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 Ag RDTs. We are currently busy evaluating assays that have already been selected (Table 1) and are selecting new tests to be evaluated by end of 2021. The expression of interest (EOI) to participate in the Ag RDT evaluations is now closed and may reopen at the end of 2021.

Antigen RDT evaluation protocol summary

Results for ongoing evaluations will continue to be updated on a routine basis (Table 1). Last update: 8 July 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/ Switzerland)
updated: 10 Dec 2020 

Results (India)
updated: 25 Jun 2020

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: 1 country Results
updated: 8 Jul 2021
Beijing Tigsun Diagnostics Co., Ltd. Tigsun COVID-19 Antigen Test PR China Visual CE-IVD Ongoing Not yet available
Bionote, Inc. NowCheck COVID-19 Ag Test – Nasopharyngeal Rep. of Korea Visual CE-IVD Completed: 1 country Results
updated: 20 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
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 To start Not yet available
Edinburgh Genetics, Ltd ActivXpress+ COVID-19 Antigen Complete Testing Kit UK 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[2] Not applicable
Green Cross Medical Science Corp. GENEDIA W COVID-19 Ag Rep. of Korea Visual CE-IVD Completed: 2 countries Results
updated: 25 Jun 2021
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 To start Not yet available
Mologic Ltd Mologic COVID-19 Rapid Test United Kingdom Visual CE-IVD Completed: 1 country Results
updated: 15 Jun 2021
Nal von Minden NADAL Covid-19 Ag Test PR China Visual CE-IVD Completed: 1 country Results
updated: 27 Apr 2021
Premier Medical Corporation Pvt., Ltd SureStatus COVID-19 Antigen Card Test –Nasopharyngeal India Visual WHO EUL Completed: 2 countries Results
updated: 5 May 2021
Premier Medical Corporation Pvt., Ltd SureStatus COVID-19 Antigen Card Test – Nasal India Visual RUO To start Not yet available
RapiGEN, Inc. BIOCREDIT COVID-19 Ag Rep. of Korea Visual Brazil; Philippines;
CE-IVD
Completed: 2 countries Results
updated: 8 Jun 2021
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/Switzerland)
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) [1] 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: 1 country Results
updated: 25 Feb 2021
Wondfo Biotech Co., Ltd 2019 n-CoV Antigen Test (Lateral Flow Method) – Nasal PR China Visual RUO To start Not yet available
[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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