Multicentre Clinical Performance Evaluation of the Molbio Diagnostics Truenat™ HCV RNA Assay

Even though hepatitis C virus (HCV) infection can now be cured, globally, fewer than 20% of the 71 million living with HCV are aware of their status; diagnosis remains a major challenge. While serology screening tests that detect the presence of antibodies against HCV, can be performed in decentralized settings, these tests cannot distinguish between resolved (about 25% of seropositive cases) and active infection. Therefore, positive serology test results require further confirmation by laboratory-based methods that detects the viral particle. The two-step testing process results in high drop-off in confirmatory testing among HCV seropositive individuals, especially in low- and middle-income countries (LMIC) where laboratory infrastructure is lacking. Providing access to confirmatory testing in decentralized settings has a high potential to increase the coverage of HCV testing services in LMIC.

Molbio Diagnostics Ltd. (India) has developed the Truelab™ Real Time quantitative PCR system that is widely used in India for diagnostics of tuberculosis (TB). The system consists of two portable machines and two microfluidic cartridges and can be used in point-of-care settings. The manufacturer has recently developed a new assay that detects HCV RNA, the Truenat™ HCV RNA assay. It is a simple two-step assay for RNA extraction and amplification with a total turnaround time of 60 min, using whole blood, plasma and serum as sample types. Most importantly, the assay can be performed from a drop of capillary blood eliminating the need for venous access and blood draw and increasing its usability in the settings where phlebotomy service are not available. To date, validation of the assay was performed using archived plasma specimens and contrived whole blood specimens. FIND aims to conduct a multicentre evaluation to assess the assay's sensitivity, specificity and quantitative accuracy in freshly collected whole blood, plasma and serum specimens from target populations. The evaluation aims to gather performance data in line with the requirements set forth in the Common Technical Specifications 2009/886/EC (CTS) of the CE In Vitro Diagnostics Medical Devices Directive 98/79/CE (CE-IVDD), as well as the World Health Organization (WHO) Technical Specification Series 10 (draft) (TSS-10) for In vitro diagnostic (IVDs) medical devices used for the qualitative and quantitative detection of HCV RNA. The data will be published as a peer-reviewed report and made available to the test manufacturer to support regulatory submissions.