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

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 inve...

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Bibliographic Details
Published in:Yàowu shi͡p︡in fenxi 2014-06, Vol.22 (2), p.279-284
Main Authors: Wang, Kun-Teng, Lin, Chia-Pei, Fang, Yi-Ya, Kao, Ming-Hui, Shih, Daniel Yang-Chih, Lo, Chi-Fang, Wang, Der-Yuan
Format: Article
Language:English
Subjects:
Antigens
Cell culture
Diagnostic systems
In vitro methods and tests
Influenza
Influenza A
Inserts
In vitro diagnostic device
Manufacturing
Mathematical analysis
Original
Outbreaks
Pandemic influenza A (H1N1) virus
Pandemics
Sensitivity
Sensitivity analysis
Specificity
Studies
Viruses
Citations: Items that this one cites
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Summary: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 500–1000 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.
ISSN:1021-9498
2224-6614
DOI:10.1016/j.jfda.2013.09.011