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 the Division of HIV/AIDS Prevention (DHAP). 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 our public health laboratories are engaged in this process.
Laboratory Testing Algorithm
APHL and CDC developed the first national algorithm for laboratory testing of HIV in 1989. APHL continued to work with partners to develop
updated recommendations which were released in 2014. These recommendations include new assays that allow for earlier detection of HIV infections and more accurate diagnosis of HIV-2 infections, fewer indeterminate results and faster turnaround times for most testing results.
The results of this 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. A brief
Quick Reference Guide is available as well as the
To see the current landscape of HIV testing 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?
CLICK TO ENROLL.
Oral Fluid Testing
In 2007, with no FDA-approved option 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.
In 2009, Avioq Inc. received FDA approval for their HIV-1 Microelisa system. This first generation viral lysate immunoassay is approved for testing serum, plasma, oral fluid and dried blood spot specimens. According to CMS, laboratories are not required to switch to this FDA-approved assay if they previously conducted a full validation that included setting performance specifications and steps to be taken if the test is not meeting those specifications.
Laboratories that took advantage of the CMS-approved, limited validations will need to implement the FDA-approved assay or perform a full validation on a different assay. If you have questions about what constitutes a full validation, you should contact your CLIA surveyor. For the status of oral fluid testing in the United States, read more in
APHL’s issue brief from 2013.
Publications and Resources
HIV Diagnostics Conference Proceedings
Lab Matters/Blog Posts