{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T11:41:24Z","timestamp":1792755684230,"version":"4.5.0"},"reference-count":30,"publisher":"Wiley","issue":"20","license":[{"start":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T00:00:00Z","timestamp":1791417600000},"content-version":"vor","delay-in-days":7,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100004608","name":"Natural Science Foundation of Jiangsu Province","doi-asserted-by":"publisher","award":["BK20231184"],"award-info":[{"award-number":["BK20231184"]}],"id":[{"id":"10.13039\/501100004608","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100013254","name":"National College Students Innovation and Entrepreneurship Training Program","doi-asserted-by":"publisher","award":["202210313033Z"],"award-info":[{"award-number":["202210313033Z"]}],"id":[{"id":"10.13039\/501100013254","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100013254","name":"National College Students Innovation and Entrepreneurship Training Program","doi-asserted-by":"publisher","award":["202410313028Z"],"award-info":[{"award-number":["202410313028Z"]}],"id":[{"id":"10.13039\/501100013254","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:italic>Klebsiella pneumoniae<\/jats:italic>\n                      <\/jats:styled-content>\n                      (KP) is an important and virulent pathogen causing acute respiratory infections in infants. Currently, traditional methods for detecting\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:italic>Klebsiella pneumoniae<\/jats:italic>\n                      <\/jats:styled-content>\n                      in babies are labour\u2010intensive and time\u2010consuming, and their accuracy and sensitivity require improvement. Recombinant enzyme polymerase amplification technology (RPA) has the advantages of good specificity, high sensitivity, and isothermal amplification. It can be combined with fluorescence immunochromatography test strip (FICTS) based on nanofluorescent microspheres (nFM) to achieve rapid, low\u2010cost, high sensitivity, and specific detection of\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:italic>Klebsiella pneumoniae<\/jats:italic>\n                      <\/jats:styled-content>\n                      in infants.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      <jats:italic>mdh<\/jats:italic>\n                      was selected as a genus\u2010specific gene from\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:italic>Klebsiella pneumoniae<\/jats:italic>\n                      <\/jats:styled-content>\n                      , and recombinant polymerase isothermal amplification\u2014nanofluorescence microsphere immunochromatography (RPA\u2010FICTS) was established by using standard strains. The sensitivity and specificity of this detection technology can be improved by the magnetic bead purification step of RPA nucleic acid amplification products. Subsequently, rapid quantitative detection of\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:italic>K. pneumoniae<\/jats:italic>\n                      <\/jats:styled-content>\n                      in infant samples was performed using fluorescent immunochromatographic test strips. A total of 19 clinical samples of\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:italic>Klebsiella pneumoniae<\/jats:italic>\n                      <\/jats:styled-content>\n                      (KP) and 7 clinical samples of non\u2010\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:italic>Klebsiella pneumoniae<\/jats:italic>\n                      <\/jats:styled-content>\n                      (nKP) were detected by the new detection technology platform established in this paper, and the specificity and sensitivity of RPA\u2010FICTS were verified by agarose gel electrophoresis.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Under the optimal detection conditions, the maximum detection limits of RPA\u2010GE (agarose gel electrophoresis) and RPA\u2010FICTS are 9.03\u2009\u00d7\u200910\n                      <jats:sup>\u22123<\/jats:sup>\n                      and 9.03\u2009\u00d7\u200910\n                      <jats:sup>\u22128<\/jats:sup>\n                      \u2009ng\/\u03bcL. RPA\u2010FICTS can quickly detect\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:italic>Klebsiella pneumoniae<\/jats:italic>\n                      <\/jats:styled-content>\n                      and specifically distinguish between\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:italic>Klebsiella pneumoniae<\/jats:italic>\n                      <\/jats:styled-content>\n                      and non\u2010\n                      <jats:italic>\n                        Klebsiella\n                        <jats:styled-content style=\"fixed-case\">pneumoniae<\/jats:styled-content>\n                      <\/jats:italic>\n                      . Compared with traditional detection methods, this method has a shorter detection time (55\u2009min), strong specificity, high sensitivity, and simple operation, providing a new method for rapid detection of human\n                      <jats:styled-content style=\"fixed-case\">\n                        <jats:italic>Klebsiella pneumoniae<\/jats:italic>\n                      <\/jats:styled-content>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jcla.70348","type":"journal-article","created":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T06:36:49Z","timestamp":1791527809000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Rapid Detection of\n                    <i>Klebsiella pneumoniae<\/i>\n                    in Infants With Severe Infection Disease by Instant Nanofluorescent Microspheres\u2010Immunochromatography Combined With Recombinase Polymerase Isothermal Amplification Technology"],"prefix":"10.1002","volume":"40","author":[{"given":"Yiping","family":"Liu","sequence":"first","affiliation":[{"name":"School of Medical Technology Xuzhou Medical University  Xuzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-7742-7818","authenticated-orcid":false,"given":"Yi","family":"Lu","sequence":"additional","affiliation":[{"name":"School of Medical Technology Xuzhou Medical University  Xuzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin","family":"Wang","sequence":"additional","affiliation":[{"name":"School of Chemical Engineering and Technology China University of Mining and Technology  Xuzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-8487-0799","authenticated-orcid":false,"given":"Hanzhong","family":"Yu","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Xuzhou First People's Hospital  Xuzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yumeng","family":"Lu","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Xuzhou First People's Hospital  Xuzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5985-6186","authenticated-orcid":false,"given":"Minghui","family":"Chen","sequence":"additional","affiliation":[{"name":"School of Medical Imaging Xuzhou Medical University  Xuzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feifan","family":"Zhu","sequence":"additional","affiliation":[{"name":"School of Medical Technology Xuzhou Medical University  Xuzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-6985-692X","authenticated-orcid":false,"given":"Xing","family":"Lv","sequence":"additional","affiliation":[{"name":"School of Medical Technology Xuzhou Medical University  Xuzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Clinical Laboratory Xuzhou First People's Hospital  Xuzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4109-2808","authenticated-orcid":false,"given":"Ying","family":"Chen","sequence":"additional","affiliation":[{"name":"School of Medical Technology Xuzhou Medical University  Xuzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,8]]},"reference":[{"key":"e_1_2_11_2_1","first-page":"569","article-title":"Investigation and Control on a Suspected Outbreak of Carbapenem\u2014Resistant \n                     Klebsiella pneumoniae\n                   Infection in the Neurological Intensive Care Unit","volume":"22","author":"Ying H.","year":"2023","journal-title":"Chinese Journal of Infection Control"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.3389\/fbioe.2023.1144463"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2021.634349"},{"key":"e_1_2_11_5_1","first-page":"362","article-title":"Clinical Characteristics,Molecular Typing and Drug Resistance Genes of Carbapenem\u2010Resistant \n                     Klebsiella pneumoniae\n                   Isolated From Blood Culturing","volume":"38","author":"Jiawei W.","year":"2023","journal-title":"Laboratory Medicine"},{"key":"e_1_2_11_6_1","first-page":"22","article-title":"Recent Progress on Isothermal Amplification Technology and Its Combination With CRISPR in Rapid Detection of Microorganisms","volume":"36","author":"Wei\u2010fang G.","year":"2020","journal-title":"Biotechnology Bulletin"},{"key":"e_1_2_11_7_1","first-page":"4479","article-title":"Application of CRISPR\u2010Cas12a in the Detection of Foodborne Pathogens","volume":"13","author":"Bu X. F.","year":"2022","journal-title":"Journal of Food Safety and Quality"},{"key":"e_1_2_11_8_1","first-page":"449","article-title":"Application of Recombinase Polymerase Amplification in Detection of Foodborne Pathogen","volume":"42","author":"Qin X.","year":"2021","journal-title":"Science and Technology of Food Industry"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pbio.0040204"},{"key":"e_1_2_11_10_1","first-page":"297","article-title":"A Review of the Application of Recombinase Polymerase Amplification, Recombinase\u2010Aided Amplification and Enzymatic Recombinase Amplification in Rapid Detection of Foodborne Pathogens","volume":"44","author":"Wang S.","year":"2023","journal-title":"Food Science"},{"key":"e_1_2_11_11_1","first-page":"117","article-title":"Advances and Applications of Recombinase Polymerase Amplification","volume":"34","author":"Du Y. N.","year":"2018","journal-title":"Shanghai Agricultural Journal"},{"key":"e_1_2_11_12_1","first-page":"423","article-title":"Principle of Recombinase Polymerase Amplification and Its Application Progress in Medical Laboratory Science","volume":"45","author":"Meiyun S.","year":"2022","journal-title":"Chinese Journal of Laboratory Medicine"},{"key":"e_1_2_11_13_1","first-page":"117","article-title":"Research and Application of Immunochromatographic Analysis","volume":"42","author":"Chang L.","year":"2021","journal-title":"Progress in Veterinary Medicine"},{"key":"e_1_2_11_14_1","first-page":"326","article-title":"Rapid Detection of \n                     Vibrio parahaemolyticus\n                   Based on Time\u2010Resolved Fluorescence Lateral Flow Immunoassay","volume":"39","author":"Qingqing C.","year":"2023","journal-title":"Modern Food Science and Technology"},{"key":"e_1_2_11_15_1","first-page":"119","article-title":"Application of Fluorescence Immunochromatography in Detection of Morphine in Hair Samples","volume":"43","author":"Hong\u2010jiang Y.","year":"2022","journal-title":"Progress in Veterinary Medicine"},{"key":"e_1_2_11_16_1","first-page":"1","article-title":"Research Progress of Lateral Flow Immunoassay in Food Safety","volume":"43","author":"Lingzhi Y.","year":"2022","journal-title":"Science and Technology of Food Industry"},{"key":"e_1_2_11_17_1","first-page":"853","article-title":"Study on Separation of CD133 Cells From Human Cord Blood and Their Amplification In\u00a0Vitro","volume":"7","author":"Ling T.","year":"2007","journal-title":"Progress in Modern Biomedicine"},{"key":"e_1_2_11_18_1","first-page":"107","article-title":"Quantitative Determination of Ochratoxin A Based on Weak Magnetic Signal","volume":"43","author":"Xinru C.","year":"2022","journal-title":"Journal of Henan University of Technology (Natural Science Edition)"},{"key":"e_1_2_11_19_1","first-page":"98","article-title":"Establishment of HBV Rapid Magnetic Immunochromatographic Method Based on Magnetic Nanoprobe for Pre\u2010S1 Antigen","volume":"33","author":"Xiao\u2010wei X.","year":"2016","journal-title":"Journal of Biology"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10895-008-0334-1"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.5740\/jaoacint.18-0055"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.3389\/fcimb.2018.00004"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.3390\/v11111080"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijid.2022.04.043"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.3389\/fmicb.2022.842415"},{"key":"e_1_2_11_26_1","first-page":"1128","article-title":"Development of a Recombinase Polymerase Amplification Assay Combined With Lateral Flow Dipstick for Detection of the Infectious Laryngotracheitis Virus","volume":"40","author":"Guohe M.","year":"2018","journal-title":"Chinese Journal of Preventive Veterinary Medicine"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.3390\/pathogens11111252"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.3389\/fcimb.2022.1019071"},{"key":"e_1_2_11_29_1","first-page":"139","article-title":"Establishment and Performance Evaluation of Quantitative Detection of Serum Placental Growth Factor by Fluorescence Lateral Flow Immunoassay","volume":"41","author":"Yatao X.","year":"2023","journal-title":"Experimental and Laboratory Medicine"},{"key":"e_1_2_11_30_1","first-page":"120","article-title":"Comparison of Detection Methods for SSR Amplified Fragments and Attentions for Its Operation in Experiments","volume":"32","author":"Jian D.","year":"2013","journal-title":"Seed"},{"key":"e_1_2_11_31_1","first-page":"128","article-title":"On the Application and Thinking of Genefinder in the Experiment Teaching Reform: The Application and Thinking of Genefinder in the Experiment Teaching of Gene Engineering","author":"Xiao\u2010yan W.","year":"2021","journal-title":"Education and Teaching Forum 30"}],"container-title":["Journal of Clinical Laboratory Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.70348","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcla.70348","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.70348","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T11:18:42Z","timestamp":1792754322000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcla.70348"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10]]},"references-count":30,"journal-issue":{"issue":"20","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["10.1002\/jcla.70348"],"URL":"https:\/\/doi.org\/10.1002\/jcla.70348","archive":["Portico"],"relation":{},"ISSN":["0887-8013","1098-2825"],"issn-type":[{"value":"0887-8013","type":"print"},{"value":"1098-2825","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10]]},"assertion":[{"value":"2026-03-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-08-06","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-10-08","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70348"}}