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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Scientific literature on COVID-19 Test Methods and Devices - detail

Comparison of four molecular in vitro diagnostic assays for the detection of sars-cov-2 in nasopharyngeal specimens

DOI
10.1128/JCM.00743-20 
Detection Principle
NucleicAcid-PCR based
Target
N1, N2 (modified CDC); ORF1ab, S (Simplexa); N (GenMark); ORF1ab (Hologic)
Testing Method Category
PCR_KIT
Testing Method
kits
Testing Method - Additional Info
the New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (modified CDC) assay, the Simplexa COVID-19 Direct (Diasorin Molecular) assay, GenMark ePlex SARS-CoV-2 (GenMark) assay, and the Hologic Panther Fusion SARS-CoV-2 (Hologic) assay
Reported Performance
LOD: 779 copies/ml (modified CDC), 39 copies/ml (Diasorin), 1000 copies/ml (GenMark), 83 copies/ml (Hologic); PPA: 100% (Diasorin, Hologic, modified CDC), 96% (GenMark); NPA: 100% (GenMark, Diasorin), 96% (Hologic), 98% (modified CDC)
Sample Size
104 samples
Peer-reviewed
yes

The database contains available information from scientific literature that is being updated periodically. Please note that the provided information (as retrieved from analysed papers) is provided only for devices commercially available with CE-IVD mark. Acknowledgements