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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.
Test complexity also depends on the Cepheid test system used. Any tests performed on the GeneXpert Infinity or Dx systems are automatically moderate. Example: the Xpert Xpress CoV-2/Flu/RSVplus is waived on GeneXpert Xpress system but same cartridge is moderately complex on Infinity or Dx. That confused me initially last year.
Hi Jennifer - I am a Cepheid Rep and can confirm that the HCV test is CLIA waived. In fact it is only CLIA waived at this point in time. The target patient population for this test is "adult individuals at risk and/or with signs and symptoms of HCV infection with or without antibody evidence of HCV infection".
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm
antibody evidence of HCV infection".