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Human Immunodeficiency Virus 1 (HIV-1), Quantitative, Real-time PCR (Nongraphical) With Reflex to HIV-1 GenoSure PRIme® or GenoSure Archive®

CPT: 87536

Synonyms

  • HIV-1 Plasma Viremia
  • HiV-1 RNA Real-time PCR, Quantitative
  • Reflex to GenoSure Archive®
  • Reflex to GenoSure PRIme®
  • Viral Load

Special Instructions

If reflex test is performed, additional charges/CPT code(s) may apply.


Related Documents


Specimen Requirements


Specimen

Plasma and whole blood


Volume

5 mL plasma and 4 mL EDTA whole blood


Minimum Volume

3.5 mL plasma and 3 mL EDTA whole blood


Container

Lavender-top (EDTA) tube, screw-capped polypropylene frozen transport tube


Collection

Both frozen plasma and frozen whole blood are required for this profile. Draw three lavender-top (EDTA) tubes. Do not use green-top (heparin) tubes.

Plasma: Centrifuge two tubes within six hours of collection. Remove plasma, transfer plasma to screw-cap polypropylene transport tubes (not "pop-top" or "snap-cap"), and freeze. Ship specimen frozen.

Whole blood: Do not centrifuge. Freeze tube immediately after draw. Ship specimen frozen.

To avoid delays in turnaround time, when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.


Storage Instructions

Freeze.


Stability Requirements

Frozen: 6 weeks


Causes for Rejection

Insufficient volume; heparinized plasma; specimen not frozen


Test Details


Use

Detect and measure HIV-1 in plasma with reflex to GenoSure PRIme® if viral load is greater than or equal to 500 copies/mL or reflex to GenoSure Archive® if viral load is less than 500 copies/mL. The GenoSure PRIme® and GenoSure Archive® assays detect mutations in the HIV viral genes that encode for HIV protease, reverse transcriptase and integrase. Mutations in these genes have been associated with resistance to antiretroviral drugs.


Limitations

This procedure should only be used for patients with a documented HIV-1 infection.


Methodology

Cobas® AmpliPrep/Cobas® TaqMan® HIV-1 Test, Version 2.0 and polymerase chain reaction (PCR) amplification and DNA sequencing


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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf