Hepatitis C Virus (HCV) GenoSure® NS3/4A

TEST: 550540
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CPT: 87900; 87902
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Synonyms

  • HCV Drug Resistance
  • NS3/4 Resistance Analysis
  • Q80K Polymorphism

Special Instructions

Please indicate the patient's HCV genotype (1a or 1b) on the test request form.

Expected Turnaround Time

10 - 14 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 Documents

For more information, please view the literature below.

HCV Specimen Collection Guide

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    Specimen Requirements

    Specimen

    Plasma (preferred) or serum, frozen

    Volume

    2 mL

    Minimum Volume

    1 mL

    Container

    Ship in plasma preparation tube (PPT™) or screw-capped polyproplylene frozen transport tube.

    Collection

    Collect specimen in one PPT™ tube, gel-barrier tube, or lavender-top (EDTA) tube. Do not use green-top (heparin) tubes. Centrifuge specimen within six hours of collection, remove serum/plasma, and transfer specimen to polypropylene screw-capped tubes, and freeze. Specimens drawn into PPT™ tubes need to be centrifuged within six hours and frozen. Ship 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.

    Causes for Rejection

    PPT™ not centrifuged; insufficient volume; heparinized plasma; nonfrozen specimens; specimens exposed to repeated freeze/thaw cycles; specimen received in "pop-top" or "snap-cap" tube

    Test Details

    Use

    Assessment of drug susceptibility by nucleic acid sequencing of a patient's hepatitis C virus (HCV) to the NS3/4A protease inhibitors. Detects Q80K polymorphism. Assay should be used for patients with documented HCV genotype 1.

    Limitations

    This procedure may not be successful when the viral load is <2000 IU/mL. This assay requires an HCV genotype of either 1a or 1b.

    Methodology

    Polymerase chain reaction (PCR) amplification and DNA next generation sequencing

    References

    Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 Sep 26; 347(13):975-982. 12324553
    Ghany MG, Strader DB, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C: An update. Hepatology. 2009 Apr; 49(4):1335-1374. 19330875
    Incivek [package insert]. Cambridge, Mass: Vertex Pharmaceuticals; 2011.
    Kwong AD, Nájera I, Bechtel J, et al. Sequence and phenotypic analysis for resistance monitoring in hepatitis C virus drug development: Recommendations from the HCV DRAG. Gastroenterology. 2011 Mar; 140(3):755-760. 21255574
    Olysio [package insert]. Titusville, NJ: Janssen Products; 2013.
    Pawlotsky JM. Treatment failure and resistance with direct-acting antiviral drugs against hepatitis C virus. Hepatology. 2011 May; 53(5):1742-1751. 21374691
    Rong L, Dahari H, Ribeiro RM, Perelson AS. Rapid emergence of protease inhibitor resistance in hepatitis C virus. Sci Transl Med. 2010 May 5; 2(30):30ra32. 20445200
    Schinazi RF, Bassit L, Gavegnano C. HCV drug discovery aimed at viral eradication. J Viral Hepat. 2010 Feb 1; 17(2):77-90. 20040045
    Victrellis [package insert]. Whitehouse Station, NJ: Merck and Co; 2011.
    Viekira Pak [package insert]. North Chicago, Ill: AbbVie Inc; 2015.

    LOINC® Map

    Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
    550540 HCV GenoSure(R) NS3/4A 550544 HCV GenoSure(R) NS3/4A PDF 32286-7
    550540 HCV GenoSure(R) NS3/4A 550545 HCV GenoSure(R) NS3/4A 32286-7
    550540 HCV GenoSure(R) NS3/4A 550546 HCV GenoSure(R) NS3/4A Interp 77202-0

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    CPT Statement/Profile Statement

    The LOINC® codes are copyright © 1994-2021, 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