Abstract Background: Misdiagnosis of peanut allergy is a significant clinical challenge. Here, a novel diagnostic blood-based test using a Bead-Based Epitope Assay (peanut BBEA) has been developed on the LEAP cohort and then independently validated on the CoFAR2 and POISED cohorts. Methods: Development of the peanut BBEA followed the National Academy of Medicine established guidelines with discovery performed on 133 subjects from the non-interventional arm of the LEAP trial and an independent validation performed on 81 subjects from the CoFAR2 study and 84 subjects from the POISED study. All subject samples were analyzed using the BBEA methodology. The peanut BBEA test measures levels of two Ara h 2 epitopes and compares their combination to a pre=specified threshold. If the combination of the two epitope levels is at or below the threshold, then the subject is ruled Not Allergic, otherwise the subject is ruled Allergic. All allergic diagnoses were OFC confirmed and subject ages were 7-55 years. Results: In validation on the CoFAR2 and POISED cohorts, the peanut BBEA test had a combined sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio and accuracy of 91%, 95%, 95%, 91%, 18.2, 0.09 and 93%, respectively. Conclusion: The peanut BBEA test performance in validation demonstrated overall high accuracy and compared very favorably with existing diagnostic tests for peanut allergy including skin prick testing, peanut sIgE and peanut component testing.

中文翻译：

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抗原表位分析用于花生过敏的高精度和可重复性诊断

摘要背景：花生过敏症的误诊是一项重大的临床挑战。在这里，已经在LEAP队列中开发了一种基于基于珠子的抗原决定簇分析（花生BBEA）的基于血液的新型诊断测试，然后在CoFAR2和POISED队列中进行了独立验证。方法：花生BBEA的开发遵循美国国家医学科学院制定的指南，对LEAP试验的非干预组的133名受试者进行了发现，对CoFAR2研究的81名受试者和POISED研究的84名受试者进行了独立验证。所有样本均使用BBEA方法进行了分析。花生BBEA测试测量两个Ara h 2表位的水平，并将它们的组合与预定阈值进行比较。如果两个表位水平的组合达到或低于阈值，那么该受试者被判定为非过敏，否则该受试者被判定为过敏。所有过敏诊断均经OFC确诊，受试者年龄为7-55岁。结果：在对CoFAR2和POISED队列进行验证时，花生BBEA测试的综合敏感性，特异性，阳性预测值，阴性预测值，阳性可能性比，阴性可能性比和准确性分别为91％，95％，95％，91 ％，18.2、0.09和93％。结论：验证的花生BBEA测试性能总体准确，与现有的花生过敏诊断测试（包括皮刺测试，花生sIgE和花生成分测试）相比非常有利。在对CoFAR2和POISED队列进行验证时，花生BBEA测试的综合敏感性，特异性，阳性预测值，阴性预测值，阳性可能性比，阴性可能性比和准确性分别为91％，95％，95％，91％，分别为18.2、0.09和93％。结论：花生BBEA的验证测试性能表明总体准确度高，与现有的花生过敏诊断测试（包括皮刺测试，花生sIgE和花生成分测试）相比非常有利。在对CoFAR2和POISED队列进行验证时，花生BBEA测试的综合敏感性，特异性，阳性预测值，阴性预测值，阳性可能性比，阴性可能性比和准确性分别为91％，95％，95％，91％，分别为18.2、0.09和93％。结论：花生BBEA的验证测试性能表明总体准确度高，与现有的花生过敏诊断测试（包括皮刺测试，花生sIgE和花生成分测试）相比非常有利。