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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Combination of serological total antibody and RT-PCR test for detection of SARS-COV-2 infections

Detection Principle
ORF1ab, N (RT-PCR);
Testing Method Category
Testing Method
Kits (CMIA and RT-PCR)
Testing Method - Additional Info
chemiluminescence microparticle immunoassay kit (CMIA) :Xiamen Wantai Kairui Biological Technology Co., Ltd, China; RT-PCR kit: Shanghai BioGerm Medical Technology Co.
Reported Performance
Sensitivity: 92.2% (RT-PCR), 95.7% (CMIA), 98.6% (combined); Specificity: 100% (RT-PCR), 98.7% (CMIA), 98.7% (combined)
Sample Size
375 patients & 234 controls

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