Transitioning to New FDA Approved Tests and HIV Diagnostic Testing Algorithm Implementation

BACKGROUND: To accommodate new FDA (Food and Drug Administration) approved HIV diagnostic tests and the discontinuation of an antibody differentiation test recommended for use in a diagnostic testing algorithm, New York State (NYS) issued to permitted clinical laboratories updated guidance for performing HIV diagnostic testing. Subsequently, updated HIV-related laboratory reporting requirements were released in the 2016 Laboratory Reporting of Communicable Diseases. The NYSDOH Clinical Laboratory Evaluation Program (CLEP) has regulatory oversight of clinical laboratories performing testing on NYS residents. NYS Public Health Law requires laboratories conducting HIV-related testing for NYS providers and/or NYS residents to electronically report any laboratory test, tests or series of tests approved for the diagnosis of HIV or for the periodic monitoring of HIV infection.

METHODS: NYS works with permitted laboratories to recruit them into public health reporting. In April 2016, the HIV surveillance program collaborated with CLEP to administer a survey of all 289 HIV-testing laboratories applying for permit renewal. Questions were designed to document labs’ HIV diagnostic testing algorithm (DTA), the protocol for confirmation, timeline for onboarding new tests and implementation plan, reference-referral relationships, and reporting to providers. Survey results were analyzed using SAS.

RESULTS: All surveyed labs responded, yielding a 100% response rate. Sixty-six duplicate responses were deleted, and one laboratory indicated that they were not renewing their CLEP permit. Survey results for the 288 were used to prioritize lab recruitment into public health reporting. The majority of labs (n=209, 73%) reported holding a diagnostic immunology permit, the permit category covering most HIV diagnostic testing. Nine laboratories indicated using newly FDA approved tests in their DTA. Over 75 laboratories have short term plans to implement new FDA approved tests. Of the 116 labs documenting reference/referral relationships, at least 40 (34%) self-report not having a system in place to transmit ordering provider information between lab systems to ensure public health reporting of this critical information.  

CONCLUSIONS: State surveillance programs should consider partnering with regulatory bodies to identify labs conducting public health reportable testing. Such approaches can be customized according to local regulatory environment for jurisdictions to aid the transition to new tests used in the DTA and have complete laboratory reporting. Since laboratory data are the foundation of HIV surveillance programs, their timeliness and completeness is critical for CDC case confirmation, data to care programs which rely on laboratory reports as markers of HIV care, and monitoring progress with the National HIV/AIDS Strategy indicators.