A point-of-care assay for hepatitis C virus (HCV) infection running on the portable Genedrive molecular diagnostic platform showed high specificity and sensitivity. A research team compared assay results of Abbott RealTime HCV test and controls.

As Dr. Darragh Duffy told, "While direct-acting antiviral therapies have revolutionized therapeutic options for treating HCV patients, the challenge remains to identify people infected with the virus, many of whom are living in geographic regions that lack access to state-of-the-art diagnostics."

To help close that gap, Dr. Duffy of the Institut Pasteur, in Paris, and colleagues developed the point-of-care (PoC) assay for qualitative detection of HCV RNA using the 600 g battery-operable Genedrive device.

The team compared assay results with those obtained with the Abbott RealTime HCV test when applied to 422 patients chronically infected with HCV and 503 controls negative for anti-HCV and HCV RNA.

Samples were tested across 12 Genedrive instruments, five operators and three different assay batches, the researchers explained in Gut, online April 3. The PoC assay identified all six major HCV genotypes, with 98.6% sensitivity and 100% specificity.

The team then went on to perform a validation study in South Africa with samples obtained from various African countries. "In this real-life clinical setting," they said, "the performance of the Genedrive HCV assay was equally specific and sensitive."

Thus, said Dr. Duffy, "The Genedrive assay is a rapid point-of-need test that enables real-time treatment and management of chronic HCV patients in decentralized settings." The team also pointed out that although final costs remain to be defined, the instrument is available for about $5,000 and each Genedrive HCV test will cost around $30 to $40.

Dr. Raymond T. Chung, who directs the Hepatology and Liver Center at Massachusetts General Hospital, in Boston, told that "this promising entry into the PoC HCV RNA testing space has high sensitivity and specificity and meets the WHO target product profile for a PoC assay."

"Moreover, it has low blood volume requirements and is a portable, low-cost instrument. These features make it potentially quite attractive for deployment for field testing in low- and middle-income countries and could help narrow the gap between HCV-infected patients and highly effective treatment," said Dr. Chung.

The study was funded overall by the European Commission with some additional financial support from Genedrive Plc. Five of the authors are full-time employees of the company.