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Technical update for HIV nucleic acid tests approved for diagnostic purposes
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May 16, 2023
[PDF-2.14 MB]
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Description:cdc:23447
The Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL) are sharing information on three HIV nucleic acid tests (NATs) approved by the U.S. Food and Drug Administration (FDA) for diagnostic use: the cobas® HIV-1/HIV-2 Qualitative test (“HIV-1/HIV-2 Qualitative test,” approved August 2020, Roche Molecular Systems Inc., Branchburg NJ), the Aptima® HIV-1 Quant Dx Assay (approved November 2020, Hologic Inc., San Diego, CA), and the Alinity m HIV-1 Assay (“HIV-1 Assay,” approved July 2022, Abbott Molecular, Inc., Des Plaines, IL); the latter two assays provide both a qualitative and quantitative result. This document provides guidance on these HIV NATs with a diagnostic claim in the third step of the current recommended algorithm for laboratory testing (see Figure 1 below). When testing for the purpose of PrEP initiation similar principles apply. Additional information is provided regarding interpretations and considerations for when a HIV NATs with a diagnostic claim might be requested as part of a test sequence that differs from the current recommended algorithm.
CDC and APHL have not changed the recommendation that laboratories perform an HIV-1/HIV-2 antibody differentiation supplemental immunoassay as the second step after a reactive antigen/antibody screening immunoassay [1,2]. Figure 1 shows the update to the recommended algorithm for the diagnosis of HIV infection in which the recently FDA-approved HIV NATs with a diagnostic claim are incorporated at the third step. In situations when the differentiation assay is negative or indeterminate for HIV-1 or HIV-2 antibodies, the laboratories should perform a NAT with a diagnostic claim as a third test [3,4]. Algorithm interpretations at decision endpoints are shown in boxes. The vast majority (99.94%) of all reactive HIV screening tests performed in the US are resolved to be HIV-1 infections [5-7].
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