title: Clinical Evaluation of Rapid Diagnostic Test Kit Using the Polysaccharide as a Genus-Specific Diagnostic Antigen for Leptospirosis in Korea, Bulgaria, and Argentina.
abstract: Leptospirosis, a zoonotic disease that is caused by many serovars which are more than 200 in the world, is an emerging worldwide disease. Accurate and rapid diagnostic tests for leptospirosis are a critical step to diagnose the disease. There are some commercial kits available for diagnosis of leptospirosis, but the obscurity of a species- or genus-specific antigen of pathogenic Leptospira interrogans causes the reduced sensitivity and specificity. In this study, the polysaccharide derived from lipopolysaccharide (LPS) of nonpathogenic Leptospira biflexa serovar patoc was prepared, and the antigenicity was confirmed by immunoblot and enzyme linked immunosorbent assay (ELISA). The performance of the rapid diagnostic test (RDT) kit using the polysaccharide as a diagnostic antigen was evaluated in Korea, Bulgaria and Argentina. The sensitivity was 93.9%, 100%, and 81.0% and the specificity was 97.9%, 100%, and 95.4% in Korea (which is a rare region occurring with 2 serovars mostly), Bulgaria (epidemic region with 3 serovars chiefly) and Argentina (endemic region with 19 serovars mainly) respectively. These results indicate that this RDT is applicable for global diagnosis of leptospirosis. This rapid and effective diagnosis will be helpful for diagnosis and manage of leptospirosis to use and the polysaccharide of Leptospira may be called as genus specific antigen for diagnosis.
authors.affiliation: Department of Microbiology, College of Medicine, Hallym University, Chuncheon, Korea.
authors.forename: Jin-Woo
authors.identifier: 0000-0003-1451-2982
authors.initials: JW
authors.lastname: Lee
authors.affiliation: Department of Microbiology, College of Medicine, Hallym University, Chuncheon, Korea.
authors.forename: Sungman
authors.identifier: 0000-0002-6105-7129
authors.initials: S
authors.lastname: Park
authors.affiliation: Department of Microbiology, College of Medicine, Hallym University, Chuncheon, Korea.
authors.forename: Seung Han
authors.identifier: 0000-0003-1310-8136
authors.initials: SH
authors.lastname: Kim
authors.affiliation: National Reference Vector-borne Infections Laboratory, National Center of Infectious and Parasitic Diseases, Bulgaria.
authors.forename: Iva
authors.identifier: 0000-0002-7878-3995
authors.initials: I
authors.lastname: Christova
authors.affiliation: Instituto Nacional de Enfermedades Respiratorias, Santa Fe, Argentina.
authors.forename: Paulina
authors.identifier: 0000-0002-4886-2086
authors.initials: P
authors.lastname: Jacob
authors.affiliation: Instituto Nacional de Enfermedades Respiratorias, Santa Fe, Argentina.
authors.forename: Norma B
authors.identifier: 0000-0002-6134-1031
authors.initials: NB
authors.lastname: Vanasco
authors.affiliation: Department of Microbiology, College of Medicine, Hallym University, Chuncheon, Korea.
authors.forename: Yeon-Mi
authors.identifier: 0000-0001-7939-9488
authors.initials: YM
authors.lastname: Kang
authors.affiliation: Department of Microbiology, College of Medicine, Hallym University, Chuncheon, Korea.
authors.forename: Ye-Ju
authors.identifier: 0000-0002-7844-546X
authors.initials: YJ
authors.lastname: Woo
authors.affiliation: Department of Microbiology, College of Medicine, Hallym University, Chuncheon, Korea.
authors.forename: Min Soo
authors.identifier: 0000-0001-7489-3532
authors.initials: MS
authors.lastname: Kim
authors.affiliation: Department of Microbiology, College of Medicine, Hallym University, Chuncheon, Korea.
authors.forename: Young-Jin
authors.identifier: 0000-0003-1996-9367
authors.initials: YJ
authors.lastname: Kim
authors.affiliation: Department of Microbiology, College of Medicine, Hallym University, Chuncheon, Korea.
authors.forename: Min-Kee
authors.identifier: 0000-0001-6245-0603
authors.initials: MK
authors.lastname: Cho
authors.affiliation: Department of Microbiology, College of Medicine, Hallym University, Chuncheon, Korea.
authors.forename: Yoon-Won
authors.identifier: 0000-0002-2242-2664
authors.initials: YW
authors.lastname: Kim
mesh_terms: D000942:Antigens, Bacterial / Q000276:immunology*; D001118:Argentina; D002031:Bulgaria; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007919:Leptospira / Q000302:isolation & purification / Q000378:metabolism; D007921:Leptospira interrogans / Q000302:isolation & purification / Q000378:metabolism; D007922:Leptospirosis / Q000175:diagnosis* / Q000382:microbiology; D008297:Male; D011134:Polysaccharides / Q000276:immunology*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D056910:Republic of Korea; D012680:Sensitivity and Specificity
chemical_list: D000942:Antigens, Bacterial; D011134:Polysaccharides; D011933:Reagent Kits, Diagnostic
keywords: Genus-specific Diagnostic Antigen; Leptospirosis; Rapid Diagnosis
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