Helicobacter pylori (Hp) IgG ELISA of the New-Generation GastroPanel® Is Highly Accurate in Diagnosis of Hp-Infection in Gastroscopy Referral Patients
Helicobacter pylori (Hp) IgG ELISA of the New-Generation GastroPanel® Is Highly Accurate in Diagnosis of Hp-Infection in Gastroscopy Referral Patients
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DOI：
10.21873/anticanres.14660
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发表时间：
2020-11-01
影响因子：
2
通讯作者：
Syrjanen, Kari
中科院分区：
文献类型：
--
作者：
Maki, Minna;Soderstrom, Daniela;Syrjanen, Kari
背景/目的：幽门螺杆菌（Helicobacter pylori，Hp）感染是胃癌（gastric cancer，GC）的主要危险因素。普通Hp检测的注意事项可以通过血清学生物标志物检测（GastroPanel（R），Biohit Oyj，赫尔辛基）来规避，这是市场上最全面的Hp检测。本文报道了新一代幽门螺杆菌IgG ELISA试验的临床验证。本研究的目的是验证幽门螺杆菌IgG ELISA检测在胃镜转诊患者中诊断活检证实的幽门螺杆菌感染的临床性能。患者和方法：通过两种测试版本检查了在胃肠病门诊部（SM诊所，圣彼得堡彼得堡）转诊进行胃镜检查的101例患者（平均年龄=50.1岁）队列，以验证新一代GastroPanel（R）。所有患者均接受胃镜检查和活检，并进行Giemsa染色以确定胃窦（A）和胃体（C）中的Hp。结果：64%的患者经活检证实为Hp感染，最常见的是局限于胃窦。Hp IgG ELISA法与胃活检法的总符合率为91%（95%CI=84.1-95.8%）。Hp IgG ELISA诊断A、C组Hp的敏感性（SE）为92.3%，特异性（SP）为88.6%，阳性预测值（PPV）为93.8%，阴性预测值（NPV）为86.1%，AUC=0.904（95%CI=0.842-0.967）。在Hp检测的ROC分析（A&C）中，Hp IgG ELISA显示AUC=0.978（95%CI=0.956-1.000）。结论：Hp IgG ELISA检测成功地完成了新一代GastroPanel（R）检测的临床验证过程，该检测保留了其所有四种生物标志物的无与伦比的诊断性能，在不同的临床环境中广泛记录了第一代检测。
Background/Aim: Helicobacter pylori (Hp) infection affects a substantial proportion of the world population and is a major risk factor of gastric cancer (GC). The caveats of common Hp-tests can be evaded by a serological biomarker test (GastroPanel (R), Biohit Oyj, Helsinki), the most comprehensive Hp-test on the market. The clinical validation of Helicobacter pylori IgG ELISA of the new-generation GastroPanel (R) test is reported. The aim of the study is to validate the clinical performance of the Helicobacter pylori IgG ELISA test in diagnosis of biopsy-confirmed Hp-infection in gastroscopy referral patients. Patients and Methods: A cohort of 101 patients (mean age=50.1 years) referred for gastroscopy at the outpatient Department of Gastroenterology (SM Clinic, St. Petersburg) were examined by two test versions to validate the new-generation GastroPanel (R). All patients were examined by gastroscopy and biopsies, which were stained with Giemsa for specific identification of Hp in the antrum (A) and corpus (C). Results: Biopsy-confirmed Hp-infection was found in 64% of patients, most often confined to antrum. The overall agreement between Hp IgG ELISA and gastric biopsies in Hp-detection was 91% (95%CI=84.1-95.8%). Hp IgG ELISA diagnosed biopsy-confirmed Hp (A&C) with sensitivity (SE) of 92.3%, specificity (SP) of 88.6%, positive predictive value (PPV) of 93.8% and negative predictive value (NPV) of 86.1%, with AUC=0.904 (95%CI=0.842-0.967). In ROC analysis for Hp detection (A&C), Hp IgG ELISA shows AUC=0.978 (95%CI=0.956-1.000). Conclusion: The Hp IgG ELISA test successfully concludes the clinical validation process of the new-generation GastroPanel (R) test, which retains the unrivalled diagnostic performance of all its four biomarkers, extensively documented for the first-generation test in different clinical settings.