Table 4

Antigen rapid tests and serological assays under evaluation for sensitivity and specificity at the time of this review by FIND

Antigen-based Rapid Detection Tests to be included in the first-round evaluation
CompanyAssayCountry of manufacturerInterpretationRegulatory status
Coris BioConceptCOVID-19 Ag Respi-StripBelgiumVisualCE-IVD
RapiGENBIOCREDIT COVID-19 AgSouth KoreaVisualRUO
SD BIOSENSORSTANDARD F COVID-19 Ag FIASouth KoreaReaderCE-IVD
SD BIOSENSORSTANDARD Q COVID-19 Ag TestSouth KoreaVisualCE-IVD
Shenzhen Bioeasy Biotechnology Co*BIOEASY 2019-nCoV Ag Fluorescence Rapid Test Kit (time-resolved fluorescence)ChinaReaderCE-IVD
Serological, Ab-based RDTs to be included in the first round evaluation
CompanyAssayTargetCountry of manufacturerInterpretationRegulatory status
Beijing Diagreat Biotechnologies Co2019-nCoV IgG/IgM Antibody Determination KitIgM/IgGChinaReader requiredCE-IVD
Beijing Tigsun Diagnostics CoTigsun COVID-19 Combo IgM/IgG Rapid Test (lateral flow)IgM/IgGChinaVisualCE-IVD, India
Beijing Wantai Biological Pharmacy Enterprise CoWantai SARS-CoV-2 Ab Rapid TestTotal AbChinaVisualAustralia
BioMedomicsCOVID-19 IgM-IgG Combined Antibody Rapid TestIgM/IgGChinaVisualCE-IVD, India
BoditechAFIAS/iChroma COVID-19 AbIgM/IgGKoreaReader requiredRUO
BTNXRapid Response COVID-19 IgG/IgM Test Cassette (whole blood/serum/plasma)IgM/IgGChinaVisualRUO
CellexCellex qSARS-CoV-2 IgG/IgM Cassette Rapid TestIgM/IgGUSAVisualCE-IVD
Changsha SinocareSARS-CoV-2 Antibody Test StripIgM/IgGChinaVisualCE-IVD
IgM/IgGChinaVisualCE-IVD
Dynamiker Biotechnology Co2019-nCOV IgG/IgM Rapid TestIgG/IgMChinaVisualCE-IVD
GenBodyGenBody COVID-19 IgM/IgGIgM/IgGRepublic of KoreaReader optionalCE-IVD
Guangzhou Wondfo Biotech CoWondfo SARS-CoV-2 Antibody Test (lateral flow method)IgM/IgGChinaVisualChina, Australia, India; CE-IVD
Hangzhou AllTest Biotech Co2019 nCoV IgG/IgM Rapid Test Cassette (whole blood, serum, plasma)IgM/IgGChinaVisualAustralia, CE-IVD
Hangzhou Biotest Biotech CoCOVID-19 IgG/IgM Rapid Test Cassette (whole blood, serum, plasma)IgM/IgGChinaVisualCE-IVD
Innovita (Tangshan) Biological Technology Co2019-nCoV Ab Test (colloidal gold)IgM/IgGChinaVisualChina, CE-IVD
InTec ProductsRapid SARS-CoV-2 Antibody TestIgM/IgGChinaVisualRUO
InTec ProductsRapid SARS-CoV-2 Antibody (IgM/IgG) TestIgM/IgGChinaVisualRUO
Jiangsu Bioperfectus Technology CoPerfectPOC Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test KitIgM/IgGChinaVisualCE-IVD
Qingdao Hightop Biotech CoHIGHTOP COVID-19 IgM/IgG Ab Rapid Test KitIgM/IgGChinaVisualRUO
RapiGENBIOCREDIT COVID-19 IgG+IgM DuoIgM/IgGRepublic of KoreaVisualRUO
SD BIOSENSORSTANDARDTM Q COVID-19 IgM/IgG Duo TestIgM/IgGRepublic of KoreaVisualCE-IVD, Brazil
Shanghai Kehua Bio-engineering CoDIAGNOSTIC KIT FOR SARS-CoV-2 IgM/IgG ANTIBODY (colloidal gold)IgM/IgGChinaVisualCE-IVD
Shenzhen Bioeasy Biotechnology Co†BIOEASY 2019-nCoV Ab (IgG/IgM) GICA Rapid Test Kit (gold colloidal immunoassay)IgM/IgGChinaVisualCE-IVD
Shenzhen Bioeasy Biotechnology Co†BIOEASY 2019-nCov Total Ab GICA Rapid Test Kit (gold colloidal immunoassay)Total AbChinaVisualCE-IVD
VivaChek Biotech (Hangzhou) CoVivaDiagTM COVID-19 IgM/IgG Rapid TestIgM/IgGChinaVisualCE-IVD; Singapore, India, Australia
Zhuhai Livzon DiagnosticsDiagnostic Kit for IgG Antibody to Corona Virus (nCoV-2019) (colloidal gold)IgGChinaVisualCE-IVD, China
Zhuhai Livzon DiagnosticsDiagnostic Kit for IgM Antibody to Corona Virus (nCoV-2019) (colloidal gold)IgMChinaVisualCE-IVD, China

  • Downloaded 10 April 2020.

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

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

  • Ab, antibody; CE-IVD, Conformité Européenne (EU Certification) In Vitro Diagnostics; RUO, research use only.