Guide
What Are CLIA-Waived Tests?
CLIA-waived tests are simple rapid tests that clinics and healthcare practitioners can run on site for fast, reliable results. Here is what they are and how to use them.
CLIA explained
The Clinical Laboratory Improvement Amendments set quality standards for laboratory testing on human samples. Tests are grouped as waived, moderate complexity or high complexity. Waived tests have a low risk of error when the instructions are followed.
Who can run waived tests
Any site holding a CLIA Certificate of Waiver can run waived tests. This includes physician offices, urgent care, university clinics, recovery centers and occupational health providers. Staff must follow the manufacturer's instructions exactly.
Benefits of point-of-care testing
Results arrive in minutes, so decisions happen during the visit. This cuts down on follow-up calls, lowers lab costs, and improves the patient experience.
Frequently asked questions
What does CLIA-waived mean?
CLIA (Clinical Laboratory Improvement Amendments) regulates laboratory testing in the US. Waived tests are simple, low-risk tests cleared by the FDA for waived use, so they can be run outside a full laboratory.
Do I need a CLIA Certificate of Waiver?
Yes. Any site that runs CLIA-waived tests on patient samples for diagnosis or treatment needs a Certificate of Waiver from CMS and must follow the manufacturer's instructions.
How do I apply for a CLIA Certificate of Waiver?
Submit form CMS-116 to your state agency and pay the certificate fee. Once approved, you receive a CLIA number to keep on file.
What are common CLIA-waived rapid tests?
Common examples include drug screens, pregnancy tests, strep A, influenza, COVID-19, urinalysis strips, glucose, and fecal occult blood tests.
Who uses CLIA-waived tests?
Physician offices, urgent care, university health clinics, recovery and treatment centers, pharmacies and occupational health providers use them for fast point-of-care results.