{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T16:16:39Z","timestamp":1767802599299,"version":"3.49.0"},"reference-count":92,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,7]]},"abstract":"<jats:title>ABSTRACT.<\/jats:title>\n                  <jats:p>\n                    The ambiguous clinical presentation of leptospirosis poses challenges for accurately assessing the global burden of this emerging disease. As a result, leptospirosis has not been recognized for inclusion in the WHO\u2019s neglected tropical diseases list. This underscores the urgent need for a diagnostic biomarker for early detection of illness and well-defined estimation of disease burden in urban and low-income settings. The recently discovered\n                    <jats:italic>PF07598<\/jats:italic>\n                    gene family encoding virulence-modifying proteins (VMPs), including full-length LA3490, its truncated N-terminal ricin-binding lectin (RBL) domain, and a natural variant encoding only the C-terminal domain (LA0591), was evaluated for its potential to detect anti-VMP-specific IgG antibodies in early infection. The study was conducted on a well-characterized sample of febrile patients from Sri Lanka, with leptospirosis confirmation by microscopic agglutination test (MAT) and Quantitative PCR. The sample included 113 confirmed cases, 45 probable cases, 75 febrile patients, and 41 healthy subjects. Among confirmed cases, mean ELISA optical density (OD) values for LA0591, LA3490, and RBLs were 1.045 (standard error [SE]: 0.063), 0.835 (SE: 0.032), and 0.536 (SE: 0.019), respectively, compared with 0.261 (SE: 0.043), 0.697 (SE: 0.026), and 0.303 (SE: 0.019) in healthy subjects. Anti-VMP antibodies were detectable as early as day 2. In seroconversion cases, ELISA OD for LA0591 in acute MAT-negative samples was 1.347, comparable with high MAT titers. ROC analysis showed AUCs of 0.947 for LA0591 and 0.930 for LA3490, confirming their reliability as diagnostic markers. LA0591 demonstrated superior sensitivity, specificity, and early diagnostic capability, establishing it as a valuable tool for leptospirosis detection.\n                  <\/jats:p>","DOI":"10.4269\/ajtmh.25-0510","type":"journal-article","created":{"date-parts":[[2025,11,6]],"date-time":"2025-11-06T17:04:02Z","timestamp":1762448642000},"page":"17-26","source":"Crossref","is-referenced-by-count":0,"title":["Early Diagnosis of Human Leptospirosis by Detection of Antibodies to Leptospira-Secreted Virulence-Modifying Protein Exotoxins"],"prefix":"10.4269","volume":"114","author":[{"given":"Reetika","family":"Chaurasia","sequence":"first","affiliation":[{"name":"Section of Infectious Diseases, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suneth","family":"Agampodi","sequence":"additional","affiliation":[{"name":"Section of Infectious Diseases, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut;"},{"name":"New Initiatives, International Vaccine Institute, Seoul, South Korea;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jane","family":"O\u2019Bryan","sequence":"additional","affiliation":[{"name":"Section of Infectious Diseases, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Janith","family":"Warnasekara","sequence":"additional","affiliation":[{"name":"Leptospirosis Research Laboratory, Department of Community Medicine, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Mihintale, Sri Lanka"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dinesha","family":"Jayasundara","sequence":"additional","affiliation":[{"name":"Leptospirosis Research Laboratory, Department of Community Medicine, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Mihintale, Sri Lanka"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Indika","family":"Senewirathna","sequence":"additional","affiliation":[{"name":"Leptospirosis Research Laboratory, Department of Community Medicine, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Mihintale, Sri Lanka"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph M.","family":"Vinetz","sequence":"additional","affiliation":[{"name":"Section of Infectious Diseases, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut;"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2795","reference":[{"key":"b1","series-title":"PLoS Negl Trop Dis","first-page":"e0003898","article-title":"Global morbidity and mortality of leptospirosis: A systematic review","volume":"9","author":"Costa","year":"2015"},{"key":"b2","series-title":"PLoS Negl Trop Dis","first-page":"e0004122","article-title":"Global burden of leptospirosis: Estimated in terms of disability adjusted life years","volume":"9","author":"Torgerson","year":"2015"},{"key":"b3","series-title":"Lancet","first-page":"200","article-title":"Global, regional, and national sepsis incidence and mortality, 1990\u20132017: Analysis for the Global Burden of Disease Study","volume":"395","author":"Rudd","year":"2020"},{"key":"b4","series-title":"PLoS Negl Trop Dis","first-page":"e0011291","article-title":"Global, regional, and country-level cost of leptospirosis due to loss of productivity in humans","volume":"17","author":"Agampodi","year":"2023"},{"key":"b5","series-title":"PLoS Negl Trop Dis","first-page":"e0010331","article-title":"Diagnostic method-based underestimation of leptospirosis in clinical and research settings; an experience from a large prospective study in a high endemic setting","volume":"16","author":"Warnasekara","year":"2022"},{"key":"b6","series-title":"Biomed J","first-page":"24","article-title":"Leptospirosis is an invasive infectious and systemic inflammatory disease","volume":"43","author":"Sun","year":"2020"},{"key":"b7","series-title":"J Am Vet Med Assoc","first-page":"472","article-title":"Leptospirosis","volume":"234","author":"Guerra","year":"2009"},{"key":"b8","series-title":"Lancet Infect Dis","first-page":"757","article-title":"Leptospirosis: A zoonotic disease of global importance","volume":"3","author":"Bharti","year":"2003"},{"key":"b9","series-title":"Nat Rev Microbiol","first-page":"297","article-title":"Virulence of the zoonotic agent of leptospirosis: Still terra incognita?","volume":"15","author":"Picardeau","year":"2017"},{"key":"b10","series-title":"J Exp Med","first-page":"755","article-title":"Spirochaeta icterohaemorrhagiae in American wild rats and its relation to the Japanese and European strains: First paper","volume":"25","author":"Noguchi","year":"1917"},{"key":"b11","series-title":"J Exp Med","first-page":"87","article-title":"Etiology of yellow fever: VII. Demonstration of Leptospira icteroides in the blood, tissues, and urine of yellow fever patients and of animals experimentally infected with the organism","volume":"30","author":"Noguchi","year":"1919"},{"key":"b12","series-title":"J Exp Med","first-page":"13","article-title":"Etiology of yellow fever: VI. Cultivation, morphology, virulence, and biological properties of Leptospira icteroides","volume":"30","author":"Noguchi","year":"1919"},{"key":"b13","series-title":"J Exp Med","first-page":"377","article-title":"The etiology, mode of infection, and specific therapy of Weil\u2019s disease (spirochaetosis icterohaemorrhagica)","volume":"23","author":"Inada","year":"1916"},{"key":"b14","series-title":"PLoS Negl Trop Dis","first-page":"e0004403","article-title":"What makes a bacterial species pathogenic?: Comparative genomic analysis of the genus Leptospira.","volume":"10","author":"Fouts","year":"2016"},{"key":"b15","series-title":"PLoS Negl Trop Dis","first-page":"e2468","article-title":"Pathogenomic inference of virulence-associated genes in Leptospira interrogans.","volume":"7","author":"Lehmann","year":"2013"},{"key":"b16","series-title":"Front Microbiol","first-page":"859680","article-title":"Pathogenic Leptospira evolved a unique gene family comprised of ricin B-like lectin domain-containing cytotoxins","volume":"13","author":"Chaurasia","year":"2022"},{"key":"b17","series-title":"Front Mol Biosci","first-page":"1092197","article-title":"In silico prediction of molecular mechanisms of toxicity mediated by the leptospiral PF07598 gene family-encoded virulence-modifying proteins","volume":"9","author":"Chaurasia","year":"2022"},{"key":"b18","series-title":"Front Cell Infect Microbiol","first-page":"926994","article-title":"Vaccination with Leptospira interrogans PF07598 gene family-encoded virulence modifying proteins protects mice from severe leptospirosis and reduces bacterial load in the liver and kidney","volume":"12","author":"Chaurasia","year":"2022"},{"key":"b19","series-title":"PLoS Negl Trop Dis","first-page":"e0009471","article-title":"Correction: 12 Novel clonal groups of Leptospira infecting humans in multiple contrasting epidemiological contexts in Sri Lanka","volume":"15","author":"Jayasundara","year":"2021"},{"key":"b20","series-title":"BMJ 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genetics era for an emerging zoonotic pathogen","volume":"7","author":"Ko","year":"2009"},{"key":"b28","series-title":"Curr Top Microbiol Immunol","first-page":"65","article-title":"Leptospirosis in humans","volume":"387","author":"Haake","year":"2015"},{"key":"b29","series-title":"Clin Microbiol Rev","first-page":"296","article-title":"Leptospirosis","volume":"14","author":"Levett","year":"2001"},{"key":"b30","series-title":"Indian J Med Res","first-page":"9","article-title":"Outbreak of leptospirosis with pulmonary involvement in north Andaman","volume":"102","author":"Sehgal","year":"1995"},{"key":"b31","series-title":"Future Microbiol","first-page":"1413","article-title":"Leptospira as an emerging pathogen: A review of its biology, pathogenesis and host immune responses","volume":"5","author":"Evangelista","year":"2010"},{"key":"b32","series-title":"J Proteomics","first-page":"105106","article-title":"Proteomic profiles of Leptospira borgpetersenii serovar Hardjo strains JB197 and HB203 cultured at different temperatures","volume":"295","author":"Putz","year":"2024"},{"key":"b33","series-title":"Biomed Res Int","first-page":"592858","article-title":"Production and characterization of a polyclonal antibody of anti-rLipL21-IgG against leptospira for early detection of acute leptospirosis","volume":"2014","author":"Seenichamy","year":"2014"},{"key":"b34","series-title":"J Clin Microbiol","first-page":"1528","article-title":"Leptospira immunoglobulin-like proteins as a serodiagnostic marker for acute leptospirosis","volume":"45","author":"Croda","year":"2007"},{"key":"b35","series-title":"Asian Pac J Allergy Immunol","first-page":"133","article-title":"LipL32, an outer membrane protein of Leptospira, as an antigen in a dipstick assay for diagnosis of leptospirosis","volume":"23","author":"Boonyod","year":"2005"},{"key":"b36","series-title":"J Clin Microbiol","first-page":"3303","article-title":"Evaluation of recombinant Leptospira antigen-based enzyme-linked immunosorbent assays for the serodiagnosis of leptospirosis","volume":"39","author":"Flannery","year":"2001"},{"key":"b37","series-title":"Comp Immunol Microbiol Infect Dis","first-page":"269","article-title":"Evaluation of a recombinant LipL41 antigen of Leptospira interrogans serovar canicola in ELISA for serodiagnosis of bovine leptospirosis","volume":"29","author":"Mariya","year":"2006"},{"key":"b38","series-title":"Zh Mikrobiol Epidemiol Immunobiol","first-page":"79","article-title":"Feasibility to use of recombinant domains of immunoglobulin-like protein LigA as a promising marker for serological testing of patients with leptospirosis","volume":"2","author":"Sharapova","year":"2010"},{"key":"b39","series-title":"DNA Cell Biol","first-page":"903","article-title":"Expression and immunologic characterization of recombinant heat shock protein 58 of Leptospira species: A major target antigen of the humoral immune response","volume":"18","author":"Park","year":"1999"},{"key":"b40","series-title":"Vaccine","first-page":"1545","article-title":"Leptospiral immunoglobulin-like proteins elicit protective immunity","volume":"22","author":"Koizumi","year":"2004"},{"key":"b41","series-title":"Clin Vaccine Immunol","first-page":"478","article-title":"Serodiagnosis of equine leptospirosis by enzyme-linked immunosorbent assay using four recombinant protein markers","volume":"21","author":"Ye","year":"2014"},{"key":"b42","series-title":"PLoS One","first-page":"e111367","article-title":"Recombinant antigens rLipL21, rLoa22, rLipL32 and rLigACon4-8 for serological diagnosis of leptospirosis by enzyme-linked immunosorbent assays in dogs","volume":"9","author":"Ye","year":"2014"},{"key":"b43","series-title":"Microbiology (Reading)","first-page":"1023","article-title":"Evaluation of a novel outer membrane surface-exposed protein, LIC13341 of Leptospira, as an adhesin and serodiagnostic candidate marker for leptospirosis","volume":"164","author":"Ghosh","year":"2018"},{"key":"b44","series-title":"Trop Med Infect Dis","first-page":"362","article-title":"A new recombinant multiepitope chimeric protein of Leptospira interrogans is a promising marker for the serodiagnosis of leptospirosis","volume":"7","author":"Fernandes","year":"2022"},{"key":"b45","series-title":"BMC Vet Res","first-page":"288","article-title":"Identification of immunodominant antigens in canine leptospirosis by Multi-Antigen Print ImmunoAssay (MAPIA)","volume":"10","author":"Thome","year":"2014"},{"key":"b46","series-title":"Int J Res Med Sci","first-page":"646","article-title":"Proteinuria in early detection of human leptospirosis","volume":"5","author":"KC","year":"2017"},{"key":"b1","series-title":"PLoS Negl Trop Dis","first-page":"e0003898","article-title":"Global morbidity and mortality of leptospirosis: A systematic review","volume":"9","author":"Costa","year":"2015"},{"key":"b2","series-title":"PLoS Negl Trop Dis","first-page":"e0004122","article-title":"Global burden of leptospirosis: Estimated in terms of disability adjusted life years","volume":"9","author":"Torgerson","year":"2015"},{"key":"b3","series-title":"Lancet","first-page":"200","article-title":"Global, regional, and national sepsis incidence and mortality, 1990\u20132017: Analysis for the Global Burden of Disease Study","volume":"395","author":"Rudd","year":"2020"},{"key":"b4","series-title":"PLoS Negl Trop Dis","first-page":"e0011291","article-title":"Global, regional, and country-level cost of leptospirosis due to loss of productivity in humans","volume":"17","author":"Agampodi","year":"2023"},{"key":"b5","series-title":"PLoS Negl Trop Dis","first-page":"e0010331","article-title":"Diagnostic method-based underestimation of leptospirosis in clinical and research settings; an experience from a large prospective study in a high endemic setting","volume":"16","author":"Warnasekara","year":"2022"},{"key":"b6","series-title":"Biomed J","first-page":"24","article-title":"Leptospirosis is an invasive infectious and systemic inflammatory disease","volume":"43","author":"Sun","year":"2020"},{"key":"b7","series-title":"J Am Vet Med Assoc","first-page":"472","article-title":"Leptospirosis","volume":"234","author":"Guerra","year":"2009"},{"key":"b8","series-title":"Lancet Infect Dis","first-page":"757","article-title":"Leptospirosis: A zoonotic disease of global importance","volume":"3","author":"Bharti","year":"2003"},{"key":"b9","series-title":"Nat Rev Microbiol","first-page":"297","article-title":"Virulence of the zoonotic agent of leptospirosis: Still terra incognita?","volume":"15","author":"Picardeau","year":"2017"},{"key":"b10","series-title":"J Exp Med","first-page":"755","article-title":"Spirochaeta icterohaemorrhagiae in American wild rats and its relation to the Japanese and European strains: First paper","volume":"25","author":"Noguchi","year":"1917"},{"key":"b11","series-title":"J Exp Med","first-page":"87","article-title":"Etiology of yellow fever: VII. Demonstration of Leptospira icteroides in the blood, tissues, and urine of yellow fever patients and of animals experimentally infected with the organism","volume":"30","author":"Noguchi","year":"1919"},{"key":"b12","series-title":"J Exp Med","first-page":"13","article-title":"Etiology of yellow fever: VI. Cultivation, morphology, virulence, and biological properties of Leptospira icteroides","volume":"30","author":"Noguchi","year":"1919"},{"key":"b13","series-title":"J Exp Med","first-page":"377","article-title":"The etiology, mode of infection, and specific therapy of Weil\u2019s disease (spirochaetosis icterohaemorrhagica)","volume":"23","author":"Inada","year":"1916"},{"key":"b14","series-title":"PLoS Negl Trop Dis","first-page":"e0004403","article-title":"What makes a bacterial species pathogenic?: Comparative genomic analysis of the genus Leptospira.","volume":"10","author":"Fouts","year":"2016"},{"key":"b15","series-title":"PLoS Negl Trop Dis","first-page":"e2468","article-title":"Pathogenomic inference of virulence-associated genes in Leptospira interrogans.","volume":"7","author":"Lehmann","year":"2013"},{"key":"b16","series-title":"Front Microbiol","first-page":"859680","article-title":"Pathogenic Leptospira evolved a unique gene family comprised of ricin B-like lectin domain-containing cytotoxins","volume":"13","author":"Chaurasia","year":"2022"},{"key":"b17","series-title":"Front Mol Biosci","first-page":"1092197","article-title":"In silico prediction of molecular mechanisms of toxicity mediated by the leptospiral PF07598 gene family-encoded virulence-modifying proteins","volume":"9","author":"Chaurasia","year":"2022"},{"key":"b18","series-title":"Front Cell Infect Microbiol","first-page":"926994","article-title":"Vaccination with Leptospira interrogans PF07598 gene family-encoded virulence modifying proteins protects mice from severe leptospirosis and reduces bacterial load in the liver and kidney","volume":"12","author":"Chaurasia","year":"2022"},{"key":"b19","series-title":"PLoS Negl Trop Dis","first-page":"e0009471","article-title":"Correction: 12 Novel clonal groups of Leptospira infecting humans in multiple contrasting epidemiological contexts in Sri Lanka","volume":"15","author":"Jayasundara","year":"2021"},{"key":"b20","series-title":"BMJ Open","first-page":"e027850","article-title":"Study protocol: Characterising the clinical, epidemiological and aetiological aspects of leptospirosis in Sri Lanka: A hospital based clinico-epidemiological study","volume":"9","author":"Agampodi","year":"2019"},{"key":"b21","series-title":"PLoS Negl Trop Dis","first-page":"e0009565","article-title":"Optimizing the microscopic agglutination test (MAT) panel for the diagnosis of Leptospirosis in a low resource, hyper-endemic setting with varied microgeographic variation in reactivity","volume":"15","author":"Jayasundara","year":"2021"},{"key":"b22","series-title":"Data Brief","first-page":"108378","article-title":"Demographic, exposure, clinical, biochemical and diagnostic data of febrile patients recruited for the largest field study on leptospirosis in Sri Lanka","volume":"43","author":"Agampodi","year":"2022"},{"key":"b23","series-title":"Protein J","first-page":"792","article-title":"Production and purification of cysteine-rich leptospiral virulence-modifying proteins with or without mCherry fusion","volume":"42","author":"Chaurasia","year":"2023"},{"key":"b24","series-title":"Nature","first-page":"680","article-title":"Cleavage of structural proteins during the assembly of the head of bacteriophage T4","volume":"227","author":"Laemmli","year":"1970"},{"key":"b25","series-title":"PLoS One","first-page":"e0129236","article-title":"Diagnosis of leptospirosis: Comparison between microscopic agglutination test, IgM-ELISA and IgM rapid immunochromatography test","volume":"10","author":"Niloofa","year":"2015"},{"key":"b26","series-title":"Eur J Clin Microbiol Infect Dis","first-page":"423","article-title":"Pathogen-specific leptospiral proteins in urine of patients with febrile illness aids in differential diagnosis of leptospirosis from dengue","volume":"37","author":"Chaurasia","year":"2018"},{"key":"b27","series-title":"Nat Rev Microbiol","first-page":"736","article-title":"Leptospira: The dawn of the molecular genetics era for an emerging zoonotic pathogen","volume":"7","author":"Ko","year":"2009"},{"key":"b28","series-title":"Curr Top Microbiol Immunol","first-page":"65","article-title":"Leptospirosis in humans","volume":"387","author":"Haake","year":"2015"},{"key":"b29","series-title":"Clin Microbiol Rev","first-page":"296","article-title":"Leptospirosis","volume":"14","author":"Levett","year":"2001"},{"key":"b30","series-title":"Indian J Med Res","first-page":"9","article-title":"Outbreak of leptospirosis with pulmonary involvement in north Andaman","volume":"102","author":"Sehgal","year":"1995"},{"key":"b31","series-title":"Future Microbiol","first-page":"1413","article-title":"Leptospira as an emerging pathogen: A review of its biology, pathogenesis and host immune responses","volume":"5","author":"Evangelista","year":"2010"},{"key":"b32","series-title":"J Proteomics","first-page":"105106","article-title":"Proteomic profiles of Leptospira borgpetersenii serovar Hardjo strains JB197 and HB203 cultured at different temperatures","volume":"295","author":"Putz","year":"2024"},{"key":"b33","series-title":"Biomed Res Int","first-page":"592858","article-title":"Production and characterization of a polyclonal antibody of anti-rLipL21-IgG against leptospira for early detection of acute leptospirosis","volume":"2014","author":"Seenichamy","year":"2014"},{"key":"b34","series-title":"J Clin Microbiol","first-page":"1528","article-title":"Leptospira immunoglobulin-like proteins as a serodiagnostic marker for acute leptospirosis","volume":"45","author":"Croda","year":"2007"},{"key":"b35","series-title":"Asian Pac J Allergy Immunol","first-page":"133","article-title":"LipL32, an outer membrane protein of Leptospira, as an antigen in a dipstick assay for diagnosis of leptospirosis","volume":"23","author":"Boonyod","year":"2005"},{"key":"b36","series-title":"J Clin Microbiol","first-page":"3303","article-title":"Evaluation of recombinant Leptospira antigen-based enzyme-linked immunosorbent assays for the serodiagnosis of leptospirosis","volume":"39","author":"Flannery","year":"2001"},{"key":"b37","series-title":"Comp Immunol Microbiol Infect Dis","first-page":"269","article-title":"Evaluation of a recombinant LipL41 antigen of Leptospira interrogans serovar canicola in ELISA for serodiagnosis of bovine leptospirosis","volume":"29","author":"Mariya","year":"2006"},{"key":"b38","series-title":"Zh Mikrobiol Epidemiol Immunobiol","first-page":"79","article-title":"Feasibility to use of recombinant domains of immunoglobulin-like protein LigA as a promising marker for serological testing of patients with leptospirosis","volume":"2","author":"Sharapova","year":"2010"},{"key":"b39","series-title":"DNA Cell Biol","first-page":"903","article-title":"Expression and immunologic characterization of recombinant heat shock protein 58 of Leptospira species: A major target antigen of the humoral immune response","volume":"18","author":"Park","year":"1999"},{"key":"b40","series-title":"Vaccine","first-page":"1545","article-title":"Leptospiral immunoglobulin-like proteins elicit protective immunity","volume":"22","author":"Koizumi","year":"2004"},{"key":"b41","series-title":"Clin Vaccine Immunol","first-page":"478","article-title":"Serodiagnosis of equine leptospirosis by enzyme-linked immunosorbent assay using four recombinant protein markers","volume":"21","author":"Ye","year":"2014"},{"key":"b42","series-title":"PLoS One","first-page":"e111367","article-title":"Recombinant antigens rLipL21, rLoa22, rLipL32 and rLigACon4-8 for serological diagnosis of leptospirosis by enzyme-linked immunosorbent assays in dogs","volume":"9","author":"Ye","year":"2014"},{"key":"b43","series-title":"Microbiology (Reading)","first-page":"1023","article-title":"Evaluation of a novel outer membrane surface-exposed protein, LIC13341 of Leptospira, as an adhesin and serodiagnostic candidate marker for 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