title: Validation according to OIE criteria of a monoclonal, recombinant p26-based, serologic competitive enzyme-linked immunosorbent assay as screening method in surveillance programs for the detection of Equine infectious anemia virus antibodies.
abstract: The Italian National Reference Center for equine infectious anemia (CRAIE; Rome, Italy) developed and validated a monoclonal, recombinant p26-based competitive enzyme-linked immunosorbent assay (cELISA) for the detection of EIA virus antibodies employing the 2010 criteria of the World Organization for Animal Health (OIE). The following parameters were evaluated: cutoff values, repeatability, reproducibility, concordance, analytical sensitivity (Se), absolute analytical specificity (Sp), and diagnostic Se and Sp. Positive and negative predictive values were also defined in relation to the estimated prevalence. When the cELISA was used as a screening test for 96,468 samples in the Italian EIA surveillance program, 17% more EIA cases were detected than by the agar gel immunodiffusion test, and the apparent diagnostic Sp estimated from these samples was 99.8%, which was more than the diagnostic Sp (80.2%) estimated from validation. The high Se and Sp of the cELISA confirm its fit for purpose as a screening test.
authors.affiliation: Istituto Zooprofilattico Sperimentale del Lazio e della Toscana "M. Aleandri", Rome, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Nardini
authors.affiliation: Istituto Zooprofilattico Sperimentale del Lazio e della Toscana "M. Aleandri", Rome, Italy.
authors.forename: Gian Luca
authors.initials: GL
authors.lastname: Autorino
authors.affiliation: Istituto Zooprofilattico Sperimentale del Lazio e della Toscana "M. Aleandri", Rome, Italy.
authors.forename: Ida
authors.initials: I
authors.lastname: Ricci
authors.affiliation: Istituto Zooprofilattico Sperimentale del Lazio e della Toscana "M. Aleandri", Rome, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Frontoso
authors.affiliation: Istituto Zooprofilattico Sperimentale del Lazio e della Toscana "M. Aleandri", Rome, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Rosone
authors.affiliation: Istituto Zooprofilattico Sperimentale del Lazio e della Toscana "M. Aleandri", Rome, Italy.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Simula
authors.affiliation: Istituto Zooprofilattico Sperimentale del Lazio e della Toscana "M. Aleandri", Rome, Italy teresa.scicluna@izslt.it.
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Scicluna
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal; D000914:Antibodies, Viral / Q000097:blood*; D004797:Enzyme-Linked Immunosorbent Assay / Q000662:veterinary*; D004859:Equine Infectious Anemia / Q000175:diagnosis* / Q000453:epidemiology; D017408:Guidelines as Topic; D006736:Horses; D004860:Infectious Anemia Virus, Equine / Q000302:isolation & purification*; D007558:Italy; D011159:Population Surveillance; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000911:Antibodies, Monoclonal; D000914:Antibodies, Viral
keywords: Competitive enzyme-linked immunosorbent assay; OIE validation; equine infectious anemia; screening test; surveillance