Inter-laboratory evaluation of the performance parameters of a Lateral Flow Test device for the detection of Bluetongue virus-specific antibodies

J Virol Methods. 2016 Feb:228:140-50. doi: 10.1016/j.jviromet.2015.12.001. Epub 2015 Dec 11.

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.

Keywords: Bluetongue; ELISA; Immuno-chromatographic strip; Lateral Flow Test; Pen-side test; Proficiency test.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Antibodies, Viral / blood*
  • Bluetongue / diagnosis
  • Bluetongue / immunology*
  • Bluetongue / virology
  • Bluetongue virus / immunology*
  • Bluetongue virus / isolation & purification
  • Cattle
  • Cattle Diseases
  • Chromatography, Affinity / methods*
  • Chromatography, Affinity / standards
  • Cooperative Behavior
  • Cross Reactions
  • Enzyme-Linked Immunosorbent Assay / instrumentation*
  • Hemorrhagic Disease Virus, Epizootic / immunology
  • Laboratory Proficiency Testing*
  • Reproducibility of Results
  • Ruminants
  • Sensitivity and Specificity
  • Serologic Tests / standards
  • Sheep

Substances

  • Antibodies, Viral