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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Development and Validation of a Rapid, Single-Step Reverse Transcriptase Loop-Mediated Isothermal Amplification (RT-LAMP) System Potentially to Be Used for Reliable and High-Throughput Screening of COVID-19

Detection Principle
NucleicAcid-PCR based
Target
N gene
Testing Method Category
LAMP
Testing Method
in house LAMP, SARS-CoV-2 kit from Shanghai BioGerm Medical Biotechnology Co. Ltd, DAAN Gene Co., Ltd
Reported Performance
specificity: 100% (serial dilutions), 99.5% (clinical samples) ; sensitivity: 500 copies/ml (serial dilutions), 91.4% (clinical samples) ; PPV: 97.7% ; NPV: 98.1%
Sample Size
260 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