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Colling, Axel; Lunt, Ross; Bergfeld, Jemma; McNabb, Leanne; Halpin, Kim; Juzva, Susan; Newberry, Kim; Morrissy, Chris; Loomes, Cameron; Warner, Simone; Diallo, Ibrahim; Kirkland, Peter; Broder, Christopher C.; Carlile, Gemma; Loh, Mai Hlaing; Waugh, Caryll; Wright, Lynda; Watson, James; Eagles, Debbie; Zuelke, Kurt; McCullough, Sam; Daniels, Peter

A network approach for provisional assay recognition of a Hendra virus antibody ELISA: test validation with low sample numbers from infected horses

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  • Media type: E-Article
  • Title: A network approach for provisional assay recognition of a Hendra virus antibody ELISA: test validation with low sample numbers from infected horses
  • Contributor: Colling, Axel; Lunt, Ross; Bergfeld, Jemma; McNabb, Leanne; Halpin, Kim; Juzva, Susan; Newberry, Kim; Morrissy, Chris; Loomes, Cameron; Warner, Simone; Diallo, Ibrahim; Kirkland, Peter; Broder, Christopher C.; Carlile, Gemma; Loh, Mai Hlaing; Waugh, Caryll; Wright, Lynda; Watson, James; Eagles, Debbie; Zuelke, Kurt; McCullough, Sam; Daniels, Peter
  • Published: SAGE Publications, 2018
  • Published in: Journal of Veterinary Diagnostic Investigation, 30 (2018) 3, Seite 362-369
  • Language: English
  • DOI: 10.1177/1040638718760102
  • ISSN: 1040-6387; 1943-4936
  • Keywords: General Veterinary
  • Origination:
  • Footnote:
  • Description: <jats:p> Obtaining statistically sound numbers of sera from Hendra virus (HeV)-infected horses is problematic because affected individuals usually die or are euthanized before developing a serum antibody response. As a consequence, test validation becomes a challenge. Our approach is an extension of OIE principles for provisional recognition and included 7 validation panels tested across multiple laboratories that provided estimates for test performance characteristics. At a 0.4 S/P cutoff, 16 of 19 sera from HeV-infected horses gave positive results in the HeV soluble G, indirect ELISA (HeVsG iELISA; DSe 84.2% [95% CI: 60.4–96.6%]); 463 of 477 non-infected horse sera tested negative (DSp 97.1% [95% CI: 95.1–98.4%]). The HeVsG iELISA eliminated almost all false-positive results from the previously used HeV iELISA, with marginally decreased relative sensitivity. Assay robustness was evaluated in inter-laboratory and proficiency testing panels. The HeVsG iELISA is considered to be fit for purpose for serosurveillance and international movement of horses when virus neutralization is used for follow-up testing of positive or inconclusive serum samples. </jats:p>
  • Access State: Open Access