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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Improved molecular diagnosis of COVID-19 by the novel, highly sensitive and specific COVID-19-RdRp/Hel real-time reverse transcription-polymerase chain reaction assay validated in vitro and with clinical specimens

Detection Principle
NucleicAcid-PCR based
Target
RdRp-region, Hel-region, S-gene, N-gene
Testing Method Category
PCR_KIT
Testing Method
Multiple-kits and in-house-methods
Testing Method - Additional Info
Kits: LightMix Modular SARS, Wuhan CoV E-gene and 3 in-house-methods
Reported Performance
LOD: 11.2 cpr (RdRp/Hel), 21.3 cpr (N gene) ; Specificity: 100% (RdRp/Hel)
Sample Size
37 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