FIND evaluation of SARS-CoV-2 antigen (Ag) detecting tests

SARS-CoV-2 antigens 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 antigen (Ag) detecting 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.

Antigen RDT evaluation protocol summary

Results for ongoing evaluations will continue to be updated on a routine basis (Table 1). Last update: 10 Oct 2021

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 to 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
Company Assay Country of manufacturer Interpretation Regulatory status Evaluation status Evaluation results
Abbott Rapid Diagnostics Panbio COVID-19 Ag Test – Nasopharyngeal Rep. of Korea Visual CE-IVD;
WHO EUL
Completed: 3 countries Results (Germany/ Switz.)
updated: 10 Dec 2020
Results (India)
updated: 25 Jun 2021
Abbott Rapid Diagnostics Panbio COVID-19 Ag Test – Nasal Rep. of Korea Visual CE-IVD;
WHO EUL
Completed: 1 country Results
updated: 11 Feb 2021
ACON BioTech (Hangzhou) Co., Ltd Flowflex -SARS-CoV-2 Ag PR China Visual CE-IVD Completed: 1 country Results
updated: 9 Jun 2021
Beijing Hotgen BioTech Co., Ltd. Hotgen – 2019 n-CoV Antigen Test (Colloidal Gold) PR China Visual CE-IVD Completed: 2 countries Results
updated: 21 Sep 2021
Beijing Tigsun Diagnostics Co., Ltd. Tigsun COVID-19 Antigen Test PR China Visual CE-IVD Ongoing Not yet available
Beijing Wantai Biological Pharmacy Co. Wantai SARS-COV-2 Ag Rapid Test (Colloidal Gold) PR China Visual CE-IVD To start Not yet available
Bionote, Inc. NowCheck COVID-19 Ag Test – Nasopharyngeal Rep. of Korea Visual CE-IVD Completed: 1 country Results
updated: 28 Apr 2021
Bionote, Inc. NowCheck COVID-19 Ag Test – Nasal Rep. of Korea Visual CE-IVD Completed: 1 country Results
updated: 30 Mar 2021
Boditech Medical, Inc. iChroma COVID-19 Ag Test Rep. of Korea Reader CE-IVD Completed: 1 country Results
updated: 23 Feb 2021
Core Technology Ltd. CoreTests Covid-19 Ag Test PR China Visual CE-IVD Ongoing Not yet available
Coris BioConcept COVID-19 Ag Respi-Strip Belgium Visual CE-IVD Completed: 2 countries Results
updated: 10 Dec 2020
CTK BioTech Inc. OnSite Covid-19 Ag PR China Visual CE-IVD Ongoing Not yet available
Edinburgh Genetics, Ltd ActivXpress+ COVID-19 Antigen Complete Testing Kit United Kingdom Visual CE-IVD Completed: 1 country Results
updated: 26 Apr 2021
Fujirebio Europe N.V. ESPLINE® SARS-CoV-2 Japan Visual CE-IVD Completed: 1 country Results
updated: 29 Mar 2021
Genbody, Inc. Genbody COVID-19 Ag Test Rep. of Korea Optional Reader CE-IVD Withdrawn[1]
Green Cross Medical Science Corp. GENEDIA W COVID-19 Ag Rep. of Korea Visual CE-IVD Completed: 2 countries Results
updated: 25 Jun 2021
Hangzhou AllTest Ltd. AllTest Covid-19 Antigen Rapid Test PR China Visual CE-IVD To start Not yet available
Hangzhou Biotest Biotech Co., Ltd. RightSign Covid-19 Ag Rapid Test PR China Visual CE-IVD Ongoing Not yet available
InTec Products Inc. Rapid SARS-Cov-2 Antigen Test PR China Visual CE-IVD To start Not yet available
JiangSu Bioperfectus Technologies Ltd. Novel Corona Virus SARS-Cov-2 Ag Rapid Test PR China Visual CE-IVD To start Not yet available
JOYSBIO (Tianjin) Biotechnology Co., Ltd SARS CoV 2 Antigen Rapid Test Kit (Colloidal Gold) PR China Visual CE-IVD Completed: 1 country Results
updated: 11 Feb 2021
LumiraDx UK Ltd LumiraDx SARS-CoV-2 Ag Test United Kingdom Reader CE-IVD Completed: 2 countries Results
updated: 8 Oct 2021
Mologic Ltd Mologic COVID-19 Rapid Test United Kingdom Visual CE-IVD Completed: 1 country Results
updated: 15 Jun 2021
Nanjing Liming BioProducts Co. StrongStep SARS Cov-2 Antigen Rapid Test PR China Visual CE-IVD To start Not yet available
Nal von Minden NADAL Covid-19 Ag Test PR China Visual CE-IVD Completed: 1 country Results
updated: 27 Apr 2021
Perkin Elmer Inc. PerkinElmer COVID-19 Antigen Test United States Visual CE-IVD; Brazil To start Not yet available
Premier Medical Corporation Pvt., Ltd SureStatus COVID-19 Antigen Card Test –Nasopharyngeal India Visual WHO EUL Completed: 2 countries Results
updated: 8 Sep 2021
Premier Medical Corporation Pvt., Ltd SureStatus COVID-19 Antigen Card Test – Nasal India Visual RUO Ongoing Not yet available
RapiGEN, Inc. BIOCREDIT COVID-19 Ag, Nasopharyngeal–1st generation Rep. of Korea Visual Brazil; Philippines;
CE-IVD
Completed: 2 countries Results
updated: 9 Jun 2021
RapiGEN, Inc. BIOCREDIT COVID-19 Ag,  Nasopharyngeal–2nd generation Rep. of Korea Visual CE-IVD; Australia; Brazil; Korea; Singapore To start  Not yet available
RapiGEN, Inc. BIOCREDIT COVID-19 Ag, Nasal Rep. of Korea Visual CE-IVD; Korea for export only To start  Not yet available
SD BIOSENSOR, INC. STANDARD F COVID-19 Ag FIA Rep. of Korea Reader Brazil;
CE-IVD
Completed: 3 countries Results (Brazil/Germany)
updated: 10 Dec 2020
Results (India)
updated: 25 Jun 2021
SD BIOSENSOR, INC. STANDARD Q COVID-19 Ag Test – Nasopharyngeal Rep. of Korea Visual Brazil;
CE-IVD;
WHO EUL
Completed: 5 countries Results (Brazil/Germany/Switz.)
updated: 10 Dec 2020
Results (India/Peru)
updated: 25 Jun 2021
SD BIOSENSOR, INC. STANDARD Q COVID-19 Ag Test – Nasal Rep. of Korea Visual CE-IVD Completed: 2 country Results
updated: 12 Apr 2021
Shenzhen Bioeasy Biotechnology Co., Ltd Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence) [2] PR China Reader CE-IVD Completed: 1 country Results
updated: 19 Jan 2021
Wondfo Biotech Co., Ltd 2019 n-CoV Antigen Test (Lateral Flow Method) – Nasopharyngeal PR China Visual RUO Completed: 2 countries Results
updated: 10 Oct 2021
Wondfo Biotech Co., Ltd 2019 n-CoV Antigen Test (Lateral Flow Method) – Nasal PR China Visual RUO Completed: 1 country Results
updated: 10 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.


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