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Test Code Discontinued Hepatitis C 1a NS5A Resistance-Associated Variants (RAVs)

Important Note

Use LAB848. See test information- https://ltd.aruplab.com/Tests/Pub/2014139

Test Name Alias

Hepatitis C Virus | HCV | 7142

Clinical Information

To test for the presence of NS5A resistance associated variants in Hepatitis C genotype 1a infected patients prior to therapy.

 

Testing for NS5A resistance-associated variants (RAVs) at amino acid positions 28 (M), 30 (Q), 31 (L) and 93 (Y) is recommended prior to initiation of treatment with elbasvir plus grazoprevir for patients with HCV genoype 1a.  The presence of one or more baseline NS5A RAVs at these positions is associated with reduced therapy efficacy for the 12 week treatment protocol in patients with an HCV genotype 1a infection.

 

This test is designed for baseline NS5A RAVs testing on patients with an HCV genotype 1a infection prior to treatment with elbasvir plus grazoprevir.  Resistance associated variants relevant to other direct-acting antiviral (DAA) agents is not covered by this test.

Specimen Requirements

Specimen Requirements:

Preferred

Specimen Type: Plasma

Container Tube: Lavender top (EDTA)

Volume: 6 mL whole blood collected in EDTA tube(s)

Minimum volume: 2 mL plasma

Collection Instructions: Centrifuge blood in EDTA tube within 6 hours of collection and transfer plasma to a screw-capped transport tube.

 

Acceptable

Specimen Type: Serum

Container Tube: Gold Top (Serum Separator-SST Gel)

Volume: 5 mL whole blood collected in Gold Top tube

Minimum volume: 2 mL serum

Collection Instructions: Centrifuge blood in Gold Top tube within 6 hours of collection and transfer serum to a screw-capped transport tube.

Specimen Transport Temperature

Prefer that plasma or serum be frozen for transport

Special Instructions

Hepatitis C Virus RNA Quantitation by RT-PCR testing (test code #4185) and Hepatitis C Genotype with Amplification (test code #4434) must be ordered before Hepatitis C Genotype 1a NS5A Resistance-Associated Variants (RAVs) will be performed.  NS5A RAVs testing is intended to be used as a follow-up procedure for patients who have been identified with an active HCV 1a infection.  HCV NS5A RAVs testing requires a Hepatitis C viral load of >500 IU/mL and a reported HCV genotype of 1a.

 

If one or more of the following tests are to be ordered, only one EDTA plasma tube or one serum tube (minimum volume 2 mL) needs to be provided:

 

  • Hepatitis C Virus RNA Quantitation by RT-PCR
  • Hepatitis C Genotype with Amplification
  • Hepatitis C Genotype 1a NS5A Resistance-Associated Variants (RAVs)

Specimen Stability

Ambient: 24 hours

Refrigerate: 3 days

Frozen: 6 weeks

Laboratory Retention: 2 months

 

Test Frequency

Test performed as needed. Usual turn around time, less than 14 days.

Reference Range

Unavailable

Performing Department

MOLECULAR DIAGNOSTICS

Performing Department Laboratory Location

Spectrum Health Advanced Technology Laboratory (ATL), Grand Rapids, MI

Methodology

RT-PCR and DNA Sequencing

CPT

87902

CDM Code

3900422

Epic Test ID

1230101916

Interface Order Alias

55098

Interface Information

65176 - NS5a

65177 - NS5a Comment

20758 - Specimen ID

Mayo Access Code

SHO55098

Additional Information

Lab Staff:

May use Hepatitis C Genotype with Amplification sample

Reviewed Date

1/25/2020