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Home / Equine Research Bank / Transbound Emerg Dis / Assessment of reproducibility of a VP7 Blocking ELISA diagno...
Transboundary and emerging diseases2018; 66(1); 83-90; doi: 10.1111/tbed.12968

Assessment of reproducibility of a VP7 Blocking ELISA diagnostic test for African horse sickness.

Abstract: The laboratory diagnosis of African horse sickness (AHS) is important for: (a) demonstrating freedom from infection in a population, animals or products for trade (b) assessing the efficiency of eradication policies; (c) laboratory confirmation of clinical diagnosis; (d) estimating the prevalence of AHS infection; and (e) assessing postvaccination immune status of individual animals or populations. Although serological techniques play a secondary role in the confirmation of clinical cases, their use is very important for all the other purposes due to their high throughput, ease of use and good cost-benefit ratio. The main objective of this study was to support the validation of AHS VP7 Blocking ELISA up to the Stage 3 of the World Animal Health Organization (OIE) assay validation pathway. To achieve this, a collaborative ring trial, which included all OIE Reference Laboratories and other AHS-specialist diagnostic centres, was conducted in order to assess the diagnostic performance characteristics of the VP7 Blocking ELISA. In this trial, a panel of sera of different epidemiological origin and infection status was used. Through this comprehensive evaluation we can conclude that the VP7 Blocking ELISA satisfies the OIE requirements of reproducibility. The VP7 Blocking ELISA, in its commercial version is ready to enter Stage 4 of the validation pathway (Programme Implementation). Specifically, this will require testing the diagnostic performance of the assay using contemporary serum samples collected during control campaigns in endemic countries.
© 2018 The Authors. Transboundary and Emerging Diseases Published by Blackwell Verlag GmbH.
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Publication Date: 2018-08-02 PubMed ID: 30070433PubMed Central: PMC6378617DOI: 10.1111/tbed.12968Google Scholar: Lookup
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Summary

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This study evaluates the reliability/reproducibility of the African horse sickness (AHS) VP7 Blocking ELISA (a diagnostic test), with results indicating that the test meets the World Animal Health Organization’s reproducibility standards and is ready for next stages of validation.

Background

  • The diagnostic test under review is for African Horse Sickness (AHS), a disease of significant economic and trade importance, which can lead to massive mortality in horse populations.
  • Diagnostic tests like this are necessary not only for confirming cases of AHS, but also key for understanding its prevalence, assessing the efficiency of eradication efforts, establishing infection-free status for trade purposes, and assessing immune response post-vaccination.

Purpose of the Study

  • This study aimed to assess whether the AHS VP7 Blocking ELISA satisfies the reproducibility requirements of the World Animal Health Organization (OIE), as defined in Stage 3 of its assay validation process.
  • Reproducibility in this context means that the test can produce consistent results when used in different labs or under varying conditions, which is crucial for a diagnostic test to have its validity universally recognized.

Methods and Findings

  • To accomplish this assessment, a ring trial was conducted. This involves multiple prestigious labs (all OIE Reference Laboratories and other AHS-specialist diagnostic centres) testing the same samples and comparing results to ensure consistency.
  • The samples tested came from a variety of different sources, covering different epidemiological origins and differing infection statuses, to ensure a broad and comprehensive evaluation.
  • The results from this trial showed that the VP7 Blocking ELISA diagnostic test does meet the requirements for reproducibility as outlined by the OIE.

Implications

  • Having met these strict reproducibility requirements, the VP7 Blocking ELISA test is now ready to enter Stage 4 of the OIE validation pathway, which involves implementing and testing the diagnostic performance of the assay using contemporary serum samples collected during control campaigns in countries where AHS is endemic.
  • This is a crucial step closer toward global acceptance of the diagnostic test as reliable, which could be instrumental in curtailing the impact of AHS worldwide.

Cite This Article

APA
Durán-Ferrer M, Agüero M, Zientara S, Beck C, Lecollinet S, Sailleau C, Smith S, Potgieter C, Rueda P, Sastre P, Monaco F, Villalba R, Tena-Tomás C, Batten C, Frost L, Flannery J, Gubbins S, Lubisi BA, Sánchez-Vizcaíno JM, Emery M, Sturgill T, Ostlund E, Castillo-Olivares J. (2018). Assessment of reproducibility of a VP7 Blocking ELISA diagnostic test for African horse sickness. Transbound Emerg Dis, 66(1), 83-90. https://doi.org/10.1111/tbed.12968

Publication

Transboundary and emerging diseases
ISSN: 1865-1682
NlmUniqueID: 101319538
Country: Germany
Language: English
Volume: 66
Issue: 1
Pages: 83-90

Researcher Affiliations

Durán-Ferrer, Manuel
  • Laboratorio Central de Veterinaria, LCV, Madrid, Spain.
Agüero, Montserrat
  • Laboratorio Central de Veterinaria, LCV, Madrid, Spain.
Zientara, Stephan
  • UMR, Laboratoire de Santé Animale, ANSES, INRA, ENVA, Maisons-Alfort, France.
Beck, Cécile
  • UMR, Laboratoire de Santé Animale, ANSES, INRA, ENVA, Maisons-Alfort, France.
Lecollinet, Sylvie
  • UMR, Laboratoire de Santé Animale, ANSES, INRA, ENVA, Maisons-Alfort, France.
Sailleau, Corinne
  • UMR, Laboratoire de Santé Animale, ANSES, INRA, ENVA, Maisons-Alfort, France.
Smith, Shirley
  • Deltamune, Pretoria, South Africa.
Potgieter, Christiaan
  • Deltamune, Pretoria, South Africa.
  • Department of Biochemistry, Centre for Human Metabolomics, North-West University, Potchefstroom, South Africa.
Rueda, Paloma
  • INGENASA, Madrid, Spain.
Sastre, Patricia
  • INGENASA, Madrid, Spain.
Monaco, Federica
  • IZS dell'Abruzzo e Molise, Teramo, Italy.
Villalba, Ruben
  • Laboratorio Central de Veterinaria, LCV, Madrid, Spain.
Tena-Tomás, Cristina
  • Laboratorio Central de Veterinaria, LCV, Madrid, Spain.
Batten, Carrie
  • The Pirbright Institute, Pirbright, UK.
Frost, Lorraine
  • The Pirbright Institute, Pirbright, UK.
Flannery, John
  • The Pirbright Institute, Pirbright, UK.
Gubbins, Simon
  • The Pirbright Institute, Pirbright, UK.
Lubisi, Baratang A
  • OVI, Pretoria, Gauteng, South Africa.
Sánchez-Vizcaíno, José Manuel
  • Universidad Complutense of Madrid, Madrid, Spain.
Emery, Michelle
  • USDA, Ames, Iowa.
Sturgill, Tracy
  • USDA, Ames, Iowa.
Ostlund, Eileen
  • USDA, Ames, Iowa.
Castillo-Olivares, Javier
  • The Pirbright Institute, Pirbright, UK.

MeSH Terms

  • African Horse Sickness / diagnosis
  • African Horse Sickness Virus / isolation & purification
  • Animals
  • Antigens, Viral / blood
  • Diagnostic Tests, Routine / methods
  • Diagnostic Tests, Routine / veterinary
  • Enzyme-Linked Immunosorbent Assay / methods
  • Enzyme-Linked Immunosorbent Assay / veterinary
  • Horse Diseases / diagnosis
  • Horses
  • Reproducibility of Results
  • Viral Core Proteins / blood

Grant Funding

  • BBS/E/I/00007036 / Biotechnology and Biological Sciences Research Council
  • AD/SR/2015/1885 / World Organisation of Animal Health (OIE)
  • BBS/E/I/00002536 / Biotechnology and Biological Sciences Research Council
  • BBS/E/I/00007037 / Biotechnology and Biological Sciences Research Council
  • BBS/E/I/00007038 / Biotechnology and Biological Sciences Research Council

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