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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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Taiwan Food and Drug Administration
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7128329/ http://dx.doi.org/10.1016/j.jfda.2013.09.011 |
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author | Wang, Kun-Teng Lin, Chia-Pei Fang, Yi-Ya Kao, Ming-Hui Shih, Daniel Yang-Chih Lo, Chi-Fang Wang, Der-Yuan |
author_facet | Wang, Kun-Teng Lin, Chia-Pei Fang, Yi-Ya Kao, Ming-Hui Shih, Daniel Yang-Chih Lo, Chi-Fang Wang, Der-Yuan |
author_sort | Wang, Kun-Teng |
collection | PubMed |
description | 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 (CCID(50)) label, the average A/H1N1 and A/H3N2 sensitivity for Flu-IVDs was log(10) 5.8 ± 0.5 and log(10) 6.6 ± 0.5 CCID(50)/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. |
format | Online Article Text |
id | pubmed-7128329 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | Taiwan Food and Drug Administration |
record_format | MEDLINE/PubMed |
spelling | pubmed-71283292020-04-08 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 J Food Drug Anal Original Article 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 (CCID(50)) label, the average A/H1N1 and A/H3N2 sensitivity for Flu-IVDs was log(10) 5.8 ± 0.5 and log(10) 6.6 ± 0.5 CCID(50)/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. Taiwan Food and Drug Administration 2013-10-06 /pmc/articles/PMC7128329/ http://dx.doi.org/10.1016/j.jfda.2013.09.011 Text en © 2014 Taiwan Food and Drug Administration https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC-BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) ). |
spellingShingle | Original Article Wang, Kun-Teng Lin, Chia-Pei Fang, Yi-Ya Kao, Ming-Hui Shih, Daniel Yang-Chih Lo, Chi-Fang Wang, Der-Yuan Sensitivity and specificity of in vitro diagnostic device used for influenza rapid test in Taiwan |
title | Sensitivity and specificity of in vitro diagnostic device used for influenza rapid test in Taiwan |
title_full | Sensitivity and specificity of in vitro diagnostic device used for influenza rapid test in Taiwan |
title_fullStr | Sensitivity and specificity of in vitro diagnostic device used for influenza rapid test in Taiwan |
title_full_unstemmed | Sensitivity and specificity of in vitro diagnostic device used for influenza rapid test in Taiwan |
title_short | Sensitivity and specificity of in vitro diagnostic device used for influenza rapid test in Taiwan |
title_sort | sensitivity and specificity of in vitro diagnostic device used for influenza rapid test in taiwan |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7128329/ http://dx.doi.org/10.1016/j.jfda.2013.09.011 |
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