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Sensitivity and specificity of in vitro diagnostic device used for influenza rapid test in Taiwan.
Wang, Kun-Teng; Lin, Chia-Pei; Fang, Yi-Ya; Kao, Ming-Hui; Shih, Daniel Yang-Chih; Lo, Chi-Fang; Wang, Der-Yuan.
Afiliación
  • Wang KT; Section of Biologics, Division of Research and Analysis, Food and Drug Administration, Ministry of Health and Welfare, Taiwan, ROC.
  • Lin CP; Section of Biologics, Division of Research and Analysis, Food and Drug Administration, Ministry of Health and Welfare, Taiwan, ROC.
  • Fang YY; Section of Biologics, Division of Research and Analysis, Food and Drug Administration, Ministry of Health and Welfare, Taiwan, ROC.
  • Kao MH; Section of Biologics, Division of Research and Analysis, Food and Drug Administration, Ministry of Health and Welfare, Taiwan, ROC.
  • Shih DY; Division of Research and Analysis, Food and Drug Administration, Ministry of Health and Welfare, Taiwan, ROC.
  • Lo CF; Food and Drug Administration, Ministry of Health and Welfare, Taiwan, ROC.
  • Wang DY; Section of Biologics, Division of Research and Analysis, Food and Drug Administration, Ministry of Health and Welfare, Taiwan, ROC.
J Food Drug Anal ; 22(2): 279-284, 2014.
Article en En | MEDLINE | ID: mdl-38620156
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 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Food Drug Anal Año: 2014 Tipo del documento: Article Pais de publicación: China
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Food Drug Anal Año: 2014 Tipo del documento: Article Pais de publicación: China