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.

Suppliers interested in having their tests considered for inclusion in these independent evaluation studies may submit their information via our technology scouting submission form. (Please select ‘Outbreak’ as the ‘Disease Area’ and ‘SARS-CoV-2 Ag evaluation’ as the ‘Disease Area Subtype’ on the form and upload the completed submission template and instructions for use.)

All test submissions are scored according to:
—their regulatory status and time to market;
—the manufacturing and distribution capacity of the supplier; and
—the supplier-reported clinical and analytical performance (target ≥ 80% sensitivity and ≥ 97% specificity).

Below is a list of all tests that have been selected to date and the status of the evaluation (please note: list is updated on a routine basis).

Participants in the Ag RDT evaluation studies include individuals presumed to have COVID-19 due to the presence of symptoms or with close contact with a confirmed case, but may not capture the full spectrum of disease; therefore, sensitivity and specificity estimates may not be indicative of the real-world performance of these tests in all intended use settings. Interim analyses are performed at 25% and 50% enrolment, and the evaluation is stopped if tests do not meet 97% specificity.

Antigen RDT evaluation protocol summary

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
Ongoing Not yet available
Bionote, Inc. NowCheck COVID-19 Ag Test – Nasopharyngeal Rep. of Korea Visual CE-IVD Completed: 1 country Results updated: 11 Dec 2020
Bionote, Inc. NowCheck COVID-19 Ag Test – Nasal Rep. of Korea Visual CE-IVD To start Not yet available
Boditech Medical, Inc. iChroma COVID-19 Ag Test Rep. of Korea Reader CE-IVD Ongoing: 1 country Not yet available
Coris BioConcept COVID-19 Ag Respi-Strip Belgium Visual CE-IVD Completed: 2 countries Results
updated: 11 Dec 2020
Edinburgh Genetics, Ltd ActivXpress+ COVID-19 Antigen Complete Testing Kit UK Visual CE-IVD Ongoing Not yet available
Fujirebio Europe N.V. ESPLINE® SARS-CoV-2 Japan Visual CE-IVD To start Not yet available
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 To start Not yet available
JOYSBIO (Tianjin) Biotechnology Co., Ltd SARS CoV 2 Antigen Rapid Test Kit (Colloidal Gold) China Visual CE-IVD Ongoing: 1 country Not yet available
Premier Medical Corporation Sure Status COVID-19 Antigen Card Test India Visual RUO Ongoing Not yet available
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: 1 country Results
updated: 19 Jan 2021
Shenzhen Bioeasy Biotechnology Co., Ltd Bioeasy 2019-nCoV Ag Fluorescence Rapid Test Kit (Time-Resolved Fluorescence) [1] China Reader CE-IVD Completed: 1 country Results
updated: 20 Jan 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: 20 January 2021

More information

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


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