HIV Viral Load (HIV 1 RNA Quantitation)
Human Immunodeficiency Virus 1 quantitation, HIV 1 RNA Quantitation By PCR , EPIC: LAB6399, SOFT: IHIVG
Specimen Collection Criteria
Preferred: One 8.5 mL Plasma Preparation Tube (PPT); Pearl Top EDTA
Acceptable: Two Lavender-top EDTA tubes.
- Minimum volume and pediatric minimum (single test with no repeat): 2.5 mL whole blood (1.1 mL plasma).
- Separate samples must be submitted when multiple tests are ordered.
One 8.5 mL Plasma Preparation Tube (PPT); Pearl Top EDTA
Physician Office/Drawsite Specimen Preparation
Centrifuge to separate plasma from cells within 24 hours of collection. Transport PPT tube directly to the laboratory for testing.
If collecting Lavender, EDTA: Transfer all available plasma to a plastic transport tube and refrigerate (2-8°C or 36-46°F). (Min: 1.1 mL)
Preparation for Courier Transport
Transport: Plasma, refrigerated (2-8°C or 36-46°F). (Min: 1.1 mL)
- Specimens not centrifuged within 24 hours of collection.
- Unlabeled tubes.
- Specimens not collected in Pearl Top EDTA or Lavender-top EDTA tubes.
- Samples exposed to repeated freeze/thaw cycles.
Once per week (Monday or Tuesday).
Results available within 7–10 days.
- HIV-1 RNA not detected. The limit of detection is 20 copies/mL
- The reportable range is 20 – 10,000,000 copies/mL.
- Results exceeding 10,000,000 copies/mL will not be diluted, and will be reported as greater than 10,000,000 copies/mL.
Quantitative real-time polymerase chain reaction (qPCR)- Roche COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 (FDA Approved).
- This test is intended for use in conjunction with clinical presentation and other laboratory markers of disease progress for the clinical management of HIV-1 infected patients. The test can be used to assess patient prognosis by measuring the baseline HIV-1 RNA level or to monitor the effects of antiretroviral therapy by measuring changes in EDTA plasma HIV-1 RNA levels during the course of antiretroviral treatment.
- This test is NOT intended for use as a screening test for the presence of HIV-1 in blood or blood products or as a diagnostic test to confirm the presence of HIV-1 infection.
- The lower limit of detection for this assay is 20 copies/mL. When HIV-1 RNA is detected, the corresponding HIV-1 RNA viral load will be reported
EPIC: LAB6399, SOFT: IHIVG