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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 validation of an automated reverse transcription-insulated isothermal PCR assay for the detection of severe

Detection Principle
NucleicAcid-PCR based
Target
ORF1ab
Testing Method Category
RT-PCR
Testing Method
POCKIT Central SARS-CoV-2 (orf 1 ab) Premix Reagent, GeneReach Biotech (RT-iiPCR assay)
Testing Method - Additional Info
POCKIT compared to real-time RT-PCR assay developed by Corman et al.
Reported Performance
sensitivity: 96.8%; specificity: 97.1%
Sample Size
31 positive and 69 negative
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