Which hepatitis C virus (HCV) RNA assays are approved by the FDA?

Updated: Oct 07, 2019
  • Author: Vinod K Dhawan, MD, FACP, FRCPC, FIDSA; Chief Editor: BS Anand, MD  more...
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Qualitative assays can be used to test for hepatitis C virus (HCV) RNA. HCV RNA can be detected in blood using amplification techniques such as polymerase chain reaction (PCR) or transcription-mediated amplification (TMA). The following are a few of the FDA-approved PCR-based tests for qualitative HCV RNA detection [61] :

  • COBAS AmpliScreen HCV Test, version 2.0: PCR with a lower limit of detection of 50 IU/mL
  • Hepatitis C Virus Reverse-Transcriptase (RT) PCR Assay
  • UltraQual HCV-RT PCR Assay
  • Versant HCV RNA Qualitative Assay: TMA with a lower limit of detection of 9.6 IU/mL

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