Hepatitis C Rapid Test: New Diagnosis Tool

A rapid, highly accurate test has been developed for diagnosing hepatitis C virus (HCV), according to a study published online Dec. 10 in the Journal of Infectious Diseases.

Jennifer L. Reed, M.D., from the Northwestern University Feinberg School of Medicine in Chicago, and colleagues describe the development and preliminary clinical validation of a rapid, user-friendly, sensitive molecular test for point-of-care HCV testing. The study evaluated the analytical performance of a 15-minute time-to-result qualitative molecular test for HCV; a small clinical validation study was independently conducted using retrospectively collected specimens.

The researchers found that the Research Use Only DASH HCV assay had a wide dynamic range, was able to detect HCV genotypes 1 to 6, and demonstrated a detection limit of 200 IU/mL with the addition of 100 µL of specimen volume. The assay demonstrated 100% positive percent agreement and 100% negative percent agreement when compared with commercial platforms in a preliminary study of 97 plasma specimens.

“This test could revolutionize HCV which in the U.S. and globally by dramatically improving diagnosis, accelerating treatment uptake, and enabling more people to be cured faster,” co-author Claudia A. Hawkins, M.D., M.P.H., also from the Feinberg School of Medicine, said in a statement.

Two authors disclosed ties to Nuclein, the manufacturer of the DASH polymerase chain reaction system.

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