Hepatitis C Virus (HCV) NS5A Drug Resistance by Sequencing




Test Mnemonic

HCVNS5

CPT Codes

  • 87902 - QTY (1)

Performing Laboratory

ARUP

FDA Category

Laboratory Developed Test


Specimen Requirements

Volume Type Container Collect Temperature Transport Temperature Special Instructions
2 mLPlasmaEDTA (Lavender) FrozenSeparate from cells ASAP or within 2 hours of collection and transfer into standard aliquot tube.

Alternate Specimen Requirements

Volume Type Container Collect Temperature Transport Temperature Special Instructions
2 mLPlasmaEDTA PPT (White) FrozenSeparate from cells ASAP or within 2 hours of collection and transfer into standard aliquot tube.
2 mLSerumSST (Gold) FrozenSeparate from cells ASAP or within 2 hours of collection and transfer into standard aliquot tube.

Minimum Specimen Requirements

Volume Type Container Collect Temperature Transport Temperature Special Instructions
1 mL     

Stability

Environmental Condition Description
Frozen4 months
Refrigerated72 hours
AmbientUnacceptable

Days Performed

Mon

Turnaround Time

11 - 14 days

Methodology

Name Description
Polymerase Chain Reaction/Sequencing 

Special Info

Heparinized specimens are unacceptable. This test is New York DOH approved.

Clinical Info

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% of total may not be detected. For more information, please refer to drug package inserts for the applicable direct-acting antiviral drug and current HCV treatment guidelines (e.g., AASLD/IDSA guidelines or EASL HCV treatment recommendations).

Clinical Limitation

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