Chembio Diagnostics has presented positive data from a study of three premarket, rapid hepatitis C virus (HCV) antibody assays.
Published online in the Journal of Clinical Virology, the article, entitled ‘Field-based performance of three premarket rapid hepatitis C virus (HCV) antibody assays in STAHR (Study to Assess Hepatitis C Risk)’, detailed the performance characteristics (sensitivity and specificity) of assays.
As part of STAHR, behavioural risk assessment surveys and testing for HCV, using DPP HCV finger-stick blood and oral fluid tests, were conducted in people who injected drugs (PWID) within the past six months.
Two commonly used testing algorithms were employed to assess the sensitivity and specificity of the rapid anti-HCV assays.
The Chembio DPP HCV finger-stick blood test showed a sensitivity of 92.8% against a laboratory-based enzyme immunoassay screening assay reference, as well as sensitivity of 97.1% against the Centers for Disease Control and Prevention reference method algorithm, which uses a third-generation recombinant immunoblot assay.
In both reference methods, the DPP finger-stick blood test achieved 99.0% of specificity.
Lawrence Siebert, Chembio CEO, said that the data independently confirm that the DPP HCV rapid assay, which is currently in development, demonstrated acceptable sensitivity and specificity in this HCV population.
"Using a sensitive anti-HCV rapid assay like our DPP HCV, PWID would receive their results at the point-of-care on the same day, increasing the likelihood that they could be provided with prevention counselling messages and referrals for follow up," Siebert added.
"We look forward to advancing the clinical development of our DPP HCV diagnostic and to bringing this rapid, POC HCV diagnostic to market as a solution for this growing public health problem."