Evaluation of CLINITEST® Rapid Covid-19 + Influenza antigen test in a cohort of symptomatic patients in an emergency department
Objectives Rapid management of patients with respiratory tract infections in hospital emergency departments is one of the main objectives since the concurrent circulation of respiratory viruses following the SARS-CoV-2 pandemic. The use of new combined point-of-care antigen tests for detecting influ...
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Veröffentlicht in: | European journal of clinical microbiology & infectious diseases 2024-05, Vol.43 (5), p.853-861 |
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creator | Maldonado-Barrueco, Alfredo Gutiérrez-Arroyo, Almudena Bloise, Iván de Ceano-Vivas, María Rivera-Nuñez, Angélica Santos-Olmos, Rosario Torres Vega, Dolores Montero García-Rodríguez, Julio |
description | Objectives
Rapid management of patients with respiratory tract infections in hospital emergency departments is one of the main objectives since the concurrent circulation of respiratory viruses following the SARS-CoV-2 pandemic. The use of new combined point-of-care antigen tests for detecting influenza A/B and SARS-CoV-2 represents an advantage in response time over the molecular tests. The objective was to evaluate the suitability of the CLINITEST® Rapid Covid-19 + Influenza Antigen test (Siemens Healthineers, Germany) (RCIA test) by measuring the sensitivity, specificity, Cohen’s kappa, and cut-off values.
Methods
Nasopharyngeal samples were collected from a randomised group of symptomatic patients of all ages at emergency department during January–February 2023. In parallel, these patients were screened for influenza A/B, and SARS-CoV-2 using RT-PCR. The Ct (cycle threshold) values were collected for positive [RT-PCR (+) /RCIA test (+)] and false negative [(RT-PCR (+) /RCIA test (-)] samples. A subanalysis was performed in the paediatric population ( 20). Despite its good specificity and Cohen’s kappa value, its use as a screening test is not comparable to RT-PCR systems in the ED environment with a high number of false negative results. |
doi_str_mv | 10.1007/s10096-024-04788-w |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2933461337</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3057566740</sourcerecordid><originalsourceid>FETCH-LOGICAL-c326t-be99be95093c0b331e80f4e2d1e13ad10084263263688522d054666e912a683b3</originalsourceid><addsrcrecordid>eNp9UUGO1DAQtBCIHQY-wAFZ4oKEDLbbcZIjGg3sSCOQYDhbnsRZskrsYDu7Gk4cuPAZHrFP4SX07iwgceDQ7UNXlbu6CHks-AvBefkyYa8141IxrsqqYpd3yEIoKJiCEu6SBa9BsbqUcEIepHTOkVSV5X1yApWSQmm9IN_WF3aYbe6Dp6Gjq-3m7Wa3_rC7-kHf26lv6Spc9C0T9c-v359jbXw3zM5_sdT63J85T7NLmfaeWtqETyHma5l0GKccRpRt6ITd-ZxuMJ660UWkNQfausnGPOLsIbnX2SG5R7fvknx8vd6tTtn23ZvN6tWWNSB1ZntX11gF2mr4HkC4infKyVY4AbbFa6AtjVDQVVVI2fICPWpXC2l1BXtYkmdH3SmGzzPubcY-NW4YrHdhTkbWAEoLwOstydN_oOdhjh63M8CLstC6VBxR8ohqYkgpus5MsR9tPBjBzXVG5piRwYzMTUbmEklPbqXn_ejaP5TfoSAAjoCEI3_m4t-__yP7C5q2nis</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3057566740</pqid></control><display><type>article</type><title>Evaluation of CLINITEST® Rapid Covid-19 + Influenza antigen test in a cohort of symptomatic patients in an emergency department</title><source>SpringerNature Journals</source><creator>Maldonado-Barrueco, Alfredo ; Gutiérrez-Arroyo, Almudena ; Bloise, Iván ; de Ceano-Vivas, María ; Rivera-Nuñez, Angélica ; Santos-Olmos, Rosario Torres ; Vega, Dolores Montero ; García-Rodríguez, Julio</creator><creatorcontrib>Maldonado-Barrueco, Alfredo ; Gutiérrez-Arroyo, Almudena ; Bloise, Iván ; de Ceano-Vivas, María ; Rivera-Nuñez, Angélica ; Santos-Olmos, Rosario Torres ; Vega, Dolores Montero ; García-Rodríguez, Julio ; SARS-CoV-2 working group</creatorcontrib><description>Objectives
Rapid management of patients with respiratory tract infections in hospital emergency departments is one of the main objectives since the concurrent circulation of respiratory viruses following the SARS-CoV-2 pandemic. The use of new combined point-of-care antigen tests for detecting influenza A/B and SARS-CoV-2 represents an advantage in response time over the molecular tests. The objective was to evaluate the suitability of the CLINITEST® Rapid Covid-19 + Influenza Antigen test (Siemens Healthineers, Germany) (RCIA test) by measuring the sensitivity, specificity, Cohen’s kappa, and cut-off values.
Methods
Nasopharyngeal samples were collected from a randomised group of symptomatic patients of all ages at emergency department during January–February 2023. In parallel, these patients were screened for influenza A/B, and SARS-CoV-2 using RT-PCR. The Ct (cycle threshold) values were collected for positive [RT-PCR (+) /RCIA test (+)] and false negative [(RT-PCR (+) /RCIA test (-)] samples. A subanalysis was performed in the paediatric population (< 16 years-old).
Results
We included 545 patients (55.8% females) with a median age of 7 years-old (IQR: 1–66.5). The RCIA test showed a sensitivity of 59.7% [95%CI: 46.9–67.33] for influenza A, 65.6% [95%CI: 49.5–80.3] for influenza B, and 76.9% [95%CI: 45.8–84.8] for SARS-CoV-2. The specificity was between 90.7%-99.7% with a moderate/high level of agreement with RT-PCR (kappa score: 0.6–0.8) for the three respiratory viruses included in the RCIA test.
Conclusions
The sensitivity of the RCIA test is insufficient for screening of patients, including patients with low Ct values (Ct > 20). Despite its good specificity and Cohen’s kappa value, its use as a screening test is not comparable to RT-PCR systems in the ED environment with a high number of false negative results.</description><identifier>ISSN: 0934-9723</identifier><identifier>EISSN: 1435-4373</identifier><identifier>DOI: 10.1007/s10096-024-04788-w</identifier><identifier>PMID: 38421466</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Antigens ; Biomedical and Life Sciences ; Biomedicine ; COVID-19 ; Emergency medical care ; Emergency medical services ; Influenza ; Influenza A ; Influenza B ; Internal Medicine ; Medical Microbiology ; Original Article ; Pandemics ; Patients ; Pediatrics ; Polymerase chain reaction ; Public health ; Respiratory tract ; Respiratory tract infection ; Sensitivity ; Sensitivity analysis ; Severe acute respiratory syndrome coronavirus 2 ; Viral diseases</subject><ispartof>European journal of clinical microbiology & infectious diseases, 2024-05, Vol.43 (5), p.853-861</ispartof><rights>The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature 2024. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c326t-be99be95093c0b331e80f4e2d1e13ad10084263263688522d054666e912a683b3</cites><orcidid>0000-0002-1856-1725</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10096-024-04788-w$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10096-024-04788-w$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>315,782,786,27931,27932,41495,42564,51326</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38421466$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Maldonado-Barrueco, Alfredo</creatorcontrib><creatorcontrib>Gutiérrez-Arroyo, Almudena</creatorcontrib><creatorcontrib>Bloise, Iván</creatorcontrib><creatorcontrib>de Ceano-Vivas, María</creatorcontrib><creatorcontrib>Rivera-Nuñez, Angélica</creatorcontrib><creatorcontrib>Santos-Olmos, Rosario Torres</creatorcontrib><creatorcontrib>Vega, Dolores Montero</creatorcontrib><creatorcontrib>García-Rodríguez, Julio</creatorcontrib><creatorcontrib>SARS-CoV-2 working group</creatorcontrib><title>Evaluation of CLINITEST® Rapid Covid-19 + Influenza antigen test in a cohort of symptomatic patients in an emergency department</title><title>European journal of clinical microbiology & infectious diseases</title><addtitle>Eur J Clin Microbiol Infect Dis</addtitle><addtitle>Eur J Clin Microbiol Infect Dis</addtitle><description>Objectives
Rapid management of patients with respiratory tract infections in hospital emergency departments is one of the main objectives since the concurrent circulation of respiratory viruses following the SARS-CoV-2 pandemic. The use of new combined point-of-care antigen tests for detecting influenza A/B and SARS-CoV-2 represents an advantage in response time over the molecular tests. The objective was to evaluate the suitability of the CLINITEST® Rapid Covid-19 + Influenza Antigen test (Siemens Healthineers, Germany) (RCIA test) by measuring the sensitivity, specificity, Cohen’s kappa, and cut-off values.
Methods
Nasopharyngeal samples were collected from a randomised group of symptomatic patients of all ages at emergency department during January–February 2023. In parallel, these patients were screened for influenza A/B, and SARS-CoV-2 using RT-PCR. The Ct (cycle threshold) values were collected for positive [RT-PCR (+) /RCIA test (+)] and false negative [(RT-PCR (+) /RCIA test (-)] samples. A subanalysis was performed in the paediatric population (< 16 years-old).
Results
We included 545 patients (55.8% females) with a median age of 7 years-old (IQR: 1–66.5). The RCIA test showed a sensitivity of 59.7% [95%CI: 46.9–67.33] for influenza A, 65.6% [95%CI: 49.5–80.3] for influenza B, and 76.9% [95%CI: 45.8–84.8] for SARS-CoV-2. The specificity was between 90.7%-99.7% with a moderate/high level of agreement with RT-PCR (kappa score: 0.6–0.8) for the three respiratory viruses included in the RCIA test.
Conclusions
The sensitivity of the RCIA test is insufficient for screening of patients, including patients with low Ct values (Ct > 20). Despite its good specificity and Cohen’s kappa value, its use as a screening test is not comparable to RT-PCR systems in the ED environment with a high number of false negative results.</description><subject>Antigens</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>COVID-19</subject><subject>Emergency medical care</subject><subject>Emergency medical services</subject><subject>Influenza</subject><subject>Influenza A</subject><subject>Influenza B</subject><subject>Internal Medicine</subject><subject>Medical Microbiology</subject><subject>Original Article</subject><subject>Pandemics</subject><subject>Patients</subject><subject>Pediatrics</subject><subject>Polymerase chain reaction</subject><subject>Public health</subject><subject>Respiratory tract</subject><subject>Respiratory tract infection</subject><subject>Sensitivity</subject><subject>Sensitivity analysis</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Viral diseases</subject><issn>0934-9723</issn><issn>1435-4373</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><recordid>eNp9UUGO1DAQtBCIHQY-wAFZ4oKEDLbbcZIjGg3sSCOQYDhbnsRZskrsYDu7Gk4cuPAZHrFP4SX07iwgceDQ7UNXlbu6CHks-AvBefkyYa8141IxrsqqYpd3yEIoKJiCEu6SBa9BsbqUcEIepHTOkVSV5X1yApWSQmm9IN_WF3aYbe6Dp6Gjq-3m7Wa3_rC7-kHf26lv6Spc9C0T9c-v359jbXw3zM5_sdT63J85T7NLmfaeWtqETyHma5l0GKccRpRt6ITd-ZxuMJ660UWkNQfausnGPOLsIbnX2SG5R7fvknx8vd6tTtn23ZvN6tWWNSB1ZntX11gF2mr4HkC4infKyVY4AbbFa6AtjVDQVVVI2fICPWpXC2l1BXtYkmdH3SmGzzPubcY-NW4YrHdhTkbWAEoLwOstydN_oOdhjh63M8CLstC6VBxR8ohqYkgpus5MsR9tPBjBzXVG5piRwYzMTUbmEklPbqXn_ejaP5TfoSAAjoCEI3_m4t-__yP7C5q2nis</recordid><startdate>20240501</startdate><enddate>20240501</enddate><creator>Maldonado-Barrueco, Alfredo</creator><creator>Gutiérrez-Arroyo, Almudena</creator><creator>Bloise, Iván</creator><creator>de Ceano-Vivas, María</creator><creator>Rivera-Nuñez, Angélica</creator><creator>Santos-Olmos, Rosario Torres</creator><creator>Vega, Dolores Montero</creator><creator>García-Rodríguez, Julio</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-1856-1725</orcidid></search><sort><creationdate>20240501</creationdate><title>Evaluation of CLINITEST® Rapid Covid-19 + Influenza antigen test in a cohort of symptomatic patients in an emergency department</title><author>Maldonado-Barrueco, Alfredo ; Gutiérrez-Arroyo, Almudena ; Bloise, Iván ; de Ceano-Vivas, María ; Rivera-Nuñez, Angélica ; Santos-Olmos, Rosario Torres ; Vega, Dolores Montero ; García-Rodríguez, Julio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c326t-be99be95093c0b331e80f4e2d1e13ad10084263263688522d054666e912a683b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Antigens</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>COVID-19</topic><topic>Emergency medical care</topic><topic>Emergency medical services</topic><topic>Influenza</topic><topic>Influenza A</topic><topic>Influenza B</topic><topic>Internal Medicine</topic><topic>Medical Microbiology</topic><topic>Original Article</topic><topic>Pandemics</topic><topic>Patients</topic><topic>Pediatrics</topic><topic>Polymerase chain reaction</topic><topic>Public health</topic><topic>Respiratory tract</topic><topic>Respiratory tract infection</topic><topic>Sensitivity</topic><topic>Sensitivity analysis</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><topic>Viral diseases</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Maldonado-Barrueco, Alfredo</creatorcontrib><creatorcontrib>Gutiérrez-Arroyo, Almudena</creatorcontrib><creatorcontrib>Bloise, Iván</creatorcontrib><creatorcontrib>de Ceano-Vivas, María</creatorcontrib><creatorcontrib>Rivera-Nuñez, Angélica</creatorcontrib><creatorcontrib>Santos-Olmos, Rosario Torres</creatorcontrib><creatorcontrib>Vega, Dolores Montero</creatorcontrib><creatorcontrib>García-Rodríguez, Julio</creatorcontrib><creatorcontrib>SARS-CoV-2 working group</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of clinical microbiology & infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Maldonado-Barrueco, Alfredo</au><au>Gutiérrez-Arroyo, Almudena</au><au>Bloise, Iván</au><au>de Ceano-Vivas, María</au><au>Rivera-Nuñez, Angélica</au><au>Santos-Olmos, Rosario Torres</au><au>Vega, Dolores Montero</au><au>García-Rodríguez, Julio</au><aucorp>SARS-CoV-2 working group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of CLINITEST® Rapid Covid-19 + Influenza antigen test in a cohort of symptomatic patients in an emergency department</atitle><jtitle>European journal of clinical microbiology & infectious diseases</jtitle><stitle>Eur J Clin Microbiol Infect Dis</stitle><addtitle>Eur J Clin Microbiol Infect Dis</addtitle><date>2024-05-01</date><risdate>2024</risdate><volume>43</volume><issue>5</issue><spage>853</spage><epage>861</epage><pages>853-861</pages><issn>0934-9723</issn><eissn>1435-4373</eissn><abstract>Objectives
Rapid management of patients with respiratory tract infections in hospital emergency departments is one of the main objectives since the concurrent circulation of respiratory viruses following the SARS-CoV-2 pandemic. The use of new combined point-of-care antigen tests for detecting influenza A/B and SARS-CoV-2 represents an advantage in response time over the molecular tests. The objective was to evaluate the suitability of the CLINITEST® Rapid Covid-19 + Influenza Antigen test (Siemens Healthineers, Germany) (RCIA test) by measuring the sensitivity, specificity, Cohen’s kappa, and cut-off values.
Methods
Nasopharyngeal samples were collected from a randomised group of symptomatic patients of all ages at emergency department during January–February 2023. In parallel, these patients were screened for influenza A/B, and SARS-CoV-2 using RT-PCR. The Ct (cycle threshold) values were collected for positive [RT-PCR (+) /RCIA test (+)] and false negative [(RT-PCR (+) /RCIA test (-)] samples. A subanalysis was performed in the paediatric population (< 16 years-old).
Results
We included 545 patients (55.8% females) with a median age of 7 years-old (IQR: 1–66.5). The RCIA test showed a sensitivity of 59.7% [95%CI: 46.9–67.33] for influenza A, 65.6% [95%CI: 49.5–80.3] for influenza B, and 76.9% [95%CI: 45.8–84.8] for SARS-CoV-2. The specificity was between 90.7%-99.7% with a moderate/high level of agreement with RT-PCR (kappa score: 0.6–0.8) for the three respiratory viruses included in the RCIA test.
Conclusions
The sensitivity of the RCIA test is insufficient for screening of patients, including patients with low Ct values (Ct > 20). Despite its good specificity and Cohen’s kappa value, its use as a screening test is not comparable to RT-PCR systems in the ED environment with a high number of false negative results.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>38421466</pmid><doi>10.1007/s10096-024-04788-w</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-1856-1725</orcidid></addata></record> |
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subjects | Antigens Biomedical and Life Sciences Biomedicine COVID-19 Emergency medical care Emergency medical services Influenza Influenza A Influenza B Internal Medicine Medical Microbiology Original Article Pandemics Patients Pediatrics Polymerase chain reaction Public health Respiratory tract Respiratory tract infection Sensitivity Sensitivity analysis Severe acute respiratory syndrome coronavirus 2 Viral diseases |
title | Evaluation of CLINITEST® Rapid Covid-19 + Influenza antigen test in a cohort of symptomatic patients in an emergency department |
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