HIV-1 RNA Detection and Quantification, Prenatal, Plasma

Clinical Use

Use

This test is useful for diagnosing HIV-1 infection in pregnant individuals with acute or early HIV-1 infection. It helps in quantifying plasma HIV-1 RNA levels, also known as viral load, in pregnant individuals living with HIV-1. This quantification is crucial before initiating anti-HIV-1 drug therapy to establish a baseline viral load, for those who might have developed HIV-1 drug resistance while on therapy, or for those who might be noncompliant with their drug therapy. Additionally, it is used to monitor HIV-1 disease progression before or during antiretroviral drug therapy in pregnant individuals.

Special Instructions

Not provided.

Limitations

This test is not licensed by the US FDA for screening in donors of blood, cells, or tissue products. A single test result should not solely guide therapeutic decisions; it should be correlated with clinical presentation and other laboratory parameters. The test may not reliably quantify plasma viral loads for HIV-1 group N and HIV-2, and results for group O strains may differ from other assays. Plasma HIV-1 RNA levels from ACD-tubes may be lower than those from EDTA-tubes by approximately 15%. Freezing plasma in PPTs may result in falsely high readings due to intracellular nucleic acid release.

Test Details

New York Approved