Sensitivity and specificity of in vitro diagnostic device used for influenza rapid test in Taiwan

K.-T. Wang
C.-P. Lin
Y.-Y. Fang
M.-H. Kao
D.Y.-C. Shih
C.-F. Lo
D.-Y. Wang

Abstract

The pandemic influenza A/H1N1 outbreak resulted in 18,449 deaths in over 214 countries. In Taiwan, the influenza rapid test, an in vitro diagnostic device (Flu-IVD), only requires documented reviews for market approval by the Taiwan Food and Drug Administration. The purpose of this study was to investigate the analytical sensitivity and specificity of Flu- IVDs used in Taiwan. Analytical sensitivity and specificity tests were performed for influenza antigens A/California/7/2009 (H1N1) virus, A/Victoria/210/2009 (H3N2) virus, B/ Brisbane/60/08 virus, and human coronavirus OC43. A total of seven domestic and 31 imported Flu-IVD samples were collected, of which, 20 samples had inadequate labeling, including those with removed package inserts or incorrect insert information. The analytical sensitivity of Flu-IVDs for A/H1N1, A/H3N2, and Flu B was 500e1000 ng/mL, 1000 ng/mL, and 1000 ng/mL, respectively. For the 50% cell culture infective dose (CCID50) label, the average A/H1N1 and A/H3N2 sensitivity for Flu-IVDs was log10 5.8 0.5 and log10 6.6 0.5 CCID50/mL, respectively. As to the specificity test, no product cross-reacted with human coronavirus OC43. This study provides important information on the Flu-IVD regulation status and can thus help the government formulate policies for the regulation of in vitro diagnostic devices in Taiwan. Copyright © 2013, Food and Drug Administration, Taiwan.

ScienceDirect Link

10.1016/j.jfda.2013.09.011

Recommended Citation

Wang, K.-T.; Lin, C.-P.; Fang, Y.-Y.; Kao, M.-H.; Shih, D.Y.-C.; Lo, C.-F.; and Wang, D.-Y. (2014) "Sensitivity and specificity of in vitro diagnostic device used for influenza rapid test in Taiwan," Journal of Food and Drug Analysis: Vol. 22 : Iss. 2 , Article 6.
Available at: https://doi.org/10.1016/j.jfda.2013.09.011