HCV Genotype

HCVGT

Plasma (EDTA)

1.5 mL

Serum

Routine Venipuncture

2 mL Screw-Cap Tube

2-8 C (Ice Packs) or Frozen

-2-8 C up to 3 days

-Frozen at -20C to -80C up to 6 weeks

eSensor technology uses a solid-phase electrochemical method for determining the presence of one or more of a defined panel of virus target sequences.

Valid results: if the assay controls pass and a valid genotype call can be made from the signals generated, the appropriate HCV type/subtype will be displayed in the summary section of the report.

HCV Not Detected=when an HCV virus is not detected.

No Genotype Detected=will be resulted when HCV is detected, but no genotype/subtype is present.

Unable to Genotype=will be resulted when HCV is detected and either a novel or partial genotype/subtype pattern is detected.

The test is designed to genotype a panel of 8 prevalent HCV type/subtypes (1a,1b,2a/c,2b,3,4,5, and 6), using the multiplex RT-PCR amplification of extracted nucleic acid followed by direct analysis on the electrochemical eSensor system. The system is designed to detect mixed infections of 1a and 1b, 1a and 2b, 1a and 2a/c, 1b and 2a/c, 1a and 3, 1b and 3, 1 and 4; however, the performance characteristics to detect mixed infections has not been established