title: Evaluation of two immunodiagnostic tests for early rapid diagnosis of leptospirosis in Sri Lanka: a preliminary study.
abstract: BACKGROUND
  Leptospirosis is often treated based on clinical diagnosis. There is a need for rapid laboratory diagnosis for this condition. The aim of this study was to compare the diagnostic accuracy of two rapid IgM based immunodiagnostic assays with the microscopic agglutination test (MAT), in acute leptospirosis infection.
  
  
  METHODS
  MAT, IgM based immunochromatographic test (Leptocheck-WB) and IgM ELISA were performed using acute sera of patients clinically suspected to have leptospirosis (n = 83). Bayesian latent class modeling was used to compare the accuracy of these tests.
  
  
  RESULTS
  Percentage positivity for MAT, Leptocheck-WB, and IgM ELISA were 48.1, 55.3, and 45.7 % respectively. Bayesian latent class modeling showed a combined positivity rate of leptospirosis of 44.7 %. The sensitivity of MAT, Leptocheck-WB and IgM ELISA were 91.4, 95 and 81.1 %, and specificity were 86.7, 76.4 and 83.1 %, respectively.
  
  
  CONCLUSIONS
  Leptocheck-WB has high sensitivity, and, because it is quick and easy to perform, would be a good screening test for acute leptospirosis infection. IgM ELISA has good specificity, and is comparable with MAT; given that it is easier to perform and more widely available than MAT, it would be a more appropriate confirmatory test for use in hospitals with limited access to a specialized laboratory.
authors.affiliation: Institute of Biochemistry, Molecular Biology and Biotechnology, University of Colombo, Colombo 03, Sri Lanka. mcjeugene@yahoo.com.
authors.forename: Egwin J
authors.initials: EJ
authors.lastname: Eugene
authors.affiliation: Institute of Biochemistry, Molecular Biology and Biotechnology, University of Colombo, Colombo 03, Sri Lanka. shiromah@gmail.com.
authors.forename: Shiroma M
authors.initials: SM
authors.lastname: Handunnetti
authors.affiliation: Institute of Biochemistry, Molecular Biology and Biotechnology, University of Colombo, Colombo 03, Sri Lanka. shalini@gmail.com.
authors.forename: Shalini A
authors.initials: SA
authors.lastname: Wickramasinghe
authors.affiliation: Institute of Biochemistry, Molecular Biology and Biotechnology, University of Colombo, Colombo 03, Sri Lanka. thilinikuoc@yahoo.com.
authors.forename: Thilini L
authors.initials: TL
authors.lastname: Kalugalage
authors.affiliation: Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo 08, Sri Lanka. chaturaka.rodrigo@gmail.com.
authors.forename: Chathuraka
authors.initials: C
authors.lastname: Rodrigo
authors.affiliation: Base Hospital, Homagama, Colombo, Sri Lanka. hasithdoc@yahoo.co.uk.
authors.forename: Hasith
authors.initials: H
authors.lastname: Wickremesinghe
authors.affiliation: Base Hospital, Homagama, Colombo, Sri Lanka. nandanadick2000@yahoo.com.
authors.forename: Nandana
authors.initials: N
authors.lastname: Dikmadugoda
authors.affiliation: Department of Bacteriology, Medical Research Institute, Colombo 08, Sri Lanka. somaratnepj@yahoo.com.
authors.forename: Pranitha
authors.initials: P
authors.lastname: Somaratne
authors.affiliation: Department of Medicine, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka. hjanakadesilva@gmail.com.
authors.forename: H Janaka
authors.initials: HJ
authors.lastname: De Silva
authors.affiliation: Department of Clinical Medicine, Faculty of Medicine, University of Colombo, Colombo 08, Sri Lanka. Senaka.ucfm@gmail.com.
authors.forename: Senaka
authors.initials: S
authors.lastname: Rajapakse
mesh_terms: D000328:Adult; D000368:Aged; D000372:Agglutination Tests; D000907:Antibodies, Bacterial / Q000097:blood*; D001499:Bayes Theorem; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006761:Hospitals; D006801:Humans; D007075:Immunoglobulin M / Q000097:blood*; D007922:Leptospirosis / Q000175:diagnosis* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D012680:Sensitivity and Specificity; D013188:Sri Lanka
chemical_list: D000907:Antibodies, Bacterial; D007075:Immunoglobulin M