OBJECTIVES Consensus is lacking regarding the number of eosinophils (eos) required for diagnosis of eosinophilic gastritis (EoG) and eosinophilic duodenitis (EoD). Additionally, thresholds that require multiple high-power fields (hpfs) may not be practical for clinical use, resulting in delayed or missed diagnoses. This pooled analysis of 4 prospective studies assessed thresholds for multiple and single hpfs used to diagnose EoG and EoD. METHODS Studies included the phase 2 ENIGMA1, the phase 3 ENIGMA2, an EoG/EoD prevalence study, and a healthy volunteer study. Eosinophils were quantified in the epithelium and lamina propria for controls and symptomatic participants. Symptomatic participants were further divided by histologic diagnosis of EoG/EoD. Peak eos counts were assessed, and area under the receiver operating characteristic (AUROC) curve was analyzed to identify eos cutoffs for detection of EoG/EoD using the Youden index and sensitivity and specificity equality approaches. RESULTS Based on the highest specificity analysis in 740 patients, the optimal eos threshold was determined to be 20 eos/hpf in 5 gastric hpfs for EoG (71% sensitivity; 94% specificity) and 33 eos/hpf in 3 duodenal hpfs for EoD (49% sensitivity; 100% specificity). For single-field analysis, the optimal eos thresholds were 33 eos/hpf (EoG) and 37 eos/hpf (EoD), both corresponding to 93% sensitivity and 93% specificity. CONCLUSIONS Highly specific single gastric and duodenal hpf thresholds may have more clinical applicability than thresholds requiring multiple hpfs and could better facilitate development of practical histopathologic guidelines to aid pathologists and clinicians in the detection and diagnosis of EoG and/or EoD.

中文翻译：

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确定诊断嗜酸性粒细胞性胃炎和十二指肠炎的最佳嗜酸性粒细胞阈值：4 项前瞻性研究的汇总分析。

目的 对于诊断嗜酸性粒细胞胃炎 (EoG) 和嗜酸性粒细胞十二指肠炎 (EoD) 所需的嗜酸性粒细胞 (eos) 数量缺乏共识。此外，需要多个高功率场 (hpfs) 的阈值可能不适合临床使用，从而导致延迟或漏诊。这项对 4 项前瞻性研究的汇总分析评估了用于诊断 EoG 和 EoD 的多个和单个 hpf 的阈值。方法 研究包括 2 期 ENIGMA1、3 期 ENIGMA2、EoG/EoD 患病率研究和健康志愿者研究。对对照组和有症状参与者的上皮和固有层中的嗜酸性粒细胞进行定量。有症状的参与者根据 EoG/EoD 的组织学诊断进一步划分。评估峰值 eos 计数，并分析受试者工作特征 (AUROC) 曲线下面积，以确定使用 Youden 指数以及灵敏度和特异性平等方法检测 EoG/EoD 的 eos 截止值。结果 根据 740 名患者的最高特异性分析，EoG 的最佳 eos 阈值确定为 5 个胃 hpf 中的 20 eos/hpf（敏感性 71%；特异性 94%），EoD 的最佳 eos 阈值确定为 3 个十二指肠 hpf 中的 33 eos/hpf（ 49% 敏感性；100% 特异性）。对于单视野分析，最佳 eos 阈值是 33 eos/hpf (EoG) 和 37 eos/hpf (EoD)，均对应于 93% 的灵敏度和 93% 的特异性。结论 高度特异性的单一胃和十二指肠 HPF 阈值可能比需要多个 hpf 的阈值具有更多的临床适用性，并且可以更好地促进实用组织病理学指南的制定，以帮助病理学家和临床医生检测和诊断 EoG 和/或 EoD。