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 has been conducting prospective diagnostic evaluation studies in collaboration with multiple, independent sites to determine the accuracy of COVID-19 Ag RDTs. Effective April 2021, selection of new tests is currently being paused, as we are busy evaluating assays that have already been selected (Table 1). We plan to select additional products in the coming months and will prioritize products undergoing review by the WHO EUL procedure and that have a clear intention of distribution in LMIC.

Suppliers interested in having their tests considered for inclusion in these future rounds of independent evaluation studies may submit their information as an expression of interest (EOI) via the FIND technology scouting submission webform. Please select ‘Outbreak’ as the ‘Disease Area’ and ‘SARS-CoV-2 Ag evaluation EOI’ as the ‘Disease Area Subtype’ to complete the online form. We will update this webpage and communicate with suppliers that have expressed their interest once the next round of review and selection will begin.

Antigen RDT evaluation protocol summary

Results for ongoing evaluations will continue to be updated on a routine basis (Table 1).

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: 2 countries Results
updated: 11 Dec 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 (Huangzhou) Co., Ltd Flowflex -SARS-CoV-2 Ag PR China Visual CE-IVD Ongoing Not yet available
Beijing Hotgen BioTech Co., Ltd. Hotgen – 2019 n-CoV Antigen Test (Colloidal Gold) PR China Visual CE-IVD To start Not yet available
Beijing Tigsun Diagnostics Co., Ltd. Tigsun COVID-19 Antigen Test 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: 31 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: 11 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 Ongoing: 2 countries Not yet available
Fujirebio Europe N.V. ESPLINE® SARS-CoV-2 Japan Visual CE-IVD Completed: 1 country Results
updated: 31 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 Ongoing: 2 countries 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
Mologic Ltd Mologic COVID-19 Rapid Test United Kingdom Visual CE-IVD Completed: 1 country Results updated: 30 Apr 2021
Nal von Minden NADAL Covid-19 Ag Test PR China Visual CE-IVD Completed: 1 country Results updated: 28 Apr 2021
Premier Medical Corporation Pvt., Ltd Sure Status COVID-19 Antigen Card Test India Visual RUO Ongoing: 2 countries Results updated: 5 May 2021
RapiGEN, Inc. BIOCREDIT COVID-19 Ag Rep. of Korea Visual Brazil; Philippines;
CE-IVD
Completed: 2 countries Results
updated: 11 Dec 2020
SD BIOSENSOR, INC. STANDARD F COVID-19 Ag FIA Rep. of Korea Reader Brazil;
CE-IVD
Completed: 2 countries Results
updated: 11 Dec 2020
SD BIOSENSOR, INC. STANDARD Q COVID-19 Ag Test – Nasopharyngeal Rep. of Korea Visual Brazil;
CE-IVD;
WHO EUL
Completed: 3 countries Results
updated: 11 Dec 2020
SD BIOSENSOR, INC. STANDARD Q COVID-19 Ag Test – Nasal Rep. of Korea Visual CE-IVD Completed: 2 country Results
updated: 13 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: 20 Jan 2021
Wondfo Biotech Co., Ltd 2019 n-CoV Antigen Test (Lateral Flow Method) PR China Visual RUO Completed: 1 country Results updated: 26 Feb 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.
Last updated: 5 May 2021

More information

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


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