The US Association of Public Health Laboratories recommends verification of all first-time positive confirmatory test results prior to the diagnosis of HIV infection. A second serum should be obtained from the patient and submitted for repeat testing to verify all positive results.
Positive HIV antibody WB results in infants of <18 months of age and born to HIV-infected mothers may indicate passive transfer of maternal HIV antibodies. Serologic tests (screening, supplemental or confirmatory) cannot distinguish between active neonatal HIV infection and passive transfer of maternal HIV antibodies in infants during the postnatal period (up to 18 months). Diagnosis of HIV infection in newborns and infants should be made by virologic tests such as detection of HIV RNA or HIV proviral DNA.
This test should be ordered only on sera that are either indeterminate or reactive for HIV-1 antibodies (regardless of the HIV-2 antibody result) by FDA approved HIV-1/2 antibody differentiation tests.
Although hemolyzed serum specimens are acceptable for testing, this assay is not FDA-approved for testing cadaveric serum specimens.
Performance characteristics have not been established for the following specimen types: Cadaveric specimens, Specimens containing particulate matter