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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Comparison of a rapid immunochromatographic test with a chemiluminescence immunoassay for detection of anti-SARS-CoV-2 IGM and IGG

Detection Principle
ImmunoAssay-Antibody
Target
IgM IgG
Testing Method Category
LFIA
Testing Method
1) IOSYNEX COVID-19 BSS IgM/IgG test 2) MAGLUMI CLIA (IgM and IgG)
Testing Method - Additional Info
Comparison of a rapid immunochromatographic test with a chemiluminescence immunoassay for detection of anti-SARS-CoV-2 IgM and IgG
Reported Performance
Biosynex Covid-19 BSS vs MAGLUMI 2019-nCov for IgM, Sensitivity: 83%; Specificity: 88%, PPV: 83%; NPV: 88%; Likehood ratio: 6.79; C-k - Cohen’s kappa: 0.71. Biosynex Covid-19 BSS vs MAGLUMI 2019-nCov for IgG, Sensitivity: 82; Specificity: 93%; PPV: 95%; NPV: 75%; Likehood ratio: 10.63; C-k cohen's kappa: 0.71
Sample Size
70 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