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Hepatitis C Virus (HCV) NS5A Drug Resistance by Sequencing
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Ordering Recommendation
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.
Mnemonic
Methodology
Polymerase Chain Reaction/Sequencing
Performed
Mon
Reported
10-13 days
New York DOH Approval Status
Specimen Required
Lavender (EDTA), Pink (K2EDTA), Plasma Preparation Tube (PPT), or Serum Separator Tube (SST).
Separate from cells ASAP or within 2 hours of collection. Transfer 2 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 1 mL)
Frozen.
Heparinized specimens.
Ambient: Unacceptable; Refrigerated: 72 hours; Frozen: 4 months
Reference Interval
By Report
Interpretive Data
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 was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.
Laboratory Developed Test (LDT)
Note
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.
Hotline History
CPT Codes
87902
Components
| Component Test Code* | Component Chart Name | LOINC |
|---|---|---|
| 2014140 | NS5A Genotype | 82512-5 |
| 2014141 | NS5A Resistance | 82380-7 |
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