HCV Drug Resistance

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Testing Indications

This test is recommended for patients who are infected with Hepatitis C and

Have failed a previous HCV therapy containing an NS3 or NS5A inhibitor, or
Are infected with HCV Genotype 1a and are being considered for Simeprevir therapy

Specimen Collection and Handling

Specimen Requirements

Test Requested	Required Requisition(s)	Specimen Type	Minimum Volume	Collection Kit
HCV Drug Resistance¹	HCV/HBV Viral Load, Genotyping, and Drug Resistance Testing Requisition	Serum²	2.5 ml	Blood - Serum Separator Vacutainer Tube (SST- yellow top)
HCV Drug Resistance¹	HCV/HBV Viral Load, Genotyping, and Drug Resistance Testing Requisition	Plasma²	2.5 ml	Plasma Vacutainer Tube (EDTA-lavender top)
HCV Drug Resistance¹	HCV/HBV Viral Load, Genotyping, and Drug Resistance Testing Requisition	Not required for a previously tested sample³

Submission and Collection Notes

HCV drug resistance testing is performed when HCV RNA > 10,000 (1x10e+4) IU/ml

Remove serum or plasma from the clot/blood cells within 6 hours of collection and send to PHO Laboratory frozen.

Indicate on the requisition that the sample has been previously submitted and provide the PHO Laboratory number and fax the requisition to 416 235-6194

Limitations

Haemolysed, icteric, lipemic or microbially contaminated serum or plasma are not acceptable for testing.

Improperly collected, labelled, or processed specimens will be rejected.

If unable to process, separate and freeze serum or plasma within 6 hours of blood collection, a whole blood specimen (SST or EDTA) may be submitted to your local PHO Laboratory within 6 hours of collection who will then process and freeze the sample prior to testing.

Storage and Transport

Label the specimen container with the patient’s full name, date of collection and one other unique identifier such as the patient’s date of birth or Health Card Number. Failure to provide this information may result in rejection or testing delay.

Special Instructions

Centrifuge blood specimen. Serum or plasma must be removed from the clot within 6 hours of collection. Place specimen in a biohazard bag and seal. Specimens should be stored frozen at -20°C or colder and shipped to PHO laboratories using ice packs or dry ice in a proper shipping container.

Requisitions and Kit Ordering

Test Frequency and Turnaround Time (TAT)

HCV Drug Resistance testing is sent to British Columbia Centre for Excellence (BCCfE) weekly on Monday to Wednesday.

Turnaround time is up to 21 days from receipt by PHO Laboratory.

Test Methods

HCV Drug Resistance test is referred by PHO Laboratory to BCCfE.

HCV Drug Resistance test is performed on a “Research Use Only” basis. The methodology is based upon traditional Sanger-sequencing and includes identification of known mutations associated with drug resistance as well as a simple interpretation.

HCV RNA specimens must have > 10000 IU/mL HCV Viral Load for the HCV Drug Resistance test to be performed.

Reporting

Results are reported to the ordering physician or health care provider as indicated on the requisition.