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首页> 外文期刊>Journal of Veterinary Diagnostic Investigation >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
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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

机译：根据OIE标准进行的基于重组，基于p26的血清学竞争性酶联免疫吸附免疫吸附试验的验证，该监测方法是用于监测马传染性贫血病毒抗体的监测程序中的筛选方法

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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.
机译：意大利国家马传染性贫血参考中心（CRAIE;意大利罗马）采用世界组织的2010年标准，开发并验证了一种基于p26的重组重组竞争性酶联免疫吸附测定（cELISA）单克隆抗体，用于检测EIA病毒抗体用于动物健康（OIE）。评估了以下参数：临界值，重复性，再现性，一致性，分析灵敏度（Se），绝对分析特异性（Sp）以及诊断性Se和Sp。还根据估计的患病率定义了阳性和阴性预测值。在意大利EIA监测计划中，将cELISA用作96,468个样品的筛查测试时，与琼脂凝胶免疫扩散测试相比，检测到的EIA病例多出17％，从这些样品中得出的明显诊断性Sp估计为99.8％，这要高得多。高于根据验证估计的诊断Sp（80.2％）。 cELISA的高Se和Sp证实其适合用作筛选测试。

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