Hepatitis C Virus (HCV) NS5A Drug Resistance Assay

TEST: 550325
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CPT: 87900; 87902
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Synonyms

  • HCV Drug Resistance
  • NS5A 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.

LabCorp offers the leading HCV menu for complete care decisions

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 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.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

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
550325 HCV NS5A Drug Resistance Assay 550316 HCV NS5A Resistance Assay PDF 72862-6
550325 HCV NS5A Drug Resistance Assay 550317 HCV NS5A Drug Resistance Assay 73655-3
550325 HCV NS5A Drug Resistance Assay 550318 HCV NS5A Resist Assay Interp 49549-9

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