Image: The Genedrive PCR diagnostics platform (Photo courtesy of Genedrive).
A rapid, point-of-care PCR-based diagnostic test will allow for the detection of occult hepatitis C virus (HCV) infections under both laboratory and field conditions.
Chronic infection with the hepatitis C virus affects approximately 1% of the global population (an estimated 71 million people) and claims about 400,000 lives every year. PCR screening for the disease requires dedicated infrastructure and qualified staff. In countries with limited resources, this type of assay is only available in centralized laboratories. Therefore, a major clinical challenge remains to identify undiagnosed patients worldwide, many of whom live in low-income and middle-income countries, where access to nucleic acid testing remains limited. The aim of the current project was to develop and validate a point-of-care (POC) assay for the qualitative detection of HCV RNA.
For this endeavor, investigators at the Pasteur Institute (Paris, France) developed a POC assay for the qualitative detection of HCV RNA on the PCR Genedrive instrument. The Genedrive instrument is a 600-gram portable device that can be battery operated, thus making it highly suitable for decentralized testing in field settings, and requires only 30 microliters of sample.
The investigators validated the Genedrive one hour HCV assay through a case–control study comparing results with those obtained with the Abbott RealTime HCV test.
Results revealed that the Genedrive PoC assay identified all major HCV genotypes, with a limit of detection of 2362 IU/milliliter. Assessing 422 patients chronically infected with HCV and 503 controls negative for anti-HCV and HCV RNA, the Genedrive HCV assay showed 98.6% sensitivity and 100% specificity to HCV.
The Genedrive HCV diagnostic kit has obtained CE certification for distribution in Europe and will be available for sale in the Middle East, Africa, South-East Asia, and India once local regulatory clearance is obtained.
The study was published in the April 3, 2018, online edition of the journal Gut.