APHL develops and promotes HIV testing best practices and guidelines for diagnostic laboratories nationwide and supports public health laboratories in the implementation of national recommendations through close collaboration with CDC's Division of HIV/AIDS Prevention. The estimated number of new HIV infections continues to decline despite the total number of persons living with HIV in the US continuing to increase. Accurate and early diagnosis of these new HIV infections is imperative to the goal of an HIV-free future and our public health laboratories are actively engaged in this process.
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 Suggested Reporting Language for the HIV Laboratory Diagnostic Testing Algorithm was updated in January 2019 and includes updates related to changes with the Geenius HIV-1/2 Supplemental Antibody Assay (FDA-approved 2017) as well as updates in the CDC Quick Reference Guide. 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 2017 HIV and HCV Diagnostics Survey Report.
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.
If you are interested in enrolling as a submitter to the HIV NAT Reference Center email
Oral Fluid Testing
In May 2017, the Oral Fluid testing market 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 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.
Integrating HIV and HCV Testing
APHL recently partnered with NASTAD to develop the Integrating HIV and HCV Testing Toolkit to assist public health programs and laboratories with identifying strategies to integrate testing at multiple levels. This toolkit and its associated slides will provide health departments (HDs) and laboratories with current information regarding HIV and HCV testing technologies, describe factors HDs should consider in determining when integration of testing is beneficial and discuss how various testing technologies and strategies for using these technologies can facilitate integration.