Truenat™ HCV RNA Assay Evaluation

The Molbio Truenat™ HCV assay (the investigational product) is a quantitative chip-based Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR) tests for the detection of HCV genomic RNA from human whole blood, EDTA plasma and serum. The Truenat™ HCV assay runs on the Truelab™ Uno, Truelab™ Duo or Truelab™ Quadro Dx. Results of testing by Truenat™ HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.

Plasma specimens will be also tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities. Only the results of Abbott RealTime HCV assay may be used to make clinical decisions.