Author: Kim, Mi-Na; Ko, Young Jin; Seong, Moon-Woo; Kim, Jae-Seok; Shin, Bo-Moon; Sung, Heungsup
Title: Analytical and Clinical Validation of Six Commercial Middle East Respiratory Syndrome Coronavirus RNA Detection Kits Based on Real-Time Reverse-Transcription PCR Document date: 2016_6_24
ID: 1le537yd_2
Snippet: The WHO and United States Centers for Disease Control and Prevention (US CDC) provided guidelines for the molecular diagnosis of MERS-CoV [3, 4] , and since June 6, 2013 the US CDC has made novel coronavirus rRT-PCR assays [5] available free of charge under emergency use authorization [6] . Although at least three commercial rRT-PCR assays for MERS-CoV detection were available from Altona Diagnostics, Fast Track Diagnostics [3] , and PrimerDesign.....
Document: The WHO and United States Centers for Disease Control and Prevention (US CDC) provided guidelines for the molecular diagnosis of MERS-CoV [3, 4] , and since June 6, 2013 the US CDC has made novel coronavirus rRT-PCR assays [5] available free of charge under emergency use authorization [6] . Although at least three commercial rRT-PCR assays for MERS-CoV detection were available from Altona Diagnostics, Fast Track Diagnostics [3] , and PrimerDesign (http://www.genesig.com) before the 2015 outbreak in Korea, only RealStar MERS-CoV (Altona Diagnostics, Hamburg, Germany) had been approved for the in vitro diagnosis of MERS-CoV by Conformité Européenne (CE) and authorized for emergency use only in the United States. Therefore, all six commercial kits evaluated in this study had not been validated for diagnostic use. This study was designed to analytically and clinically validate the six above-mentioned commercial MERS CoV RNA detection kits.
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