title: Diagnostic accuracy of loopamp Trypanosoma brucei detection kit for diagnosis of human African trypanosomiasis in clinical samples.
abstract: BACKGROUND
  Molecular methods have great potential for sensitive parasite detection in the diagnosis of human African trypanosomiasis (HAT), but the requirements in terms of laboratory infrastructure limit their use to reference centres. A recently developed assay detects the Trypanozoon repetitive insertion mobile element (RIME) DNA under isothermal amplification conditions and has been transformed into a ready-to-use kit format, the Loopamp Trypanosoma brucei. In this study, we have evaluated the diagnostic performance of the Loopamp Trypanosoma brucei assay (hereafter called LAMP) in confirmed T.b. gambiense HAT patients, HAT suspects and healthy endemic controls from the Democratic Republic of the Congo (DRC).
  
  
  RESULTS
  142 T.b. gambiense HAT patients, 111 healthy endemic controls and 97 HAT suspects with unconfirmed status were included in this retrospective evaluation. Reference standard tests were parasite detection in blood, lymph or cerebrospinal fluid. Archived DNA from blood of all study participants was analysed in duplicate with LAMP. Sensitivity of LAMP in parasitologically confirmed cases was 87.3% (95% CI 80.9-91.8%) in the first run and 93.0% (95% CI 87.5-96.1%) in the second run. Specificity in healthy controls was 92.8% (95% CI 86.4-96.3%) in the first run and 96.4% (95% CI 91.1-98.6%) in the second run. Reproducibility was excellent with a kappa value of 0.81.
  
  
  CONCLUSIONS
  In this laboratory-based study, the Loopamp Trypanosoma brucei Detection Kit showed good diagnostic accuracy and excellent reproducibility. Further studies are needed to assess the feasibility of its routine use for diagnosis of HAT under field conditions.
authors.affiliation: Institute of Tropical Medicine, Antwerp, Belgium ; Faculty of Medicine, Kinshasa University, Kinshasa, Democratic Republic of the Congo ; Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo.
authors.forename: Patrick
authors.initials: P
authors.lastname: Mitashi
authors.forename: Epco
authors.initials: E
authors.lastname: Hasker
authors.forename: Dieudonné Mumba
authors.initials: DM
authors.lastname: Ngoyi
authors.forename: Pati Patient
authors.initials: PP
authors.lastname: Pyana
authors.forename: Veerle
authors.initials: V
authors.lastname: Lejon
authors.forename: Wim
authors.initials: W
authors.lastname: Van der Veken
authors.forename: Pascal
authors.initials: P
authors.lastname: Lutumba
authors.forename: Philippe
authors.initials: P
authors.lastname: Büscher
authors.forename: Marleen
authors.initials: M
authors.lastname: Boelaert
authors.forename: Stijn
authors.initials: S
authors.lastname: Deborggraeve
mesh_terms: D001769:Blood / Q000469:parasitology; D002555:Cerebrospinal Fluid / Q000469:parasitology; D006801:Humans; D008196:Lymph / Q000469:parasitology; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D010274:Parasitology / Q000379:methods*; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D014346:Trypanosoma brucei brucei / Q000235:genetics / Q000302:isolation & purification*; D014353:Trypanosomiasis, African / Q000175:diagnosis*