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COVID-19 exhibits a strong human-to-human transmission infectivity and could cause acute respiratory diseases. Asymptomatic carriers are able to infect other healthy persons, and this poses a challenge for public health; the World Health Organization (WHO) has already announced COVID-19 as a global pandemic. Nucleic acid testing, considered as the current primary method for diagnosing COVID-19, might lead to false negatives and is difficult to be applied for every suspected patient because of the existence of asymptomatic carriers. Meanwhile, detecting specific antibodies in blood, such as the IgM antibody, against the SARS-CoV-2 virus is another choice for COVID-19 diagnosis, as it is widely accepted that IgM is an important indicator in the acute infection period. In this study, a colloidal gold nanoparticle-based lateral-flow (AuNP-LF) assay was developed to achieve rapid diagnosis and on-site detection of the IgM antibody against the SARS-CoV-2 virus through the indirect immunochromatography method. For preparing AuNP-LF strips, the SARS-CoV-2 nucleoprotein (SARS-CoV-2 NP) was coated on an analytical membrane for sample capture, and antihuman IgM was conjugated with AuNPs to form the detecting reporter. Optimization of AuNP-LF assay was carried out by altering the pH value and the amount of antihuman IgM. The performance of AuNP-LF assay was evaluated by testing serum samples of COVID-19 patients and normal humans. The results were compared with the real-time polymerase chain reaction. The sensitivity and specificity of AuNP-LF assay were determined to be 100 and 93.3%, respectively, and an almost perfect agreement was exhibited by Kappa statistics (\u03ba coefficient = 0.872). AuNP-LF assay showed outstanding selectivity in the detection of IgM against the SARS-CoV-2 virus with no interference from other viruses such as severe fever with thrombocytopenia syndrome virus (SFTSV) and dengue virus (DFV). AuNP-LF assay was able to achieve results within 15 min and needed only 10\u201320 \u03bcL serum for each test. As a whole, in the light of its advantages such as excellent specificity and stability, easy operation, low cost, and being less time-consuming, AuNP-LF assay is a feasible method for the diagnosis of COVID-19 in primary hospitals and laboratories, especially in emergency situations in which numerous samples need to be tested on time.<\/jats:p>","DOI":"10.1021\/acsomega.0c01554","type":"journal-article","created":{"date-parts":[[2020,5,18]],"date-time":"2020-05-18T16:04:48Z","timestamp":1589817888000},"page":"12550-12556","source":"Crossref","is-referenced-by-count":325,"title":["Rapid Detection of IgM Antibodies against the SARS-CoV-2\nVirus via Colloidal Gold Nanoparticle-Based Lateral-Flow Assay"],"prefix":"10.1021","volume":"5","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4061-1573","authenticated-orcid":true,"given":"Chao","family":"Huang","sequence":"first","affiliation":[{"name":"Jiangsu Province Center for Disease Control and Prevention , , , ,","place":["Nanjing, Jiangsu Province, P. R. China, 210009"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tian","family":"Wen","sequence":"additional","affiliation":[{"name":"Jiangsu Province Center for Disease Control and Prevention , , , ,","place":["Nanjing, Jiangsu Province, P. R. China, 210009"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng-Juan","family":"Shi","sequence":"additional","affiliation":[{"name":"Jiangsu Province Center for Disease Control and Prevention , , , ,","place":["Nanjing, Jiangsu Province, P. R. China, 210009"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiao-Yan","family":"Zeng","sequence":"additional","affiliation":[{"name":"Jiangsu Province Center for Disease Control and Prevention , , , ,","place":["Nanjing, Jiangsu Province, P. R. China, 210009"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yong-Jun","family":"Jiao","sequence":"additional","affiliation":[{"name":"Jiangsu Province Center for Disease Control and Prevention , , , ,","place":["Nanjing, Jiangsu Province, P. R. China, 210009"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"316","published-online":{"date-parts":[[2020,5,18]]},"reference":[{"key":"2026090210494765600_cit1","doi-asserted-by":"publisher","first-page":"401","DOI":"10.1002\/jmv.25678","article-title":"Outbreak\nof Pneumonia of Unknown\nEtiology in Wuhan China: the Mystery and the Miracle","volume":"92","author":"Lu","year":"2020","journal-title":"J. Med. Virol."},{"key":"2026090210494765600_cit2","doi-asserted-by":"publisher","first-page":"727","DOI":"10.1056\/nejmoa2001017","article-title":"A Novel Coronavirus\nfrom Patients with Pneumonia in China, 2019","volume":"382","author":"Zhu","year":"2020","journal-title":"N. Engl. J. Med."},{"key":"2026090210494765600_cit3","doi-asserted-by":"publisher","first-page":"1353","DOI":"10.1016\/s0140-6736(03)14630-2","article-title":"Epidemiology and cause\nof severe\nacute respiratory syndrome (SARS) in Guangdong, People\u2019s Republic\nof China, in February, 2003","volume":"362","author":"Zhong","year":"2003","journal-title":"Lancet"},{"key":"2026090210494765600_cit4","doi-asserted-by":"publisher","first-page":"1953","DOI":"10.1056\/nejmoa030781","article-title":"A novel\ncoronavirus associated with severe acute respiratory syndrome","volume":"348","author":"Ksiazek","year":"2003","journal-title":"N. Engl. J. Med."},{"key":"2026090210494765600_cit5","doi-asserted-by":"publisher","first-page":"1967","DOI":"10.1056\/nejmoa030747","article-title":"Identification of\na novel coronavirus in patients with severe acute respiratory syndrome","volume":"348","author":"Drosten","year":"2003","journal-title":"N. Engl. J. 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Res."},{"key":"2026090210494765600_cit11","doi-asserted-by":"publisher","first-page":"457","DOI":"10.1186\/1756-0500-4-457","article-title":"False negative\nresults from using common PCR reagents","volume":"4","author":"Bacich","year":"2011","journal-title":"BMC\nRes. Notes"},{"key":"2026090210494765600_cit12","doi-asserted-by":"publisher","first-page":"505","DOI":"10.3348\/kjr.2020.0146","article-title":"False-Negative\nResults of Real-Time Reverse-Transcriptase\nPolymerase Chain Reaction for Severe Acute Respiratory Syndrome Coronavirus\n2: Role of Deep-Learning-Based CT Diagnosis and Insights from Two\nCases","volume":"21","author":"Li","year":"2020","journal-title":"Korean J. 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Bioelectron."},{"key":"2026090210494765600_cit23","doi-asserted-by":"publisher","first-page":"162","DOI":"10.1002\/bio.3588","article-title":"Rapid detection\nof severe fever with thrombocytopeniasyndrome virus (SFTSV) total\nantibodies by up-converting phosphor technology-based lateral-flow\nassay","volume":"34","author":"Huang","year":"2019","journal-title":"Luminescence"},{"key":"2026090210494765600_cit24","doi-asserted-by":"publisher","first-page":"76","DOI":"10.1039\/c9an01996k","article-title":"Rapid detection of Shiga Toxin type\nII by lateral flow immunochromatography test strips of colorimetry\nand fluorimetry","volume":"145","author":"Lu","year":"2019","journal-title":"Analyst"},{"key":"2026090210494765600_cit25","doi-asserted-by":"publisher","first-page":"734","DOI":"10.1016\/j.bios.2016.05.057","article-title":"Dual FITC lateral flow immunoassay\nfor sensitive detection of Escherichia coli O157:H7 in food samples","volume":"85","author":"Song","year":"2016","journal-title":"Biosens. Bioelectron."},{"key":"2026090210494765600_cit26","doi-asserted-by":"publisher","first-page":"29569","DOI":"10.3390\/s151129569","article-title":"Automated\nlow-cost smartphone-based lateral flow saliva test reader for drugs-of-abuse\ndetection","volume":"15","author":"Carrio","year":"2015","journal-title":"Sensors"},{"key":"2026090210494765600_cit27","doi-asserted-by":"publisher","first-page":"661","DOI":"10.1055\/s-0034-1368589","article-title":"Strips of Hope: Accuracy of Home Pregnancy Tests and\nNew Developments","volume":"74","author":"Gnoth","year":"2014","journal-title":"Geburtshilfe Frauenheilkd."},{"key":"2026090210494765600_cit28","doi-asserted-by":"publisher","first-page":"6781","DOI":"10.1021\/acs.analchem.7b01149","article-title":"Dual recognition element lateral\nflow assay toward\nmultiplex strain specific influenza virus detection","volume":"89","author":"Le","year":"2017","journal-title":"Anal. Chem."},{"key":"2026090210494765600_cit29","doi-asserted-by":"publisher","first-page":"63","DOI":"10.1021\/acsnano.7b07021","article-title":"A Serological\nPoint-of-Care Test\nfor the Detection of IgG Antibodies against Ebola Virus in Human Survivors","volume":"12","author":"Brangel","year":"2018","journal-title":"ACS Nano"},{"key":"2026090210494765600_cit30","doi-asserted-by":"publisher","first-page":"18","DOI":"10.1039\/c7nr06367a","article-title":"Gold nanoparticle-based\ncolorimetric\nbiosensors","volume":"10","author":"Aldewachi","year":"2018","journal-title":"Nanoscale"},{"key":"2026090210494765600_cit31","doi-asserted-by":"publisher","first-page":"2849","DOI":"10.1039\/c1cs15280g","article-title":"Gold nanoparticle-enabled biological and chemical detection and analysis","volume":"41","author":"Jans","year":"2012","journal-title":"Chem. Soc. Rev."},{"key":"2026090210494765600_cit32","doi-asserted-by":"publisher","first-page":"1605","DOI":"10.2174\/1568026615666150414144750","article-title":"Biomedical\nApplications of Gold Nanoparticles","volume":"15","author":"Cabuzu","year":"2015","journal-title":"Curr. Top.\nMed. Chem."},{"key":"2026090210494765600_cit33","doi-asserted-by":"publisher","first-page":"24","DOI":"10.1016\/j.aca.2012.08.043","article-title":"Sensing colorimetric approaches based\non gold and silver nanoparticles aggregation: chemical creativity\nbehind the assay. A review","volume":"751","author":"Vilela","year":"2012","journal-title":"Anal. Chim. Acta"},{"key":"2026090210494765600_cit34","doi-asserted-by":"publisher","DOI":"10.1007\/s11262-020-01742-8","article-title":"Development of a colloidal gold-based\nimmunochromatographic strip test using two monoclonal antibodies to\ndetect H7N9 avian influenza virus","author":"Yang","year":"2020","journal-title":"Virus Genes"},{"key":"2026090210494765600_cit35","doi-asserted-by":"publisher","first-page":"126546","DOI":"10.1016\/j.foodchem.2020.126546","article-title":"Single-chain\nvariable\nfragment antibody-based immunochromatographic strip for rapid detection\nof fumonisin B1 in maize samples","volume":"319","author":"Ren","year":"2020","journal-title":"Food Chem."},{"key":"2026090210494765600_cit36","doi-asserted-by":"publisher","first-page":"110","DOI":"10.1007\/s00604-017-2657-6","article-title":"A lateral flow assay\nfor the determination of human tetanus antibody in whole blood by\nusing gold nanoparticle labeled tetanus antigen","volume":"185","author":"Liu","year":"2018","journal-title":"Mikrochim. Acta"},{"key":"2026090210494765600_cit37","doi-asserted-by":"publisher","first-page":"16026","DOI":"10.1039\/c9nr03740c","article-title":"Homogeneous and high-density gold\nunit implanted optical labels for robust and sensitive point-of-care\ndrug detection","volume":"11","author":"Huang","year":"2019","journal-title":"Nanoscale"},{"key":"2026090210494765600_cit38","doi-asserted-by":"publisher","first-page":"4215","DOI":"10.1021\/ac0702084","article-title":"Determination of\nsize and concentration of gold nanoparticles from UV-vis spectra","volume":"79","author":"Haiss","year":"2007","journal-title":"Anal. Chem."},{"key":"2026090210494765600_cit39","doi-asserted-by":"publisher","first-page":"109","DOI":"10.1007\/978-1-60761-783-9_8","article-title":"Preparation\nof Colloidal Gold Particles and Conjugation to Protein A, IgG, F(ab\u2019)\n2, and Streptavidin","volume":"657","author":"Yokota","year":"2010","journal-title":"Methods Mol. Biol."},{"key":"2026090210494765600_cit40","doi-asserted-by":"publisher","first-page":"45","DOI":"10.1016\/j.colsurfb.2011.09.040","article-title":"Development of a high-performance\nimmunolatex based on \u201csoft landing\u201d antibody immobilization\nmechanism","volume":"99","author":"Yuan","year":"2012","journal-title":"Colloids Surf., B"},{"key":"2026090210494765600_cit41","doi-asserted-by":"publisher","first-page":"1074","DOI":"10.1177\/26.12.366014","article-title":"Ultrastructural\nlocalization of intracellular\nantigens by the use of protein A-gold complex","volume":"26","author":"Roth","year":"1978","journal-title":"J. Histochem. Cytochem."},{"key":"2026090210494765600_cit42","doi-asserted-by":"publisher","first-page":"20","DOI":"10.1038\/physci241020a0","article-title":"Controlled\nNucleation for the Regulation of the Particle Size in Monodisperse\nGold Suspensions","volume":"241","author":"Frens","year":"1973","journal-title":"Nature, Phys. Sci."},{"key":"2026090210494765600_cit43","doi-asserted-by":"publisher","first-page":"3189","DOI":"10.7150\/thno.24034","article-title":"A hook\neffect-free immunochromatographic assay (HEF-ICA) for measuring the\nC-reactive protein concentration in one drop of human serum","volume":"8","author":"Oh","year":"2018","journal-title":"Theranostics"},{"key":"2026090210494765600_cit44","doi-asserted-by":"publisher","first-page":"565","DOI":"10.1016\/S1473-3099(20)30196-1","article-title":"Temporal\nprofiles of viral load in posterior oropharyngeal saliva samples and\nserum antibody responses during infection by SARS-CoV-2: an observational\ncohort study","volume":"20","author":"To","year":"2020","journal-title":"Lancet Infect. Dis."},{"key":"2026090210494765600_cit45","doi-asserted-by":"publisher","first-page":"386","DOI":"10.1080\/22221751.2020.1729071","article-title":"Molecular and serological investigation\nof 2019-nCoV infected patients:\nimplication of multiple shedding routes","volume":"9","author":"Zhang","year":"2020","journal-title":"Emerging\nMicrobes Infect."},{"key":"2026090210494765600_cit46","doi-asserted-by":"publisher","first-page":"735","DOI":"10.1021\/ac00100a008","article-title":"Preparation and\ncharacterization of Au colloid monolayers","volume":"67","author":"Grabar","year":"1995","journal-title":"Anal.\nChem."},{"key":"2026090210494765600_cit47","doi-asserted-by":"publisher","first-page":"372","DOI":"10.1128\/jcm.01319-11","article-title":"Preparation and evaluation\nof recombinant severe fever with thrombocytopenia\nsyndrome virus nucleocapsid protein for detection of total antibodies\nin human and animal sera by double-antigen sandwich enzyme-linked\nimmunosorbent assay","volume":"50","author":"Jiao","year":"2012","journal-title":"J. Clin. Microbiol."}],"container-title":["ACS Omega"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/pubs.acs.org\/doi\/pdf\/10.1021\/acsomega.0c01554","content-type":"application\/pdf","content-version":"vor","intended-application":"unspecified"},{"URL":"https:\/\/pubs.acs.org\/acsodf\/article-pdf\/5\/21\/12550\/67803720\/acsomega.0c01554.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/pubs.acs.org\/acsodf\/article-pdf\/5\/21\/12550\/67803720\/acsomega.0c01554.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,2]],"date-time":"2026-09-02T14:50:16Z","timestamp":1788360616000},"score":1,"resource":{"primary":{"URL":"https:\/\/pubs.acs.org\/acsodf\/article\/5\/21\/12550\/1400407\/Rapid-Detection-of-IgM-Antibodies-against-the-SARS"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,5,18]]},"references-count":47,"journal-issue":{"issue":"21","published-online":{"date-parts":[[2020,5,18]]},"published-print":{"date-parts":[[2020,6,2]]}},"URL":"https:\/\/doi.org\/10.1021\/acsomega.0c01554","relation":{},"ISSN":["2470-1343"],"issn-type":[{"value":"2470-1343","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,5,18]]}}}