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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Performance assessment of 11 commercial serological tests for SARS-CoV-2 on hospitalised COVID-19 patients.

Detection Principle
Testing Method Category
Other Immuno assay
Testing Method
Abbott, Euroimmun, Snibe, Cellex, Getein, Innovita, Liming Bio, Leccurate, Medomics, Render, Sd,
Testing Method - Additional Info
testing of semiquantitative (enzyme-linked immune-absorbent assays [ELISA] and chemiluminescence immunoassays [CLIA]) and qualitative assays (lateral flow immunoassays [LFIA]) from 11 different suppliers
Reported Performance
Specificity: 97.4% (Abbott, Euroimmun), 88.6% (Snibe), 76% (Cellex), 96% (Getein, SD, Leccurate), 97.1% (Innovita), 100% (Liming, Render), 95.8% (Medomics) ; Sensitivity: 87.9% (Abbott), 91.4% (Euroimmun), 90.6% (Snibe), 87.5% (Cellex), 83.3% (Getein, Innovita), 75% (Leccurate), 82.9% (Liming), 77.8% (Medomics), 80% (Render), 81.3% (SD) ; NPA: 99.3% (Abbott, Snibe, Getein, SD), 99.6% (Euroimmun), 99.1% (Cellex, Innovita, Leccurate, Medomics), 99.2% (Liming), 99% (Renger) ; PPV: 99.8% (Abbott, Euroimmun, Innovita), 99.3% (Snibe), 98.4% (Cellex), 99.7% (Getein, Leccurate, Medomics, SD), 100% (Liming, Renger) ; Remarks: all reported values are for combined Ig detection but single Ig detection values are also available. Sensitivity values are for more than 21 days since symptoms onset but values for earlier determinations are also available. Reported NPA and PPA values are calculated on 3% and 95% population prevalence, respectively, but other values are also available.
Sample Size
126 patients

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