{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T10:05:20Z","timestamp":1791281120358,"version":"4.1.0"},"reference-count":21,"publisher":"American Society for Microbiology","issue":"6","license":[{"start":{"date-parts":[[2025,6,3]],"date-time":"2025-06-03T00:00:00Z","timestamp":1748908800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,6,3]],"date-time":"2025-06-03T00:00:00Z","timestamp":1748908800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"DOI":"10.13039\/100004423","name":"World Health Organization","doi-asserted-by":"publisher","award":["2020\/1033973-0"],"award-info":[{"award-number":["2020\/1033973-0"]}],"id":[{"id":"10.13039\/100004423","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Microbiol Spectr"],"published-print":{"date-parts":[[2025,6,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title\/>\n                    <jats:p>\n                      Leptospirosis is an endemic zoonotic disease with protean clinical manifestations caused by pathogenic spirochetes of the\n                      <jats:italic toggle=\"yes\">Leptospira<\/jats:italic>\n                      genus. The microscopic agglutination test (MAT) is the gold standard for leptospirosis diagnosis and can only be conducted in a reference laboratory. Therefore, alternative tests, such as the IgM anti-\n                      <jats:italic toggle=\"yes\">Leptospira<\/jats:italic>\n                      rapid diagnostic test (RDT), are preferred for general use. In this study, we aimed to compare the accuracy of four products of anti-\n                      <jats:italic toggle=\"yes\">Leptospira<\/jats:italic>\n                      IgM detection RDTs, which are available in Indonesia, against the gold standard of\n                      <jats:italic toggle=\"yes\">Leptospira<\/jats:italic>\n                      MAT. This study was a diagnostic validation test using bioarchived serum from 364 human serum samples tested by MAT from August to September 2020 in Demak, Central Java, Indonesia. The four products were (i) Fokus\n                      <jats:italic toggle=\"yes\">Leptospira<\/jats:italic>\n                      , (ii) Answer\n                      <jats:italic toggle=\"yes\">Leptospira<\/jats:italic>\n                      , (iii) SD Bioline\n                      <jats:italic toggle=\"yes\">Leptospira<\/jats:italic>\n                      IgG\/IgM, and (iv) Uji\n                      <jats:italic toggle=\"yes\">Leptospira<\/jats:italic>\n                      IgM, sequentially renamed RDT-1 to RDT-4. Interobserver agreements were analyzed using the kappa value. The diagnostic performance of the four RDTs were compared against MAT results as the gold standard. We also evaluated the combination of two RDTs\u2019 performance, which were RDT (1 + 2), RDT (1 + 3), RDT (1 + 4), RDT (2 + 4), and RDT (3 + 4). We found that the kappa coefficients of RDT-1, RDT-2, and RDT-4 were greater than 80%, while RDT-3 had a moderate kappa value of 69.1%. RDT-1, RDT-2, and RDT-4 had moderate to good sensitivities of 78.2%, 74.3%, and 83.6%, respectively, while RDT-3 had the lowest sensitivity at 30.9%. RDT-3 demonstrated the highest specificity. RDT-2 showed the highest predictive value at 75.9%, while RDT-4 showed the highest negative predictive value at 96.9%. In addition, the combination of two RTDs provided better diagnostic performances. The four RDTs performed varied in their ability to diagnose leptospirosis, but only RDT-4 showed a sensitivity of more than 80%. We recommend caution in diagnosing only one RDT result. Testing by other RDTs and confirmation by MAT are strongly recommended.\n                    <\/jats:p>\n                    <jats:sec>\n                      <jats:title>IMPORTANCE<\/jats:title>\n                      <jats:p>\n                        The performance of the anti-\n                        <jats:italic toggle=\"yes\">Leptospira<\/jats:italic>\n                        IgM antibody rapid diagnostic tests (RDTs) has yet to be evaluated. In this study, we compare the accuracy of these four RDTs available in Indonesia against the gold standard of\n                        <jats:italic toggle=\"yes\">Leptospira<\/jats:italic>\n                        microscopic agglutination test (MAT). Utilizing the best performance of RDT in the point of care with limited facilities will be effective since MAT is complicated, laborious, and time-consuming if done at public health centers. The MAT requires maintaining the culture of each live\n                        <jats:italic toggle=\"yes\">Leptospira<\/jats:italic>\n                        strain circulating in the region and needs trained personnel.\n                      <\/jats:p>\n                    <\/jats:sec>\n                  <\/jats:sec>","DOI":"10.1128\/spectrum.01524-24","type":"journal-article","created":{"date-parts":[[2025,4,30]],"date-time":"2025-04-30T21:08:54Z","timestamp":1746047334000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":2,"title":["Accuracy of four rapid diagnostic tests (RDTs) for human leptospirosis diagnosis in Indonesia"],"prefix":"10.1128","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8540-2700","authenticated-orcid":true,"given":"Farida","family":"Handayani","sequence":"first","affiliation":[{"name":"Doctoral Program in Biomedical Sciences, Faculty of Medicine, University of Indonesia","place":["Jakarta, Indonesia"]},{"id":[{"id":"https:\/\/ror.org\/02hmjzt55","id-type":"ROR","asserted-by":"publisher"}],"name":"Eijkman Research Center for Molecular Biology-Indonesian National Research and Innovation Agency (BRIN)","place":["Jakarta, Indonesia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Endah Tri","family":"Widanarti","sequence":"additional","affiliation":[{"name":"Research Center for Care and Control of Infectious Disease (RC3ID) Universitas Padjadjaran","place":["Bandung, Indonesia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Citra W.","family":"Kusuma","sequence":"additional","affiliation":[{"name":"Ministry of the Health Republic of Indonesia, NIHRD IVRCRD","place":["Salatiga, Indonesia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ristiyanto","family":"Ristiyanto","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/02hmjzt55","id-type":"ROR","asserted-by":"publisher"}],"name":"Research Center for Public Health and Nutrition, National Research and Innovation Agency (BRIN)","place":["Jakarta, Indonesia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5856-4808","authenticated-orcid":true,"given":"Amin","family":"Soebandrio","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/0116zj450","id-type":"ROR","asserted-by":"publisher"}],"name":"Department of Clinical Microbiology, Faculty of Medicine, University of Indonesia-Dr. Cipto Mangunkusumo Hospital","place":["Jakarta, Indonesia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muhammad Hussein","family":"Gasem","sequence":"additional","affiliation":[{"id":[{"id":"https:\/\/ror.org\/040f86t49","id-type":"ROR","asserted-by":"publisher"}],"name":"Division of Infectious Diseases and Tropical Medicine, Dr. Kariadi Hospital","place":["Semarang, Indonesia"]},{"name":"Faculty of Medicine, Universitas Gunung Jati (UGJ)","place":["Cirebon, Indonesia"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_4_2_2","unstructured":"Day N Calderwood SB Hall KK. 2023. Leptospirosis epidemiology microbiology clinical manifestations and diagnosis. Available from: https:\/\/www.uptodate.com\/contents\/leptospirosis-epidemiology-microbiology-clinical-manifestations-and-diagnosis. Retrieved 25 Apr 2023."},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1590\/s1678-9946201860023"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0003898"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0004122"},{"key":"e_1_3_4_6_2","unstructured":"CDC. 2018. Leptospirosis: fact sheet for clinicians. Available from: https:\/\/www.cdc.gov\/leptospirosis\/pdf\/fs-leptospirosis-clinicians-eng-508. Retrieved 25 Apr 2023."},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0003843"},{"key":"e_1_3_4_8_2","unstructured":"CDC. 2019. Signs and symptoms leptospirosis. Available from: https:\/\/www.cdc.gov\/leptospirosis\/symptoms\/index.html. Retrieved 25 Apr 2023."},{"key":"e_1_3_4_9_2","unstructured":"WHO and ILS. 2003. Human leptospirosis: guidance for diagnosis surveillance and control. WHO library cataloging-in-publication data World Health Organization (WHO) and International Leptospirosis Society (ILS) Vancouver Canada. Available from: https:\/\/apps.who.int\/iris\/handle\/10665\/42667"},{"key":"e_1_3_4_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.biologicals.2013.06.010"},{"key":"e_1_3_4_11_2","article-title":"Assessment of The Efficacy of An IgM ELISA and Microscopic Agglutination Test (MAT) in The Diagnosis of Acute Leptospirosis","author":"Cumberland P","year":"2005","unstructured":"Cumberland P, Everard COR, Levett PN. 2005. Assessment of The Efficacy of An IgM ELISA and Microscopic Agglutination Test (MAT) in The Diagnosis of Acute Leptospirosis. Am J Trop Med Hyg","journal-title":"Am J Trop Med Hyg"},{"key":"e_1_3_4_12_2","unstructured":"Fokus Diagnostic. Leptospira IgM Cassette. Available from: https:\/\/e-katalog.lkpp.go.id\/katalog\/produk\/detail\/55238229?lang=id&type=general. Retrieved 13 Dec 2023."},{"key":"e_1_3_4_13_2","unstructured":"Answer Leptospira IgG\/IgM Combo Rapid Test. Available from: https:\/\/fdokumen.com\/document\/answer-leptospira-igg-igm-combo-rapid-answer-leptospira-igg-igm-combo-rapid.html?page=1. Retrieved 13 Dec 2023."},{"key":"e_1_3_4_14_2","unstructured":"Pakar Biomedika Indonesia. Uji Leptospira IgM. Available from: https:\/\/pakarbiomedika.co.id\/img\/cms\/PI\/PI-Leptospira.pdf. Retrieved 19 Apr 2023."},{"key":"e_1_3_4_15_2","unstructured":"SD Bioline Leptospira series. Retrieved 19 Apr 2023. https:\/\/maxanim.com\/content\/abbott\/SD-bioline\/SD-bioline-leptospira-series.pdf."},{"key":"e_1_3_4_16_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0002290"},{"key":"e_1_3_4_17_2","doi-asserted-by":"crossref","unstructured":"Sulistyawati NT Mardenta RN. 2016. Spatial analysis of leptospirosis disease in bantul regency yogyakarta. Available from: http:\/\/journal.unnes.ac.id\/nju\/index.php\/kemas","DOI":"10.15294\/kemas.v12i1.4615"},{"key":"e_1_3_4_18_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12879-020-4903-5"},{"key":"e_1_3_4_19_2","doi-asserted-by":"publisher","DOI":"10.4269\/ajtmh.17-0702"},{"key":"e_1_3_4_20_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2013.09.012"},{"key":"e_1_3_4_21_2","doi-asserted-by":"crossref","unstructured":"LandisJR Koch GG. 1977. The measurement of observer agreement for categorical data. Available from: https:\/\/pubmed.ncbi.nlm.nih.gov\/843571\/","DOI":"10.2307\/2529310"},{"key":"e_1_3_4_22_2","doi-asserted-by":"publisher","DOI":"10.1128\/CVI.00219-06"}],"container-title":["Microbiology Spectrum"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.01524-24","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/spectrum.01524-24","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,6,3]],"date-time":"2025-06-03T09:02:45Z","timestamp":1748941365000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/spectrum.01524-24"}},"subtitle":[],"editor":[{"given":"Remi N.","family":"Charrel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2025,6,3]]},"references-count":21,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2025,6,3]]}},"alternative-id":["10.1128\/spectrum.01524-24"],"URL":"https:\/\/doi.org\/10.1128\/spectrum.01524-24","relation":{},"ISSN":["2165-0497"],"issn-type":[{"value":"2165-0497","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,6,3]]},"assertion":[{"value":"2024-07-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-01-30","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e01524-24"}}