title: Accordance and concordance of PCR and NASBA followed by oligochromatography for the molecular diagnosis of Trypanosoma brucei and Leishmania.
abstract: OBJECTIVE
  To evaluate the repeatability and reproducibility of four simplified molecular assays for the diagnosis of Trypanosoma brucei spp. or Leishmania ssp. in a multicentre ring trial with seven participating laboratories.
  
  
  METHODS
  The tests are based on PCR or NASBA amplification of the parasites nucleic acids followed by rapid read-out by oligochromatographic dipstick (PCR-OC and NASBA-OC).
  
  
  RESULTS
  On purified nucleic acid specimens, the repeatability and reproducibility of the tests were Tryp-PRC-OC, 91.7% and 95.5%; Tryp-NASBA-OC, 95.8% and 100%; Leish-PCR-OC, 95.9% and 98.1%; Leish-NASBA-OC, 92.3% and 98.2%. On blood specimens spiked with parasites, the repeatability and reproducibility of the tests were Tryp-PRC-OC, 78.4% and 86.6%; Tryp-NASBA-OC, 81.5% and 89.0%; Leish-PCR-OC, 87.1% and 91.7%; Leish-NASBA-OC, 74.8% and 86.2%.
  
  
  CONCLUSIONS
  As repeatability and reproducibility of the tests were satisfactory, further phase II and III evaluations in clinical and population specimens from disease endemic countries are justified.
authors.affiliation: Department of Veterinary Parasitology and Microbiology, Makerere University, Kampala, Uganda.
authors.forename: Claire M
authors.initials: CM
authors.lastname: Mugasa
authors.forename: Stijn
authors.initials: S
authors.lastname: Deborggraeve
authors.forename: Gerard J
authors.initials: GJ
authors.lastname: Schoone
authors.forename: Thierry
authors.initials: T
authors.lastname: Laurent
authors.forename: Mariska M
authors.initials: MM
authors.lastname: Leeflang
authors.forename: Rosine A
authors.initials: RA
authors.lastname: Ekangu
authors.forename: Sayda
authors.initials: S
authors.lastname: El Safi
authors.forename: Al-farazdag A
authors.initials: AF
authors.lastname: Saad
authors.forename: Frank L
authors.initials: FL
authors.lastname: Basiye
authors.forename: Simone
authors.initials: S
authors.lastname: De Doncker
authors.forename: George W
authors.initials: GW
authors.lastname: Lubega
authors.forename: Piet A
authors.initials: PA
authors.lastname: Kager
authors.forename: Philippe
authors.initials: P
authors.lastname: Büscher
authors.forename: Henk D F H
authors.initials: HD
authors.lastname: Schallig
mesh_terms: D000818:Animals; D016054:DNA, Protozoan / Q000032:analysis; D006801:Humans; D007893:Leishmania donovani / Q000235:genetics / Q000302:isolation & purification*; D007898:Leishmaniasis, Visceral / Q000175:diagnosis*; D016133:Polymerase Chain Reaction / Q000379:methods*; D015203:Reproducibility of Results; D021161:Self-Sustained Sequence Replication / Q000379:methods*; D013048:Specimen Handling / Q000379:methods; D014347:Trypanosoma brucei gambiense / Q000235:genetics / Q000302:isolation & purification*; D014353:Trypanosomiasis, African / Q000175:diagnosis*
chemical_list: D016054:DNA, Protozoan