Test Overview
Test Methodology

Real-Time Reverse Transcriptase Polymerase Chain Reaction Amplification (RT-PCR)

Test Usage

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.

Reference Range *

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 20 -10,000,000 HIV-1 RNA copies/mL (Log10: 1.3 - 7.0).

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Test Limitations

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.

Test Details
Days Set Up
Varies; test performed twice per week.
Analytic Time

4 hours

Soft Order Code
QHIV
MiChart Code
HIV-1 RNA, Quantitative, PCR
Synonyms
  • 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
Laboratory
Microbiology
Section
Microbiology
Specimen Requirements
Collection Instructions

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.

Normal Volume
2.5 mL plasma
Minimum Volume
1.2 mL plasma
Storage Temperature
Transport whole blood at room temperature or refrigerated. Whole blood may be stored between draw and plasma separation, and is stable for 2 days at 2-8 degrees C and 1 day at 15-30 degrees C. Plasma may be stored in primary or secondary tubes after separation from blood cells, and is stable for 3 days at 2-8 degrees C, 1 day at 15-30 degrees C, 60 days at -20 degrees C, and 6 months at -70 degrees C or colder.
Do not allow frozen specimen to thaw at any time during storage or transport due to possible degradation of RNA.
Rejection Criteria
Specimens received in polystyrene aliquot tubes; plasma whole blood not received within 1 day of collection if stored at room temperature or within 2 days if stored refrigerated; plasma specimen stored refrigerated longer than 3 days or frozen longer than 60 days.
Additional Information

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.

Billing
CPT Code
87536
Fee Code
32308
LOINC
21008-8
NY State Approved
No