PRODUCT EVALUATION STATUS ANTIBODY TEST KITS

Updated as of 13 May 2022

A. RDT Antibody Test Kits
A. RDT Antibody Test Kits
No.Product NameManufacturerSTATUS
1Arton COVID-19 IgM/IgG Antibody TestArtron Laboratories Inc. STAGE 2
Kindly contact technical team ;please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
2SMART COVID-19 IgM-IgG RDTCell Id Pte LtdSTAGE 2
Pending delivery; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
B. Enzyme Immunoassays (EIAs) Test Kits
B. Enzyme Immunoassays (EIAs) Test Kits
No.Product NameManufacturerSTATUS
1MDGen-AB96 COVID-19 IgGMicrodigital Co., Ltd.STAGE 3
Ongoing
2COVID-19 IgM/IgG Antibody ELISA Test KitBeijing Kewei Clinical Diagnostic Reagent Inc.STAGE 2
Pending for delivery of suppliers; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
3ACCEL ELISA COVID-19Plexence, Inc.STAGE 2
Pending for delivery of suppliers; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
C. Equipment-based - Antibody Test Kits
No.Product NameManufacturerSTATUS
1SARS-CoV-2 IgG (CLIA)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Stage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
2SARS-CoV-2 IgM (CLIA)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Stage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
3SARS-CoV-2 IgG ASSAY for ALINITY INSTRUMENTAbbot Ireland Diagnostics DivisionStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
4VIDAS® SARS-COV-2 IgMBiomérieux SaStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
5VIDAS® SARS-COV-2 IgGBiomérieux SaStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
6Diazyme DZ-Lite SARS-CoV-2 IgG/IgM CLIA KitDiazyme Laboratories, IncStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
7Dimension EXL SARS-CoV-2 Total antibody assay (CV2T)Siemens Healthcare Diagnostics Inc.Stage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
8SARS-COV-2 IgM (Electrochemiluminescence Immunoassay)Shenzhen Lifotronic Technology Co., Ltd.Stage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
9SARS-COV-2 IgG (Electrochemiluminescence Immunoassay)Shenzhen Lifotronic Technology Co., Ltd.Stage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
10Elecsys Anti-SARS-CoV-2 SRoche Diagnostic GmbhStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
11Elecsys Anti-SARS-CoV-2 E2GRoche Diagnostic GmbhStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
12SARS-CoV-2 IgM Reagent kitAbbot Ireland Diagnostics DivisionStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
13Access SARS-CoV-2 IgG IIBeckman Coulter, Inc.Stage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
14SARS-CoV-2 IgG II Quant assayAbbott Ireland Diagnostics DivisionStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
15VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG 2 Reagent Pack used in combination with the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 IgG 2 CalibratorOrtho-Clinical DiagnosticsStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
16VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 IgG Quantitative CalibratorOrtho-Clinical DiagnosticsStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
17Vidas SARS-COV-2 IgG IIBioMérieux SA-3Stage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
18ADVIA CENTAUR SARS-CoV-2 TOTAL (COV2T)Siemens Healthcare Diagnostics Inc.Stage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
19ATELLICA IM SARS-CoV-2 TOTAL (COV2T)Siemens Healthcare Diagnostics Inc.Stage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
20DIMENSION EXL SARS-CoV-2 IgG (CV2G) Assay kitSiemens Healthcare Diagnostics Inc.Stage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
21SARS-CoV-2 IgG II CLIA MicroparticlesAutobio Diagnostics Co., LtdStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
22SARS-CoV-2 IgM II CLIA MicroparticlesAutobio Diagnostics Co., LtdStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
23Elecsys Anti-SARS-CoV-2 S (Material Code: 09289267190)Roche Diagnostics GmbHStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
24Elecsys Anti-SARS-CoV-2 S (Material Code: 09289275190)Roche Diagnostics GmbHStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
25ABBOTT Alinity i SARS-CoV-2 IgGAbbott Ireland Diagnostics DivisionStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
26ABBOTT Alinity i SARS-CoV-2 IgMAbbott Ireland Diagnostics DivisionStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
27ATELLICA IM SARS-CoV-2 IgG (sCOVG)Siemens Healthcare Diagnostics Inc.Stage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
28ADVIA CENTAUR SARS-COv-2 IgG (sCOVG)Siemens Healthcare Diagnostics Inc.Stage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
29MINDRAY Severe Acute Respiratory Syndrome Coronavirus 2 S-RBD IgG (CLIA)Shenzhen New Industries Biomedical Engineering Co., LtdStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
30Finecare 2019-nCoV RBD Antibody TestGuangzhou Wondfo Biotech o., Ltd.Stage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information
31MDGen AB96-COVID-19 SP RBD IgGMicroDigital Co., LtdStage 2
Kindly await email instructions from the team; please submit independent/third-party performance reports from other reputable agencies, if available. Please see advisory for more information