Laboratory Testing Algorithm
APHL continues to monitor the HIV diagnostic landscape to provide members the most useful information. Since the 2014 HIV Laboratory Testing Algorithm several resources have been developed to assist laboratories with understanding, using and reporting results from the diagnostic algorithm.
The results of the diagnostic algorithm may be used to identify persons likely to benefit from treatment, to reassure persons who are uninfected and for reporting evidence of HIV infection to public health authorities. The
Quick Reference Guide was updated in January 2018 which updated the algorithm figure and accounts for the availability of new diagnostic tests and provides updated reporting language. The full recommendations still contain the most comprehensive information and are a useful resource for understanding the algorithm
To see the current landscape of HIV testing in US PHLs please view the
2014 HIV Diagnostics Survey Issue Brief.
HIV NAT Reference Centers
APHL manages two HIV Nucleic Acid Testing Reference Centers, New York State Department of Health Wadsworth Center and the Florida Bureau of Public Health Laboratories. The Reference Centers were set up in 2012 to ensure that the HIV-1 NAT, the critical final step in the algorithm to reconcile discordant results, would be available to all public health laboratories. For labs that do not have a platform available, it is prohibitively expensive to bring it in-house. By virtue of the new algorithm, a single laboratory would have a relatively low volume of specimens requiring this technique.
Interested in enrolling as an HIV NAT Reference Center? Email
Oral Fluid Testing
In May 2017, the Oral Fluid testing market has changed again with the announcement by
OraSure Technologies that the OraSure HIV-1 Western Blot for confirmation of HIV in Oral Fluid specimens would be discontinued. Additionally, APHL has confirmed that OraSure will continue to offer the OraSure HIV-1 Oral Specimen Collection Device and
Avioq will continue to manufacture the HIV-1 Microelisa system kit.
Laboratories still requiring an assay to confirm HIV in oral fluid specimens will need to validate an alternative assay. APHL continues to track different laboratory approaches and will share any information we can regarding successful validation of alternative assays. At this time we are aware of laboratories pursuing validation of the Geenius HIV-1/2 Supplemental Assay and the GS HIV-1 Western Blot. For reference, in 2007 when no FDA-approved option existed for testing oral fluid specimens, APHL sought and received approval from the Centers for Medicare & Medicaid Services (CMS) to allow public health laboratories to perform a limited validation of a serum-based HIV screening assay to test oral fluid specimens. The proposal helped public health laboratories continue oral fluid testing with minimal interruption.
If you have any questions or want to share any data with APHL to benefit the broader community please email