{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,27]],"date-time":"2025-11-27T15:56:59Z","timestamp":1764259019344,"version":"build-2065373602"},"reference-count":29,"publisher":"MDPI AG","issue":"1","license":[{"start":{"date-parts":[[2023,12,26]],"date-time":"2023-12-26T00:00:00Z","timestamp":1703548800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Viruses"],"abstract":"<jats:p>To carry out effective and quick identification of SARS-CoV-2 from nasopharyngeal swabs and contain outbreaks, reliable and rapid tools are needed. Herein, we compared a rapid antigen test based on active microfluidic technology to an RT-qPCR assay in pediatric and young adult patients admitted to the Pediatric Emergency Unit of a Children\u2019s Hospital. Nasopharyngeal swabs collected from patients with suspected COVID-19 disease and from those without COVID-19 related symptoms, but requiring hospitalization, were performed with both antigen test and RT-qPCR assays. We included 375 patients with a median age of 5 years in the study, with an estimated overall prevalence of 7.2%. Overall, we observed a specificity of 97.4% (95% CI: 94.9\u201398.7) and a sensitivity of 66.6% (95% CI: 46.0\u201382.7) with a positive likelihood ratio (LR+) of 25.8 (95% CI: 12.8\u201351.8). In the subgroup of symptomatic patients, the specificity and the sensitivity were 95.2% (95% CI: 89.4\u201398.0) and 80.0% (95% CI: 44.2\u201396.5) respectively; LR+ was 16.6 (95% CI: 7.19\u201338.6). In the asymptomatic subset, the performance showed a specificity of 98.7% (95% CI: 95.8\u201399.7), a sensitivity of 58.8% (95% CI: 33.5\u201380.6), and an LR+ of 43.7 (95% CI: 13.3\u2013144.0). Compared to RT-qPCR, the new microfluidic-based antigen test showed higher specificity (&gt;95%) in the pediatric population, thus representing a suitable point-of-care testing (POCT) in a clinical setting with low prevalence of COVID-19.<\/jats:p>","DOI":"10.3390\/v16010041","type":"journal-article","created":{"date-parts":[[2023,12,27]],"date-time":"2023-12-27T05:43:15Z","timestamp":1703655795000},"page":"41","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Application of a SARS-CoV-2 Antigen Rapid Immunoassay Based on Active Microfluidic Technology in a Setting of Children and Young Adults"],"prefix":"10.3390","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8689-7028","authenticated-orcid":false,"given":"Christian","family":"Leli","sequence":"first","affiliation":[{"name":"Microbiology and Virology Laboratory, A.O. \u201cSS. Antonio e Biagio e C. Arrigo\u201d, Via Venezia 16, 15121 Alessandria, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0029-5673","authenticated-orcid":false,"given":"Lidia","family":"Ferrara","sequence":"additional","affiliation":[{"name":"Microbiology and Virology Laboratory, A.O. \u201cSS. Antonio e Biagio e C. Arrigo\u201d, Via Venezia 16, 15121 Alessandria, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6337-5729","authenticated-orcid":false,"given":"Paolo","family":"Bottino","sequence":"additional","affiliation":[{"name":"Microbiology and Virology Laboratory, A.O. \u201cSS. Antonio e Biagio e C. Arrigo\u201d, Via Venezia 16, 15121 Alessandria, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina","family":"Bara","sequence":"additional","affiliation":[{"name":"Microbiology and Virology Laboratory, A.O. \u201cSS. Antonio e Biagio e C. Arrigo\u201d, Via Venezia 16, 15121 Alessandria, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9508-3037","authenticated-orcid":false,"given":"Iacopo","family":"Megna","sequence":"additional","affiliation":[{"name":"Research and Innovation Department (DAIRI), A.O. \u201cSS. Antonio e Biagio e C. Arrigo\u201d, Via Venezia 16, 15121 Alessandria, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Serena","family":"Penpa","sequence":"additional","affiliation":[{"name":"Research and Innovation Department (DAIRI), A.O. \u201cSS. Antonio e Biagio e C. Arrigo\u201d, Via Venezia 16, 15121 Alessandria, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Enrico","family":"Felici","sequence":"additional","affiliation":[{"name":"Pediatric and Pediatric Emergency Unit, A.O. \u201cSS. Antonio e Biagio e C. Arrigo\u201d, Via Venezia 16, 15121 Alessandria, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1904-7277","authenticated-orcid":false,"given":"Antonio","family":"Maconi","sequence":"additional","affiliation":[{"name":"Research and Innovation Department (DAIRI), A.O. \u201cSS. Antonio e Biagio e C. Arrigo\u201d, Via Venezia 16, 15121 Alessandria, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Rocchetti","sequence":"additional","affiliation":[{"name":"Microbiology and Virology Laboratory, A.O. \u201cSS. Antonio e Biagio e C. Arrigo\u201d, Via Venezia 16, 15121 Alessandria, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2023,12,26]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"270","DOI":"10.1038\/s41586-020-2012-7","article-title":"A pneumonia outbreak associated with a new coronavirus of probable bat origin","volume":"579","author":"Zhou","year":"2020","journal-title":"Nature"},{"doi-asserted-by":"crossref","unstructured":"Coronaviridae Study Group of the International Committee on Taxonomy of Viruses (2020). The species severe acute respiratory syndrome-related coronavirus: Classifying 2019-nCoV and naming it SARS-CoV-2. Nat. Microbiol., 5, 536\u2013544.","key":"ref_2","DOI":"10.1038\/s41564-020-0695-z"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1718","DOI":"10.1007\/s00284-021-02413-z","article-title":"Ongoing COVID-19 Pandemic: A Concise but Updated Comprehensive Review","volume":"78","author":"Wang","year":"2021","journal-title":"Curr. Microbiol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"726","DOI":"10.7326\/M20-1301","article-title":"Diagnostic Testing for Severe Acute Respiratory Syndrome-Related Coronavirus 2: A Narrative Review","volume":"172","author":"Cheng","year":"2020","journal-title":"Ann. Intern. Med."},{"doi-asserted-by":"crossref","unstructured":"Berger, A., Nsoga, M.T.N., Perez-Rodriguez, F.J., Aad, Y.A., Sattonnet-Roche, P., Gayet-Ageron, A., Jaksic, C., Torriani, G., Boehm, E., and Kronig, I. (2021). Diagnostic accuracy of two commercial SARS-CoV-2 antigen-detecting rapid tests at the point of care in community-based testing centers. PLoS ONE, 16.","key":"ref_5","DOI":"10.1371\/journal.pone.0248921"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"201","DOI":"10.1016\/j.ijid.2021.04.087","article-title":"Performance of SARS-CoV-2 rapid antigen test compared with real-time RT-QPCR in asymptomatic individuals","volume":"107","author":"Ampuero","year":"2021","journal-title":"Int. J. Infect. Dis."},{"doi-asserted-by":"crossref","unstructured":"Jamiruddin, M.R., Meghla, B.A., Islam, D.Z., Tisha, T.A., Khandker, S.S., Khondoker, M.U., Haq, M.A., Adnan, N., and Haque, M. (2022). Microfluidics Technology in SARS-CoV-2 Diagnosis and Beyond: A Systematic Review. Life, 12.","key":"ref_7","DOI":"10.3390\/life12050649"},{"doi-asserted-by":"crossref","unstructured":"Khalid, M.F., Selvam, K., Jeffry, A.J.N., Salmi, M.F., Najib, M.A., Norhayati, M.N., and Aziah, I. (2022). Performance of Rapid Antigen Tests for COVID-19 Diagnosis: A Systematic Review and Meta-Analysis. Diagnostics, 12.","key":"ref_8","DOI":"10.3390\/diagnostics12010110"},{"doi-asserted-by":"crossref","unstructured":"Bottino, P., Pizzo, V., Castaldo, S., Scomparin, E., Bara, C., Cerrato, M., Sisinni, S., Penpa, S., Roveta, A., and Gerbino, M. (2023). Clinical Evaluation and Comparison of Two Microfluidic Antigenic Assays for Detection of SARS-CoV-2 Virus. Microorganisms, 11.","key":"ref_9","DOI":"10.3390\/microorganisms11112709"},{"doi-asserted-by":"crossref","unstructured":"Yin, B., Wan, X., Sohan, A.S.M.M.F., and Lin, X. (2022). Microfluidics-Based POCT for SARS-CoV-2 Diagnostics. Micromachines, 13.","key":"ref_10","DOI":"10.3390\/mi13081238"},{"doi-asserted-by":"crossref","unstructured":"Li, Q., Zhou, X., Wang, Q., Liu, W., and Chen, C. (2023). Microfluidics for COVID-19: From Current Work to Future Perspective. Biosensors, 13.","key":"ref_11","DOI":"10.3390\/bios13020163"},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"385","DOI":"10.1097\/INF.0000000000003101","article-title":"Think of the Children: Evaluation of SARS-CoV-2 Rapid Antigen Test in Pediatric Population","volume":"40","author":"Bloise","year":"2021","journal-title":"Pediatr. Infect. Dis. J."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"e2021050832","DOI":"10.1542\/peds.2021-050832","article-title":"Performance of a Rapid SARS-CoV-2 Antigen Detection Assay in Symptomatic Children","volume":"148","author":"Shaikh","year":"2021","journal-title":"Pediatrics"},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"287","DOI":"10.1016\/j.jpeds.2021.01.027","article-title":"Diagnostic Accuracy of the Panbio Severe Acute Respiratory Syndrome Coronavirus 2 Antigen Rapid Test Compared with Reverse-Transcriptase Polymerase Chain Reaction Testing of Nasopharyngeal Samples in the Pediatric Population","volume":"232","author":"Villaverde","year":"2021","journal-title":"J. Pediatr."},{"doi-asserted-by":"crossref","unstructured":"Mboma, O., Rieke, E., Ahmad-Nejad, P., Wirth, S., and Aydin, M. (2021). Diagnostic Performance of SARS-CoV-2 Rapid Antigen Test in a Large, German Cohort. Children, 8.","key":"ref_15","DOI":"10.3390\/children8080682"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"599","DOI":"10.1111\/irv.12768","article-title":"Identification and management of asymptomatic carriers of coronavirus disease 2019 (COVID-19) in China","volume":"14","author":"Peng","year":"2020","journal-title":"Influenza Respir. Viruses"},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"104357","DOI":"10.1016\/j.jcv.2020.104357","article-title":"Epidemiology and clinical features of COVID-19: A review of current literature","volume":"127","author":"Siordia","year":"2020","journal-title":"J. Clin. Virol."},{"unstructured":"(2022, August 04). Alinity m SARS-CoV-2 Assay. Available online: https:\/\/www.molecular.abbott\/int\/en\/alinity-m-sars-cov-2-assay.","key":"ref_18"},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"135","DOI":"10.1016\/j.ijid.2021.07.043","article-title":"Performance of a SARS-CoV-2 antigen rapid immunoassay in patients admitted to the emergency department","volume":"110","author":"Leli","year":"2021","journal-title":"Int. J. Infect. Dis."},{"unstructured":"(2022, August 04). LumiraDx SARS-CoV-2 Antigen (Ag) Test: Superior Analytical Sensitivity Compared to Several Lateral Flow Tests. Available online: https:\/\/www.lumiradx.com\/assets\/pdfs\/white-papers\/sars-cov-2-ag-test-superior-analytical-sensitivity.pdf?v=1.","key":"ref_20"},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"18","DOI":"10.4103\/0019-5154.198047","article-title":"Biostatistics Series Module 7: The Statistics of Diagnostic Tests","volume":"62","author":"Hazra","year":"2017","journal-title":"Indian. J. Dermatol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"e00683","DOI":"10.1128\/Spectrum.00683-21","article-title":"Generation of false-positive SARS-CoV-2 antigen results with testing conditions outside manufacturer recommendations: A scientific approach to pandemic misinformation","volume":"9","author":"Patriquin","year":"2021","journal-title":"Microbiol. Spectr."},{"unstructured":"(2023, December 20). SARS-CoV-2 ag Test Strip Product Insert. Available online: https:\/\/www.lumiradx.com\/assets\/pdfs\/covid-19-antigen-test\/sars-cov-2-antigen-product-insert\/sars-cov-2-ag-test-strip-product-insert-en-fr-de-it-es-nl.pdf.","key":"ref_23"},{"doi-asserted-by":"crossref","unstructured":"Lau, C.S., and Aw, T.C. (2021). Disease Prevalence Matters: Challenge for SARS-CoV-2 Testing. Antibodies, 10.","key":"ref_24","DOI":"10.3390\/antib10040050"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"104455","DOI":"10.1016\/j.jcv.2020.104455","article-title":"Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis","volume":"129","author":"Scohy","year":"2020","journal-title":"J. Clin. Virol."},{"key":"ref_26","first-page":"e00977","article-title":"Evaluation of a Rapid Diagnostic Assay for Detection of SARS-CoV-2 Antigen in Nasopharyngeal Swabs","volume":"58","author":"Cuffel","year":"2020","journal-title":"J. Clin. Microbiol."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"247","DOI":"10.1016\/j.pedneo.2022.07.012","article-title":"Diagnostic accuracy of SARS-CoV-2 antigen test in the pediatric population: A systematic review and meta-analysis","volume":"64","author":"Chen","year":"2023","journal-title":"Pediatr. Neonatol."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"602","DOI":"10.1093\/ajcp\/aqab173","article-title":"Performance of the LumiraDx Microfluidic Immunofluorescence Point-of-Care SARS-CoV-2 Antigen Test in Asymptomatic Adults and Children","volume":"157","author":"Drain","year":"2022","journal-title":"Am. J. Clin. Pathol."},{"unstructured":"(2022, August 04). COVID-19 Integrated Surveillance Data in Italy. Available online: https:\/\/www.epicentro.iss.it\/coronavirus\/pdf\/sars-cov-2-monitoraggio-varianti-indagini-rapide-24-agosto-2021.pdf.","key":"ref_29"}],"container-title":["Viruses"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1999-4915\/16\/1\/41\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T21:42:19Z","timestamp":1760132539000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1999-4915\/16\/1\/41"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12,26]]},"references-count":29,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,1]]}},"alternative-id":["v16010041"],"URL":"https:\/\/doi.org\/10.3390\/v16010041","relation":{},"ISSN":["1999-4915"],"issn-type":[{"type":"electronic","value":"1999-4915"}],"subject":[],"published":{"date-parts":[[2023,12,26]]}}}