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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Clinical Utility of a Highly Sensitive Lateral Flow Immunoassay as determined by Titer Analysis for the Detection of anti-SARS-CoV-2 Antibodies at the Point-of-Care

Detection Principle
Testing Method Category
Testing Method
LFIA kits vs ELISA and viral neutralization assay
Testing Method - Additional Info
LFIA kits: Pinnacle Biolabs SARS CoV-2 IgG/IgM One Step Rapid Test Device (Pinnacle); Wuhan EasyDiagnosis Biomedicine Co., Ltd COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit, reference SA-2-D (EDiagnostics); SafeCare Bio-Tech COVID-19 IgG/IgM Rapid Test Device (WB/S/P) ref NCO-4022 (SafeCare), AcroBiotech 2019-nCoV IgG/IgM Rapid Test Cassette reference INCP-402 (AcroBiotech); LumiQuick Diagnostics Quick Profile 2019 nCoV IgG/IgM Test Card ref 71108B (LumiQuick); Cellex qSARS-COV-2 IgG/IgM Rapid Test (Cellex); CALTH Care Health AllCheck COVID-19 IgG/IgM reference CHR09E (AllCheck); and Healgen COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device reference GCCOV-402a (Healgen). Coronavirus (SARS-CoV-2) IgG Test Kit ref CG-COV-IgG (RayBiotech IgG), and Coronavirus (SARS-CoV-2) IgM Test Kit ref CG-CoV-IgM-FP (RayBiotech IgM)
Reported Performance
Remark: RayBiotech and EDiagnostics, showed similar analytical sensitivity to the ELISA
Sample Size
27 patients & 7 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