A network approach for provisional assay recognition of a Hendra virus antibody ELISA: test validation with low sample numbers from infected horses
| Autor: | Cameron Loomes, Chris Morrissy, Peter Daniels, A. Colling, Ibrahim Diallo, Kim M. Newberry, Sam McCullough, Debbie Eagles, Peter D. Kirkland, Gemma Carlile, Mai Hlaing Loh, Lynda Wright, Simone Warner, Ross A. Lunt, Christopher C. Broder, Leanne McNabb, Susan Juzva, Caryll Waugh, James Watson, Kurt Zuelke, Jemma Bergfeld, Kim Halpin |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Indirect elisa 040301 veterinary sciences Enzyme-Linked Immunosorbent Assay Antibodies Viral Sensitivity and Specificity 0403 veterinary science Hendra Virus 03 medical and health sciences Medicine Animals Full Scientific Reports Horses General Veterinary biology business.industry Horse 04 agricultural and veterinary sciences Serum samples Virology 030104 developmental biology Elisa test biology.protein Test performance Horse Diseases Antibody business Network approach |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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