Hepatitis C Virus (HCV) NS5B Drug Resistance Assay

TEST: 550505
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CPT: 87900; 87902
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Synonyms

  • HCV Drug Resistance
  • NS5B Resistance Analysis

Special Instructions

Please indicate the patient's HCV genotype (1a or 1b) on the test request form. Submit a separate frozen specimen for each test ordered.

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 Information

Related Documents

For more information, please view the literature below.

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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 tubes.

    Collection

    Collect specimen in two PPT™ tubes, gel-barrier tubes, or lavender-top (EDTA) tubes. 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 NS5B inhibitors. Assay should be used for patients with documented HCV genotype 1.

    Limitations

    This procedure may not be successful when the HCV viral load is <1000 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

    Harvoni [package insert]. Foster City, Calif; Gilead Sciences Inc; 2014.
    Poveda E, Wyles DL, Mena A, Pedreira JD, Castro-Iglesias A, Cachay E. Update on hepatitis C virus resistance to direct-acting antiviral agents. Antiviral Res. 2014 Aug; 108:181-191. Erratum: Antiviral Res. 2014 Nov; 111:154. 24911972
    Viekira Pak [package insert]. Highlights of Prescribing Information. Viekira PAK (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets). North Chicago, Ill: AbbVie Inc; 2015.

    LOINC® Map

    Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
    550505 HCV NS5B Drug Resistance Assay 550506 HCV NS5B Resistance Assay PDF 72862-6
    550505 HCV NS5B Drug Resistance Assay 550507 HCV NS5B Drug Resistance Assay 73655-3
    550505 HCV NS5B Drug Resistance Assay 550516 HCV NS5B Resist Assay Interp 49549-9

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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