Point-of-Care and CLIA-Waived Tests: Normal Values
Waived tests are simple tests with low risk of a wrong result; the lab must hold a Certificate of Waiver and follow the manufacturer's instructions exactly.
CLIA waiver basics
- CLIA categories: waived, moderate complexity (includes provider-performed microscopy) and high complexity (42 CFR 493.5).
- Waived tests are cleared by FDA for home use, or are so simple and accurate that errors are unlikely, or pose no reasonable risk of harm if done incorrectly (493.15(b)).
- Labs with a Certificate of Waiver must follow the manufacturer's instructions and meet the waiver requirements (493.15(e)).
- Tests named in the regulation as waived: non-automated dipstick or tablet urinalysis (bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrite, pH, protein, specific gravity, urobilinogen); non-automated fecal occult blood; visual ovulation tests; visual urine pregnancy tests; non-automated ESR; copper sulfate hemoglobin; blood glucose by FDA home-use meters; spun microhematocrit; hemoglobin by single-analyte instruments.
- Other products (e.g., many rapid strep and some PT/INR meters) are waived by FDA categorization; check the FDA CLIA database for the specific device.
Preview only. The full sheet also covers: Common POC tests and expected values.
Sources
- 42 CFR 493.15 Laboratories performing waived tests · U.S. Government Publishing Office (govinfo)
- CLIA Categorizations · U.S. Food and Drug Administration
- 2. Diagnosis and Classification of Diabetes: Standards of Care in Diabetes-2026 (Diabetes Care) · American Diabetes Association via PubMed Central
- Standards of Care in Diabetes-2026, Section 6: Glycemic Goals, Hypoglycemia, and Hyperglycemic Crises (Recommendation 6.2) · American Diabetes Association (Diabetes Care) via PubMed Central
- Hemoglobin (Medical Encyclopedia) · MedlinePlus, U.S. National Library of Medicine
- Hematocrit (Medical Encyclopedia) · MedlinePlus, U.S. National Library of Medicine
- Urinalysis (Medical Encyclopedia) · MedlinePlus, U.S. National Library of Medicine
- Urine specific gravity test (Medical Encyclopedia) · MedlinePlus, U.S. National Library of Medicine
- Urine pH test (Medical Encyclopedia) · MedlinePlus, U.S. National Library of Medicine
- Prothrombin time (PT) (Medical Encyclopedia) · MedlinePlus, U.S. National Library of Medicine
- Strep A Test (Medical Tests) · MedlinePlus, U.S. National Library of Medicine
- Pregnancy Test (Medical Test) · MedlinePlus, U.S. National Library of Medicine
- Clinical Nursing Skills, 10.1 Urine Specimen · OpenStax, Rice University (CC BY-NC-SA 4.0)