PRODUCT EVALUATION STATUS ANTIBODY TEST KITS

Updated as of April 26, 2021

A. RDT Antibody Test Kits
A. RDT Antibody Test Kits
No.Product NameManufacturerSTATUS
1FREND COVID-19 total AbNanoentek, Inc.ONGOING
2Rapid Immunochromatographic Test for Detection of IgG/IgM Antibodies to Coronavirus 2019-nCoV Xiamen Biotime Biotechnology Co.ONGOING
3GenSureTM COVID-19 IgG/IgM Rapid TestHebei Gensure Biotech Inc.ONGOING
4SMART COVID-19 IgM-IgG RDTCell Id Pte LtdPENDING
B. Enzyme Immunoassays (EIAs) Test Kits
B. Enzyme Immunoassays (EIAs) Test Kits
No.Product NameManufacturerSTATUS
1AFIAS COVID-19 AbBoditech Med Inc.PENDING
2ichroma™ COVID-19 AbBoditech Med Inc.PENDING
3SARS-CoV-2 IgG ASSAYAbbot Ireland Diagnostics DivisionPENDING
4COVID-19 (SARS-CoV-2) IgA, IgM, IgG ELISADemeditec Diagnostics GmbhPENDING
5GA CoV-2 IgG, IgM, IgG+GA Generic Assays GmbhPENDING
6COVID-19 IgM/IgG Antibody ELISA Test KitBeijing Kewei Clinical Diagnostic Reagent Inc.PENDING
7SuperFlex Anti-SARS-CoV-2 Ab/IgM/IgGSuzhou Sym-bio Lifescience Co., Ltd.PENDING
8Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)Siemens Healthcare Diagnostics Inc.PENDING
9GenScript SARS-CoV-2 Neutralization Antibody Detection KitGenscript Biotech (Singapore) Pte LtdPENDING
10SCoV-2 Detect IgG/IgM ELISAInbios International Inc.PENDING
11Kit for the detection of class G immunoglobulins (IgG) to the SARS-CoV-2 coronavirus by the enzyme immunoassay "SARS-CoV-2-IgG-ELISA"Allel LlcPENDING
12SARS-CoV-2 IgM Reagent kitAbbot Ireland Diagnostics DivisionPENDING
13SARS-CoV-2 IgG ScreenImbian Lab Llc.PENDING
14MDGen-AB96 COVID-19 IgGMicrodigital Co., Ltd.PENDING
C. Equipment-based - Antibody Test Kits
C. Equipment-based - Antibody Test Kits
No.Product NameManufacturerSTATUS
1VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgGOrtho-Clinical Diagnostics, Inc.PENDING
2LIAISON® SARS-CoV-2 S1/S2 IgGDiasorin S.P.APENDING
3VITROS Anti-SARS-CoV-2 Total AssayOrtho-Clinical Diagnostics, Inc.PENDING
4SARS-CoV-2 IgM/IgG (CLIA)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.PENDING
5SARS-CoV-2 IgG ASSAY for ALINITY INSTRUMENTAbbot Ireland Diagnostics DivisionPENDING
6VIDAS® SARS-COV-2 IgM/IgGBiomérieux SaPENDING
7Diazyme DZ-Lite SARS-CoV-2 IgG/IgM CLIA KitDiazyme Laboratories, IncPENDING
8ACCESS SARS-CoV-2 IgG/IgMBeckman Coulter, Inc.PENDING
9SARS-COV-2 IgG/IgM (Electrochemiluminescence Immunoassay)Shenzhen Lifotronic Technology Co., Ltd.PENDING
10Elecsys Anti-SARS-CoV-2 E2GRoche Diagnostic GmbhPENDING
11SARS-CoV-2 S-RBD IgG (CLIA)Shenzhen New Industries Biomedical Engineering Co., Ltd.PENDING