{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T11:19:13Z","timestamp":1779103153846,"version":"3.51.4"},"reference-count":29,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2021,12,23]],"date-time":"2021-12-23T00:00:00Z","timestamp":1640217600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2022,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Globally, real\u2010time reverse transcription\u2013polymerase chain reaction (rRT\u2010PCR) is the reference detection technique for SARS\u2010CoV\u20102, which is expensive, time consuming, and requires trained laboratory personnel. Thus, a cost\u2010effective, rapid antigen test is urgently needed. This study evaluated the performance of the rapid antigen tests (RATs) for SARS\u2010CoV\u20102 compared with rRT\u2010PCR, considering different influencing factors.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We enrolled a total of 214\u00a0symptomatic individuals with known COVID\u201019\u00a0status using rRT\u2010PCR. We collected and tested paired nasopharyngeal (NP) and nasal swab (NS) specimens (collected from same individual) using rRT\u2010PCR and RATs (InTec and SD Biosensor). We assessed the performance of RATs considering specimen types, viral load, the onset of symptoms, and presenting symptoms.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We included 214 paired specimens (112\u00a0NP and 100\u00a0NS SARS\u2010CoV\u20102 rRT\u2010PCR positive) to the analysis. For NP specimens, the average sensitivity, specificity, and accuracy of the RATs were 87.5%, 98.6%, and 92.8%, respectively, when compared with rRT\u2010PCR. While for NS, the overall kit performance was slightly lower than that of NP (sensitivity 79.0%, specificity 96.1%, and accuracy 88.3%). We observed a progressive decline in the performance of RATs with increased Ct values (decreased viral load). Moreover, the RAT sensitivity using NP specimens decreased over the time of the onset of symptoms.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The RATs showed strong performance under field conditions and fulfilled the minimum performance limit for rapid antigen detection kits recommended by World Health Organization. The best performance of the RATs can be achieved within the first week of the onset of symptoms with high viral load.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcla.24203","type":"journal-article","created":{"date-parts":[[2021,12,24]],"date-time":"2021-12-24T00:47:52Z","timestamp":1640306872000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Factors influencing the performance of rapid SARS\u2010CoV\u20102 antigen tests under field condition"],"prefix":"10.1002","volume":"36","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7975-9383","authenticated-orcid":false,"given":"Mst. Noorjahan","family":"Begum","sequence":"first","affiliation":[{"name":"Virology Laboratory, Infectious Diseases Division icddr, b: International Centre for Diarrhoeal Disease Research Dhaka Bangladesh"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohammad","family":"Jubair","sequence":"additional","affiliation":[{"name":"Virology Laboratory, Infectious Diseases Division icddr, b: International Centre for Diarrhoeal Disease Research Dhaka Bangladesh"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kamrun","family":"Nahar","sequence":"additional","affiliation":[{"name":"Virology Laboratory, Infectious Diseases Division icddr, b: International Centre for Diarrhoeal Disease Research Dhaka Bangladesh"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0092-9261","authenticated-orcid":false,"given":"Sezanur","family":"Rahman","sequence":"additional","affiliation":[{"name":"Virology Laboratory, Infectious Diseases Division icddr, b: International Centre for Diarrhoeal Disease Research Dhaka Bangladesh"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Muhammad","family":"Talha","sequence":"additional","affiliation":[{"name":"Virology Laboratory, Infectious Diseases Division icddr, b: International Centre for Diarrhoeal Disease Research Dhaka Bangladesh"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Md Safiullah","family":"Sarker","sequence":"additional","affiliation":[{"name":"Virology Laboratory, Infectious Diseases Division icddr, b: International Centre for Diarrhoeal Disease Research Dhaka Bangladesh"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A K M Nasir","family":"Uddin","sequence":"additional","affiliation":[{"name":"DNCC Dedicated Covid\u201019 Hospital Dhaka Bangladesh"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Saifuddin","family":"Khaled","sequence":"additional","affiliation":[{"name":"DNCC Dedicated Covid\u201019 Hospital Dhaka Bangladesh"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohammed Shehab","family":"Uddin","sequence":"additional","affiliation":[{"name":"Kuwait Bangladesh Friendship Government Hospital Dhaka Bangladesh"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zhibiao","family":"Li","sequence":"additional","affiliation":[{"name":"InTec PRODUCTS, INC Fujian China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tianlin","family":"Ke","sequence":"additional","affiliation":[{"name":"InTec PRODUCTS, INC Fujian China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mohammed Ziaur","family":"Rahman","sequence":"additional","affiliation":[{"name":"Virology Laboratory, Infectious Diseases Division icddr, b: International Centre for Diarrhoeal Disease Research Dhaka Bangladesh"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6876-0191","authenticated-orcid":false,"given":"Mustafizur","family":"Rahman","sequence":"additional","affiliation":[{"name":"Virology Laboratory, Infectious Diseases Division icddr, b: International Centre for Diarrhoeal Disease Research Dhaka Bangladesh"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,12,23]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.8259"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.2807\/1560-7917.ES.2020.25.3.2000045"},{"key":"e_1_2_9_4_1","unstructured":"Organization. Laboratory testing strategy recommendations for COVID\u201019: interim guidance [Internet]. World Health.2020;. [cited 21 March 2020]. Available from:https:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/331509\/WHO\u2010COVID\u201019\u2010lab_testing\u20102020.1\u2010eng.pdfhttps:\/\/apps.who.int\/iris\/bitstream\/handle\/10665\/331509\/WHO\u2010COVID\u201019\u2010lab_testing\u20102020.1\u2010eng.pdf"},{"key":"e_1_2_9_5_1","unstructured":"[Internet]. Overview of Testing for SARS\u2010CoV\u20102 (COVID\u201019).2021;.Available from:https:\/\/www.cdc.gov\/coronavirus\/2019\u2010ncov\/hcp\/testing\u2010overview.htmlhttps:\/\/www.cdc.gov\/coronavirus\/2019\u2010ncov\/hcp\/testing\u2010overview.html"},{"key":"e_1_2_9_6_1","article-title":"Rapid, point\u2010of\u2010care antigen and molecular\u2010based tests for diagnosis of SARS\u2010CoV\u20102 infection","volume":"3","author":"Dinnes J","year":"2021","journal-title":"Cochrane Database Syst Rev"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.3390\/v12121420"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(21)00048-7"},{"key":"e_1_2_9_9_1","unstructured":"GOV.UK. Liverpool COVID\u201019 community testing pilot: interim evaluation report summary. 2021"},{"key":"e_1_2_9_10_1","doi-asserted-by":"crossref","unstructured":"PetoT COVID U. COVID\u201019: rapid antigen detection for SARS\u2010CoV\u20102 by lateral flow assay: a national systematic evaluation for mass\u2010testing. medRxiv. 2021;26","DOI":"10.1101\/2021.01.13.21249563"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n208"},{"key":"e_1_2_9_12_1","article-title":"SARS\u2010CoV\u20102 infectivity by viral load, S gene variants and demographic factors and the utility of lateral flow devices to prevent transmission","author":"Lee LY","year":"2021","journal-title":"medRxiv"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(20)30985-3"},{"key":"e_1_2_9_14_1","article-title":"The accuracy of novel antigen rapid diagnostics for SARS\u2010CoV\u20102: a living systematic review and meta\u2010analysis","author":"Bruemmer LE","year":"2021","journal-title":"medRxiv"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12985-020-01452-5"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.heliyon.2021.e08455"},{"key":"e_1_2_9_17_1","unstructured":"2020 WHO Antigen\u2010detection in the diagnosis of SARS\u2010CoV\u20102 infection using rapid immunoassays"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00027-19"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.3855\/jidc.12942"},{"key":"e_1_2_9_20_1","unstructured":"Food and Drug Administration. Policy for coronavirus disease\u20102019 tests during the public health emergency (revised) [Internet]. United States.2020;.Available from:https:\/\/www.hsdl.org\/?view&did=838010https:\/\/www.hsdl.org\/?view&did=838010"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.46234\/ccdcw2020.116"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.3390\/tropicalmed6020041"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/0169-2607(95)01703-8"},{"key":"e_1_2_9_24_1","unstructured":"Nucleic Acid Amplification Tests (NAATs) [Internet]. 2021 [cited June 2021.]. Available from:https:\/\/www.cdc.gov\/coronavirus\/2019\u2010ncov\/lab\/naats.html"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00028-20"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11481-020-09944-5"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamainternmed.2020.3862"},{"key":"e_1_2_9_28_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcla.23745"},{"key":"e_1_2_9_29_1","article-title":"Time scale performance of rapid antigen testing for SARS\u2010COV\u20102: evaluation of ten rapid antigen assays","author":"Abusrewil Z","year":"2021","journal-title":"medRxiv"},{"key":"e_1_2_9_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2666-5247(21)00143-9"}],"container-title":["Journal of Clinical Laboratory Analysis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.24203","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/jcla.24203","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcla.24203","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,27]],"date-time":"2023-08-27T05:49:23Z","timestamp":1693115363000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/jcla.24203"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,12,23]]},"references-count":29,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2022,2]]}},"alternative-id":["10.1002\/jcla.24203"],"URL":"https:\/\/doi.org\/10.1002\/jcla.24203","archive":["Portico"],"relation":{},"ISSN":["0887-8013","1098-2825"],"issn-type":[{"value":"0887-8013","type":"print"},{"value":"1098-2825","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,12,23]]},"assertion":[{"value":"2021-11-16","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-12-14","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-12-23","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e24203"}}