id author title date pages extension mime words sentences flesch summary cache txt cord-333239-nj5dma98 Ducrest, P. J. Development and evaluation of a new IgM/IgG rapid diagnostic test for SARS-CoV-2 2020-10-13 .txt text/plain 1771 121 63 Diagnostic performance of IgG/IgM RDT was assessed using both gold standard RT-PCR and Electro-chemiluminescence immunoassay (ECLIA) Elecsys Anti-SARS-CoV-2 total Ig. Overall, RDT sensitivity was 100% (95% confidence interval [95%CI]: 88-100%) and specificity 93% (95% CI: 85-97%). The aim of this study is to develop and evaluate the performance of a new IgM/IgG rapid diagnostic test (RDT) based on lateral flow assay (LFA) technology, in a high COVID-19 prevalence setting using gold standard RT-PCR as well as an Electro-chemiluminescence immunoassay (ECLIA) Elecsys® Anti-SARS-CoV-2 total Ig (Roche, Switzerland). The key finding of the present evaluation study, using an unmatched case-control design including 73.5% of negative control samples, is that the diagnostic accuracy of IgG/IgM RDT on plasma samples when compared to RT-PCR or ECLIA is the same and displayed a SE of 100%, a SP of 93% and a NPV of 100%. ./cache/cord-333239-nj5dma98.txt ./txt/cord-333239-nj5dma98.txt