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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Evaluation of six commercial mid to high volume antibody and six point of care lateral flow assays for detection of SARS-CoV-2 antibodies

Detection Principle
IgA, IgM, IgG
Testing Method Category
Other Immuno assay
Testing Method
SARS-CoV-2 IgG assay (Abbott Laboratories, Abbott Park, IL, USA), SARS-CoV-2 S1/S2 IgG (DiaSorin, Stillwater, MN, USA), COVID-19 IgM and IgG ELISA (Epitope Diagnostics Inc., supplied by Affinity Diagnostics Corp., Toronto, ON, Canada), COVID-19 IgM and IgG assay (DRG International Inc., supplied by Bio-Rad, Hercules, CA, USA), anti-SARS-CoV-2 ELISA IgA and IgG assay (Euroimmun, Mississauga, ON, Canada), ECLIA anti-SARS-CoV-2 (Roche Diagnostics, Indianapolis, IN, USA), Rapid Response (BTNX, Markham, Ontario, Canada), 2019 nCoV IgM/IgG detection kit (Biolidics Limited, Singapore), SARS-CoV-2 IgG/IgM Ab test kit (Anhui Deep Blue Medical Technology Co., Ltd., Anhui, China), Novel Coronavirus IgG/IgM test kit (Genrui; Genrui Biotech Inc., Shenzhen, China), One Step Test for Novel Coronavirus (Getein Biotech Inc., Nanjing, China), and the 2019-nCoV Ab test (Innovita Biological Technology Co. Ltd., Qian'an, Hebei, China)
Testing Method - Additional Info
Comparison of commercial chemiluminescence immunoassays (CLIA), enzyme-linked immunosorbent assays (ELISA), electrochemiluminescence immunoassay (ECLIA), point-of-care lateral flow tests (POCTs)
Reported Performance
Sensitivity (all time points): 81% (Abbott), 68-95% (Affinity), 55-88% (Biorad), 62% (Diasorin), 63-83% (Euroimmun), 71% (Roche), 50-75% (BTNX), 18-78% (Biolidics), 53-70% (Deep Blue), 65-80% (Genrui), 3-64% (Getein), 20-45% (Innovita) ; Precision (all EIAs): 100% ; Reproducibility (all EIAs): 100% ; Remarks: sample size varies for different performance studies, percentages range among different target antibodies
Sample Size
96 samples

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