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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Evaluation of the RealStarĀ® SARS-CoV-2 RT-PCR kit RUO performances and limit of detection

Detection Principle
NucleicAcid-PCR based
Target
E gene
Testing Method Category
RT-PCR
Testing Method
RealStar SARS-CoV-2 assay
Reported Performance
LOD: 625 copies/ml, Sensitivity: 97.8%, Specificity: 97.3%
Sample Size
83 clinical 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