title: Non-invasive cytology brush PCR diagnostic testing in mucosal leishmaniasis: superior performance to conventional biopsy with histopathology.
abstract: BACKGROUND
  Traditional methods of diagnosing mucosal leishmaniasis (ML), such as biopsy with histopathology, are insensitive and require collection of an invasive diagnostic specimen.
  
  
  METHODS
  We compared standard invasive procedures including biopsy histopathology, biopsy PCR, and leishmanin skin test (LST) to a novel, non-invasive, cytology-brush based PCR for the diagnosis of ML in Lima, Peru. Consensus reference standard was 2/4 tests positive, and outcome measures were sensitivity and specificity. Leishmania species identification was performed by PCR-based assays of positive specimens.
  
  
  RESULTS
  Twenty-eight patients were enrolled, 23 of whom fulfilled criteria for a diagnosis of ML. Sensitivity and specificity of biopsy with histopathology were 21.7% [95% CI 4.9-38.5%] and 100%; 69.6% [95% CI 50.8-88.4%] and 100% for LST; 95.7% [95% CI 87.4-100%] and 100% for biopsy PCR; and 95.7% [95% CI 87.4-100%] and 90% [95% CI 71.4-100%] for cytology brush PCR using both Cervisoft® and Histobrush® cervical cytology brushes. Represented species identified by PCR-RFLP included: L. (V). braziliensis (n = 4), and L. (V). peruviana (n = 3).
  
  
  CONCLUSIONS
  Use of commercial grade cytology brush PCR for diagnosis of ML is sensitive, rapid, well tolerated, and carries none of the risks of invasive diagnostic procedures such as biopsy. Further optimization is required for adequate species identification. Further evaluation of this method in field and other settings is warranted.
authors: Tropical Disease Unit, Division of Infectious Diseases, Toronto General Hospital, University of Toronto, Toronto, Canada. andrea.boggild@utoronto.ca
authors: Andrea K
authors: AK
authors: Boggild
authors: Braulio Mark
authors: BM
authors: Valencia
authors: Nicolas
authors: N
authors: Veland
authors: Ana
authors: A
authors: Pilar Ramos
authors: Flor
authors: F
authors: Calderon
authors: Jorge
authors: J
authors: Arevalo
authors: Donald E
authors: DE
authors: Low
authors: Alejandro
authors: A
authors: Llanos-Cuentas
mesh_terms: D001706:Biopsy; D006801:Humans; D007897:Leishmaniasis, Mucocutaneous / Q000175:diagnosis*; D025202:Molecular Diagnostic Techniques / Q000379:methods / Q000592:standards; D010568:Peru; D016133:Polymerase Chain Reaction / Q000295:instrumentation / Q000379:methods* / Q000592:standards; D012680:Sensitivity and Specificity; D012882:Skin Tests