3SD
IgM TV ± 20% TV ± 3SD
Infectious mononucleosis Positive or negative TV ± 2 dilutions or pos or neg
Rhematoid factor TV ± 3 SD or positive or negative TV ± 2 dilutions or pos or neg
Rubella TV ± 3 SD or positive or negative TV ± 2 dilutions or pos or neg

Endocrinology

Endocrinology CLIA 2019    
Analyte or Test NEW Criteria for AP OLD AP
Cancer antigen (CA) 125 TV ± 20% None
Carcinoembryonic antigen (CEA) TV ± 15% None
Cortisol TV ± 20% TV ± 25%
Estradiol TV ± 30% None
Folate, serum TV ± 1 ng/mL or ± 30% (greater) None
Follicle stimulating hormone TV ± 2 IU/L or ± 18% (greater) None
Free throxine TV ± 0.3 ng/dL or ± 15% (greater) TV ± 3SD
Human chorionic gonadotropin  TV ± 18% or positive or negative TV ± 3SD or positive or negative
Luteinizing hormone TV ± 20% None
Parathyroid hormone TV ± 30% None
Progesterone TV ± 25% None
Prolactin TV ± 20% None
Testosterone TV ± 20 ng/dL or ±30% (greater) None
T3 uptake TV ± 18% TV ± 3SD
Triiodothyronine TV ± 30% TV ± 3SD
Tyroid stimulating hormone TV ± 20% or ± 2 mIU/L (greater) TV ± 3SD
Thyroxine  TV ± 20% or ± 1.0 mcg/dL (greater) Same
Vitamin B12 TV ± 25% TV ± 30%

Toxicology

Toxicology CLIA 2019    
Analyte or Test NEW Criteria for AP OLD AP
Acetaminophen TV ± 15% None
Alcohol, blood TV ± 20% TV ± 25%
Blood lead TV ± 10% or 2mcg/dL (greater) TV ± 10% or ±4 mcg/dL (greater)
Carbamazepine TV ± 20% TV ± 25%
Digoxin TV ± 15% or ± 2 ng/mL  (greater) None
Gentamicin TV ± 25% Same
Lithium TV ± 15% TV ±  0.3 mmol/L or 20% (greater)
Phenobarbital TV ± 15% TV ± 20%
Phenytoin TV ± 15% or ± 2 mcg/dL (greater) TV ± 25%
Salicylate TV ± 15% None
Theophylline TV ± 20% TV ± 25%
Tobramycin TV ± 20% TV ± 25%
Valproic acid TV ±20% TV ± 25%
Vancomycin TV ± 15% or ± 2 mcg/dL (greater) None

Hematology

Hematology CLIA 2019    
Analyte or Test NEW Criteria for AP OLD AP
Cell identification 80% or greater consensus 90% or greater consensus
White blood cell differential TV ± 3 SD Same
Erythrocyte count TV ± 4% TV ± 6% 
Hematocrit TV ± 4% TV ± 6%
Hemoglobin TV ± 4% TV ± 7%
Leukocyte count TV ± 5% TV ± 15%
Platelet count TV ± 25% Same
Fibrinogen TV ± 20% Same
Partial thromboplastin time TV ± 15% Same
Prothrombin time TV ± 15% Same
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