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Hepatitis C Virus (HCV) NS3 Protease Drug Resistance Sequencing

Test Code: 10000

Cpt Code:

87902 (x1)

Clinical Utility

The HCV NS3 Protease Drug Resistance Sequencing assay detects NS3 (nonstructural protein 3) mutations and polymorphisms in HCV genotypes 1a and 1b that are associated with resistance to direct-acting protease inhibitors (antivirals) boceprevir (VictrelisTM), paritaprevir (in Viekira PakTM), telaprevir (IncivekTM), grazoprevir (in ZepatierTM), and simeprevir (OlysioTM). The assay is intended to be used for patients with HCV viral loads who are being screened prior to treatment with the direct-acting HCV protease antivirals, or during treatment with these antivirals when drug resistance is suspected.

Procedure

Hepatitis C Virus NS3 Protease Drug Resistance Sequencing assay utilizes RT-PCR amplification with primers in highly conserved viral genomic regions to amplify HCV genotypes 1a and 1b. The fragments are purified and sequenced using sequencing primers from conserved regions of the fragments. The sequence is compared to a database of mutations associated with antiviral resistance. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Assay Range

Mutations in the NS3 gene will be reported as Resistant/None Detected. Interpretation of gene mutations and association with antiviral resistance, including Simeprevir (OlysioTM), Boceprevir (VictrelisTM), Paritaprevir (in Viekira PakTM), Grazoprevir (in ZepatierTM), and Telaprevir (IncivekTM), will be provided with the report. See HCV NS3 Reportable Mutations in the test information navigation (right side of webpage). Additonally the presence or absence of mutation Q80K is reported individually.

 

Causes For Rejection

HCV RNA concentrations too low to allow antiviral resistance testing (minimum volume 1 mL with viral load of 1000 IU/mL), subtypes other than HCV 1a or 1b, whole blood frozen, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

Turnaround Time

4-11 days, performed weekly on Monday with results reported on Thursday.

Shipping

Ship Monday through Friday on dry ice. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr., Lee's Summit, MO 64086.

Specimen Information

plasma

NY approved. Collect 4-5 mL whole blood in EDTA, ACD or PPT, centrifuge and transfer 2 mL plasma to a sterile, screw top tube (minimum volume 1 mL, minimum viral load of 1000 IU/mL). If the specimen was collected in PPT, the entire tube can be shipped following centrifugation. Ship frozen in dry ice Monday through Friday.

serum

NY approved. Collect 4-5 mL whole blood in red-top tube or SST, centrifuge and transfer 2 mL serum to a sterile, screw top tube (minimum volume 1 mL, minimum viral load of 1000 IU/mL). If the specimen was collected in SST, the entire tube can be shipped following centrifugation. Ship frozen in dry ice Monday through Friday.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above. The CPT codes provided are based on Viracor-IBT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

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