title: Comparative study of the sensitivity of different diagnostic methods for the laboratory diagnosis of Buruli ulcer disease.
abstract: BACKGROUND
  Several diagnostic laboratory methods are available for case confirmation of Buruli ulcer disease. This study assessed the sensitivity of various diagnostic tests in relation to clinical presentation of the disease, type of diagnostic specimen, and treatment history.
  
  
  METHODS
  Swab samples, 3-mm punch biopsy tissue specimens, and surgically excised tissue specimens from 384 individuals with suspected Buruli ulcer disease were obtained at 9 different study sites in Ghana and were evaluated with dry reagent-based polymerase chain reaction (PCR), microscopic examination, culture, and histopathological analysis. The study subjects presented with nonulcerative and ulcerative lesions and were divided into 3 treatment groups: (1) previously untreated patients scheduled for antimycobacterial treatment, (2) patients treated with surgery alone, and (3) patients treated with surgery in combination with previous antimycobacterial treatment.
  
  
  RESULTS
  Of 384 suspected cases of Buruli ulcer disease, 268 were confirmed by at least 1 positive test result. The overall sensitivity of PCR (85%) was significantly higher than that of microscopic examination (57%) and culture (51%). After data were stratified by treatment group, type of lesion, and diagnostic specimen type, analysis revealed that PCR of 3-mm punch biopsy tissue specimens (obtained from previously untreated nonulcerative lesions) and of swab samples (obtained from previously untreated ulcers) had the highest diagnostic sensitivity (94% and 90%, respectively). Although duration of the disease did not significantly influence the sensitivity of any test, previous antimycobacterial treatment was significantly associated with decreased sensitivity of PCR and culture.
  
  
  CONCLUSIONS
  Across all subgroups, PCR had the highest sensitivity. PCR assessment of 3-mm punch biopsy tissue specimens proved to be the best diagnostic tool for nonulcerative lesions, and PCR assessment of swab samples was the best diagnostic tool for ulcerative lesions. For monitoring of antimycobacterial treatment success within controlled trials, however, only culture is appropriate.
authors.affiliation: Department of Infectious Diseases and Tropical Medicine, Ludwig-Maximilians University of Munich, Munich, Germany. herbinger@lrz.uni-muenchen.de
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Herbinger
authors.forename: Ohene
authors.initials: O
authors.lastname: Adjei
authors.forename: Nana-Yaa
authors.initials: NY
authors.lastname: Awua-Boateng
authors.forename: Willemien A
authors.initials: WA
authors.lastname: Nienhuis
authors.forename: Letitia
authors.initials: L
authors.lastname: Kunaa
authors.forename: Vera
authors.initials: V
authors.lastname: Siegmund
authors.forename: Jörg
authors.initials: J
authors.lastname: Nitschke
authors.forename: William
authors.initials: W
authors.lastname: Thompson
authors.forename: Erasmus
authors.initials: E
authors.lastname: Klutse
authors.forename: Pius
authors.initials: P
authors.lastname: Agbenorku
authors.forename: Alexander
authors.initials: A
authors.lastname: Schipf
authors.forename: Simone
authors.initials: S
authors.lastname: Reu
authors.forename: Paul
authors.initials: P
authors.lastname: Racz
authors.forename: Bernhard
authors.initials: B
authors.lastname: Fleischer
authors.forename: Marcus
authors.initials: M
authors.lastname: Beissner
authors.forename: Erna
authors.initials: E
authors.lastname: Fleischmann
authors.forename: Kerstin
authors.initials: K
authors.lastname: Helfrich
authors.forename: Tjip S
authors.initials: TS
authors.lastname: van der Werf
authors.forename: Thomas
authors.initials: T
authors.lastname: Löscher
authors.forename: Gisela
authors.initials: G
authors.lastname: Bretzel
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001431:Bacteriological Techniques; D054312:Buruli Ulcer / Q000175:diagnosis* / Q000473:pathology; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D003627:Data Interpretation, Statistical; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008853:Microscopy; D008875:Middle Aged; D019911:Mycobacterium ulcerans / Q000235:genetics* / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction; D012680:Sensitivity and Specificity; D055815:Young Adult