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Development of quantified HIV-1 antigen panel for evaluating HIV Ag/Ab combination tests using the RT-qPCR method

ABSTRACT: We established a human immunodeficiency virus type 1 (HIV-1) antigen (Ag) panel from culture supernatants of 27 HIV-1 isolates, including 11 HIV-1 subtypes, circulating recombinant forms (CRFs), and groups (HIV-1 types), to evaluate the HIV-1 Ag detection sensitivity and HIV-1 type specificity of three HIV-1 Ag/antibody (Ab) combination tests approved in Japan. The HIV-1 copy numbers were quantified by the reverse transcription quantitative polymerase chain reaction (RT-qPCR) method. They were diluted to four different copy numbers and used in this evaluation. Enzygnost HIV Integral IV gave HIV-positive results in nearly all samples, with the single exception being an HIV-negative result in a case with a value just below the cut-off in a CRF08_BC member (100,000 copies/mL). Genscreen HIV Ag-Ab ULT showed low sensitivity to HIV-1 group O members, but this is not an urgent problem as no HIV-1 group O infection cases have been reported in Japan. The detection sensitivity of Determine HIV Early Detect was lower than that of the aforementioned two tests by ten-to hundred-fold, indicating that the kit may have limited performance in the acute phase of HIV-1 infection. Our HIV-1 Ag panel is useful for evaluating the HIV-1 Ag sensitivity of HIV-1 Ag/Ab combination tests. Highlights • Most HIV IVDs for screening test approved in Japan consist of Ag/Ab combination tests.• Seroconversion panels cannot evaluate the HIV-1 type-specificity of Ag detection.• We establish a new HIV-1 Ag panel without a complicated procedure and at low cost.• The panel is useful to deduce the performance of acute phase HIV-1 infection.

SUBMITTER: Kusagawa S

PROVIDER: S-EPMC9530611 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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