Performance differences among commercially available antigen rapid tests for COVID-19 in Brazil
A rapid and accurate diagnosis is a crucial strategy for containing the coronavirus disease (COVID-19) pandemic. Considering the obstacles to upscaling the use of RT-qPCR, rapid tests based on antigen detection (Ag-RDT) have become an alternative to enhance mass testing, reducing the time for a prom...
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| Veröffentlicht in: | PloS one 2022-06, Vol.17 (6), p.e0269997-e0269997 |
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| creator | Freire, Mariana Lourenço Alves, Lindicy Leidicy de Souza, Carolina Senra Saliba, Juliana Wilke Faria, Verônica Pedras, Mariana Junqueira Carvalho, Nara de Oliveira Andrade, Gláucia Queiroz Rabello, Ana Avelar, Daniel Moreira Cota, Gláucia |
| description | A rapid and accurate diagnosis is a crucial strategy for containing the coronavirus disease (COVID-19) pandemic. Considering the obstacles to upscaling the use of RT-qPCR, rapid tests based on antigen detection (Ag-RDT) have become an alternative to enhance mass testing, reducing the time for a prompt diagnosis and virus spreading. However, the performances of several commercially available Ag-RDTs have not yet been evaluated in several countries. Here, we evaluate the performance of eight Ag-RDTs available in Brazil to diagnose COVID-19. Patients admitted to tertiary hospitals with moderate or mild COVID-19 symptoms and presenting risk factors for severe disease were included. The tests were performed using a masked protocol, strictly following the manufacturer's recommendations and were compared with RT-qPCR. The overall sensitivity of the tests ranged from 9.8 to 81.1%, and specificity greater than 83% was observed for all the evaluated tests. Overall, slight or fair agreement was observed between Ag-RDTs and RT-PCR, except for the Ag-RDT COVID-19 (Acro Biotech), in which moderate agreement was observed. Lower sensitivity of Ag-RDTs was observed for patients with cycle threshold > 25, indicating that the sensitivity was directly affected by viral load, whereas the effect of the disease duration was unclear. Despite the lower sensitivity of Ag-RDTs compared with RT-qPCR, its easy fulfillment and promptness still justify its use, even at hospital admission. However, the main advantage of Ag-RDTs seems to be the possibility of increasing access to the diagnosis of COVID-19 in patients with a high viral load, allowing immediate clinical management and reduction of infectivity and community transmission. |
| doi_str_mv | 10.1371/journal.pone.0269997 |
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Considering the obstacles to upscaling the use of RT-qPCR, rapid tests based on antigen detection (Ag-RDT) have become an alternative to enhance mass testing, reducing the time for a prompt diagnosis and virus spreading. However, the performances of several commercially available Ag-RDTs have not yet been evaluated in several countries. Here, we evaluate the performance of eight Ag-RDTs available in Brazil to diagnose COVID-19. Patients admitted to tertiary hospitals with moderate or mild COVID-19 symptoms and presenting risk factors for severe disease were included. The tests were performed using a masked protocol, strictly following the manufacturer's recommendations and were compared with RT-qPCR. The overall sensitivity of the tests ranged from 9.8 to 81.1%, and specificity greater than 83% was observed for all the evaluated tests. Overall, slight or fair agreement was observed between Ag-RDTs and RT-PCR, except for the Ag-RDT COVID-19 (Acro Biotech), in which moderate agreement was observed. Lower sensitivity of Ag-RDTs was observed for patients with cycle threshold > 25, indicating that the sensitivity was directly affected by viral load, whereas the effect of the disease duration was unclear. Despite the lower sensitivity of Ag-RDTs compared with RT-qPCR, its easy fulfillment and promptness still justify its use, even at hospital admission. However, the main advantage of Ag-RDTs seems to be the possibility of increasing access to the diagnosis of COVID-19 in patients with a high viral load, allowing immediate clinical management and reduction of infectivity and community transmission.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0269997</identifier><identifier>PMID: 35709075</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Accuracy ; Agreements ; Antigens ; Biology and life sciences ; Coronaviruses ; COVID-19 ; Diagnosis ; Disease transmission ; Engineering and Technology ; Health risks ; Infectivity ; Laboratories ; Medical diagnosis ; Medicine and Health Sciences ; Pandemics ; Patients ; People and places ; Performance evaluation ; Risk analysis ; Risk factors ; Sensitivity ; Severe acute respiratory syndrome coronavirus 2 ; Signs and symptoms ; Tertiary ; Viral diseases ; Viruses</subject><ispartof>PloS one, 2022-06, Vol.17 (6), p.e0269997-e0269997</ispartof><rights>COPYRIGHT 2022 Public Library of Science</rights><rights>2022 Freire et al. 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Considering the obstacles to upscaling the use of RT-qPCR, rapid tests based on antigen detection (Ag-RDT) have become an alternative to enhance mass testing, reducing the time for a prompt diagnosis and virus spreading. However, the performances of several commercially available Ag-RDTs have not yet been evaluated in several countries. Here, we evaluate the performance of eight Ag-RDTs available in Brazil to diagnose COVID-19. Patients admitted to tertiary hospitals with moderate or mild COVID-19 symptoms and presenting risk factors for severe disease were included. The tests were performed using a masked protocol, strictly following the manufacturer's recommendations and were compared with RT-qPCR. The overall sensitivity of the tests ranged from 9.8 to 81.1%, and specificity greater than 83% was observed for all the evaluated tests. Overall, slight or fair agreement was observed between Ag-RDTs and RT-PCR, except for the Ag-RDT COVID-19 (Acro Biotech), in which moderate agreement was observed. Lower sensitivity of Ag-RDTs was observed for patients with cycle threshold > 25, indicating that the sensitivity was directly affected by viral load, whereas the effect of the disease duration was unclear. Despite the lower sensitivity of Ag-RDTs compared with RT-qPCR, its easy fulfillment and promptness still justify its use, even at hospital admission. However, the main advantage of Ag-RDTs seems to be the possibility of increasing access to the diagnosis of COVID-19 in patients with a high viral load, allowing immediate clinical management and reduction of infectivity and community transmission.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>35709075</pmid><doi>10.1371/journal.pone.0269997</doi><tpages>e0269997</tpages><orcidid>https://orcid.org/0000-0003-3380-2651</orcidid><orcidid>https://orcid.org/0000-0002-4564-2045</orcidid><orcidid>https://orcid.org/0000-0003-2494-6178</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Public Library of Science (PLoS) Journals Open Access; DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Accuracy Agreements Antigens Biology and life sciences Coronaviruses COVID-19 Diagnosis Disease transmission Engineering and Technology Health risks Infectivity Laboratories Medical diagnosis Medicine and Health Sciences Pandemics Patients People and places Performance evaluation Risk analysis Risk factors Sensitivity Severe acute respiratory syndrome coronavirus 2 Signs and symptoms Tertiary Viral diseases Viruses |
| title | Performance differences among commercially available antigen rapid tests for COVID-19 in Brazil |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-29T00%3A17%3A04IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Performance%20differences%20among%20commercially%20available%20antigen%20rapid%20tests%20for%20COVID-19%20in%20Brazil&rft.jtitle=PloS%20one&rft.au=Freire,%20Mariana%20Louren%C3%A7o&rft.date=2022-06-16&rft.volume=17&rft.issue=6&rft.spage=e0269997&rft.epage=e0269997&rft.pages=e0269997-e0269997&rft.issn=1932-6203&rft.eissn=1932-6203&rft_id=info:doi/10.1371/journal.pone.0269997&rft_dat=%3Cgale_plos_%3EA707329726%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2686270078&rft_id=info:pmid/35709075&rft_galeid=A707329726&rft_doaj_id=oai_doaj_org_article_82e188f8553f433a9c49fc1b2bf42a6f&rfr_iscdi=true |