{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,2]],"date-time":"2026-11-02T21:52:36Z","timestamp":1793656356293,"version":"4.5.1"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,10,31]],"date-time":"2022-10-31T00:00:00Z","timestamp":1667174400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,10,31]],"date-time":"2022-10-31T00:00:00Z","timestamp":1667174400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Infect Dis"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background:<\/jats:title>\n                <jats:p>There is limited information to compare the qualitative and semi-quantitative performance of rapid diagnostic tests (RDT) and serology for the assessment of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Therefore, the objective of the study was (a) to compare the efficacy of SARS-CoV-2 antibody detection between RDT and laboratory serology, trying to identify appropriate semi-quantitative cut-offs for RDT in relation with quantitative serology values and to (b) evaluate diagnostic accuracy of RDT compared to the NAAT gold standard in an unselected adult population.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods:<\/jats:title>\n                <jats:p>SARS-CoV-2 antibodies were simultaneously measured with lateral flow immunochromatographic assays (LFA), the Cellex qSARS-CoV-2 IgG\/IgM Rapid Test (by capillary blood), the iFlash-SARS-CoV-2 IgG\/IgM chemiluminescent immunoassay (CLIA) (by venous blood) and the nucleic acid amplification test (NAAT) in samples from in- and out-patients with confirmed, suspected and negative diagnosis of coronavirus disease 2019 (COVID-19) attending Udine Hospital (Italy) (March-May 2020). Interpretation of RDT was qualitative (positive\/negative) and semi-quantitative based on a chromatographic intensity scale (negative, weak positive, positive).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results:<\/jats:title>\n                <jats:p>Overall, 720 paired antibody measures were performed on 858 patients. The qualitative and semiquantitative agreement analysis performed in the whole sample between LFA and CLIA provided a Kendall\u2019s tau of 0.578 (p\u2009&lt;\u20090.001) and of 0.623 (p\u2009&lt;\u20090.001), respectively, for IgM and IgG. In patients with a diagnosis of COVID-19, accordance between LFA and CLIA was maintained as a function of time from the onset of COVID-19 disease and the severity of disease both for qualitative and semi-quantitative assessments. RDT compared to the NAAT gold standard in 858 patients showed 78.5% sensitivity (95% CI 75.1%-81.7%) and 94.1% specificity (95% CI 90.4%-96.8%), with variable accordance depending on the timing from symptom onset.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion:<\/jats:title>\n                <jats:p>The RDT used in our study can be a non-invasive and reliable alternative to serological tests and facilitate both qualitative and a semi-quantitative antibody detection in COVID-19.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12879-022-07786-5","type":"journal-article","created":{"date-parts":[[2022,10,31]],"date-time":"2022-10-31T08:04:07Z","timestamp":1667203447000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Evaluation of qualitative and semi-quantitative cut offs for rapid diagnostic lateral flow test in relation to serology for the detection of SARS-CoV-2 antibodies: findings of a prospective study"],"prefix":"10.1186","volume":"22","author":[{"given":"Maddalena","family":"Peghin","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia","family":"Bontempo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"De Martino","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alvisa","family":"Palese","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Valentina","family":"Gerussi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Graziano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Fabris","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"D\u2019Aurizio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Sbrana","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Ripoli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Curcio","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miriam","family":"Isola","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlo","family":"Tascini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,10,31]]},"reference":[{"key":"7786_CR1","first-page":"CD013705","volume":"3","author":"J Dinnes","year":"2021","unstructured":"Dinnes J, Deeks JJ, Berhane S, Taylor M, Adriano A, Davenport C, et al. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2021;3:CD013705.","journal-title":"Cochrane Database Syst Rev"},{"key":"7786_CR2","doi-asserted-by":"publisher","first-page":"e0113821","DOI":"10.1128\/JCM.01138-21","volume":"59","author":"M Peghin","year":"2021","unstructured":"Peghin M, De Martino M, Fabris M, Palese A, Visintini E, Graziano E, et al. The fall in antibody response to SARS-CoV-2: a longitudinal study of asymptomatic to critically ill patients up to 10 months after recovery. J Clin Microbiol. 2021;59:e0113821.","journal-title":"J Clin Microbiol"},{"key":"7786_CR3","doi-asserted-by":"crossref","unstructured":"Drain PK. Rapid diagnostic testing for SARS-CoV-2. N Engl J Med. 2022.","DOI":"10.1056\/NEJMcp2117115"},{"key":"7786_CR4","unstructured":"World Health Organization. Clinical management of COVID-19: interim guidance, 25 January 2021. 2021.https:\/\/www.who.int\/publications\/i\/item\/WHO-2019-nCoV-clinical-2021-1. Accessed 21 Nov 2021."},{"key":"7786_CR5","unstructured":"World Health Organization. Laboratory testing for coronavirus disease (COVID-19) in suspected human cases interim guidance, 14 January 2020 (No. WHO\/2019-nCoV\/laboratory\/2020.2). 2020. https:\/\/www.who.int\/publications-detail\/laboratory-testing-for-2019-novel-coronavirus-in-suspected-human-cases-20200117. Accessed 21 Nov 2021."},{"key":"7786_CR6","unstructured":"Cellex qSARS-CoV-2 IgG\/IgM rapid test. https:\/\/www.fda.gov\/media\/136625\/download. Accessed 17 Feb 2022."},{"key":"7786_CR7","unstructured":"Johns Hopkins Center for Health Security. Serology tests for COVID-19. https:\/\/www.centerforhealthsecurity.org\/resources\/COVID-19\/serology\/Serology-based-tests-for-COVID-19.html (2022). Accessed 17 Feb 2022."},{"key":"7786_CR8","doi-asserted-by":"crossref","unstructured":"Hanson KE, Caliendo AM, Arias CA, Englund JA, Hayden MK, Lee MJ, et al. Infectious Diseases Society of America guidelines on the diagnosis of COVID-19: serologic testing. Clin Infect Dis. 2020.","DOI":"10.1093\/cid\/ciaa1343"},{"key":"7786_CR9","doi-asserted-by":"publisher","first-page":"557797","DOI":"10.3389\/fmed.2020.557797","volume":"7","author":"J Jacobs","year":"2020","unstructured":"Jacobs J, Kuhne V, Lunguya O, Affolabi D, Hardy L, Vandenberg O. Implementing COVID-19 (SARS-CoV-2) rapid diagnostic tests in Sub-Saharan Africa: a review. Front Med (Lausanne). 2020;7:557797.","journal-title":"Front Med (Lausanne)"},{"key":"7786_CR10","doi-asserted-by":"publisher","first-page":"e23","DOI":"10.1016\/S0140-6736(20)31830-4","volume":"396","author":"C Rosadas","year":"2020","unstructured":"Rosadas C, Randell P, Khan M, McClure MO, Tedder RS. Testing for responses to the wrong SARS-CoV-2 antigen? Lancet. 2020;396:e23.","journal-title":"Lancet"},{"key":"7786_CR11","doi-asserted-by":"publisher","first-page":"e13357","DOI":"10.1111\/eci.13357","volume":"50","author":"DO Andrey","year":"2020","unstructured":"Andrey DO, Cohen P, Meyer B, Torriani G, Yerly S, Mazza L, et al. Diagnostic accuracy of Augurix COVID-19 IgG serology rapid test. Eur J Clin Invest. 2020;50:e13357.","journal-title":"Eur J Clin Invest"},{"key":"7786_CR12","doi-asserted-by":"publisher","first-page":"e0237694","DOI":"10.1371\/journal.pone.0237694","volume":"15","author":"T Prazuck","year":"2020","unstructured":"Prazuck T, Colin M, Giache S, Gubavu C, Seve A, Rzepecki V, et al. Evaluation of performance of two SARS-CoV-2 Rapid IgM-IgG combined antibody tests on capillary whole blood samples from the fingertip. PLoS ONE. 2020;15:e0237694.","journal-title":"PLoS ONE"},{"key":"7786_CR13","doi-asserted-by":"publisher","first-page":"103729","DOI":"10.1016\/j.ebiom.2021.103729","volume":"74","author":"TS Fulford","year":"2021","unstructured":"Fulford TS, Van H, Gherardin NA, Zheng S, Ciula M, Drummer HE, et al. A point-of-care lateral flow assay for neutralising antibodies against SARS-CoV-2. EBioMedicine. 2021;74:103729.","journal-title":"EBioMedicine"},{"key":"7786_CR14","unstructured":"Centers For Disease Control and Prevention. Interim guidelines for COVID-19 antibody testing. 2022. https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/resources\/antibody-tests-guidelines.html. Accessed 17 Feb 2022."},{"key":"7786_CR15","doi-asserted-by":"crossref","unstructured":"Mendels DA, Dortet L, Emeraud C, Oueslati S, Girlich D, Ronat JB, et al. Using artificial intelligence to improve COVID-19 rapid diagnostic test result interpretation. Proc Natl Acad Sci U S A. 2021;118.","DOI":"10.1073\/pnas.2019893118"},{"key":"7786_CR16","unstructured":"European Centre for Disease Prevention and Control. Options for the use of rapid antigen tests for COVID-19 in the EU\/EEA - first update. 2021. https:\/\/www.ecdc.europa.eu\/en\/publications-data\/options-use-rapid-antigen-tests-covid-19-eueea-first-update. Accessed 16 Jan 2022."},{"key":"7786_CR17","doi-asserted-by":"crossref","unstructured":"Dortet L, Ronat JB, Vauloup-Fellous C, Langendorf C, Mendels DA, Emeraud C, et al. Evaluating 10 commercially available SARS-CoV-2 rapid serological tests by use of the STARD (Standards for Reporting of Diagnostic Accuracy Studies) method. J Clin Microbiol. 2021;59.","DOI":"10.1128\/JCM.02342-20"},{"key":"7786_CR18","doi-asserted-by":"publisher","first-page":"112909","DOI":"10.1016\/j.jim.2020.112909","volume":"489","author":"MA Black","year":"2021","unstructured":"Black MA, Shen G, Feng X, Garcia Beltran WF, Feng Y, Vasudevaraja V, et al. Analytical performance of lateral flow immunoassay for SARS-CoV-2 exposure screening on venous and capillary blood samples. J Immunol Methods. 2021;489:112909.","journal-title":"J Immunol Methods"}],"container-title":["BMC Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12879-022-07786-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12879-022-07786-5\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12879-022-07786-5.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,10,31]],"date-time":"2022-10-31T08:05:36Z","timestamp":1667203536000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcinfectdis.biomedcentral.com\/articles\/10.1186\/s12879-022-07786-5"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,10,31]]},"references-count":18,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022,12]]}},"alternative-id":["7786"],"URL":"https:\/\/doi.org\/10.1186\/s12879-022-07786-5","relation":{},"ISSN":["1471-2334"],"issn-type":[{"value":"1471-2334","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,10,31]]},"assertion":[{"value":"28 February 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 September 2022","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 September 2022","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"31 October 2022","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This study was approved by the Ethics Committee of the Friuli Venezia Giulia Region (CORMOR 3\u20134 protocol; CEUR-2020-OS-219 and CEUR-2020-OS-205).All procedures were carried out in accordance with the ethical standards of the University of Udine and the Azienda Sanitaria Universitaria Friuli Centrale and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Patients gave their written consent prior the participation on the study and informed consent was obtained from all the participants.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"MP reports receiving grants and personal fees from Pfizer, MSD, Menarini and Dia Sorin outside the submitted work. CT has received grants in the last two years from Correvio, Biotest, Biomerieux, Gilead, Angelini, MSD, Pfizer, Thermofisher, Zambon, Shionogi, Avir Pharma and Hikma outside the submitted work. The other authors have no conflict of interest to declare.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"810"}}