title: Evaluation of the immunochromatographic (Leptocheck) test for detection of specific antibodies against leptospires.
abstract: BACKGROUND
  Leptospirosis is a febrile worldwide zoonosis. Routine diagnosis of leptospiral infection is based on demonstration of specific antibodies with serological tests. Performance of the reference serological test, the microscopic agglutination test (MAT), requires significant expertise. The aim of our study was to find out if leptospiral infection can be proven with simple, rapid, commercially available immunochromatographic Leptocheck test in order to introduce it for the first level diagnosis in emergency cases with less specialized laboratory staff.
  
  
  METHODS
  In all, 590 serum samples of patients with clinical manifestations suggestive of leptospirosis were collected and tested with MAT and Leptocheck test. For confirmation of the results some other diagnostic methods such as polymerase chain reaction (PCR) and Leptospira isolation were performed.
  
  
  RESULTS
  Results of both serological tests were consistent in 576/590 (97.63%) cases but Leptocheck gave more positive results in comparison to MAT (36 and 12, respectively) at first patient's testing. Following up the patient, MAT became positive in majority of Leptocheck positive patients at first visit. Leptospiral DNA was detected in nine blood and six urine samples belonging to thirteen different patients while only two samples were culture positive.
  
  
  CONCLUSIONS
  In comparison with serological tests, PCR and culture have low sensitivity. According to our findings we conclude that Leptocheck test can prove leptospiral infection and could be used for rapid diagnosis of leptospirosis, later the sample should be confirmed with MAT.
authors.affiliation: Faculty of Medicine Ljubljana, Institute of Microbiology and Immunology, Zaloška 4, 1000, Ljubljana, Slovenia. dasa.podgorsek@gmail.com.
authors.forename: Daša
authors.initials: D
authors.lastname: Podgoršek
authors.affiliation: Faculty of Medicine Ljubljana, Institute of Microbiology and Immunology, Zaloška 4, 1000, Ljubljana, Slovenia.
authors.forename: Tjaša
authors.initials: T
authors.lastname: Cerar
authors.affiliation: Department of Infectious Diseases, University Medical Center Ljubljana, Zaloška 2, 1000, Ljubljana, Slovenia.
authors.forename: Mateja
authors.initials: M
authors.lastname: Logar
authors.affiliation: Department of Infectious Diseases, General Hospital Celje, Oblakova 5, 3000, Celje, Slovenia.
authors.forename: Gorazd
authors.initials: G
authors.lastname: Lešničar
authors.affiliation: Department of Infectious Diseases, General Hospital Novo mesto, Šmihelska cesta 1, 8000, Novo mesto, Slovenia.
authors.forename: Tatjana
authors.initials: T
authors.lastname: Remec
authors.affiliation: Department of Infectious Diseases, University Medical Center Maribor, Ljubljanska ulica 5, 2000, Maribor, Slovenia.
authors.forename: Zvonko
authors.initials: Z
authors.lastname: Baklan
authors.affiliation: Department of Infectious Diseases, General Hospital Murska Sobota, Ulica dr. Vrbnjaka 6, 9000, Murska Sobota, Slovenia.
authors.forename: Emil
authors.initials: E
authors.lastname: Pal
authors.affiliation: Faculty of Medicine Ljubljana, Institute of Microbiology and Immunology, Zaloška 4, 1000, Ljubljana, Slovenia.
authors.forename: Eva
authors.initials: E
authors.lastname: Ružić-Sabljić
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood* / Q000276:immunology; D002846:Chromatography, Affinity / Q000379:methods*; D042241:Early Diagnosis; D005260:Female; D006801:Humans; D007919:Leptospira / Q000276:immunology* / Q000302:isolation & purification; D007922:Leptospirosis / Q000097:blood* / Q000175:diagnosis* / Q000276:immunology; D008297:Male; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D000907:Antibodies, Bacterial; D011933:Reagent Kits, Diagnostic
keywords: Diagnostics; Leptocheck test; Leptospirosis; Microagglutination test; Serological tests