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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

Detection Principle
NucleicAcid-PCR based
N, N1, N2, S, ORF1ab regions
Testing Method Category
Testing Method
New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic EUA Panel (Modified WHO-7), DiaSorin Molecular Simplexa COVID-19 Direct EUA, GenMark ePlex SARS-CoV-2 EUA panel, Hologic Panther Fusion SARS-CoV-2 EUA
Reported Performance
LOD: 779±27 copies/ml (modified WHO-7), 39±23 copies/ml (DiaSorin Molecular), 1000 copies/ml (GenMark), 83±36 copies/ml (Hologic) ; sensitivity: 100% (modified WHO-7, DiaSorin Molecular, Hologic), 96% (GenMark) ; specificity: 100% (GenMark, DiaSorin Molecular), 98% (modified WHO-7), 96% (Hologic)
Sample Size
104 samples

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