title: Performance of seven serological assays for diagnosing tularemia.
abstract: BACKGROUND
  Tularemia is a rare zoonotic disease caused by the Gram-negative bacterium Francisella tularensis. Serology is frequently the preferred diagnostic approach, because the pathogen is highly infectious and difficult to cultivate. The aim of this retrospective study was to determine the diagnostic accuracy of tularemia specific tests.
  
  
  METHODS
  The Serazym®Anti-Francisella tularensis ELISA, Serion ELISA classic Francisella tularensis IgG/IgM, an in-house ELISA, the VIRapid® Tularemia immunochromatographic test, an in-house antigen microarray, and a Western Blot (WB) assay were evaluated. The diagnosis tularemia was established using a standard micro-agglutination assay. In total, 135 sera from a series of 110 consecutive tularemia patients were tested.
  
  
  RESULTS
  The diagnostic sensitivity and diagnostic specificity of the tests were VIRapid (97.0% and 84.0%), Serion IgG (96.3% and 96.8%), Serion IgM (94.8% and 96.8%), Serazym (97.0% and 91.5%), in-house ELISA (95.6% and 76.6%), WB (93.3% and 83.0%), microarray (91.1% and 97.9%).
  
  
  CONCLUSIONS
  The diagnostic value of the commercial assays was proven, because the diagnostic accuracy was >90%. The diagnostic sensitivity of the in-house ELISA and the WB were acceptable, but the diagnostic accuracy was <90%. Interestingly, the antigen microarray test was very specific and had a very good positive predictive value.
authors.forename: Valérie
authors.initials: V
authors.lastname: Chaignat
authors.forename: Marina
authors.initials: M
authors.lastname: Djordjevic-Spasic
authors.forename: Anke
authors.initials: A
authors.lastname: Ruettger
authors.forename: Peter
authors.initials: P
authors.lastname: Otto
authors.forename: Diana
authors.initials: D
authors.lastname: Klimpel
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Müller
authors.forename: Konrad
authors.initials: K
authors.lastname: Sachse
authors.forename: George
authors.initials: G
authors.lastname: Araj
authors.forename: Roland
authors.initials: R
authors.lastname: Diller
authors.affiliation: Institute of Bacterial Infections and Zoonoses, Friedrich-Loeffler-Institut (Federal Research Institute for Animal Health), Naumburger Str, 96a, Jena 07743, Germany. herbert.tomaso@fli.bund.de.
authors.forename: Herbert
authors.initials: H
authors.lastname: Tomaso
mesh_terms: D000372:Agglutination Tests; D000818:Animals; D000907:Antibodies, Bacterial / Q000097:blood*; D015153:Blotting, Western; D004797:Enzyme-Linked Immunosorbent Assay; D005604:Francisella tularensis / Q000302:isolation & purification*; D006801:Humans; D012189:Retrospective Studies; D014406:Tularemia / Q000097:blood / Q000175:diagnosis*; D015047:Zoonoses
chemical_list: D000907:Antibodies, Bacterial