FIND evaluation update: SARS-CoV-2 immunoassays

FIND evaluation update: SARS-CoV-2 immunoassays

On 13 March 2020, FIND launched an expression of interest (EOI) process for test developers interested in having their immunoassays (manual ELISA, machine-based or lateral flow, rapid tests specific for SARS-CoV-2 antigen or antibodies) evaluated using a standardized, independent protocol. The EOI closed on 20 March 2020.

Close to 100 immunoassay submissions were received, including 19 for antigen detection, and over 70 for antibody detection.

We have prioritized review of rapid diagnostic tests (RDT). All test submissions were reviewed according to these criteria:

  • Regulatory status and time to market
  • Manufacturing and distribution capacity of the supplier
  • Clinical and analytical performance

 

Five out of 17 antigen-detection RDTs and 26 out of 53 antibody-detection (serological) RDTs have now been selected for the first round of evaluation. Additional tests will continue to be reviewed on a rolling basis. Results from the independent performance evaluations will be posted here as soon as they are available.

Antigen-based RDTs to be included in the first round evaluation

Company Assay Country of manufacturer Interpretation Regulatory status
Coris BioConcept COVID-19 Ag Respi-Strip Belgium Visual CE-IVD
RapiGEN, Inc BIOCREDIT COVID-19 Ag South Korea Visual RUO
SD BIOSENSOR, INC STANDARD F COVID-19 Ag FIA South Korea Reader CE-IVD
SD BIOSENSOR, INC STANDARD Q COVID-19 Ag Test South Korea Visual CE-IVD
Shenzhen Bioeasy Biotechnology Co, Ltd.* BIOEASY 2019-nCoV Ag Fluorescence Rapid Test Kit (time-resolved fluorescence) China Reader CE-IVD

*This fluorescence-based test is different from the colloidal gold Ag test that has now been withdrawn by the company.

 

Serological, antibody (Ab)-based RDTs to be included in the first round evaluation

Company Assay Target Country of manufacturer Interpretation Regulatory status
Beijing Diagreat Biotechnologies Co. Ltd. 2019-nCoV IgG/IgM Antibody Determination Kit IgM/IgG China Reader required CE-IVD
Beijing Tigsun Diagnostics Co. Ltd. Tigsun COVID-19 Combo IgM/IgG Rapid Test (lateral flow) IgM/IgG China Visual CE-IVD; India
Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. Wantai SARS-CoV-2 Ab Rapid Test Total Ab China Visual Australia
BioMedomics, Inc.  COVID-19 IgM-IgG Combined Antibody Rapid Test IgM/IgG China Visual CE-IVD; India
BTNX, Inc. Rapid Response COVID-19 IgG/IgM Test Cassette (whole blood/serum/plasma) IgM/IgG China Visual RUO
Cellex, Inc. Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test IgM/IgG USA Visual CE-IVD
Changsha Sinocare, Inc. SARS-CoV-2 Antibody Test Strip IgM/IgG China Visual CE-IVD
Core Technology Co. Ltd. COVID-19 IgM/IgG Ab Test IgM/IgG China Visual CE-IVD
Dynamiker Biotechnology Co. Ltd. 2019-nCOV IgG/IgM Rapid Test IgG/IgM China Visual CE-IVD
GenBody Inc. GenBody COVID-19 IgM/IgG IgM/IgG Republic of Korea Reader optional CE-IVD
Guangzhou Wondfo Biotech Co. Ltd. Wondfo SARS-CoV-2 Antibody Test (lateral flow method) IgM/IgG China Visual China; Australia; India; CE-IVD
Hangzhou AllTest Biotech Co. Ltd. 2019 nCoV IgG/IgM Rapid Test Cassette (whole blood, serum, plasma) IgM/IgG China Visual Australia; CE-IVD;
Hangzhou Biotest Biotech Co. Ltd. COVID-19 IgG/IgM Rapid Test Cassette (whole blood, serum, plasma) IgM/IgG China Visual CE-IVD
Innovita (Tangshan) Biological Technology Co. Ltd. 2019-nCoV Ab Test (colloidal gold) IgM/IgG China Visual China; CE-IVD
InTec Products, Inc. Rapid SARS-CoV-2 Antibody Test IgM/IgG China Visual RUO
InTec Products, Inc. Rapid SARS-CoV-2 Antibody (IgM/IgG) Test IgM/IgG China Visual RUO
Jiangsu Bioperfectus Technology Co. Ltd. PerfectPOC Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit IgM/IgG China Visual CE-IVD
Qingdao Hightop Biotech Co. Ltd. HIGHTOP COVID-19 IgM/IgG Ab Rapid Test Kit IgM/IgG China Visual RUO
RapiGEN BIOCREDIT COVID-19 IgG+IgM Duo IgM/IgG Republic of Korea Visual RUO
SD BIOSENSOR, INC STANDARDTM Q COVID-19 IgM/IgG Duo Test  IgM/IgG Republic of Korea Visual CE-IVD; Brazil
Shanghai Kehua Bio-engineering Co. Ltd. DIAGNOSTIC KIT FOR SARS-CoV-2 IgM/IgG ANTIBODY (colloidal gold) IgM/IgG China Visual CE-IVD
Shenzhen Bioeasy Biotechnology Co. Ltd.* BIOEASY 2019-nCoV Ab (IgG/IgM) GICA Rapid Test Kit (gold colloidal immunoassay) IgM/IgG China Visual CE-IVD
Shenzhen Bioeasy Biotechnology Co. Ltd.* BIOEASY 2019-nCov Total Ab GICA Rapid Test Kit (gold colloidal immunoassay) Total Ab China Visual CE-IVD
VivaChek Biotech (Hangzhou) Co. Ltd. VivaDiagTM COVID-19 IgM/IgG Rapid Test IgM/IgG China Visual CE-IVD; Singapore; India; Australia
Zhuhai Livzon Diagnostics, Inc. Diagnostic Kit for IgG Antibody to Corona Virus (nCoV-2019) (colloidal gold) IgG China Visual CE-IVD; China
Zhuhai Livzon Diagnostics, Inc. Diagnostic Kit for IgM Antibody to Corona Virus (nCoV-2019) (colloidal gold) IgM China Visual CE-IVD; China

*These colloidal gold Ab tests are different from the colloidal gold Ag test that has now been withdrawn by the company.

CE-IVD – conformité européenne (EU certification)-in vitro diagnostics
RUO – Research Use Only

More information

For questions relating to the evaluation of immunoassays, please contact our Emerging Threats team.


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