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Hepatitis C Virus (HCV) NS5A Drug Resistance by Sequencing
2014139
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
HCV NS5A
Methodology
Polymerase Chain Reaction/Sequencing
Performed
Mon
Reported
10-13 days
New York DOH Approval Status
Specimens from New York clients will be sent out to a New York DOH approved laboratory, if possible.
Submit With Order
ARUP Consult®
Disease Topics
Specimen Required
Patient Preparation
 
Collect
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
Frozen. 
Unacceptable Conditions
Heparinized specimens. 
Remarks
 
Stability
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: 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.

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.
CPT Code(s)
87902
Components
Component Test Code*Component Chart NameLOINC
2014140NS5A Genotype
2014141NS5A Resistance
* 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.
Aliases