Researchers at the Institut Pasteur and Inserm in France have partnered with UK-based firm genedrive for the development and validation of a rapid, point-of-care assay for hepatitis C virus (HCV).
The new diagnostic test is intended to allow early treatment for patients suffering from hepatitis C, a liver disease caused by the virus and characterised by complications such as cirrhosis and liver cancer.
Reported to result in 400,000 deaths annually, the condition can be successfully treated in 95% of cases using direct-acting antivirals but is said to be limited due to lack of diagnosis of chronic asymptomatic cases, especially in low and middle-income areas.
The new assay initially tests for specific HCV antibodies, followed by a polymerase chain reaction (PCR) assay to identify HCV RNA in the blood in order to confirm the presence or absence of a chronic infection.
A miniaturised, less expensive device is employed for the PCR and can analyse 40 successive reaction cycles. The new assay is expected to cater to even countries with limited resources and delivers results in around one hour.
The team validated the test in the Institut Pasteur and the National Health Service, UK cohorts, along with datasets from South Africa, Kenya, Ghana, Nigeria and Uganda.
Study results revealed that the HCV assay demonstrated 100% specificity without any false positives and 98.6% sensitivity. These findings are said to meet the WHO requirements for such assays.
The test secured the European CE-Mark, and is additionally seeking regulatory approvals in the Middle East, Africa, South-East Asia and India.