SLIDE 14 16.07.2020 | 14 in.vent Diagnostica GmbH | Dr. J.-M. Hollidt | SARS-CoV-2 antibody tests
Diagnostics
Company Ab class Antigen certification Abbott Diagnostics IgG N CE-IVD
IgG, IgM No information CE-IVD Bestbion dx GmbH IgG, IgM, IgA No information CE-IVD Bio-Rad Laboratories GmbH IgG, IgM, IgA N CE-IVD DiaSorin Deutschland GmbH IgG S1, S2 CE-IVD FDA-EUA* EUROIMMUN Medizinische Labordiagnostika AG IgG, IgA; IgG, IgM S1; N (diagnostic relevant epitops) CE-IVD FDA-EUA* GA Generic Assays GmbH IgG, IgM; IgG+ Combind N+S N, S1, S2 CE-IVD Medac GmbH Diagnostika IgG, IgM N, S CE-IVD MIKROGEN GmbH IgG, IgA N CE-IVD Ortho Clinical Diagnostics Total Ig, IgG S1 CE-IVD FDA-EUA* Roche Diagnostics Deutschland GmbH IgG, IgM N CE-IVD, FDA-EUA* Institut Virion/Serion GmbH IgG, IgM, IgA Ectodomain N, Ectodomain CE-IVD VIROTECH Diagnostics GmbH IgG, IgM, IgA N CE-IVD Aidian Germany GmbH IgG, IgM CE-IVD Company Ab class Antigen certification Assure Tech IgG, IgM N, S1 CE-IVD Augurix IgG, IgM N, S1 CE-IVD CeGaT IgG S1 CE-IVD IBL International IgG, IgM, IgA Full-length N CE-IVD Bio-Rad Total Ig N CE-IVD FDA-EUA* Autobio IgG, IgM S FDA-EUA* Babson Diagnostics IgG S FDA-EUA* Biohit Healthcare IgG, IgM N FDA-EUA* Cellex, Inc. IgG, IgM N, S FDA-EUA* Emory Medical Laboratories IgG RBD FDA-EUA* Hangzhou Biotest Biotech IgG, IgM RBD FDA-EUA* Hangzhou Laihe Biotech IgG, IgM S FDA-EUA* Healgen IgG, IgM S1 FDA-EUA* InBios IgG S FDA-EUA* Mount Sinai Hospital IgG RBD FDA-EUA* Siemens Healthcare Diagnostics Total Ig RBD FDA-EUA* Vibrant America Clinical Labs IgG, IgM S1, RBD, S2, N FDA-EUA* Wadsworth Center, NY State Department of Health Total Ig Full-length N (from SARS-CoV-1) FDA-EUA* *FDA-EUA: Emergency Use Authorization by FDA
Sources unless otherwise deposited: U.S. Food & Drug Administration; Trillium Diagnostik (14.07.2020)
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