[Evaluation of the sensitivity of a densitometry system, in judging the result of influenza virus antigen-detection kit using immunochromatography].

Abstract

Immunochromatography viral antigen-detection kits have become popular in clinical settings in Japan. Influenza virus detection kit is one of them. It is sometimes used in early phase of the disease, combined with the early treatment with anti-influenza drugs. Most of them are invented to visually read the test line on their kits. However, we should be careful about their reliability of them. Sometimes human errors occur at the visual tests, and they have different sensitivities among the kits from different companies. In this report, we evaluated the sensitivity of BD Veritor System Flu with its reader by comparing with conventional visual tests. A total of 84 people including laboratory technologists were asked to visually read test line and their answers were compared with results of BD Veritor System Reader. This study showed that the lower the concentration of standard sample was applied, the greater the error ratio of visual test became, indicating the stable sensitivity of Veritor System. Moreover, the sensitivity was compared with three other major products approved in Japan, using four influenza viruses: type A of H1N1 seasonal 2009, H1N1 pandemic 2009, H3N2 seasonal 2012 and type B of seasonal 2012. It was indicated that Veritor System had the highest limit of detection from the kits.