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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Clinical evaluation of a SARS-CoV-2 RT-PCR assay on a fully automated system for rapid on-demand testing in the hospital setting

Detection Principle
NucleicAcid-PCR based
Target
E gene
Testing Method Category
RT-PCR
Testing Method
Gene-LDT assay setup (NeuMoDx 96 system)
Testing Method - Additional Info
fully automated T system for rapid on-demand testing
Reported Performance
LOD: 95.55 copies/ml, Positive agreement: 100%, Negative agreement: 99.2% Invalid rate: 6.3%
Sample Size
176 patients
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