Appendix F: Additional Information Available on CLIA Waived Rapid Tests
Rapid HIV test technology is evolving and it is expected that there will be a number of tests to choose from in the future. What rapid HIV test product an agency uses is based on a variety of issues such as cost, east of use, and population served.
Some rapid HIV tests are designated as moderately complex by CLIA, and due to its complexity it must be performed in a traditional clinical laboratory. This entails fulfilling requirements that are likely beyond the means of non-clinical providers, unless they have an affiliation or partnership with a clinical provider.
More information on rapid tests
- "General and Laboratory Consideration: Rapid HIV Tests Currently Available in the United States" - The Centers for Diseases Control and Prevention (CDC)
- Rapid test technology updates and information regarding new product approval can be found on the FDA website