title: Inter-laboratory evaluation of the performance parameters of a Lateral Flow Test device for the detection of Bluetongue virus-specific antibodies.
abstract: Bluetongue (BT) is a viral vector-borne disease affecting domestic and wild ruminants worldwide. In this study, a commercial rapid immuno-chromatographic method or Lateral Flow Test (LFT) device, for the detection of BT virus-specific antibodies in animal serum, was evaluated in an international inter-laboratory proficiency test. The evaluation was done with sera samples of variable background (ruminant species, serotype, field samples, experimental infections, vaccinated animals). The diagnostic sensitivity was 100% (95% C.I. [90.5-100]) and the diagnostic specificity was 95.2% (95% C.I. [76.2-99.9]). The repeatability (accordance) and reproducibility (concordance) were 100% for seropositive samples but were lower for two of the seronegative samples (45% and 89% respectively). The analytical sensitivity, evaluated by testing positive sera at increasing dilutions was better for the BT LFT compared to some commercial ELISAs. Seroconversion of an infected sheep was detected at 4 days post infection. Analytical specificity was impaired by cross-reactions observed with some of the samples seropositive for Epizootic Haemorrhagic Disease Virus (EHDV). The agreement (Cohen's kappa) between the LFT and a commercial BT competitive ELISA was 0.79 (95% CI [0.62-0.95]). Based on these results, it can be concluded that the BT LFT device is a rapid and sensitive first-line serological test that can be used in the field, especially in areas endemic for the disease where there is a lack of diagnostic facilities.
authors.affiliation: Veterinary and Agrochemical Research Centre (CODA-CERVA), Coordination of the Veterinary Diagnostic, Epidemiology and Risk Analysis Unit (CDV-ERA), Groeselenberg 99, 1180 Brussels, Belgium. Electronic address: jbhan@coda-cerva.be.
authors.forename: Jean-Baptiste
authors.initials: JB
authors.lastname: Hanon
authors.affiliation: Veterinary and Agrochemical Research Centre (CODA-CERVA), Coordination of the Veterinary Diagnostic, Epidemiology and Risk Analysis Unit (CDV-ERA), Groeselenberg 99, 1180 Brussels, Belgium.
authors.forename: Valerie
authors.initials: V
authors.lastname: Vandenberge
authors.affiliation: Veterinary and Agrochemical Research Centre (CODA-CERVA), Coordination of the Veterinary Diagnostic, Epidemiology and Risk Analysis Unit (CDV-ERA), Groeselenberg 99, 1180 Brussels, Belgium.
authors.forename: Matthias
authors.initials: M
authors.lastname: Deruelle
authors.affiliation: Veterinary and Agrochemical Research Centre (CODA-CERVA), Vesicular and Exotic Diseases Unit, National Reference Laboratory for Bluetongue, Groeselenberg 99, 1180 Brussels, Belgium.
authors.forename: Ilse
authors.initials: I
authors.lastname: De Leeuw
authors.affiliation: Veterinary and Agrochemical Research Centre (CODA-CERVA), Vesicular and Exotic Diseases Unit, National Reference Laboratory for Bluetongue, Groeselenberg 99, 1180 Brussels, Belgium.
authors.forename: Kris
authors.initials: K
authors.lastname: De Clercq
authors.affiliation: Veterinary and Agrochemical Research Centre (CODA-CERVA), Molecular Platform Unit, Groeselenberg 99, 1180 Brussels, Belgium.
authors.forename: Steven
authors.initials: S
authors.lastname: Van Borm
authors.affiliation: Veterinary and Agrochemical Research Centre (CODA-CERVA), Coordination of the Veterinary Diagnostic, Epidemiology and Risk Analysis Unit (CDV-ERA), Groeselenberg 99, 1180 Brussels, Belgium.
authors.forename: Frank
authors.initials: F
authors.lastname: Koenen
authors.affiliation: National Veterinary Institute (SVA), Department of Virology, Immunobiology and Parasitology (VIP), SE-751 89 Uppsala, Sweden.
authors.forename: Lihong
authors.initials: L
authors.lastname: Liu
authors.affiliation: Friedrich-Loeffler-Institut (FLI), Institute of Diagnostic Virology, Südufer 10, 17493 Greifswald-Insel Riems, Germany.
authors.forename: Bernd
authors.initials: B
authors.lastname: Hoffmann
authors.affiliation: The Pirbright Institute, Non Vesicular Reference Laboratory, Ash Road, Pirbright, Woking GU240NF, United Kingdom.
authors.forename: Carrie Anne
authors.initials: CA
authors.lastname: Batten
authors.affiliation: Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), UPE, UMR Anses, INRA, ENVA, 14 rue Pierre et Marie Curie, laboratoire de santé animale, Maisons-Alfort, France.
authors.forename: Stéphan
authors.initials: S
authors.lastname: Zientara
authors.affiliation: Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail (ANSES), UPE, UMR Anses, INRA, ENVA, 14 rue Pierre et Marie Curie, laboratoire de santé animale, Maisons-Alfort, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Breard
authors.affiliation: Veterinary and Agrochemical Research Centre (CODA-CERVA), Coordination of the Veterinary Diagnostic, Epidemiology and Risk Analysis Unit (CDV-ERA), Groeselenberg 99, 1180 Brussels, Belgium; Ghent University, Department of Virology, Parasitology and Immunology, Faculty of Veterinary Medicine, Salisburylaan 133, 9820 Merelbeke, Belgium.
authors.forename: Yves
authors.initials: Y
authors.lastname: Van der Stede
mesh_terms: D000818:Animals; D000914:Antibodies, Viral / Q000097:blood*; D001819:Bluetongue / Q000175:diagnosis / Q000276:immunology* / Q000821:virology; D001820:Bluetongue virus / Q000276:immunology* / Q000302:isolation & purification; D002417:Cattle; D002418:Cattle Diseases; D002846:Chromatography, Affinity / Q000379:methods* / Q000592:standards; D003299:Cooperative Behavior; D003429:Cross Reactions; D004797:Enzyme-Linked Immunosorbent Assay / Q000295:instrumentation*; D018164:Hemorrhagic Disease Virus, Epizootic / Q000276:immunology; D059021:Laboratory Proficiency Testing; D015203:Reproducibility of Results; D012418:Ruminants; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000592:standards; D012756:Sheep
chemical_list: D000914:Antibodies, Viral
keywords: Bluetongue; ELISA; Immuno-chromatographic strip; Lateral Flow Test; Pen-side test; Proficiency test