Real-Time Reverse Transcriptase Polymerase Chain Reaction Amplification (RT-PCR)
The Abbott RealTime HIV-1 assay is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. Although this assay is not FDA-approved for diagnosis, guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection (United States Department of Health and Human Services) equally recommend plasma HIV RNA or cell-associated HIV DNA nucleic acid tests to diagnose HIV in infants and children aged <18 months with perinatal and postnatal HIV exposure.
Not Detected. A result of "Not Detected" does not rule out the presence of HIV-1 RNA. A positive result indicates the presence of viral RNA, reported as the number of HIV-1 RNA copies/mL of plasma. The linear range of this assay is 40 -10,000,000 HIV-1 RNA copies/mL (Log10: 1.6 - 7.0).
A single assay result should not be used as the only criteria to form a clinical conclusion. Results should be correlated with serologic tests, patients symptoms and clinical presentation.
- HIV Type 1 p24 Antigen Replacement Assay
- HIV Viral Load, Ultrasensitive
- Viral Load, HIV Type 1 RNA, Ultrasensitive
- HIV Viral Load
- Human Immunodeficiency Virus Type 1 RNA by PCR
- Viral Load, HIV Type 1 RNA
- HIV-1 QUANTITATIVE RNA ASSAY
- HIV-1 ULTRA-QUANT. RNA ASSAY
- HIV-1 Proviral DNA, Blood
Collect specimen in lavender top (EDTA) tube. Centrifuge for 20 minutes at 800 - 1600 x g at room temperature and aliquot plasma into a polypropylene plastic vial within 6 hours of collection. Refrigerate for up to 5 days or freeze for longer storage. Do not allow frozen specimens to thaw at any time during storage or transport due to possible degradation of RNA. Specimens submitted in polystyrene tubes are not acceptable. Specimens sent for Microbiology molecular testing require a dedicated sample and cannot be shared with other laboratories.
Results above 10,000,000 HIV-1 RNA copies/mL fall outside the upper limit of the linear range of the assay and will be reported as >10,000,000 HIV-1 copies/mL detected. Since, clinically, a viral load above this level is sufficient to warrant a change in the patient's treatment regimen, such specimens will not routinely be diluted and retested to obtain the actual viral load level. For MLabs, please contact client services center if actual viral load is needed. Specimen will be held for 1 month.