Diagnostic accuracy of a SARS-CoV-2 rapid antigen test among military and civilian personnel of an Air Force airport in central Italy
Most SARS-CoV-2 rapid antigen detection tests (RADTs) validation studies have been performed on specimens from COVID-19 patients and negative controls or from mostly symptomatic individuals. Herein we evaluated the diagnostic accuracy of AFIAS COVID-19 Ag, hereinafter denominated as AFIAS, during a...
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| Veröffentlicht in: | PloS one 2022-11, Vol.17 (11), p.e0277904-e0277904 |
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| creator | Verde, Paola Marcantonio, Cinzia Costantino, Angela Martina, Antonio Simeoni, Matteo Taffon, Stefania Tritarelli, Elena Campanella, Carmelo Cresta, Raffaele Bruni, Roberto Ciccaglione, Anna Rita Pisani, Giulio Nisini, Roberto Spada, Enea |
| description | Most SARS-CoV-2 rapid antigen detection tests (RADTs) validation studies have been performed on specimens from COVID-19 patients and negative controls or from mostly symptomatic individuals. Herein we evaluated the diagnostic accuracy of AFIAS COVID-19 Ag, hereinafter denominated as AFIAS, during a COVID-19 screening program surveillance testing conducted among personnel of an Italian military airport.
Nasopharyngeal swabs (NPSs) were collected from study participants and were analysed by both AFIAS and RT-PCR assay. A questionnaire collecting demographic and exposure data were administered to all participants. AFIAS accuracy parameters including Cohen's kappa (K) were determined.
Overall, from November 2020 to April 2021, 1294 (NPSs) were collected from 1183 participants (88.6% males, 11.4% females; mean age were 41.3, median age 42). Forty-nine NPSs (3.78%) were positive by RT-PCR, while 54 NPSs were positive by AFIAS. Overall baseline sensitivity, specificity, positive and negative predictive values were 0.633, 0.981, 0.574, 0.985, respectively and K was 0.585 (moderate). AFIAS sensitivity tended to be higher for NPSs with higher viral load. A higher sensitivity (0.944) compared to the overall baseline sensitivity (0.633) was also found for NPSs from participants with COVID-19 compatible symptoms, for which K was 0.891 (almost perfect). Instead, AFIAS sensitivity was quite poor for NPSs from asymptomatic participants. Most false negative NPSs in this group had moderate viral load.
Overall, AFIAS showed high specificity but only moderate sensitivity, mainly because of the high proportion of asymptomatic participants. However, AFIAS showed good sensitivity for NPSs with high viral load and nearly optimal accuracy parameters for NPSs from participants with COVID-19 compatible symptoms. Thus, taking into consideration its performance features, this test can be useful for COVID-19 case identification and management as well as for infection control. |
| doi_str_mv | 10.1371/journal.pone.0277904 |
| format | Article |
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Nasopharyngeal swabs (NPSs) were collected from study participants and were analysed by both AFIAS and RT-PCR assay. A questionnaire collecting demographic and exposure data were administered to all participants. AFIAS accuracy parameters including Cohen's kappa (K) were determined.
Overall, from November 2020 to April 2021, 1294 (NPSs) were collected from 1183 participants (88.6% males, 11.4% females; mean age were 41.3, median age 42). Forty-nine NPSs (3.78%) were positive by RT-PCR, while 54 NPSs were positive by AFIAS. Overall baseline sensitivity, specificity, positive and negative predictive values were 0.633, 0.981, 0.574, 0.985, respectively and K was 0.585 (moderate). AFIAS sensitivity tended to be higher for NPSs with higher viral load. A higher sensitivity (0.944) compared to the overall baseline sensitivity (0.633) was also found for NPSs from participants with COVID-19 compatible symptoms, for which K was 0.891 (almost perfect). Instead, AFIAS sensitivity was quite poor for NPSs from asymptomatic participants. Most false negative NPSs in this group had moderate viral load.
Overall, AFIAS showed high specificity but only moderate sensitivity, mainly because of the high proportion of asymptomatic participants. However, AFIAS showed good sensitivity for NPSs with high viral load and nearly optimal accuracy parameters for NPSs from participants with COVID-19 compatible symptoms. Thus, taking into consideration its performance features, this test can be useful for COVID-19 case identification and management as well as for infection control.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0277904</identifier><identifier>PMID: 36441672</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Accuracy ; Adult ; Air bases ; Air forces ; Airports ; Analysis ; Antibodies ; Antigens ; Biology and Life Sciences ; Collaboration ; Coronaviruses ; COVID-19 ; COVID-19 - diagnosis ; COVID-19 - epidemiology ; Diagnostic systems ; Disease transmission ; Female ; Genes ; Genomes ; Health aspects ; Humans ; Infection control ; Infections ; Italy - epidemiology ; Laboratories ; Male ; Medical diagnosis ; Medical tests ; Medicine and Health Sciences ; Methods ; Military Personnel ; Officials and employees ; Parameters ; Personnel ; Polymerase chain reaction ; Population ; Public health ; Research and Analysis Methods ; Safety and security measures ; SARS-CoV-2 ; Sensitivity ; Severe acute respiratory syndrome coronavirus 2 ; Social Sciences ; Testing ; Viral diseases</subject><ispartof>PloS one, 2022-11, Vol.17 (11), p.e0277904-e0277904</ispartof><rights>Copyright: © 2022 Verde et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.</rights><rights>COPYRIGHT 2022 Public Library of Science</rights><rights>2022 Verde et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2022 Verde et al 2022 Verde et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-ea8c3fbf7a0c3ed93da48c77cccb16173f74f5d5de9d0436d0566775f920a4bb3</citedby><cites>FETCH-LOGICAL-c692t-ea8c3fbf7a0c3ed93da48c77cccb16173f74f5d5de9d0436d0566775f920a4bb3</cites><orcidid>0000-0002-8496-5381</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9704652/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9704652/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,728,781,785,865,886,2103,2929,23871,27929,27930,53796,53798</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36441672$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Ito, Etsuro</contributor><creatorcontrib>Verde, Paola</creatorcontrib><creatorcontrib>Marcantonio, Cinzia</creatorcontrib><creatorcontrib>Costantino, Angela</creatorcontrib><creatorcontrib>Martina, Antonio</creatorcontrib><creatorcontrib>Simeoni, Matteo</creatorcontrib><creatorcontrib>Taffon, Stefania</creatorcontrib><creatorcontrib>Tritarelli, Elena</creatorcontrib><creatorcontrib>Campanella, Carmelo</creatorcontrib><creatorcontrib>Cresta, Raffaele</creatorcontrib><creatorcontrib>Bruni, Roberto</creatorcontrib><creatorcontrib>Ciccaglione, Anna Rita</creatorcontrib><creatorcontrib>Pisani, Giulio</creatorcontrib><creatorcontrib>Nisini, Roberto</creatorcontrib><creatorcontrib>Spada, Enea</creatorcontrib><title>Diagnostic accuracy of a SARS-CoV-2 rapid antigen test among military and civilian personnel of an Air Force airport in central Italy</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Most SARS-CoV-2 rapid antigen detection tests (RADTs) validation studies have been performed on specimens from COVID-19 patients and negative controls or from mostly symptomatic individuals. Herein we evaluated the diagnostic accuracy of AFIAS COVID-19 Ag, hereinafter denominated as AFIAS, during a COVID-19 screening program surveillance testing conducted among personnel of an Italian military airport.
Nasopharyngeal swabs (NPSs) were collected from study participants and were analysed by both AFIAS and RT-PCR assay. A questionnaire collecting demographic and exposure data were administered to all participants. AFIAS accuracy parameters including Cohen's kappa (K) were determined.
Overall, from November 2020 to April 2021, 1294 (NPSs) were collected from 1183 participants (88.6% males, 11.4% females; mean age were 41.3, median age 42). Forty-nine NPSs (3.78%) were positive by RT-PCR, while 54 NPSs were positive by AFIAS. Overall baseline sensitivity, specificity, positive and negative predictive values were 0.633, 0.981, 0.574, 0.985, respectively and K was 0.585 (moderate). AFIAS sensitivity tended to be higher for NPSs with higher viral load. A higher sensitivity (0.944) compared to the overall baseline sensitivity (0.633) was also found for NPSs from participants with COVID-19 compatible symptoms, for which K was 0.891 (almost perfect). Instead, AFIAS sensitivity was quite poor for NPSs from asymptomatic participants. Most false negative NPSs in this group had moderate viral load.
Overall, AFIAS showed high specificity but only moderate sensitivity, mainly because of the high proportion of asymptomatic participants. However, AFIAS showed good sensitivity for NPSs with high viral load and nearly optimal accuracy parameters for NPSs from participants with COVID-19 compatible symptoms. Thus, taking into consideration its performance features, this test can be useful for COVID-19 case identification and management as well as for infection control.</description><subject>Accuracy</subject><subject>Adult</subject><subject>Air bases</subject><subject>Air forces</subject><subject>Airports</subject><subject>Analysis</subject><subject>Antibodies</subject><subject>Antigens</subject><subject>Biology and Life Sciences</subject><subject>Collaboration</subject><subject>Coronaviruses</subject><subject>COVID-19</subject><subject>COVID-19 - diagnosis</subject><subject>COVID-19 - epidemiology</subject><subject>Diagnostic systems</subject><subject>Disease transmission</subject><subject>Female</subject><subject>Genes</subject><subject>Genomes</subject><subject>Health aspects</subject><subject>Humans</subject><subject>Infection control</subject><subject>Infections</subject><subject>Italy - epidemiology</subject><subject>Laboratories</subject><subject>Male</subject><subject>Medical diagnosis</subject><subject>Medical tests</subject><subject>Medicine and Health Sciences</subject><subject>Methods</subject><subject>Military Personnel</subject><subject>Officials and employees</subject><subject>Parameters</subject><subject>Personnel</subject><subject>Polymerase chain reaction</subject><subject>Population</subject><subject>Public health</subject><subject>Research and Analysis Methods</subject><subject>Safety and security measures</subject><subject>SARS-CoV-2</subject><subject>Sensitivity</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Social Sciences</subject><subject>Testing</subject><subject>Viral 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accuracy of a SARS-CoV-2 rapid antigen test among military and civilian personnel of an Air Force airport in central Italy</title><author>Verde, Paola ; Marcantonio, Cinzia ; Costantino, Angela ; Martina, Antonio ; Simeoni, Matteo ; Taffon, Stefania ; Tritarelli, Elena ; Campanella, Carmelo ; Cresta, Raffaele ; Bruni, Roberto ; Ciccaglione, Anna Rita ; Pisani, Giulio ; Nisini, Roberto ; Spada, Enea</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-ea8c3fbf7a0c3ed93da48c77cccb16173f74f5d5de9d0436d0566775f920a4bb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Accuracy</topic><topic>Adult</topic><topic>Air bases</topic><topic>Air forces</topic><topic>Airports</topic><topic>Analysis</topic><topic>Antibodies</topic><topic>Antigens</topic><topic>Biology and Life Sciences</topic><topic>Collaboration</topic><topic>Coronaviruses</topic><topic>COVID-19</topic><topic>COVID-19 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Raffaele</au><au>Bruni, Roberto</au><au>Ciccaglione, Anna Rita</au><au>Pisani, Giulio</au><au>Nisini, Roberto</au><au>Spada, Enea</au><au>Ito, Etsuro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Diagnostic accuracy of a SARS-CoV-2 rapid antigen test among military and civilian personnel of an Air Force airport in central Italy</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2022-11-28</date><risdate>2022</risdate><volume>17</volume><issue>11</issue><spage>e0277904</spage><epage>e0277904</epage><pages>e0277904-e0277904</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Most SARS-CoV-2 rapid antigen detection tests (RADTs) validation studies have been performed on specimens from COVID-19 patients and negative controls or from mostly symptomatic individuals. Herein we evaluated the diagnostic accuracy of AFIAS COVID-19 Ag, hereinafter denominated as AFIAS, during a COVID-19 screening program surveillance testing conducted among personnel of an Italian military airport.
Nasopharyngeal swabs (NPSs) were collected from study participants and were analysed by both AFIAS and RT-PCR assay. A questionnaire collecting demographic and exposure data were administered to all participants. AFIAS accuracy parameters including Cohen's kappa (K) were determined.
Overall, from November 2020 to April 2021, 1294 (NPSs) were collected from 1183 participants (88.6% males, 11.4% females; mean age were 41.3, median age 42). Forty-nine NPSs (3.78%) were positive by RT-PCR, while 54 NPSs were positive by AFIAS. Overall baseline sensitivity, specificity, positive and negative predictive values were 0.633, 0.981, 0.574, 0.985, respectively and K was 0.585 (moderate). AFIAS sensitivity tended to be higher for NPSs with higher viral load. A higher sensitivity (0.944) compared to the overall baseline sensitivity (0.633) was also found for NPSs from participants with COVID-19 compatible symptoms, for which K was 0.891 (almost perfect). Instead, AFIAS sensitivity was quite poor for NPSs from asymptomatic participants. Most false negative NPSs in this group had moderate viral load.
Overall, AFIAS showed high specificity but only moderate sensitivity, mainly because of the high proportion of asymptomatic participants. However, AFIAS showed good sensitivity for NPSs with high viral load and nearly optimal accuracy parameters for NPSs from participants with COVID-19 compatible symptoms. Thus, taking into consideration its performance features, this test can be useful for COVID-19 case identification and management as well as for infection control.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>36441672</pmid><doi>10.1371/journal.pone.0277904</doi><tpages>e0277904</tpages><orcidid>https://orcid.org/0000-0002-8496-5381</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2022-11, Vol.17 (11), p.e0277904-e0277904 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2740840901 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Accuracy Adult Air bases Air forces Airports Analysis Antibodies Antigens Biology and Life Sciences Collaboration Coronaviruses COVID-19 COVID-19 - diagnosis COVID-19 - epidemiology Diagnostic systems Disease transmission Female Genes Genomes Health aspects Humans Infection control Infections Italy - epidemiology Laboratories Male Medical diagnosis Medical tests Medicine and Health Sciences Methods Military Personnel Officials and employees Parameters Personnel Polymerase chain reaction Population Public health Research and Analysis Methods Safety and security measures SARS-CoV-2 Sensitivity Severe acute respiratory syndrome coronavirus 2 Social Sciences Testing Viral diseases |
| title | Diagnostic accuracy of a SARS-CoV-2 rapid antigen test among military and civilian personnel of an Air Force airport in central Italy |
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