Comparative study of the sensitivity of different diagnostic methods for the laboratory diagnosis of Buruli ulcer disease.
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.
Herbinger
Karl-Heinz
KH
Department of Infectious Diseases and Tropical Medicine, Ludwig-Maximilians University of Munich, Munich, Germany. herbinger@lrz.uni-muenchen.de
Adjei
Ohene
O
Awua-Boateng
Nana-Yaa
NY
Nienhuis
Willemien A
WA
Kunaa
Letitia
L
Siegmund
Vera
V
Nitschke
Jörg
J
Thompson
William
W
Klutse
Erasmus
E
Agbenorku
Pius
P
Schipf
Alexander
A
Reu
Simone
S
Racz
Paul
P
Fleischer
Bernhard
B
Beissner
Marcus
M
Fleischmann
Erna
E
Helfrich
Kerstin
K
van der Werf
Tjip S
TS
Löscher
Thomas
T
Bretzel
Gisela
G
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