Hepatitis C Virus (HCV) Genotype 3 NS5A Drug Resistance Assay

TEST: 550603
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CPT: 87900; 87902
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Synonyms

  • NS5A Resistance Analysis

Special Instructions

Please confirm the patient's HCV genotype 3 prior to submitting sample for testing.

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 tubes (PPT™) or screw-capped polypropylene 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, 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 NS5A inhibitors. Assay should be used for patients with documented HCV genotype 3.

    Limitations

    This procedure may not be successful when the HCV viral load is <500 IU/mL. This assay requires an HCV genotype of 3.

    Methodology

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

    References

    Highlights of Prescribing Information. Daklinza™ (daclatasvir) tablets [package insert]. Princeton, NJ; Bristol-Myers Squibb Co; 2015.
    McCormack PL. Daclatasvir: A review of its use in adult patients with chronic hepatitis C virus infection. Drugs. 2015 Apr; 75(5):515-524. 25721433

    LOINC® Map

    Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
    550603 HCV GT3 NS5A Drug Resist Assay 550598 HCV NS5A Resist Assay PDF 72862-6
    550603 HCV GT3 NS5A Drug Resist Assay 550599 HCV NS5A Drug Resist Assay 73655-3
    550603 HCV GT3 NS5A Drug Resist Assay 550601 HCV NS5A Resist Assay Interp 49549-9

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    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