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 5000 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. 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 before shipment, and transport 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:

- <5000

- 5000 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 manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into a plastic vial.