e-journal

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

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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

Keywords:
In vitro diagnostic device Pandemic influenza A (H1N1) virus Sensitivity Specificity

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Ketersediaan

Tidak ada salinan data

Informasi Detail

Judul Seri

j ournal of food and drug anal ys i s

No. Panggil

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Penerbit

: Elsevier Taiwan., 2014

Deskripsi Fisik

j ournal of food and drug anal ys i s 2 2 ( 2 0 1 4 ) 2 7 9 e2 8 4

Bahasa

English

ISBN/ISSN

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Klasifikasi

-

Tipe Isi

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Tipe Media

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Tipe Pembawa

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Edisi

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Subjek

Food And Health

Info Detail Spesifik

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Pernyataan Tanggungjawab

Wati/Agus

Versi lain/terkait

Lampiran Berkas

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