Details

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

Collect:

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)

Rejection Criteria

  • 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.

Performed

Once per week (Monday or Tuesday).
Results available within 7–10 days.

Reference Range

  • 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.

Test Methodology

Quantitative real-time polymerase chain reaction (qPCR)- Roche COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 (FDA Approved).

Clinical Utility

  • 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

CPT Code

87536

Test Codes

EPIC: LAB6399, SOFT: IHIVG

Last Updated

7/11/2019