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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Pushing beyond specifications: Evaluation of linearity and clinical performance of a fully automated SARS-CoV-2 RT-PCR assay for reliable quantification in blood and other materials outside recommendations

Detection Principle
NucleicAcid-PCR based
Target
RdRp & E-Gene
Testing Method Category
PCR_KIT
Testing Method
SARS-CoV-2 IVD (cobas6800/8800 system)
Testing Method - Additional Info
fully automated sample-to-result platform, test for E-gene and RdRp are compared
Reported Performance
Positive agreement 95.7%, negative agreement 98.9%
Sample Size
235 samples
Assay Type
 
Peer-reviewed
no

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