FAQ · Testing Basics
What does “CLIA-certified” mean, and why does it matter?
CLIA — the Clinical Laboratory Improvement Amendments — is the federal certification program for U.S. labs that test human samples, administered by CMS with FDA and CDC involvement. Certification covers personnel, quality control, and proficiency testing. It matters because it is the baseline separating real laboratory testing from unregulated analysis; reputable at-home services name their CLIA-certified (often also CAP-accredited) lab partners. It certifies the lab’s quality, not whether a given test is the right one to take — that judgment belongs with a healthcare provider.
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