title: A stepwise approach to the laboratory diagnosis of Buruli ulcer disease.
abstract: OBJECTIVE
  In view of technical and financial limitations in areas of endemicity, the current practice and recommendations for the laboratory diagnosis of Buruli ulcer disease (BUD) may have to be reconsidered. We reviewed diagnostic results in order to explore options for a modified, more practicable, cost-effective and timely approach to the laboratory diagnosis of BUD.
  
  
  METHODS
  Diagnostic specimens from 161 clinically diagnosed BUD patients from four different treatment centres in Ghana were subjected to laboratory analysis. The positivity rates of the laboratory assays were compared.
  
  
  RESULTS
  The number of laboratory-confirmed clinically diagnosed BUD cases with one positive confirmative test was 20% higher than that with two positive confirmative tests. The specificity of microscopy (MIC) and PCR was 96.6% and 100%, respectively. Subsequent analysis of specimens from surgically excised pre-ulcerative tissue-by-tissue MIC and tissue PCR rendered 65% laboratory-confirmed BUD cases. Subsequent analysis of diagnostic swabs from ulcerative lesions by swab smear MIC and swab PCR rendered 70% of laboratory-confirmed BUD cases.
  
  
  CONCLUSIONS
  The specificity of the diagnostic tests used in this study suggests that one positive diagnostic test may be considered sufficient for the laboratory confirmation of BUD. Subsequent application of different diagnostic tests rendered a laboratory confirmation of 65% pre-ulcerative and of 70% ulcerative lesions. Implementation of a stepwise, subsequent analysis of diagnostic specimens will result in considerable cost saving compared with simultaneous testing of specimens by several diagnostic assays.
authors.affiliation: Department of Infectious Diseases and Tropical Medicine (DITM), University of Munich, Munich, Germany. bretzel@lrz.uni-muenchen.de
authors.forename: G
authors.initials: G
authors.lastname: Bretzel
authors.forename: V
authors.initials: V
authors.lastname: Siegmund
authors.forename: J
authors.initials: J
authors.lastname: Nitschke
authors.forename: K H
authors.initials: KH
authors.lastname: Herbinger
authors.forename: W
authors.initials: W
authors.lastname: Thompson
authors.forename: E
authors.initials: E
authors.lastname: Klutse
authors.forename: K
authors.initials: K
authors.lastname: Crofts
authors.forename: W
authors.initials: W
authors.lastname: Massavon
authors.forename: S
authors.initials: S
authors.lastname: Etuaful
authors.forename: R
authors.initials: R
authors.lastname: Thompson
authors.forename: K
authors.initials: K
authors.lastname: Asamoah-Opare
authors.forename: P
authors.initials: P
authors.lastname: Racz
authors.forename: F
authors.initials: F
authors.lastname: Vloten
authors.forename: C
authors.initials: C
authors.lastname: van Berberich
authors.forename: T
authors.initials: T
authors.lastname: Kruppa
authors.forename: E
authors.initials: E
authors.lastname: Ampadu
authors.forename: B
authors.initials: B
authors.lastname: Fleischer
authors.forename: O
authors.initials: O
authors.lastname: Adjei
mesh_terms: D003362:Cost-Benefit Analysis / Q000379:methods; D019353:Endemic Diseases; D005869:Ghana / Q000453:epidemiology; D006801:Humans; D008853:Microscopy / Q000379:methods; D009165:Mycobacterium Infections, Nontuberculous / Q000175:diagnosis* / Q000453:epidemiology / Q000382:microbiology; D019911:Mycobacterium ulcerans / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction / Q000379:methods; D012680:Sensitivity and Specificity; D017192:Skin Diseases, Bacterial / Q000175:diagnosis*; D012883:Skin Ulcer / Q000175:diagnosis*