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

CPT: 87900; 87902
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Test Details

Synonyms

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

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

Specimen Requirements

Specimen

Plasma (preferred) or serum, frozen

Volume

3 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

Clinical Information

Special Instructions

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

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.

For Providers

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