Hepatitis C Virus (HCV) GT1a NS5A Profile

CPT: 87522. If reflex testing is performed, concomitant CPT codes/charges will apply.
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Test Details

Use

The HCV GT1a NS5A profile is intended for baseline determination of HCV viral load, HCV genotype, and HCV NS5A drug resistance in patients with documented HCV infection and HCV genotype 1a. HCV quantitative RT PCR: Determine the number of international units (IU) of hepatitis C virus (HCV) RNA per milliliter in serum or plasma in known HCV-positive patients. HCV genotyping: Genotyping of the six major HCV types and their most common subtypes. HCV NS5A drug resistance assay: Assessment of drug susceptibility by nucleic acid sequencing of a patient's hepatitis C virus (HCV) to the NS5A inhibitors. Detects resistance associated variants at positions 28, 30, 31, and 93 in genotype 1a HCV.

Limitations

HCV quantitative RT PCR: The quantifiable range of the assay is 15 IU/mL to 100,000,000 IU/mL. HCV genotyping may not be successful when the HCV viral load is <1000 IU/mL serum/plasma. The HCV NS5A drug resistance assay may not be successful when the HCV viral load is <500 IU/mL.

Methodology

HCV quantitative RT PCR: Cobas® AmpliPrep/Cobas® TaqMan® HCV Test v2.0; HCV genotyping: Polymerase chain reaction (PCR) amplification and solid-phase electrochemical detection; HCV NS5A drug resistance assay: Polymerase chain reaction (PCR) amplification and DNA next generation sequencing (NGS)

Specimen Requirements

Specimen

Plasma (preferred) or serum, frozen

Volume

4 mL

Minimum Volume

3 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, yellow-top (ACD) 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

Hemolysis; green-top (heparin) tube; specimen not frozen on date of collection; PPT™ not centrifuged; specimen received in "pop-top" or "snap-cap" tube; specimen shipped at room temperature

Clinical Information

References

Kleiber J, Walter T, Haberhausen G, Tsang S, Babiel R, Rosenstraus M. Performance characteristics of a quantitative, homogeneous TaqMan RT-PCR test for HCV RNA. J Mol Diagn. 2000 Aug; 2(3):158-166.
Zepatier™ (elbasvir and grazoprevir) tablets, for oral use [package insert]. Initial US Approval: 2016. Whitehouse Station, NJ: Merck and Co Inc; 2016.

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2018, 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