Background: 

Helicobacter pylori (HP) infection has been implicated in several malignant and nonmalignant conditions. The confirmatory diagnosis of HP requires an endoscopic biopsy, followed by a rapid urease test, culture, and/or histopathologic examination using hemotoxylin and eosin, histochemical stains, or immunohistochemistry against HP. EndoFaster is a novel device that can perform real-time ammonium and pH measurements in gastric juice, allowing a diagnosis of HP during gastroduodenal endoscopy.

Goal: 

This study aimed to validate the accuracy of EndoFaster and to compare different histochemical and immunohistochemical techniques for the diagnosis of HP infection.

Study: 

Consecutive patients who underwent upper endoscopy at our center were prospectively enrolled. During the endoscopy procedure, gastric juice was aspirated to perform an automatic analysis by EndoFaster and gastric biopsies were taken. Histologic sections were reviewed to assess the histopathologic features. The sensitivity, specificity, positive predictive value, and negative predictive value were calculated for the EndoFaster test, Diff-Quick (DQ), and immunohistochemistry against HP (anti-HP) using Warthin-Starry as the gold standard for HP detection.

Results: 

Overall, 80 patients were enrolled. In 19 cases (23,75%), histology was normal. In the remaining cases, varying degrees of inflammation were found. The sensitivity, specificity, positive predictive value, and negative predictive value were 73.33%, 86.00%, 75.86%, and 84.31% for the EndoFaster test using 67 ppm/mL as the positive threshold; 73.33%, 100%, 100%, and 86.21% for DQ; and 79.31%, 88.00%, 79.31%, and 88.00% for anti-HP, respectively.

Conclusions: 

The EndoFaster test has good sensitivity and specificity for the diagnosis of HP during the gastroscopy procedure. DQ and anti-HP are excellent alternatives to Warthin-Starry for the detection of HP.

中文翻译：

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实时铵和 pH 测量、免疫组织化学和组织化学在幽门螺杆菌诊断中的比较

背景： 

幽门螺杆菌(HP) 感染与多种恶性和非恶性疾病有关。HP 的确诊需要进行内镜活检，然后进行快速尿素酶试验、培养和/或使用苏木精和伊红、组织化学染色或HP免疫组织化学检查。EndoFaster 是一种新型设备，可以实时测量胃液中的铵和 pH 值，从而可以在胃十二指肠内窥镜检查过程中诊断 HP。

目标： 

本研究旨在验证 EndoFaster 的准确性，并比较诊断 HP 感染的不同组织化学和免疫组织化学技术。

学习： 

前瞻性招募了在我们中心连续接受上消化道内窥镜检查的患者。在内窥镜检查过程中，吸出胃液，通过 EndoFaster 进行自动分析，并进行胃活检。检查组织学切片以评估组织病理学特征。使用 Warthin-Starry作为 HP 检测的金标准，计算 EndoFaster 测试、Diff-Quick (DQ) 和HP免疫组织化学（抗 HP）的灵敏度、特异性、阳性预测值和阴性预测值。

结果： 

总共有 80 名患者入组。19 例 (23.75%) 组织学正常。其余病例均发现不同程度的炎症。使用 67 ppm/mL 作为阳性阈值的 EndoFaster 检测的敏感性、特异性、阳性预测值和阴性预测值分别为 73.33%、86.00%、75.86% 和 84.31%；DQ 为 73.33%、100%、100% 和 86.21%；抗HP分别为79.31%、88.00%、79.31%和88.00%。

结论： 

EndoFaster 测试对于胃镜检查过程中 HP 的诊断具有良好的敏感性和特异性。DQ 和 anti-HP 是检测 HP 时 Warthin-Starry 的绝佳替代品。