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Technical update : Use of the Determine HIV 1/2 Ag/Ab combo test with serum or plasma in the laboratory algorithm for HIV diagnosis
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10/4/2017
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Source: To be used in conjunction with: Laboratory testing for the diagnosis of HIV infection : updated recommendations.
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Description:In 2014 the Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL) published recommendations for the laboratory diagnosis of HIV infection.1 This technical update provides information on the use of the Alere Determine HIV 1/2 Ag/Ab Combo single use rapid test (Determine) in laboratories where it is not feasible to conduct an instrumented antigen/antibody test as the initial test in the algorithm. In 2014, sufficient data were only available to recommend instrumented antigen/antibody tests. Since then, data describing Determine’s performance using specimens typically used for laboratory testing (plasma and serum) have become available. We are writing to share this new information and to describe its implications for the recommendations for laboratory diagnosis of HIV infection.
The CDC and APHL continue to recommend that laboratories use an instrumented, laboratory-based antigen/antibody HIV screening immunoassay, followed, when reactive, by an HIV-1/HIV-2 antibody differentiation immunoassay. When the differentiation assay interpretation is negative or indeterminate for HIV-1, perform an HIV-1 nucleic acid test (NAT). Instrumented antigen/antibody tests are preferred over Determine because the former are more sensitive for HIV during acute infection.2,3 However, Determine can detect infection earlier than IgM/IgG sensitive (antibody-only) immunoassays when used with plasma.2,3,4 For laboratories in which instrumented antigen/antibody testing is not feasible, Determine can be used with serum/plasma as the first step in the laboratory algorithm. It may not detect infection as early as the instrumented tests. Laboratories using Determine are advised to acknowledge the limitations of the testing procedure when reporting results.
As additional data become available, CDC and APHL may make additional clarifications to the 2014 recommendations for the laboratory diagnosis of HIV infection. Thank you for your commitment to accurate laboratory testing for HIV. Please send any comments or questions to www.cdc.gov/info or 1-800-CDC-INFO.
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