Hepatitis C Virus (HCV) NS5A Drug Resistance by Sequencing
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.

Polymerase Chain Reaction/Sequencing
10-13 days
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
ARUP Consult®
Disease Topics
Specimen Required
Patient Preparation
Lavender (EDTA), Pink (K2EDTA), Plasma Preparation Tube (PPT), or Serum Separator Tube (SST). 
Specimen Preparation
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) 
Storage/Transport Temperature
Unacceptable Conditions
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).

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

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
Component Test Code*Component Chart NameLOINC
2014140NS5A Genotype82512-5
2014141NS5A Resistance82380-7
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.