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Hepatitis C Virus (HCV) NS5B Drug Resistance Assay

CPT 87900; 87902
Synonyms
  • HCV Drug Resistance
  • NS5B Resistance Analysis

Test Details

Methodology

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

Result 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 Documents

For more information, please view the literature below.

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Use

Assessment of drug susceptibility by nucleic acid sequencing of a patient's hepatitis C virus (HCV) to the NS5B inhibitors. Assay should be used for patients with documented HCV genotype 1.

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.

Limitations

This procedure may not be successful when the HCV viral load is <1000 IU/mL. This assay requires an HCV genotype of either 1a or 1b.

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.

Specimen Requirements

Specimen

Plasma (preferred) or serum, frozen

Volume

2 mL

Minimum Volume

1 mL

Container

Ship in plasma preparation tube (PPT™) or screw-capped polyproplylene frozen transport tubes.

Collection Instructions

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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
550505 HCV NS5B Drug Resistance Assay 550506 HCV NS5B Resistance Assay PDF 72862-6
550505 HCV NS5B Drug Resistance Assay 550507 HCV NS5B Drug Resistance Assay 73655-3
550505 HCV NS5B Drug Resistance Assay 550516 HCV NS5B Resist Assay Interp 49549-9
Order Code550505
Order Code NameHCV NS5B Drug Resistance Assay
Order Loinc
Result Code550506
Result Code NameHCV NS5B Resistance Assay PDF
UofM
Result LOINC72862-6
Order Code550505
Order Code NameHCV NS5B Drug Resistance Assay
Order Loinc
Result Code550507
Result Code NameHCV NS5B Drug Resistance Assay
UofM
Result LOINC73655-3
Order Code550505
Order Code NameHCV NS5B Drug Resistance Assay
Order Loinc
Result Code550516
Result Code NameHCV NS5B Resist Assay Interp
UofM
Result LOINC49549-9