{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T21:12:46Z","timestamp":1784754766889,"version":"3.55.0"},"reference-count":21,"publisher":"Walter de Gruyter GmbH","issue":"8","license":[{"start":{"date-parts":[[2021,4,7]],"date-time":"2021-04-07T00:00:00Z","timestamp":1617753600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Reale Group"},{"name":"Fondazione Valentino Garavani & Giancarlo Giammetti"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,7,27]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2021-0182_abs_001_w2aab3b7c97b1b6b1aab1c16b1Aa\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Compared to RT-PCR, lower performance of antigen detection assays, including the Lumipulse G SARS-CoV-2 Ag assay, may depend on specific testing scenarios.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2021-0182_abs_002_w2aab3b7c97b1b6b1aab1c16b2Aa\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We tested 594 nasopharyngeal swab samples from individuals with COVID-19 (RT-PCR cycle threshold [Ct] values\u00a0\u2264\u00a040) or non-COVID-19 (Ct values\u00a0&gt;40) diagnoses. RT-PCR positive samples were assigned to diagnostic, screening, or monitoring groups of testing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2021-0182_abs_003_w2aab3b7c97b1b6b1aab1c16b3Aa\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      With a limit of detection of 1.2\u00a0\u00d7\u00a010\n                      <jats:sup>4<\/jats:sup>\n                      SARS-CoV-2 RNA copies\/mL, Lumipulse showed positive percent agreement (PPA) of 79.9% (155\/194) and negative percent agreement of 99.3% (397\/400), whereas PPAs were 100% for samples with Ct values of &lt;18 or 18\u2013&lt;25 and 92.5% for samples with Ct values of 25\u2013&lt;30. By three groups, Lumipulse showed PPA of 87.0% (60\/69), 81.1% (43\/53), or 72.2% (52\/72), respectively, whereas PPA was 100% for samples with Ct values of &lt;18 or 18\u2013&lt;25, and was 94.4, 80.0, or 100% for samples with Ct values of 25\u2013&lt;30, respectively. Additional testing of RT-PCR positive samples for SARS-CoV-2 subgenomic RNA showed that, by three groups, PPA was 63.8% (44\/69), 62.3% (33\/53), or 33.3% (24\/72), respectively. PPAs dropped to 55.6, 20.0, or 41.7% for samples with Ct values of 25\u2013&lt;30, respectively. All 101 samples with a subgenomic RNA positive result had a Lumipulse assay\u2019s antigen positive result, whereas only 54 (58.1%) of remaining 93 samples had a Lumipulse assay\u2019s antigen positive result.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2021-0182_abs_004_w2aab3b7c97b1b6b1aab1c16b4Aa\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Lumipulse assay was highly sensitive in samples with low RT-PCR Ct values, implying repeated testing to reduce consequences of false-negative results.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2021-0182","type":"journal-article","created":{"date-parts":[[2021,4,7]],"date-time":"2021-04-07T17:30:01Z","timestamp":1617816601000},"page":"1468-1476","source":"Crossref","is-referenced-by-count":20,"title":["Lumipulse G SARS-CoV-2 Ag assay evaluation using clinical samples from different testing groups"],"prefix":"10.1515","volume":"59","author":[{"given":"Giulia","family":"Menchinelli","sequence":"first","affiliation":[{"name":"Dipartimento di Scienze Biotecnologiche di Base, Cliniche Intensivologiche e Perioperatorie , Universit\u00e0 Cattolica del Sacro Cuore , Rome , Italy"},{"name":"Dipartimento di Scienze di Laboratorio e Infettivologiche , Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Licia","family":"Bordi","sequence":"additional","affiliation":[{"name":"Istituto Nazionale per le Malattie Infettive (INMI) Lazzaro Spallanzani IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Flora Marzia","family":"Liotti","sequence":"additional","affiliation":[{"name":"Dipartimento di Scienze Biotecnologiche di Base, Cliniche Intensivologiche e Perioperatorie , Universit\u00e0 Cattolica del Sacro Cuore , Rome , Italy"},{"name":"Dipartimento di Scienze di Laboratorio e Infettivologiche , Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivana","family":"Palucci","sequence":"additional","affiliation":[{"name":"Dipartimento di Scienze Biotecnologiche di Base, Cliniche Intensivologiche e Perioperatorie , Universit\u00e0 Cattolica del Sacro Cuore , Rome , Italy"},{"name":"Dipartimento di Scienze di Laboratorio e Infettivologiche , Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Rosaria","family":"Capobianchi","sequence":"additional","affiliation":[{"name":"Istituto Nazionale per le Malattie Infettive (INMI) Lazzaro Spallanzani IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Sberna","sequence":"additional","affiliation":[{"name":"Istituto Nazionale per le Malattie Infettive (INMI) Lazzaro Spallanzani IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleonora","family":"Lalle","sequence":"additional","affiliation":[{"name":"Istituto Nazionale per le Malattie Infettive (INMI) Lazzaro Spallanzani IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucio","family":"Romano","sequence":"additional","affiliation":[{"name":"Dipartimento di Scienze di Laboratorio e Infettivologiche , Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia","family":"De Angelis","sequence":"additional","affiliation":[{"name":"Dipartimento di Scienze Biotecnologiche di Base, Cliniche Intensivologiche e Perioperatorie , Universit\u00e0 Cattolica del Sacro Cuore , Rome , Italy"},{"name":"Dipartimento di Scienze di Laboratorio e Infettivologiche , Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simona","family":"Marchetti","sequence":"additional","affiliation":[{"name":"Dipartimento di Scienze di Laboratorio e Infettivologiche , Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurizio","family":"Sanguinetti","sequence":"additional","affiliation":[{"name":"Dipartimento di Scienze Biotecnologiche di Base, Cliniche Intensivologiche e Perioperatorie , Universit\u00e0 Cattolica del Sacro Cuore , Rome , Italy"},{"name":"Dipartimento di Scienze di Laboratorio e Infettivologiche , Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paola","family":"Cattani","sequence":"additional","affiliation":[{"name":"Dipartimento di Scienze Biotecnologiche di Base, Cliniche Intensivologiche e Perioperatorie , Universit\u00e0 Cattolica del Sacro Cuore , Rome , Italy"},{"name":"Dipartimento di Scienze di Laboratorio e Infettivologiche , Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brunella","family":"Posteraro","sequence":"additional","affiliation":[{"name":"Dipartimento di Scienze Biotecnologiche di Base, Cliniche Intensivologiche e Perioperatorie , Universit\u00e0 Cattolica del Sacro Cuore , Rome , Italy"},{"name":"Dipartimento di Scienze Mediche e Chirurgiche , Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2021,4,7]]},"reference":[{"key":"2023033110551323072_j_cclm-2021-0182_ref_001_w2aab3b7c97b1b6b1ab2b1b1Aa","doi-asserted-by":"crossref","unstructured":"Brooks, ZC, Das, S. COVID-19 testing. Am J Clin Pathol 2020;154:575\u201384. https:\/\/doi.org\/10.1093\/ajcp\/aqaa141.","DOI":"10.1093\/ajcp\/aqaa141"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_002_w2aab3b7c97b1b6b1ab2b1b2Aa","doi-asserted-by":"crossref","unstructured":"Cheng, MP, Papenburg, J, Desjardins, M, Kanjilal, S, Quach, C, Libman, M, et al.. Diagnostic testing for severe acute respiratory syndrome\u2013related coronavirus-2: a narrative review. Ann Intern Med 2020:M20\u20131301.","DOI":"10.7326\/M20-1301"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_003_w2aab3b7c97b1b6b1ab2b1b3Aa","doi-asserted-by":"crossref","unstructured":"Mak, GC, Lau, SS, Wong, KK, Chow, NL, Lau, CS, Lam, ET, et al.. Analytical sensitivity and clinical sensitivity of the three rapid antigen detection kits for detection of SARS-CoV-2 virus. J Clin Virol 2020;133:104684. https:\/\/doi.org\/10.1016\/j.jcv.2020.104684.","DOI":"10.1016\/j.jcv.2020.104684"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_004_w2aab3b7c97b1b6b1ab2b1b4Aa","doi-asserted-by":"crossref","unstructured":"Ogawa, T, Fukumori, T, Nishihara, Y, Sekine, T, Okuda, N, Nishimura, T, et al.. Another false-positive problem for a SARS-CoV-2 antigen test in Japan. J Clin Virol 2020;131:104612. https:\/\/doi.org\/10.1016\/j.jcv.2020.104612.","DOI":"10.1016\/j.jcv.2020.104612"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_005_w2aab3b7c97b1b6b1ab2b1b5Aa","unstructured":"European Centre for Disease Prevention and Control (ECDC). Options for the use of rapid antigen tests for COVID-19 in the EU\/EEA and the UK. 19 November 2020. Stockholm: ECDC; 2020."},{"key":"2023033110551323072_j_cclm-2021-0182_ref_006_w2aab3b7c97b1b6b1ab2b1b6Aa","doi-asserted-by":"crossref","unstructured":"Hirotsu, Y, Maejima, M, Shibusawa, M, Nagakubo, Y, Hosaka, K, Amemiya, K, et al.. Comparison of automated SARS-CoV-2 antigen test for COVID-19 infection with quantitative RT-PCR using 313 nasopharyngeal swabs, including from seven serially followed patients. Int J Infect Dis 2020;99:397\u2013402. https:\/\/doi.org\/10.1016\/j.ijid.2020.08.029.","DOI":"10.1016\/j.ijid.2020.08.029"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_007_w2aab3b7c97b1b6b1ab2b1b7Aa","doi-asserted-by":"crossref","unstructured":"Hirotsu, Y, Maejima, M, Shibusawa, M, Amemiya, K, Nagakubo, Y, Hosaka, K, et al.. Analysis of a persistent viral shedding patient infected with SARS-CoV-2 by RT-qPCR, FilmArray Respiratory Panel v2.1, and antigen detection. J Infect Chemother 2021;27:406\u20139. https:\/\/doi.org\/10.1016\/j.jiac.2020.10.026.","DOI":"10.1016\/j.jiac.2020.10.026"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_008_w2aab3b7c97b1b6b1ab2b1b8Aa","doi-asserted-by":"crossref","unstructured":"Hirotsu, Y, Maejima, M, Shibusawa, M, Amemiya, K, Nagakubo, Y, Hosaka, K, et al.. Prospective study of 1308 nasopharyngeal swabs from 1033 patients using the LUMIPULSE SARS-CoV-2 antigen test: comparison with RT-qPCR. Int J Infect Dis 2021;105:7\u201314. https:\/\/doi.org\/10.1016\/j.ijid.2021.02.005.","DOI":"10.1016\/j.ijid.2021.02.005"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_009_w2aab3b7c97b1b6b1ab2b1b9Aa","doi-asserted-by":"crossref","unstructured":"Basso, D, Aita, A, Padoan, A, Cosma, C, Navaglia, F, Moz, S, et al.. Salivary SARS-CoV-2 antigen rapid detection: a prospective cohort study. Clin Chim Acta 2021;517:54\u20139. https:\/\/doi.org\/10.1016\/j.cca.2021.02.014.","DOI":"10.1016\/j.cca.2021.02.014"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_010_w2aab3b7c97b1b6b1ab2b1c10Aa","doi-asserted-by":"crossref","unstructured":"W\u00f6lfel, R, Corman, VM, Guggemos, W, Seilmaier, M, Zange, S, M\u00fcller, MA, et al.. Virological assessment of hospitalized patients with COVID-2019. Nature 2020;581:465\u20139. https:\/\/doi.org\/10.1038\/s41586-020-2196-x.","DOI":"10.1038\/s41586-020-2196-x"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_011_w2aab3b7c97b1b6b1ab2b1c11Aa","doi-asserted-by":"crossref","unstructured":"Liotti, FM, Menchinelli, G, Marchetti, S, Morandotti, GA, Sanguinetti, M, Posteraro, B, et al.. Evaluation of three commercial assays for SARS-CoV-2 molecular detection in upper respiratory tract samples. Eur J Clin Microbiol Infect Dis 2021;40:269\u201377. https:\/\/doi.org\/10.1007\/s10096-020-04025-0.","DOI":"10.1007\/s10096-020-04025-0"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_012_w2aab3b7c97b1b6b1ab2b1c12Aa","doi-asserted-by":"crossref","unstructured":"Liotti, FM, Menchinelli, G, Lalle, E, Palucci, I, Marchetti, S, Colavita, F, et al.. Performance of a novel diagnostic assay for rapid SARS-CoV-2 antigen detection in nasopharynx samples. Clin Microbiol Infect 2021;27:487\u20138. https:\/\/doi.org\/10.1016\/j.cmi.2020.09.030.","DOI":"10.1016\/j.cmi.2020.09.030"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_013_w2aab3b7c97b1b6b1ab2b1c13Aa","doi-asserted-by":"crossref","unstructured":"Poljak, M, Korva, M, Knap Ga\u0161per, N, Fujs Komlo\u0161, K, Sagadin, M, Ur\u0161i\u010d, T, et al.. Clinical evaluation of the Cobas SARS-CoV-2 test and a diagnostic platform switch during 48 hours in the midst of the COVID-19 pandemic. J Clin Microbiol 2020;58:e00599\u201320. https:\/\/doi.org\/10.1128\/jcm.00599-20.","DOI":"10.1128\/JCM.00599-20"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_014_w2aab3b7c97b1b6b1ab2b1c14Aa","doi-asserted-by":"crossref","unstructured":"Procop, GW, Brock, JE, Reineks, EZ, Shrestha, NK, Demkowicz, R, Cook, E, et al.. Comparison of five SARS-CoV-2 molecular assays\u00a0with clinical correlations. Am J Clin Pathol 2021;155:69\u201378. https:\/\/doi.org\/10.1093\/ajcp\/aqaa181.","DOI":"10.1093\/ajcp\/aqaa181"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_015_w2aab3b7c97b1b6b1ab2b1c15Aa","doi-asserted-by":"crossref","unstructured":"Liotti, FM, Menchinelli, G, Marchetti, S, Morandotti, GA, Sanguinetti, M, Posteraro, B, et al.. Evaluating the newly developed BioFire COVID-19 test for SARS-CoV-2 molecular detection. Clin Microbiol Infect 2020;26:1699\u2013700. https:\/\/doi.org\/10.1016\/j.cmi.2020.07.026.","DOI":"10.1016\/j.cmi.2020.07.026"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_016_w2aab3b7c97b1b6b1ab2b1c16Aa","doi-asserted-by":"crossref","unstructured":"Liotti, FM, Menchinelli, G, Marchetti, S, Posteraro, B, Landi, F, Sanguinetti, M, et al.. Assessment of SARS-CoV-2 RNA test results among patients who recovered from COVID-19 with prior negative results. JAMA Intern Med 2020:e207570. https:\/\/doi.org\/10.1001\/jamainternmed.2020.7570.","DOI":"10.1001\/jamainternmed.2020.7570"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_017_w2aab3b7c97b1b6b1ab2b1c17Aa","doi-asserted-by":"crossref","unstructured":"Alexandersen, S, Chamings, A, Bhatta, TR. SARS-CoV-2 genomic and subgenomic RNAs in diagnostic samples are not an indicator of active replication. Nat Commun 2020;11:6059. https:\/\/doi.org\/10.1038\/s41467-020-19883-7.","DOI":"10.1038\/s41467-020-19883-7"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_018_w2aab3b7c97b1b6b1ab2b1c18Aa","doi-asserted-by":"crossref","unstructured":"Rodr\u00edguez-Grande, C, Ad\u00e1n-Jim\u00e9nez, J, Catal\u00e1n, P, Alcal\u00e1, L, Est\u00e9vez, A, Mu\u00f1oz, P, et al.. Inference of active viral replication in cases with sustained positive RT-PCRs for SARS-CoV-2. J Clin Microbiol 2021;59:e02277\u201320. https:\/\/doi.org\/10.1128\/jcm.02277-20.","DOI":"10.1128\/JCM.02277-20"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_019_w2aab3b7c97b1b6b1ab2b1c19Aa","doi-asserted-by":"crossref","unstructured":"Avanzato, VA, Matson, MJ, Seifert, SN, Pryce, R, Williamson, BN, Anzick, SL, et al.. Case Study: prolonged infectious SARS-CoV-2 shedding from an asymptomatic immunocompromised individual with cancer. Cell 2020;183:1901\u201312. https:\/\/doi.org\/10.1016\/j.cell.2020.10.049.","DOI":"10.1016\/j.cell.2020.10.049"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_020_w2aab3b7c97b1b6b1ab2b1c20Aa","doi-asserted-by":"crossref","unstructured":"van Kampen JJA, van de Vijver, DAMC, Fraaij, PLA, Haagmans, BL, Lamers, MM, Okba, N, et al.. Duration and key determinants of infectious virus shedding in hospitalized patients with coronavirus disease-2019 (COVID-19). Nat Commun 2021;12:267. https:\/\/doi.org\/10.1038\/s41467-020-20568-4.","DOI":"10.1101\/2020.06.08.20125310"},{"key":"2023033110551323072_j_cclm-2021-0182_ref_021_w2aab3b7c97b1b6b1ab2b1c21Aa","doi-asserted-by":"crossref","unstructured":"Dinnes, J, Deeks, JJ, Adriano, A, Berhane, S, Davenport, C, Dittrich, S, et al.. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev 2020;8:CD013705. https:\/\/doi.org\/10.1002\/14651858.cd013705.","DOI":"10.1002\/14651858.CD013705"}],"container-title":["Clinical Chemistry and Laboratory Medicine (CCLM)"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2021-0182\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2021-0182\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,3,31]],"date-time":"2023-03-31T09:43:46Z","timestamp":1680255826000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.degruyter.com\/document\/doi\/10.1515\/cclm-2021-0182\/html"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,4,7]]},"references-count":21,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2021,2,10]]},"published-print":{"date-parts":[[2021,7,27]]}},"alternative-id":["10.1515\/cclm-2021-0182"],"URL":"https:\/\/doi.org\/10.1515\/cclm-2021-0182","relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2021.01.26.21250533","asserted-by":"object"}]},"ISSN":["1437-4331","1434-6621"],"issn-type":[{"value":"1437-4331","type":"electronic"},{"value":"1434-6621","type":"print"}],"subject":[],"published":{"date-parts":[[2021,4,7]]}}}