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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Analysis of adjunctive serological detection to nucleic acid test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection diagnosis

Detection Principle
ImmunoAssay-Antibody
Target
IgM, IgG and ORF1ab/N
Testing Method Category
Mixed
Testing Method
kits
Testing Method - Additional Info
SARS-CoV-2 ORF1ab/N PCR detection kit (GeneoDx Biotech, Shanghai, China), and SARS-CoV-2 antibody detection kit (YHLO Biotech, Shenzhen, China).
Reported Performance
Positive rate of detection: 65.9% (RT-PCR, moderate cases), 71.2% (RT-PCR, severe cases), and 67.6% (RT-PCR, critical cases), 79.5% (IgM, moderate cases), 93.2% (IgG, moderate cases), 82.7% (IgM, severe cases), 100% (IgG, severe cases), 73.0% (IgM, critical cases), 97.3% (IgG, critical cases)
Sample Size
133 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