Access HIV Ag/Ab Combo Assay - European Union (EU) Clinical Trial Protocol

Inclusion Criteria: Anonymized or pseudo-anonymized leftover samples from * Males or females * Aged ≥18 years of age * Belonging to one of the following enrollment groups: * Unselected blood donor * Hospitalized patient * Known HIV-1 antibody positive patients * confirmed positive by Immunoblot, Western blot or HIV-1/HIV-2 antibody differentiation test either at time of enrollment vai same study draw or historically from medical record * Known HIV-2 antibody positive patients * confirmed HIV-2 positive by BioPlex 2200 HIV Ag-Ab Assay * Known HIV-1 Ag positive patients * For samples from HIV seroconversion panels * Tested during EU HIV clinical trial: confirmed positive by screening HIV Ag/Ab combo positive for p24 Ag, and p24 Ag screening test positive (result from CoA or additional testing) * Tested as part of seroconversion panel studies (V\&V studies): First sample of the panel that is ARCHITECT Ag/Ab combo assay positive or BioPlex 2200 HIV Ag-Ab Assay p24 positive, and p24 Ag test positive (result from CoA or additional R\&D testing) * For routine clinical samples: * Confirmed positive by screening HIV Ag/Ab combo assay positive for p24 Ag , and p24 Ag test positive by confirmatory test, or * Confirmed positive by screening HIV Ag/Ab combo assay HIV positive, and p24 Ag test positive by confirmatory test and PCR HIV POS and IB/WB HIV negative or indetermined. * with at least 2.0 mL leftover EDTA plasma sample from…