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Disease/health condition -
Coronavirus disease (COVID-19)
SARS-CoV-2 antigen
Assay format
Lateral flow RDT
Information History
First added in 2020
Purpose type
Screening, Aid to diagnosis
Purpose
To diagnose COVID-19 in settings where NAT is unavailable or where prolonged turnaround times preclude clinical utility. To aid in the diagnosis of COVID-19 in the early symptomatic phases of illness, or in asymptomatic individuals with known contact with a confirmed case.
Specimen types
Upper respiratory specimens (e.g., Nasal swab, Nasopharyngeal swab, Nasopharyngeal aspirate or wash)
WHO prequalified or recommended products
N/A
GMDN
64787
SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method* . This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024* lateral flow test
EMDN
W0105099099
VIROLOGY - RT & POC - OTHER
The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdnWHO supporting publications
World Health Organization. (2021). Antigen-detection in the diagnosis of SARS-CoV-2 infection: interim guidance, 6 October 2021. World Health Organization. https://iris.who.int/handle/10665/345948 ; World Health Organization. (2020). Priority medical devices list for the COVID-19 response and associated technical specifications: interim guidance, 19 November 2020. World Health Organization. https://iris.who.int/handle/10665/336745
Technical specifications
N/A
SAGE IVD recommended including the SARS-CoV-2 antigen test in the third EDL:
• as a disease-specific IVD for use in community settings and health facilities without laboratories (EDL 3, Section I.b, Coronavirus disease (COVID-19));
• using an RDT format, handheld or small benchtop instrument for POC use;
• to aid in the diagnosis of COVID-19 in settings where NAT is unavailable or where prolonged turnaround times preclude clinical utility; and
• to aid in the diagnosis of COVID-19 in the early symptomatic phases of illness, or in asymptomatic individuals with known close contact with a confirmed case. The test was recommended for inclusion provided that the following caveats are clearly stated:
• A negative test does not rule out infection and should not determine clinical care.
• Listing was based on available evidence and interim WHO guidelines and is subject to change.
• as a disease-specific IVD for use in community settings and health facilities without laboratories (EDL 3, Section I.b, Coronavirus disease (COVID-19));
• using an RDT format, handheld or small benchtop instrument for POC use;
• to aid in the diagnosis of COVID-19 in settings where NAT is unavailable or where prolonged turnaround times preclude clinical utility; and
• to aid in the diagnosis of COVID-19 in the early symptomatic phases of illness, or in asymptomatic individuals with known close contact with a confirmed case. The test was recommended for inclusion provided that the following caveats are clearly stated:
• A negative test does not rule out infection and should not determine clinical care.
• Listing was based on available evidence and interim WHO guidelines and is subject to change.
Several concerns were raised about the unreliable sensitivity of the SARS CoV-2 antigen tests as shown in the various studies conducted to date. However, the test was considered essential especially to provide access to testing in settings where RT-PCR is not available. Nonetheless, it should be listed with clear caveats. SAGE IVD also decided not to recommend the test for use in asymptomatic individuals without known close contact with confirmed cases, because of concerns about the variable sensitivity and lack of test performance data in these individuals.
Other concerns expressed related to the rapidly evolving evidence base and ongoing updates to guidelines, and how these factors may affect the stated test purpose. It was decided that these concerns should also be included in the caveats to the test purpose for this test.
The first field studies of these tests are now emerging. The studies show that whereas the specificity of the tests is generally very high (97–99%), their sensitivity may be compromised. Evaluations in different settings have shown that sensitivity varies among them. There are no convincing data of the sensitivity of these tests in asymptomatic people. Although high specificity suggests that positive results in symptomatic patients indicate SARS-Cov-2 infection, the poor and variable sensitivity indicates that negative test results do not rule out disease, and a second test is required before infection can be ruled out.
World Health Organization. (2021). The selection and use of essential in vitro diagnostics: report of the third meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2020 (including the third WHO model list of essential in vitro diagnostics). World Health Organization. https://iris.who.int/handle/10665/339064