PRODUCT EVALUATION STATUS ANTIBODY TEST KITS

Updated as of July 21, 2021

A. RDT Antibody Test Kits
A. RDT Antibody Test Kits
No.Product NameManufacturerSTATUS
1Rapid Immunochromatographic Test for Detection of IgG/IgM Antibodies to Coronavirus 2019-nCoV Xiamen Biotime Biotechnology Co.PENDING
2GenSureTM COVID-19 IgG/IgM Rapid TestHebei Gensure Biotech Inc.PENDING
3SMART COVID-19 IgM-IgG RDTCell Id Pte LtdPENDING
B. Enzyme Immunoassays (EIAs) Test Kits
B. Enzyme Immunoassays (EIAs) Test Kits
No.Product NameManufacturerSTATUS
1COVID-19 (SARS-CoV-2) IgA, IgM, IgG ELISADemeditec Diagnostics GmbhPENDING
2COVID-19 IgM/IgG Antibody ELISA Test KitBeijing Kewei Clinical Diagnostic Reagent Inc.PENDING
3GenScript SARS-CoV-2 Neutralization Antibody Detection KitGenscript Biotech (Singapore) Pte LtdPENDING
4SCoV-2 Detect IgG/IgM ELISAInbios International Inc.PENDING
5Kit 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
6MDGen-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
2SARS-CoV-2 IgG ASSAYAbbot Ireland Diagnostics DivisionPENDING
3LIAISON® SARS-CoV-2 S1/S2 IgGDiasorin S.P.APENDING
4VITROS Anti-SARS-CoV-2 Total AssayOrtho-Clinical Diagnostics, Inc.PENDING
5SARS-CoV-2 IgM/IgG (CLIA)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.PENDING
6SARS-CoV-2 IgG ASSAY for ALINITY INSTRUMENTAbbot Ireland Diagnostics DivisionPENDING
7AFIAS COVID-19 AbBoditech Med Inc.PENDING
8ichroma™ COVID-19 AbBoditech Med Inc.PENDING
9VIDAS® SARS-COV-2 IgM/IgGBiomérieux SaPENDING
10Diazyme DZ-Lite SARS-CoV-2 IgG/IgM CLIA KitDiazyme Laboratories, IncPENDING
11SuperFlex Anti-SARS-CoV-2 Ab/IgM/IgGSuzhou Sym-bio Lifescience Co., Ltd.PENDING
12Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)Siemens Healthcare Diagnostics Inc.PENDING
13ACCESS SARS-CoV-2 IgG/IgMBeckman Coulter, Inc.PENDING
14SARS-COV-2 IgG/IgM (Electrochemiluminescence Immunoassay)Shenzhen Lifotronic Technology Co., Ltd.PENDING
15Elecsys Anti-SARS-CoV-2 E2GRoche Diagnostic GmbhPENDING
16SARS-CoV-2 IgM Reagent kitAbbot Ireland Diagnostics DivisionPENDING
17SARS-CoV-2 S-RBD IgG (CLIA)Shenzhen New Industries Biomedical Engineering Co., Ltd.PENDING
18SARS-CoV-2 IgG II Quant Reagent KitAbbot Ireland Diagnostics DivisionPENDING
19MAGLUMI® SARS-CoV-2 Neutralizing Antibody (CLIA)Shenzhen New Industries Biomedical Engineering Co., Ltd.PENDING
20CHORUS SARS-COV-2 IgG Code: 81400DIESSE Diagnostica Senese S.p.APENDING
21CHORUS SARS-COV-2 IgM Code: 81401DIESSE Diagnostica Senese S.p.APENDING
22CHORUS SARS-CoV-2 Screen Serum Code: 81406DIESSE Diagnostica Senese S.p.A.PENDING
23ACCESS SARS-CoV-2 IgGBeckman Coulter, Inc.PENDING
24ACCESS SARS-CoV-2 IgMBeckman Coulter, Inc.PENDING