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

TEST: 550630
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CPT: 87536
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Synonyms

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

Special Instructions

Submit the patient's Social Security number for serial monitoring. To order this test without serial monitoring, use test 550655. Submit a separate frozen specimen for each test requested.

Expected Turnaround Time

17 - 25 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Information

Related Documents

For more information, please view the literature below.

A Comprehensive Resistance Profile in a Single Test

GenoSure PRIme®: Detection of HIV-1 Protease, Reverse Transcriptase, and Integrase Inhibitor Resistance

HIV Specimen Collection Guide

HIV-1 Lifecycle, Drugs, and Susceptibility Assays

    Specimen Requirements

    Specimen

    Plasma, frozen

    Volume

    6 mL

    Minimum Volume

    4 mL (Note: This volume does not allow for repeat testing.)

    Container

    Lavender-top (EDTA) or plasma preparation tubes (PPT™). Ship in two or more screw-cap polypropylene frozen transport tubes.

    Collection

    Collect specimen in three lavender-top (EDTA) tubes or three PPT™ tubes. Do not use green-top (heparin) tubes. Centrifuge specimen within six hours of collection. Transfer plasma to one or more screw-cap polypropylene transport tube(s). Snap-cap or pop-top tubes should be avoided and may result in specimen rejection. Immediately freeze specimen at -20°C. Do not place samples on dry ice until completely frozen. Ship specimens 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. A separate frozen sample is required for GenoSure PRIme portion of the test. Frozen sample preferred for viral load assay but also stable at room temperature for one day or refrigerated for five days. Freeze for long-term storage.

    Causes for Rejection

    Hemolysis; green-top (heparin) tube; nonfrozen specimens; specimens exposed to repeated freeze/thaw cycles; quantity not sufficient for analysis; frozen PPT™

    Test Details

    Use

    Detect and measure HIV-1 in plasma with reflex to GenoSure PRIme® if viral load is ≥500 copies/mL. GenoSure PRIme® assay detects 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

    Assay range: 20−10,000,000 copies/mL

    Methodology

    Cobas® AmpliPrep/Cobas® TaqMan® HIV-1 Test, Version 2.0

    LOINC® Map

    Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
    550630 RNA, PCR(Graph)rfx/GenoPRI 550407 HIV-1 RNA by PCR copies/mL 20447-9
    550630 RNA, PCR(Graph)rfx/GenoPRI 550409 log10 HIV-1 RNA log10copy/mL 29541-0
    550630 RNA, PCR(Graph)rfx/GenoPRI 550631 HIV GenoSure PRIme(R) N/A
    550630 RNA, PCR(Graph)rfx/GenoPRI 511958 PDF 80563-0
    Reflex Table for HIV GenoSure PRIme(R)
    Order Code Order Name Result Code Result Name UofM Result LOINC
    Reflex 1 551711 Reflex to GenoSure PRIme(R) 551703 PDF 51969-4
    Reflex Table for HIV GenoSure PRIme(R)
    Order Code Order Name Result Code Result Name UofM Result LOINC
    Reflex 1 551711 Reflex to GenoSure PRIme(R) 551701 HIV GenoSure PRIme(R) 93047-9
    Reflex 2 551704 GenoSure PRIme(R) 551704 GenoSure PRIme(R) N/A
    Reflex Table for HIV GenoSure PRIme(R)
    Order Code Order Name Result Code Result Name UofM Result LOINC
    Reflex 1 551711 Reflex to GenoSure PRIme(R) 551702 HIV GenoSure PRIme(R) 80689-3
    Reflex 2 551707 GenoSure PRIme(R) Interp 551707 GenoSure PRIme(R) Interp N/A
    Reflex Table for HIV GenoSure PRIme(R)
    Order Code Order Name Result Code Result Name UofM Result LOINC
    Reflex 1 551711 Reflex to GenoSure PRIme(R) 551706 HIV GenoSure PRIme(R) Interp 62364-5

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