Apr 29, 2020

In silico analysis of RT-qPCR designs recommended by WHO for detection of SARS-CoV-2 and a commercial kit validated following UNE/EN ISO 17025:2005 and two reference laboratories

BioRxiv : the Preprint Server for Biology
Antonio J Martinez-MurciaL. Perez

Abstract

The Corona Virus Disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), has become a serious infectious disease affecting human health worldwide and rapidly declared a pandemic by WHO. Early, because the urgent need of reliable and rapid SARS-CoV-2 detection strategies and once the first SARS-CoV-2 genome sequence was available, several reference laboratories developed RT-qPCR methods which have been deposited in the WHO website. Only weeks later, after additional SARS-CoV-2 genomes were sequenced by several unrelated laboratories, the kit GPSTM CoVID-19 dtec-RT-qPCR Test developed by scientific team from Genetic PCR SolutionsTM (GPSTM, Alicante, Spain) was one of the first commercially available worldwide. The parameters specificity (inclusivity/exclusivity), quantitative phase analysis (10-106 copies), reliability (repeatability/reproducibility) and sensitivity (detection/quantification limits) of this qPCR kit were validated with the strict acceptance criteria recommended by the UNE/EN ISO 17025:2005 and ISO/IEC 15189:2012. Diagnostic validation was achieved by two independent reference laboratories, the Instituto de Salud Carlos III (ISCIII), (Madrid, Spain) and the Public Health En...Continue Reading

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