Qualitative HIV-1 proviral DNA PCR tests have three main diagnostic applications. These include direct detection of viral sequences in the pre-seroconversion window period which may be positive up to 8 days prior to the development of HIV specific antibodies; resolution of indeterminate HIV serological tests and in the diagnosis of neonates born to seropositive mothers where maternal antibodies may be detectable for up to 15 months past partum.
This assay is optimized for the detection of HIV-1 groups M (subtypes A to H), N and O, but it may not detect all HIV-1 group N or O strains.
A “Detected” result is consistent with HIV infection. An “Undetected” result indicates that neither HIV-1 DNA nor RNA is detected in the specimen. An “Inconclusive” result indicates that the absence or presence of HIV-1 DNA or RNA could not be determined with certainty after repeat testing of the clinical specimens in the laboratory, possibly due to PCR inhibition. The lower limits of detection of this assay in plasma are 311 copies/mL for HIV-1 DNA and 75 copies/mL for HIV-1 RNA.
