Sign in →

Test Code HCVDR Hepatitis C Virus Genotypic Antiviral Drug Resistance, Serum


Ordering Guidance


This test is intended for detection of preexisting antiviral drug resistance-associated substitutions in individuals known to be infected with hepatitis C virus (HCV) genotype 1a, 1b, or 3 (any subtype) and being considered for HCV NS3, NS5A, and NS5B inhibitor combination therapy.



Additional Testing Requirements


Prior to requesting this test, patients must have a confirmed serum or plasma hepatitis C virus (HCV) RNA level of 50,000 IU/mL or higher within the preceding 30 days and a known HCV genotype result of 1a, 1b, or 3 (any subtype). The following tests are available to provide these prerequisite results:

-HCVQG / Hepatitis C Virus (HCV) RNA Quantification with Reflex to HCV Genotype, Serum

-HCVQN / Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR, Serum

-HCVG / Hepatitis C Virus Genotype, Serum



Shipping Instructions


1. Freeze serum immediately, and ship specimen frozen on dry ice only.

2. If shipment will be delayed for more than 24-hours, freeze serum at -20 to -80° C (for up to 60 days) prior to shipment on dry ice.



Necessary Information


The following 2 questions must be answered at the time of test ordering (if not ordering electronically, note the answers on the test request):

 

1. What Is the Hepatitis C Virus (HCV) RNA level in IU/mL within the last 30 days? Provide an answer using the following ranges:

- <50,000

- 50,000 to 1,000,000

- 1,000,001 to 10,000,000

- 10,000,001 to 100,000,000

- >100,000,000

Note: If the answer to this question is not answered or is “Unknown," testing will be canceled.

 

2. Does the patient have a known hepatitis C genotype of 1a, 1b, or 3 (any subtype)? Yes or No.

Note: If the answer to this question is "No," testing will be canceled.



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 2.5 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into plastic vial.


Useful For

Detection and identification of codon substitutions in the hepatitis C virus (HCV) NS3, NS5A, and NS5B genomic regions that confer resistance to current direct-acting antiviral drugs used for treatment of chronic hepatitis C infection due to HCV genotype 1a, 1b, or 3 (any subtype)

 

Guiding initiation or change of antiviral drug combinations for the treatment of chronic HCV infection

 

This assay should not be used as a screening test for HCV infection.

 

This test should not be ordered for HCV infection due to genotypes 2, 4, 5, or 6.

Testing Algorithm

Testing is successful only if there is sufficient hepatitis C viral (HCV) RNA present in the serum specimen (ie, 50,000 IU/mL or above) in the preceding 30 days. If the HCV RNA level within the last 30 days is unknown or not provided, then this test will be canceled.

 

For more information see Chronic Hepatitis C Treatment and Monitoring Algorithm: Direct Antiviral Agent (DAA) Combination.

Method Name

Polymerase Chain Reaction (PCR) followed by Next-Generation Sequencing

Reporting Name

HCV Genotypic Drug Resistance, S

Specimen Type

Serum SST

Specimen Minimum Volume

1.6 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 60 days ALIQUOT TUBE
  Refrigerated  7 days ALIQUOT TUBE

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Friday

Report Available

4 to 14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

87900

87902

87522 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HCVDR HCV Genotypic Drug Resistance, S 82525-7

 

Result ID Test Result Name Result LOINC Value
604410 HCV Genotypic Drug Resistance, S 77202-0
604376 HCV Genotype 92731-9
604377 HCV NS3 RAS 73654-6
604378 Sequence failure at codons: 92732-7
604379 Glecaprevir resistance 92733-5
604380 Grazoprevir resistance 82523-2
604382 Voxilaprevir resistance 92734-3
604383 HCV NS5A RAS 73655-3
604384 Sequence failure at codons: 92732-7
604385 Daclatasvir resistance 82379-9
604386 Elbasvir resistance 82376-5
604387 Ledipasvir resistance 82377-3
604388 Pibrentasvir resistance 92735-0
604389 Velpatasvir resistance 82520-8
604390 HCV NS5B RAS 73655-3
604391 Sequence failure at codons: 92732-7
604392 Sofosbuvir resistance 82382-3
604393 HCV Genotype 92731-9
604394 HCV NS3 RAS 73654-6
604395 Sequence failure at codons: 92732-7
604396 Glecaprevir resistance 92733-5
604397 Grazoprevir resistance 82523-2
604399 Voxilaprevir resistance 92734-3
604400 HCV NS5A RAS 73655-3
604401 Sequence failure at codons: 92732-7
604402 Daclatasvir resistance 82379-9
604403 Elbasvir resistance 82376-5
604404 Ledipasvir resistance 82377-3
604405 Pibrentasvir resistance 92735-0
604406 Velpatasvir resistance 82520-8
604407 HCV NS5B RAS 73655-3
604408 Sequence failure at codons: 92732-7
604409 Sofosbuvir resistance 82382-3
HCVLR HCV RNA level IU/mL last 30 days = 86955-2
HCVKG Is known HCV genotype 1a, 1b, or 3? 86955-2

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T732) with the specimen.