Hepatitis C Virus (HCV) NS5A Drug Resistance Assay

CPT: 87900; 87902
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Test Details

Synonyms

  • HCV Drug Resistance
  • NS5A Resistance Analysis

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 1.

Limitations

This procedure may not be successful when the HCV viral load is <500 IU/mL. This assay requires an HCV genotype of either 1a or 1b.

Methodology

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

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

Clinical Information

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.

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.

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