FIND evaluations of SARS-CoV-2 Ag tests

SARS-CoV-2 antigens (Ag) are shed as the virus replicates during active infection, and thus their detection can be used to diagnose current infection.

FIND is conducting prospective diagnostic evaluation studies in collaboration with multiple, independent sites to determine the accuracy of COVID-19 Ag rapid diagnostic tests (RDTs). We are currently busy evaluating assays that have already been selected (Table 1) and the expression of interest (EOI) to participate in the Ag RDT evaluations is now closed.

Test submissions were selected through a scoring system taking into consideration:

  • supplier-reported analytical performance
  • supplier-reported clinical performance and size of the related study population/number of COVID-19 positive cases
  • ease of use of the test (need for an instrument, sample type)
  • manufacturing and distribution capacity (especially related to the ability of the company to access LMICs market)
  • regulatory status – products with approval from stringent regulatory bodies such as FDA EUA or WHO EUL are scored higher than CE-IVD self-reported tests which are in turn scored higher than RUO tests.

Status of submission to WHO EUL or approval/failure of another COVID-19 test has also been considered for the final stage of selection.

Ag RDT evaluation protocol

Results for ongoing evaluations will continue to be updated on a routine basis (Table 1). Last update: 18 January 2023

Note: Lower test sensitivity has been observed repeatedly in the evaluations performed in the study sites in India. A root-cause analysis exercise, which included sampling and testing parameters, has been conducted and did not return a conclusive cause for this lower performance compared with results obtained at other study sites. It must be noted that all the referenced evaluations were conducted prior to the emergence of the newly detected variants in India, such as B.1.617. A remaining hypothesis, which has not been confirmed, is that the higher temperature and humidity conditions observed in India may be contributing to varied performance.

Table 1. Antigen(Ag)-detection RDTs undergoing evaluation

CompanyAssayCountry of manufacturerInterpretationRegulatory statusEvaluation statusEvaluation results
Abbott Rapid DiagnosticsPanbio COVID-19 Ag Test – NasopharyngealRep. of KoreaVisualCE-IVD;
WHO EUL
Completed: 3 countries

India
Germany
Switzerland
Results (Germany/Switz.) updated: 10 Dec 2020

Results (India) updated: 25 Jun 2021

Results – Omicron study (Switzerland) updated: 28 April 2022

Abbott Rapid DiagnosticsPanbio COVID-19 Ag Test – NasalRep. of KoreaVisualCE-IVD;
WHO EUL
Completed: 2 country

Germany
South Africa
Results
updated: 11 Feb 2021

Results – Omicron study (South Africa
updated: 28 April 2022

ACON BioTech (Hangzhou) Co., LtdFlowflex -SARS-CoV-2 AgPR ChinaVisualCE-IVDCompleted: 3 countries

Peru
South Africa
Switzerland
Results
updated: 15 Feb 2022
Beijing Hotgen BioTech Co., Ltd.Hotgen – 2019 n-CoV Antigen Test (Colloidal Gold)PR ChinaVisualCE-IVDCompleted: 2 countries

Brazil
UK
Results
updated: 22 Sep 2022
Beijing Tigsun Diagnostics Co., Ltd.Tigsun COVID-19 Antigen TestPR ChinaVisualCE-IVDCompleted: 2 countries

Peru
Uganda
Results- Omicron results
updated: 22 Sep 2022
Beijing Wantai Biological Pharmacy Co.Wantai SARS-COV-2 Ag Rapid Test (Colloidal Gold)PR ChinaVisualCE-IVDCompleted: 1 country

Peru
Results
updated: 04 Jan 2023
Bionote, Inc.NowCheck COVID-19 Ag Test – NasopharyngealRep. of KoreaVisualCE-IVDCompleted: 1 country

Brazil
Results
updated: 22 Sep 2022
Bionote, Inc.NowCheck COVID-19 Ag Test – NasalRep. of KoreaVisualCE-IVDCompleted: 1 country

Brazil
Results
updated: 31 Mar 2021
Boditech Medical, Inc.iChroma COVID-19 Ag TestRep. of KoreaReaderCE-IVDCompleted: 1 country

Switzerland
Results
updated: 23 Feb 2021
Core Technology Ltd.CoreTests Covid-19 Ag TestPR ChinaVisualCE-IVDCompleted: 2 countries

Switzerland
Uganda
Results
updated: 22 Sep 2022
Coris BioConceptCOVID-19 Ag Respi-StripBelgiumVisualCE-IVDCompleted: 2 countries

Germany
UK
Results
updated: 11 Dec 2020
CTK BioTech Inc.OnSite Covid-19 AgPR ChinaVisualCE-IVDCompleted: 1 country

Brazil
Results
updated: 30 Sep 2022
Edinburgh Genetics, LtdActivXpress+ COVID-19 Antigen Complete Testing KitUnited KingdomVisualCE-IVDCompleted: 1 country

Peru
Results
updated: 12 May 2021
Fujirebio Europe N.V.ESPLINE® SARS-CoV-2JapanVisualCE-IVDCompleted: 2 countries

Germany
South Africa
Results
updated: 22 Sep 2022
Genbody, Inc.Genbody COVID-19 Ag TestRep. of KoreaOptional ReaderCE-IVDWithdrawn[1]
Green Cross Medical Science Corp.GENEDIA W COVID-19 AgRep. of KoreaVisualCE-IVDCompleted: 1 countries

Peru
Results
updated: 10 Jun 2022
Hangzhou AllTest Ltd.AllTest Covid-19 Antigen Rapid TestPR ChinaVisualCE-IVD;
Brazil;
UK;
Argentina
Completed: 2 country

Brazil
South Africa
Results
updated: 30 Sep 2022
Hangzhou Biotest Biotech Co., Ltd.RightSign Covid-19 Ag Rapid TestPR ChinaVisualCE-IVDCompleted: 2 country

South Africa
Switzerland
Results
updated: 22 Sep 2022
InTec Products Inc.Rapid SARS-Cov-2 Antigen TestPR ChinaVisualCE-IVD;
UK;
Germany
Completed: 2 countries

Switzerland
Uganda
Results
updated: 04 Jan 2023
JiangSu Bioperfectus Technologies Ltd.Novel Corona Virus SARS-Cov-2 Ag Rapid TestPR ChinaVisualCE-IVDTo startNot yet available
JOYSBIO (Tianjin) Biotechnology Co., LtdSARS CoV 2 Antigen Rapid Test Kit (Colloidal Gold)PR ChinaVisualCE-IVDCompleted: 1 country

Switzerland
Results
updated: 11 Feb 2021
LumiraDx UK LtdLumiraDx SARS-CoV-2 Ag TestUnited KingdomReaderCE-IVDCompleted: 2 countries

Brazil
Germany
Results
updated: 8 Oct 2021
Mologic LtdMologic COVID-19 Rapid TestUnited KingdomVisualCE-IVDCompleted: 2 country

Germany
Uganda
Results
updated: 21 Jul 2022
Nanjing Liming BioProducts Co.StrongStep SARS Cov-2 Antigen Rapid TestPR ChinaVisualCE-IVDCompleted: 2 country

Peru
South Africa
Results
updated: 18 Jan 2023
Nal von MindenNADAL Covid-19 Ag TestPR ChinaVisualCE-IVDCompleted: 2 country

Brazil
Switzerland
Results
updated: 22 Sep 2022
Perkin Elmer Inc.PerkinElmer COVID-19 Antigen TestUnited StatesVisualCE-IVD;
Brazil
Completed: 1 country

Brazil
Results
updated: 22 Sep 2022
Premier Medical Corporation Pvt., LtdSureStatus COVID-19 Antigen Card Test –NasopharyngealIndiaVisualWHO EULCompleted: 3 countries

Germany
India
UK
Results
updated: 1 Dec 2021
Premier Medical Corporation Pvt., LtdSureStatus COVID-19 Antigen Card Test – NasalIndiaVisualRUOCompleted: 2 country

Switzerland
UK
Results
updated: 1 Dec 2021

Results – Omicron study
updated: 3 May 2022
RapiGEN, Inc.BIOCREDIT COVID-19 Ag, Nasopharyngeal–1st generationRep. of KoreaVisualCE-IVD;
Brazil;
Philippines;
Completed: 2 countries

Brazil
Germany
Results
updated: 9 Jun 2021
RapiGEN, Inc.BIOCREDIT COVID-19 Ag,  Nasopharyngeal–2nd generationRep. of KoreaVisualCE-IVD;
Australia;
Brazil;
Korea;
Singapore
Completed: 1 country

UK
Results
updated: 9 Jun 2022

Results (Brazil)
updated: 30 Sep 2022
RapiGEN, Inc.BIOCREDIT COVID-19 Ag, NasalRep. of KoreaVisualCE-IVD;
Korea for export only
Completed: 1 country

UK
Results
updated: 9 Jun 2022
SD BIOSENSOR, INC.STANDARD F COVID-19 Ag FIARep. of KoreaReaderCE-IVD;
Brazil
Completed: 3 countries

Brazil
Germany
India
Results (Brazil/Germany)
updated: 30 Dec 2022

Results (India)
updated: 30 Sep 2022
SD BIOSENSOR, INC.STANDARD Q COVID-19 Ag Test – NasopharyngealRep. of KoreaVisualCE-IVD;
WHO EUL;
Brazil
Completed: 6 countries

Brazil
Germany
India
Peru
South Africa
Switzerland
Results (Brazil/Germany/Switz.)
updated: 10 Dec 2020

Results (India/Peru)
updated: 25 Jun 2021

Results - Omicron study (South Africa)
updated: 30 Sep 2022
SD BIOSENSOR, INC.STANDARD Q COVID-19 Ag Test – NasalRep. of KoreaVisualCE-IVDCompleted: 2 country

Brazil
Germany
Results
updated: 13 Apr 2021

Results – Omicron study (South Africa)
updated: 30 Sep 2022

Shenzhen Bioeasy Biotechnology Co., LtdBioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence) [2]PR ChinaReaderCE-IVDCompleted: 1 country

Germany
Results
updated: 20 Jan 2021
Wondfo Biotech Co., Ltd2019 n-CoV Antigen Test (Lateral Flow Method) – NasopharyngealPR ChinaVisualRUOCompleted: 2 countries

Brazil
Switzerland
Results
updated: 22 Sep 2022
Wondfo Biotech Co., Ltd2019 n-CoV Antigen Test (Lateral Flow Method) – NasalPR ChinaVisualRUOCompleted: 1 country

Brazil
Results
updated: 11 Oct 2021
[1] This fluorescence-based test is different from the colloidal gold Ag test that was withdrawn by the company.

[2]
The company requested their test be withdrawn prior to study start; FIND will not be evaluating this product.

More information

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