title: Evaluation of Six Commercially Available Rapid Immunochromatographic Tests for the Diagnosis of Rabies in Brain Material.
abstract: Rabies is a neglected zoonotic disease that causes an estimated 60,000 human deaths annually. The main burden lies on developing countries in Asia and Africa, where surveillance and disease detection is hampered by absence of adequate laboratory facilities and/or the difficulties of submitting samples from remote areas to laboratories. Under these conditions, easy-to-use tests such as immunochromatographic assays, i.e. lateral flow devices (LFD), may increase surveillance and improve control efforts. Several LFDs for rabies diagnosis are available but, except for one, there are no data regarding their performance. Therefore, we compared six commercially available LFDs for diagnostic and analytical sensitivity, as well as their specificity and their diagnostic agreement with standard rabies diagnostic techniques using different sample sets, including experimentally infected animals and several sets of field samples. Using field samples the sensitivities ranged between 0% up to 100% depending on the LFD and the samples, while for experimentally infected animals the maximum sensitivity was 32%. Positive results in LFD could be further validated using RT-qPCR and sequencing. In summary, in our study none of the tests investigated proved to be satisfactory, although the results somewhat contradict previous studies, indicating batch to batch variation. The high number of false negative results reiterates the necessity to perform a proper test validation before being marketed and used in the field. In this respect, marketing authorization and batch release control could secure a sufficient quality for these alternative tests, which could then fulfil their potential.
authors.affiliation: WHO Collaborating Centre for Rabies Surveillance and Research, Friedrich-Loeffler-Institut (FLI), Federal Research Institute for Animal Health, Institute of Molecular Virology and Cell Biology, Greifswald-Insel Riems, Germany.
authors.forename: Elisa
authors.initials: E
authors.lastname: Eggerbauer
authors.affiliation: FAO Reference Centre for Rabies, Instituto Zooprofilattico Sperimentale delle Venezie, Legnaro, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: de Benedictis
authors.affiliation: FLI, Institute of Diagnostic Virology, Greifswald-Insel Riems, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Hoffmann
authors.affiliation: WHO Collaborating Centre for Rabies Surveillance and Research, Friedrich-Loeffler-Institut (FLI), Federal Research Institute for Animal Health, Institute of Molecular Virology and Cell Biology, Greifswald-Insel Riems, Germany.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Mettenleiter
authors.affiliation: FLI, Institute of Diagnostic Virology, Greifswald-Insel Riems, Germany.
authors.forename: Kore
authors.initials: K
authors.lastname: Schlottau
authors.affiliation: OIE Rabies Reference Laboratory, Agricultural Research Council, Onderstepoort Veterinary Institute, Pretoria, South Africa.
authors.forename: Ernest C
authors.initials: EC
authors.lastname: Ngoepe
authors.affiliation: OIE Rabies Reference Laboratory, Agricultural Research Council, Onderstepoort Veterinary Institute, Pretoria, South Africa.
authors.forename: Claude T
authors.initials: CT
authors.lastname: Sabeta
authors.affiliation: WHO Collaborating Centre for Rabies Surveillance and Research, Friedrich-Loeffler-Institut (FLI), Federal Research Institute for Animal Health, Institute of Molecular Virology and Cell Biology, Greifswald-Insel Riems, Germany.
authors.forename: Conrad M
authors.initials: CM
authors.lastname: Freuling
authors.affiliation: WHO Collaborating Centre for Rabies Surveillance and Research, Friedrich-Loeffler-Institut (FLI), Federal Research Institute for Animal Health, Institute of Molecular Virology and Cell Biology, Greifswald-Insel Riems, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Müller
mesh_terms: D000818:Animals; D001921:Brain / Q000821:virology*; D002846:Chromatography, Affinity / Q000379:methods* / Q000592:standards; D006801:Humans; D008322:Mammals; D012367:RNA, Viral / Q000302:isolation & purification; D011818:Rabies / Q000175:diagnosis / Q000662:veterinary* / Q000821:virology; D011820:Rabies virus / Q000302:isolation & purification*; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012680:Sensitivity and Specificity; D019562:Viral Load
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic