{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T21:40:27Z","timestamp":1788385227714,"version":"build-2803163510"},"reference-count":48,"publisher":"Wiley","issue":"40","license":[{"start":{"date-parts":[[2025,8,23]],"date-time":"2025-08-23T00:00:00Z","timestamp":1755907200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,8,23]],"date-time":"2025-08-23T00:00:00Z","timestamp":1755907200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Small"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Administration of mAb therapeutics often elicits the production of neutralizing anti\u2010drug antibodies (nADA) in patients. Current nADA assays are drug\u2010sensitive and detect only free nADA, thereby overlooking drug\u2010bound antibodies and reducing sensitivity. An extra preparatory step of acid dissociation is often applied to resolve the immunocomplexes and subsequently detect the resultant free nADA separately. This tedious sample preparation limits them to lab settings and exposes the antibodies to harsh conditions. Here, a modified lateral flow assay platform, namely sequential binding flow immunoassay (SBFIA) is presented for nADA determination that circumvents the drug's interference through a distinctive approach. Drawing inspiration from chromatography, sequential binding events (competitive and direct) are exploited\u00a0to eliminate drugs\u2019 interference, enabling sensitive detection of drug\u2010bound nADA. The platform is optimized using Infliximab (IFX) as a drug and neutralizing anti\u2010Infliximab antibodies (n\u03b1IFX) as a model analyte. After optimization, a minimum concentration of 103\u00a0ng mL\n                    <jats:sup>\u22121<\/jats:sup>\n                    \u00a0n\u03b1IFX is detected. The assay shows remarkable drug tolerance and specificity to n\u03b1IFX.\u00a0Based on its point\u2010of\u2010care (POC) advantages while avoiding harsh, acidic sample pretreatment, the assay can assist physicians in rapid and accurate decision\u2010making. By tweaking the bioreceptors, the configuration can adapt well to other biologics and respective nADA.\n                  <\/jats:p>","DOI":"10.1002\/smll.202505975","type":"journal-article","created":{"date-parts":[[2025,8,23]],"date-time":"2025-08-23T09:34:17Z","timestamp":1755941657000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Drug\u2010Tolerant, Chemiluminescent Lateral Flow Immunoassay Platform for the Determination of Neutralizing Anti\u2010Drug Antibodies"],"prefix":"10.1002","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5123-1771","authenticated-orcid":false,"given":"Frans","family":"Kokojka","sequence":"first","affiliation":[{"name":"Department of Biotechnology Engineering Faculty of Engineering Science Ben\u2010Gurion University of the Negev  Beer\u2010Sheva 8410501 Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ron","family":"Ramon","sequence":"additional","affiliation":[{"name":"Department of Biotechnology Engineering Faculty of Engineering Science Ben\u2010Gurion University of the Negev  Beer\u2010Sheva 8410501 Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sigal","family":"Pressman","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Rambam Health Care Campus  Haifa 3109601 Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yehuda","family":"Chowers","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Rambam Health Care Campus  Haifa 3109601 Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9697-3805","authenticated-orcid":false,"given":"Robert S.","family":"Marks","sequence":"additional","affiliation":[{"name":"Department of Biotechnology Engineering Faculty of Engineering Science Ben\u2010Gurion University of the Negev  Beer\u2010Sheva 8410501 Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,8,23]]},"reference":[{"key":"e_1_2_8_1_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrrheum.2013.4"},{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2036.2011.04612.x"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40259-018-0300-7"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2665-9913(23)00341-7"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41584-020-00540-8"},{"key":"e_1_2_8_6_1","first-page":"109","volume":"6","author":"Bendtzen K.","year":"2015","journal-title":"Front. Immunol."},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/cei.12742"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2012.363"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtauto.2019.100004"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40259-022-00559-1"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2020.01365"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/kead690"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001396"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.22214"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1136\/flgastro-2016-100692"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jim.2011.08.022"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-018-37950-4"},{"key":"e_1_2_8_18_1","unstructured":"BuhlmannLabs Anti\u2010IFX Antibodies \u2010 Quantum Blue\u00aehttps:\/\/www.buhlmannlabs.ch\/wp\u2010content\/uploads\/2015\/01\/Quantum\u2010Blue\u2010Anti\u2010Infliximab_MF069ML\u201005E.pdf(accessed 12 November 2024)."},{"key":"e_1_2_8_19_1","unstructured":"IDKmonitor \u2010 Infliximab Total ADA ELISAhttps:\/\/www.idkna.com\/wp\u2010content\/uploads\/2024\/11\/FOG_41_US_Therapeutic_Drug_Monitoring\u201021AUG24\u2010website.pdf(accessed 07 January 2025)."},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jim.2015.08.002"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bios.2024.117030"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1039\/D4LC01075B"},{"key":"e_1_2_8_23_1","unstructured":"World Health Organization \u2010 Technical document: Target product profile for readers of rapid diagnostic testshttps:\/\/www.who.int\/publications\/i\/item\/9789240067172(accessed 23 June 2025)."},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ebiom.2021.103414"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bios.2021.113883"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ebiom.2021.103729"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bios.2022.114449"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bios.2024.116920"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.bioconjchem.8b00592"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bios.2020.112168"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bios.2020.112015"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1021\/acs.analchem.6b01034"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1177\/000456329903600603"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.autrev.2014.10.018"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1111\/cei.13112"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2015.02.031"},{"key":"e_1_2_8_37_1","doi-asserted-by":"publisher","DOI":"10.1002\/ibd.21919"},{"key":"e_1_2_8_38_1","doi-asserted-by":"publisher","DOI":"10.1177\/0004563218782286"},{"key":"e_1_2_8_39_1","unstructured":"iLite \u2010 iLite\u2122 Biomonitor Infliximab NAbhttps:\/\/fnkprddata.blob.core.windows.net\/domestic\/data\/datasheet\/NTB\/71\u201088R.pdf(accessed 05 January 2025)."},{"key":"e_1_2_8_40_1","unstructured":"Bio\u2010Rad \u2010 Human Anti Infliximab:Hrphttps:\/\/images.bio\u2010rad\u2010antibodies.com\/datasheets\/datasheet\u2010HCA216P.pdf(accessed 29 June 2025)."},{"key":"e_1_2_8_41_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0021-9258(18)96680-9"},{"key":"e_1_2_8_42_1","first-page":"429","volume-title":"Antibodies, Second ed","author":"Berg E. A.","year":"2014"},{"key":"e_1_2_8_43_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2009.201533"},{"key":"e_1_2_8_44_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2020.104529"},{"key":"e_1_2_8_45_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2021.104818"},{"key":"e_1_2_8_46_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-021-94431-x"},{"key":"e_1_2_8_47_1","doi-asserted-by":"publisher","DOI":"10.1038\/256495a0"},{"key":"e_1_2_8_48_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.talanta.2024.127240"}],"container-title":["Small"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/smll.202505975","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/smll.202505975","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/smll.202505975","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T18:46:10Z","timestamp":1772995570000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/smll.202505975"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8,23]]},"references-count":48,"journal-issue":{"issue":"40","published-print":{"date-parts":[[2025,10]]}},"alternative-id":["10.1002\/smll.202505975"],"URL":"https:\/\/doi.org\/10.1002\/smll.202505975","archive":["Portico"],"relation":{},"ISSN":["1613-6810","1613-6829"],"issn-type":[{"value":"1613-6810","type":"print"},{"value":"1613-6829","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8,23]]},"assertion":[{"value":"2025-05-19","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-08-23","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e05975"}}