Test Catalog

Test ID: HCVDR    
Hepatitis C Virus Genotypic Antiviral Drug Resistance, Serum

Testing Algorithm Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

See Chronic Hepatitis C Treatment and Monitoring Algorithm: Direct Antiviral Agent (DAA) Combination in Special Instructions.

Specimen Type Describes the specimen type validated for testing

Serum SST

Advisory Information

This test is intended for detection of preexisting antiviral drug resistance-associated substitutions (RAS) 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 RNA Quantification with Reflex to HCV Genotype, Serum

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

-HCVG / Hepatitis C Virus Genotype, Serum

Shipping Instructions

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

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

Necessary Information

The following 2 ask-at-order entry questions must be answered at the time of test ordering:

1. Does the patient have a hepatitis C quantification test result (viral load) within the last 30 days that is greater than 50,000 IU/mL? Answer "Yes" or "No".

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

Note: Test orders for submitted specimens with a "No" answer to either ask-at-order entry question above will be canceled.

Specimen Required Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Aliquot Tube, 5 mL (T465)

Collection Container/Tube: Serum gel

Submission Container/Tube: Polypropylene vial

Specimen Volume: 2.5 mL

Collection Instructions:

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

2. Transfer serum into aliquot tube.

Special Instructions Library of PDFs including pertinent information and forms related to the test

Specimen Minimum Volume Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.8 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis

Mild OK; Gross OK

Lipemia

Mild OK; Gross OK

Icterus

Mild OK; Gross OK

Other

Red-top tube or tube with any anticoagulant

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen TypeTemperatureTime
Serum SSTFrozen (preferred)60 days
 Refrigerated 7 days