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Epic Code LAB848 Hepatitis C Virus (HCV) 1a NS5A  Drug Resistance by Sequencing

Important Note

Order as Reference Miscellaneous #LAB848; indicate complete test name when ordering.

Test Name Alias

Hepatitis C Virus | HCV | 7142 | Hepatitis C 1a NS5A Resistance-Associated Variants (RAVs)

Clinical Information

Order before initiating treatment with NS5A inhibitors. Do not order prior to molecular confirmation of positive hepatitis C virus (HCV) screen and confirmation of genotype 1a or 1b.

This assay detects resistance-associated variants in NS5A codons 20-101 for HCV genotypes 1a and 1b. Variants in viral sub-populations below 20 percent of total may not be detected. For further information, please refer to drug package inserts for the applicable direct-acting antiviral drug and current HCV treatment guidelines (eg., AASLD/IDSA guidelines or EASL HCV treatment recommendations).

This test may be unsuccessful if the HCV RNA viral load is less than log 3.4 or 2500 IU/mL and/or if the HCV RNA genotype is not 1a or 1b.

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 2 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 2 hours of collection and transfer serum to a screw-capped transport tube.

Specimen Transport Temperature

Frozen

Specimen Stability

Ambient: 24 hours

Refrigerate: 3 days

Frozen: 6 weeks

Laboratory Retention: 2 months

 

Test Frequency

Reported: 10-13 days

Performing Department

REFERRALS SEND OUTS

Performing Department Laboratory Location

Send Out to ARUP Laboratory

Methodology

Polymerase Chain Reaction/Sequencing

Reviewed Date

6/9/2023