{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,6,13]],"date-time":"2025-06-13T23:25:16Z","timestamp":1749857116953,"version":"3.40.5"},"reference-count":18,"publisher":"Public Library of Science (PLoS)","issue":"1","license":[{"start":{"date-parts":[[2022,1,13]],"date-time":"2022-01-13T00:00:00Z","timestamp":1642032000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:sec id=\"sec001\">\n<jats:title>Objectives<\/jats:title>\n<jats:p>The aim of this study was to evaluate the clinical performance of the Fluorecare SARS-CoV-2 Spike Protein Test Kit, a rapid immunochromatographic assay for SARS-CoV-2 detection. Moreover, we sought to point out the strategy adopted by a local company to lift the lockdown without leading to an increase in the number of COVID-19 cases, by performing a precise and timely health surveillance.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec002\">\n<jats:title>Methods<\/jats:title>\n<jats:p>The rapid Fluorecare SARS-CoV-2 Spike Protein Test was performed immediately after sampling following the manufacturer\u2019s instructions. RT-PCRs were performed within 24 hours of specimen collection. A total amount of 253 nasopharyngeal samples from 121 individuals were collected between March 16 and April 2, 2021 and tested.<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec003\">\n<jats:title>Results<\/jats:title>\n<jats:p>Of 253 nasopharyngeal samples, 11 (9.1%) were positive and 242 (90.9%) were negative for SARS-CoV-2 RNA by RT-PCR assays. The rapid SARS-CoV-2 antigen detection test\u2019s mean sensitivity and specificity were 84,6% (95% CI, 54.6\u201398.1%) and 100% (95% CI, 98.6\u2013100%), respectively. Two false negative test results were obtained from samples with high RT-PCR cycle threshold (Ct).<\/jats:p>\n<\/jats:sec>\n<jats:sec id=\"sec004\">\n<jats:title>Conclusion<\/jats:title>\n<jats:p>Our study suggested that Fluorecare SARS-CoV-2 Spike Protein Test can be introduced into daily diagnostic practice, as its mean sensitivity and specificity follow the standards recommended by WHO and IFCC Task Force. In addition, we underlined how the strategy adopted by a local company to risk assessment and health surveillance was appropriate for infection containment. This real-life scenario gave us the possibility to experience potential approaches aimed to preserve public health and work activities.<\/jats:p>\n<\/jats:sec>","DOI":"10.1371\/journal.pone.0262174","type":"journal-article","created":{"date-parts":[[2022,1,13]],"date-time":"2022-01-13T18:52:29Z","timestamp":1642099949000},"page":"e0262174","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":4,"title":["Efficacy of Fluorecare SARS-CoV-2 Spike Protein Test Kit for SARS-CoV-2 detection in nasopharyngeal samples of 121 individuals working in a manufacturing company"],"prefix":"10.1371","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7441-2700","authenticated-orcid":true,"given":"Valentina","family":"Tonelotto","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annamaria","family":"Davini","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Cardarelli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Milena","family":"Calderone","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paola","family":"Marin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2022,1,13]]},"reference":[{"key":"pone.0262174.ref001","doi-asserted-by":"crossref","first-page":"105067","DOI":"10.1016\/j.ssci.2020.105067","article-title":"Strategies to exiting the COVID-19 lockdown for workplace and school: A scoping review.","volume":"134","author":"D D\u2019angelo","year":"2011","journal-title":"Saf Sci"},{"key":"pone.0262174.ref002","doi-asserted-by":"crossref","first-page":"e0248874","DOI":"10.1371\/journal.pone.0248874","article-title":"Risk assessment at work and prevention strategies on COVID-19 in Italy.","volume":"16","author":"S Iavicoli","year":"2021","journal-title":"PLoS One"},{"key":"pone.0262174.ref003","first-page":"184","article-title":"Coronavirus Disease 2019 (COVID-19) in adolescents: An update on current clinical and diagnostic characteristics","volume":"91","author":"V De Sanctis","year":"2020","journal-title":"Acta Biomed"},{"key":"pone.0262174.ref004","doi-asserted-by":"crossref","first-page":"565","DOI":"10.1016\/S0140-6736(20)30251-8","article-title":"Genomic characterisation and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding","volume":"395","author":"R Lu","year":"2020","journal-title":"Lancet"},{"key":"pone.0262174.ref005","doi-asserted-by":"crossref","first-page":"104381","DOI":"10.1016\/j.jcv.2020.104381","article-title":"Ad hoc laboratory-based surveillance of SARS-CoV-2 by real-time RT-PCR using minipools of RNA prepared from routine respiratory samples","volume":"127","author":"AM Eis-H\u00fcbinger","year":"2020","journal-title":"J Clin Virol"},{"key":"pone.0262174.ref006","doi-asserted-by":"crossref","first-page":"901","DOI":"10.1016\/j.jiph.2020.06.005","article-title":"Rajkumar. 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Fast","year":"2020","journal-title":"Nat Biotechnol"},{"journal-title":"Antigen-detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays Interim guidance","year":"2020","author":"World Health Organization","key":"pone.0262174.ref010"},{"key":"pone.0262174.ref011","doi-asserted-by":"crossref","first-page":"1507","DOI":"10.1515\/cclm-2021-0455","article-title":"IFCC interim guidelines on rapid point-of-care antigen testing for SARS-CoV-2 detection in asymptomatic and symptomatic individuals","volume":"59","author":"MK Bohn","year":"2021","journal-title":"Clin Chem Lab Med"},{"key":"pone.0262174.ref012","doi-asserted-by":"crossref","first-page":"905","DOI":"10.3390\/diagnostics10110905","article-title":"Development of diagnostic tests for detection of SARS-CoV-2","volume":"10","author":"NNT Nguyen","year":"2020","journal-title":"Diagnostics (Basel)."},{"key":"pone.0262174.ref013","doi-asserted-by":"crossref","first-page":"e02589","DOI":"10.1128\/JCM.02589-20","article-title":"Evaluation of the Panbio COVID-19 Rapid Antigen Detection Test Device for the Screening of Patients with COVID-19","volume":"59","author":"F Fenollar","year":"2021","journal-title":"J Clin Microbiol"},{"key":"pone.0262174.ref014","unstructured":"FIND SARS-CoV-2 Diagnostic Pipeline. 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