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Hepatitis C Virus (HCV) Genotype 3 NS5A Drug Resistance Assay

CPT 87900; 87902
Synonyms
  • NS5A Resistance Analysis

Test Details

Methodology

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

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 NS5A inhibitors. Assay should be used for patients with documented HCV genotype 3.

Special Instructions

Please confirm the patient's HCV genotype 3 prior to submitting sample for testing.

Limitations

This procedure may not be successful when the HCV viral load is <500 IU/mL. This assay requires an HCV genotype of 3.

References

Highlights of Prescribing Information. Daklinza™ (daclatasvir) tablets [package insert]. Princeton, NJ; Bristol-Myers Squibb Co; 2015.
McCormack PL. Daclatasvir: A review of its use in adult patients with chronic hepatitis C virus infection. Drugs. 2015 Apr; 75(5):515-524. 25721433

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 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, 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
550603 HCV GT3 NS5A Drug Resist Assay 550598 HCV NS5A Resist Assay PDF 72862-6
550603 HCV GT3 NS5A Drug Resist Assay 550599 HCV NS5A Drug Resist Assay 73655-3
550603 HCV GT3 NS5A Drug Resist Assay 550601 HCV NS5A Resist Assay Interp 49549-9
Order Code550603
Order Code NameHCV GT3 NS5A Drug Resist Assay
Order Loinc
Result Code550598
Result Code NameHCV NS5A Resist Assay PDF
UofM
Result LOINC72862-6
Order Code550603
Order Code NameHCV GT3 NS5A Drug Resist Assay
Order Loinc
Result Code550599
Result Code NameHCV NS5A Drug Resist Assay
UofM
Result LOINC73655-3
Order Code550603
Order Code NameHCV GT3 NS5A Drug Resist Assay
Order Loinc
Result Code550601
Result Code NameHCV NS5A Resist Assay Interp
UofM
Result LOINC49549-9