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: this 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 | Results updated: 11 Feb 2021 |
ACON BioTech (Huangzhou) Co., Ltd | Flowflex -SARS-CoV-2 Ag | PR China | Visual | CE-IVD | To start | 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 Hotgen BioTech 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: 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 | 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 | Not yet available |
Fujirebio Europe N.V. | ESPLINE® SARS-CoV-2 | Japan | Visual | CE-IVD | Ongoing | 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) | PR China | Visual | CE-IVD | Ongoing: 1 country | Results updated: 11 Feb 2021 |
Mologic Ltd | Mologic COVID-19 Rapid Test | United Kingdom | Visual | CE-IVD | To start | Not yet available |
Nal von Minden | NADAL Covid-19 Ag Test | PR China | Visual | CE-IVD | To start | Not yet available |
Premier Medical Corporation Pvt., Ltd | 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] | 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: 26 February 2021 |
More information
For questions relating to the evaluation of immunoassays, please contact our Emerging Threats team.
Quick links