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 |