Groupsites are branded collaboration communities that empower groups of all types and sizes to communicate, collaborate and connect around a shared mission, organization, cause or company.
$99/month
All-inclusive
No per-user fees
Try FREE for 30 days
No credit card required
After free trial ends, 30 days notice prior to cancellation
I am having a hard time finding documented evidence of the CLIA test complexity for the hepatitis C viral load test offered by Cephied. I called them and they stated it was waived. However, when I search the FDA database the only information I can find is about the regular HCV qualitative test. Does anyone have an IFU or decision summary document stating the CLIA test complexity? Attached is the IFU I found online.Xpert HCV VL FS CE-IVD ENGLISH Package Insert 301-8378 Rev. H.pdfThank you in advance!
303-3318 Rev A Xpert HCV IFU.pdf Not sure if it is because the package insert you attached was from 2022 and it didn't get FDA clearance yet until 2024 but this attached one clearly states its CLIA waived. Hopefully that solves the mystery!
Thank you! Unfortunately, the IFU you attached is for the qualitative test. I am looking for the quantitative test that results the viral load "HCV VL".
The HCV viral load may not be available in the Unites States. I only see the Xpert waived one when I search in Cepheid website (USA). When I searched for viral load, it kicked me to a United Kingdon Cepheid website. I would check with the manufacturer again. They may have assumed you wanted the waived one.