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. Author manuscript; available in PMC: 2020 Sep 8.
Published in final edited form as: Hepatology. 2009 Apr;49(4):1335–1374. doi: 10.1002/hep.22759

Table 4.

FDA Approved Qualitative Assays for Detection of HCV RNA

Assay and Manufacturer Method Lower Limit of Detection IU/mL Setting
Amplicor HCV v2.0 (Roche Molecular Systems) Manual RT-PCR 50 Diagnosis and monitoring
Cobas Amplicor HCV v2.0 (Roche Molecular Systems) Semi-automated RT-PCR 50 Diagnosis and monitoring
Ampliscreen (Roche Molecular Systems) Semi-automated RT-PCR <50 Blood screening
Versant HCV RNA Qualitative Assay, (Siemens Healthcare Diagnostics) Semi-automated TMA 10 Diagnosis and monitoring
Procleix HIV-1/HCV Assay (Chiron Corporation) Manual TMA <50 Blood screening

Abbreviations: RT-PCR, reverse transcription polymerase chain reaction; TMA, transcription-mediated amplification