- This assay should not be used as a screening test for hepatitis C virus (HCV) infection. It should be requested only on specimens obtained from patients confirmed to have HCV RNA levels in serum that are greater than or equal to 1000 IU/mL.
- An undetected or indeterminate HCV genotype result does not rule-out active HCV infection. Test results should be correlated with routine serologic and molecular-based testing, as well as clinical presentation.
- Specimens containing low HCV viral load (i.e. less than 1,000 IU/mL) may yield indeterminate results.
- 500uL of serum or plasma (Separate from cells within six hours.)
- Heparinized specimens
Remarks: Submit the most recent viral load and test date along with the specimen (if available).
- On Cells:
- Ambient: Six hours
- After Separation from Cells:
- Refrigerated: 72 hours
- Frozen: Four months
Additional Information: Specimens should containa recommended minimum hepatitis C viral load of 1000 IU/mL.
This test is designed to genotype a panel of eight prevalent HCV types/subtypes (1a, 1b, 2a/c, 2b, 3, 4, 5 and 6), using multiplex reverse transcription (RT).
Polymerase chain reaction (PCR) amplification of estracted nucleic acid followed by a direct analysis of the electrochemical eSensor XT-8 detection system
Within 9 business days