Xpert HCV VL Fingerstick testing assay receives CE-IVD mark

Cepheid received the CE-IVD mark for the Xpert HCV VL Fingerstick, a molecular test designed to detect and quantify hepatitis C RNA levels from a fingerstick blood sample, according to a press release.

“Over the past few years, Cepheid, with its collaborators at the Kirby Institute and FIND have been able to demonstrate that a rapid and accurate test for active HCV infection can be performed on a drop of blood,” David H. Persing, MD, PhD, chief medical and technology officer at Cepheid, said in the release. “This is the first HCV RNA detection technology sensitive enough for both active case finding and use as a potential test of cure at the point of care.”

The Xpert HCV VL Fingerstick is a redesigned version of the Xpert HCV Viral Load assay. It can test a 100 µL sample of capillary blood and demonstrated 100% sensitivity and specificity for HCV RNA quantification (95% CI, 93.9-100 and 95% CI, 96.6-100, respectively) in a previous study.

The HCV assay is currently available in the EU and all countries recognizing the CE-mark.

Reference: www.cepheid.com