Performance of a new rapid diagnostic test for the detection of antibodies to hepatitis C virus.

Rapid diagnostic tests (RDTs) represent an attractive alternative to conventional diagnostic methods for hepatitis C virus (HCV) infection. The aim of the present study was to assess the clinical performance of the new CE-marked Advanced Quality™ Rapid Anti-HCV Test for the detection of HCV antibodies in various patient populations. A total of 396 individuals, including 178 patients with chronic HCV infection, 26 patients with resolved HCV infection, and 192 subjects not infected with HCV, were studied. The clinical sensitivity and specificity in serum samples of the Advanced Quality™ Rapid Anti-HCV Test were both 99%. The new CE-marked RDT Advanced Quality™ Rapid Anti-HCV Test fulfills the World Health Organization recommendations acceptance criteria for serological assays in terms of sensitivity and specificity and can thus be confidently used for the screening of HCV antibodies.