Clinical Evaluation of Rapid Diagnostic Test Kit Using the Polysaccharide as a Genus-Specific Diagnostic Antigen for Leptospirosis in Korea, Bulgaria, and Argentina.
10.3346/jkms.2016.31.2.183
- Author:
Jin Woo LEE
1
;
Sungman PARK
;
Seung Han KIM
;
Iva CHRISTOVA
;
Paulina JACOB
;
Norma B VANASCO
;
Yeon Mi KANG
;
Ye Ju WOO
;
Min Soo KIM
;
Young Jin KIM
;
Min Kee CHO
;
Yoon Won KIM
Author Information
1. Department of Microbiology, College of Medicine, Hallym University, Chuncheon, Korea. ywkim@hallym.ac.kr
- Publication Type:Evaluation Studies ; Original Article ; Research Support, Non-U.S. Gov't
- Keywords:
Leptospirosis;
Genus-specific Diagnostic Antigen;
Rapid Diagnosis
- MeSH:
Antigens, Bacterial/*immunology;
Argentina;
Bulgaria;
Enzyme-Linked Immunosorbent Assay;
Female;
Humans;
Leptospira/isolation & purification/metabolism;
Leptospira interrogans/isolation & purification/metabolism;
Leptospirosis/*diagnosis/microbiology;
Male;
Polysaccharides/*immunology;
Reagent Kits, Diagnostic/*standards;
Republic of Korea;
Sensitivity and Specificity
- From:Journal of Korean Medical Science
2016;31(2):183-189
- CountryRepublic of Korea
- Language:English
-
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.
