title: Validation of a Rapid Rabies Diagnostic Tool for Field Surveillance in Developing Countries.
abstract: BACKGROUND
  One root cause of the neglect of rabies is the lack of adequate diagnostic tests in the context of low income countries. A rapid, performance friendly and low cost method to detect rabies virus (RABV) in brain samples will contribute positively to surveillance and consequently to accurate data reporting, which is presently missing in the majority of rabies endemic countries.
  
  
  RESULTS
  We evaluated a rapid immunodiagnostic test (RIDT) in comparison with the standard fluorescent antibody test (FAT) and confirmed the detection of the viral RNA by real time reverse transcription polymerase chain reaction (RT-qPCR). Our analysis is a multicentre approach to validate the performance of the RIDT in both a field laboratory (N'Djamena, Chad) and an international reference laboratory (Institut Pasteur, Paris, France). In the field laboratory, 48 samples from dogs were tested and in the reference laboratory setting, a total of 73 samples was tested, representing a wide diversity of RABV in terms of animal species tested (13 different species), geographical origin of isolates with special emphasis on Africa, and different phylogenetic clades. Under reference laboratory conditions, specificity was 93.3% and sensitivity was 95.3% compared to the gold standard FAT test. Under field laboratory conditions, the RIDT yielded a higher reliability than the FAT test particularly on fresh and decomposed samples. Viral RNA was later extracted directly from the test filter paper and further used successfully for sequencing and genotyping.
  
  
  CONCLUSIONS
  The RIDT shows excellent performance qualities both in regard to user friendliness and reliability of the result. In addition, the test cassettes can be used as a vehicle to ship viral RNA to reference laboratories for further laboratory confirmation of the diagnosis and for epidemiological investigations using nucleotide sequencing. The potential for satisfactory use in remote locations is therefore very high to improve the global knowledge of rabies epidemiology. However, we suggest some changes to the protocol, as well as careful further validation, before promotion and wider use.
authors.affiliation: Swiss Tropical and Public Health Institute, Basel, Switzerland.|University of Basel, Basel, Switzerland.
authors.forename: Monique
authors.initials: M
authors.lastname: Léchenne
authors.affiliation: Institut de Recherche en Elevage pour le Developpement, Farcha, N'Djamena, Chad.
authors.forename: Kemdongarti
authors.initials: K
authors.lastname: Naïssengar
authors.affiliation: Institut Pasteur, Unit Lyssavirus Dynamics and Host Adaptation, National Reference Center for Rabies and WHO Collaborating Centre for Reference and Research on Rabies, Paris, France.
authors.forename: Anthony
authors.initials: A
authors.lastname: Lepelletier
authors.affiliation: Institut de Recherche en Elevage pour le Developpement, Farcha, N'Djamena, Chad.
authors.forename: Idriss Oumar
authors.initials: IO
authors.lastname: Alfaroukh
authors.affiliation: Institut Pasteur, Unit Lyssavirus Dynamics and Host Adaptation, National Reference Center for Rabies and WHO Collaborating Centre for Reference and Research on Rabies, Paris, France.
authors.forename: Hervé
authors.initials: H
authors.lastname: Bourhy
authors.affiliation: Swiss Tropical and Public Health Institute, Basel, Switzerland.|University of Basel, Basel, Switzerland.
authors.forename: Jakob
authors.initials: J
authors.lastname: Zinsstag
authors.affiliation: Institut Pasteur, Unit Lyssavirus Dynamics and Host Adaptation, National Reference Center for Rabies and WHO Collaborating Centre for Reference and Research on Rabies, Paris, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Dacheux
mesh_terms: D000349:Africa / Q000453:epidemiology; D000818:Animals; D000956:Antigens, Viral / Q000302:isolation & purification; D001921:Brain / Q000821:virology; D002596:Chad / Q000453:epidemiology; D003906:Developing Countries; D004283:Dog Diseases / Q000175:diagnosis* / Q000453:epidemiology / Q000821:virology; D004285:Dogs; D062665:Epidemiological Monitoring; D019085:Fluorescent Antibody Technique, Direct; D005838:Genotype; D007159:Immunologic Tests / Q000379:methods*; D007753:Laboratories; D010802:Phylogeny; D012367:RNA, Viral / Q000302:isolation & purification; D011818:Rabies / Q000175:diagnosis / Q000453:epidemiology / Q000662:veterinary* / Q000821:virology; D011820:Rabies virus / Q000235:genetics / Q000302:isolation & purification*; D060888:Real-Time Polymerase Chain Reaction; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction; D012680:Sensitivity and Specificity
chemical_list: D000956:Antigens, Viral; D012367:RNA, Viral