Evaluation of the Point of Care Molecular Diagnostic Genedrive HCV ID Kit for the detection of HCV RNA in clinical samples.

Abstract

2. Abstract BACKGROUND Despite the availability of an effective treatment for HCV infection, major bottle neck in the HCV care cascade is difficulty in getting the HCV RNA done on serologically positive (antibody to HCV) patients. This is due to the limited availability of HCV RNA test in the periphery. Nucleic acid amplification testing at point of care might revolutionise the HCV care continuum through its increased sensitivity, decreased turn around time and ease of performance in the field. Genedrive is one such assay which has recently got a CE- IVD certification. OBJECTIVES The diagnostic accuracy of Genedrive HCV ID kit for the qualitative detection of HCV RNA was evaluated by comparing with Abbott HCV RNA in an Indian demographic setting and across a range of different genotypes commonly found in India. STUDY DESIGN For the assay evaluation 150 HCV RNA positive and 170 HCV RNA negative samples as tested by Abbott HCV RNA assay (Abbott, Wiesbaden, Germany) on Automated m2000sp/m2000rt platform, as per the manufacturer’s instructions, that were retrieved from −80°C in the Virology repository were included in the study. All the samples were retrieved and re tested for HCV RNA on Genedrive HCV ID kit and compared with Abbott HCV RNA results. RESULTS Comparison of the Genedrive HCV ID kit with the Abbott Real Time HCV assay revealed a sensitivity of 100 % (95% CI 97.9 to 100) and a specificity of 100 % (95% CI 97.9 to 100) with a positive predictive value and negative predictive value of 100%. Overall diagnostic accuracy of Genedrive was found to be 100% (95% CI 98.9 to 100). CONCLUSION This study demonstrates that Genedrive HCV ID kit can be used for decentralised testing of HCV and ultimately finding the missing million. Highlights Decentralisation of HCV RNA assays is the need of hour for finding the missing millions. Genedrive HCV ID kit is one such assay which can qualitatively detect HCV RNA and can be used as a point of care molecular assay thereby reducing the dropouts and improving the HCV care cascade.