title: [Latex agglutination system for the rapid diagnosis of leptospirosis in Cuba].
abstract: OBJECTIVE
  To assess the sensitivity, specificity, reproducibility, and stability of five latex agglutination systems for detecting antibodies against leptospira in human and animal sera, by using the Leptospira serotypes that are most widely prevalent in Cuba.
  
  
  METHODS
  We performed an analytic and descriptive study with 706 human sera (65 tested positive for antibodies against leptospira with microagglutination (MAT) and hemagglutination (HA) techniques; 156 sera that tested negative with MAT and HA); 485 sera from 424 patients who had clinical or epidemiologic signs of leptospirosis; and 29 animal sera (16 from equines, 6 from bovines, 5 from porcines, 1 from a canine, and 1 from an ovine). All of the samples were tested with five latex conjugates made from whole cells of Leptospira interrogans, specifically the four serogroups that circulated most widely in Cuba from 2002 to 2004. The cells obtained from cultured cell lines yielded four specific conjugates (latex-canicola, latex-icterohemorrhagiae, latexpomona, and latex-sejroe), as well as one latex conjugate made from a combination of all four serogroups in equal quantities (latex-pool). In addition, samples were tested with the commercial latex agglutination Lepto Tek Tri Dot (bioMeriuex, France) kit. The stability and reproducibility of the latex conjugates were assessed through monthly controls over a period of 6 months with positive and negative sera.
  
  
  RESULTS
  Of the systems that were assessed, the best combination of sensitivity and specificity was obtained with the latex-Pool conjugate (93,8% and 90,4%, respectively). The best combination of positive and negative predictive values was seen with the latex-Sejroe conjugate (90,9% and 95,8%), respectively), followed by the latex-Pool conjugate (94.2% and 96.6%, respectively). The positive and negative predictive values of the Lepto Tek Dri Dot commercial system were 78.5% and 88.4%, respectively. Among the 137 patient samples that tested positive for one of the serotypes when MAT was used, latex conjugates succeeded in correctly identifying 107 (78.1%), whereas the latex-Pool conjugate detected 116 (84.7%) positive sera. When animal sera were tested, the latex-Pool conjugate detected the greatest number of positive serum samples and showed the greatest concordance with MAT (93.1%). The conjugates studied showed good stability and reproducibility.
  
  
  CONCLUSIONS
  Latex conjugates made from whole cells of the most widely circulating leptospira in Cuba showed a degree of concordance with MAT that was similar to or better than that seen with the Lepto Tek Dri Dot commercial system, both in human and animal sera. We recommend more widespread use of the latex-Pool conjugate in Cuba in the initial screening for antibodies against leptospira.
authors.affiliation: Laboratorio Nacional de Referencia de Leptospi- ras, Instituto de Medicina Tropical Pedro Kourí, Ciudad de La Habana, Cuba. amobregon@ipk.sld.cu
authors.forename: Ana Margarita
authors.initials: AM
authors.lastname: Obregón
authors.forename: Carmen
authors.initials: C
authors.lastname: Fernández
authors.forename: Islay
authors.initials: I
authors.lastname: Rodríguez
authors.forename: Yinia
authors.initials: Y
authors.lastname: Balbis
authors.forename: Beatriz
authors.initials: B
authors.lastname: Martínez
authors.forename: José
authors.initials: J
authors.lastname: Rodríguez
mesh_terms: D000818:Animals; D000907:Antibodies, Bacterial / Q000097:blood*; D000942:Antigens, Bacterial / Q000276:immunology; D002417:Cattle; D003462:Cuba; D004285:Dogs; D006801:Humans; D007841:Latex Fixation Tests / Q000379:methods*; D007921:Leptospira interrogans / Q000145:classification / Q000276:immunology*; D007922:Leptospirosis / Q000145:classification / Q000276:immunology*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012703:Serotyping; D012756:Sheep; D013552:Swine
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial