Diagnostic accuracy evaluation of the ImmunoFlow HCV rapid immunochromatographic test for the detection of hepatitis C antibodies.

Abstract

2% of the world's population lives with a hepatitis C virus (HCV) infection with highest rates in developing countries. The most common mode of transmission takes place via unsafe blood transfusions and unsafe therapeutic injections. Thus, screening potential blood donors for hepatitis C infection is a must to ensure safe blood transfusions. Rapid immunochromatographic tests are the best suitable test format to be used for screening for blood donors in resource-limited settings. The ImmunoFlow HCV from Core Diagnostics was evaluated at the Paul-Ehrlich-Institute, Germany for its test accuracy on three seropanels. Panel 1 consisted of 26 HCV positive and 55 negative samples, panel 2 of 193 HCV positive samples. Panel 3 contained 116 samples of 10 patients during seroconversion period. 39 of these 116 samples were characterized as HCV positive. The HCV ImmunoFlow had a sensitivity of 100% (95% CI: 93.5-100) and a specificity of 100% (95% CI: 86.8-100) when samples of panel 1 were tested. 191 samples of the 193 samples in panel 2 were correctly by the HCV Immunoflow, resulting in a sensitivity of 99.0%. 9 of 10 HCV infections were detected by the HCV ImmunoFlow when panel 3 was used. This evaluation revealed good sensitivity of the HCV ImmunoFlow test from and compares favorably with the results from the WHO evaluation and a systematic review conducted of field evaluations of Hepatitis C rapid diagnostic and other point of care tests.