|Last Updated: November 11, 2019 @ 10:13 am|
Hepatitis C Genotype
|Stability:||Ambient: 6 Hour(s); Refrigerated: 3 Day(s); Frozen: 1 Month(s); Incubated: Unacceptable|
Testing is performed once per week, and takes two days to complete, beginning on Thursday morning, completing on Friday afternoon.
Assay methodology is Multiplex Reverse Transcription-PCR amplification using eSensor HCVg Direct cartridges to test for the identification of Hepatitis C RNA Genotype using the GenMark XT-8. The following subtypes are tested for: 1a, 1b, 2a/c, 2b, 3, 4, 5, and 6. This test was developed and its performance characteristics have been determine by Interpath Laboratory, Inc. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary . The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
A sample is required to have a minimum HCV Viral Load of 1000 IU/mL in order to be tested for an HCV Genotype. Insufficient viral loads may not be able to provide a Genotype.