HIV-1 Quantitative Real-time RT-PCR

Test Code: 1801
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Clinical and Procedure
Clinical Utility

Human Immunodeficiency Virus (HIV) is the etiologic agent of Acquired Immunodeficiency Syndrome (AIDS). Quantitative measurement of HIV levels in peripheral blood has been shown to be an essential parameter in prognosis and management of HIV infected individuals. Decisions regarding initiation or changes in antiretroviral therapy are guided by monitoring plasma HIV RNA levels (viral load), CD4+ T cell count, and the patient’s clinical condition. The goal of antiretroviral therapy is to reduce the HIV virus in plasma to below detectable levels of available viral load tests.

The 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 type 1 (HIV-1) RNA levels. This assay is not intended to be used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.

Procedure

The COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, v2.0 is a nucleic acid amplification test for the quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma.

Specificity

Detects and quantitates all known HIV-1 groups M, N, and O, as well as non-B subtypes. Rebaselining not required with current HIV-1 viral load tests (correlation coefficient, 0.936).

Specificity was evaluated at three external sites by testing 514 HIV-1 seronegative plasma specimens from volunteer blood donors. HIV-1 RNA was not detected for all 514 specimens and the Real-time HIV-1 assay specificity was estimated to be 100% (514/514), 95% CI 99.28 to 100%.

Turnaround Time

7 business days from receipt of specimen.

Specimen Information
Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
Plasma (1) 1801 87536 Yes

2 mL (min. 1.5 mL)

20 Copies/mL to 1.00x107 Copies/mL
  • Collect 4-5 mL whole blood in EDTA tube.
  • Centrifuge and transfer 2 mL plasma to sterile, screw top tube.
  • Samples needing testing for HIV-1 Genotypic Drug Resistance Sequencing should be centrifuged, separated and shipped frozen.
  • Plasma specimens may be stored at room temperature (25°C to 30°C) for up to 1 day.
  • Plasma specimens may be stored at 2°C to 8°C for up to 6 days.
  • Plasma specimens may be stored frozen at -20°C to -80°C for up to 6 weeks.
  • Ship Monday through Friday. Friday specimens must be labeled for Saturday delivery.
Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor Eurofins test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 18000 W 99th St., Lenexa, KS 66219.

Causes for Rejection

Plasma received ambient, whole blood not separated from plasma within 24 hours of collection.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Viracor-IBT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

Package Insert; COBAS® AmpliPrep/COBAS® TaqMan® HIV-1 Test, version 2.0

COBAS® AmpliPrep®

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