Division of Gastroenterology and Hepatology, Department of Internal Medicine, Baylor College of Medicine, Houston, TX 77030, USA.
Division of Gastroenterology, Nutrition and Hepatology, Department of Pediatrics, Baylor College of Medicine, Houston, TX 77030, USA.
Biomed Res Int. 2020 Mar 19;2020:7189519. doi: 10.1155/2020/7189519. eCollection 2020.
Antigens derived from can be used as stool biomarkers to assist in the diagnosis of infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian.
This prospective multisite study enrolled patients undergoing an esophagogastroduodenoscopy with collection of biopsy and stool specimens. Adult patients (≥22 years) participated in the study from February 2017 to August 2018. Specimens of the stomach were tested by three methods, known as the Composite Reference Method: (1) histological evaluation, (2) culture of the organism, and (3) rapid urease detection test. infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian.
277 patients (63% female) were included in the study. The prevalence of infected subjects was 24.2% in this study cohort. Clinical performance assessed against the Composite Reference Method showed very good agreement (Cohen's kappa = 0.922), with good sensitivity (95.5%) and specificity (97.6%). Reproducibility study results showed total imprecision ranging from 3.1% to 13.9% CV.
The automated LIAISON® Meridian SA assay brings reliable noninvasive testing for to the laboratory that is in very good agreement with the current, more invasive biopsy-based methods such as histology, culture, or rapid urease test. The clinical trial identifiers are NCT03060746 (pretherapy) and NCT03060733 (posttherapy). infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian infection. Since current assays have variable performance, we assessed the clinical performance of the automated LIAISON® Meridian.
可以使用来源于 的抗原作为粪便生物标志物来辅助 感染的诊断。由于目前的检测方法具有不同的性能，因此我们评估了自动 LIAISON® Meridian 感染检测的临床性能。
本前瞻性多中心研究纳入了接受食管胃十二指肠镜检查并采集活检和粪便标本的患者。2017 年 2 月至 2018 年 8 月期间，年龄≥22 岁的成年患者参与了该研究。采用三种方法（称为综合参考方法）对胃标本进行检测：（1）组织学评估，（2）培养该生物体，和（3）快速尿素酶检测试验。
本研究共纳入 277 例患者（63%为女性）。在该研究队列中，受感染患者的患病率为 24.2%。与综合参考方法相比，临床性能评估显示出非常好的一致性（Cohen's kappa=0.922），具有良好的敏感性（95.5%）和特异性（97.6%）。重复性研究结果显示总不精密度范围为 3.1%至 13.9%CV。
自动 LIAISON® Meridian 抗原检测为实验室提供了可靠的非侵入性 检测方法，与目前更具侵袭性的基于活检的方法（如组织学、培养或快速尿素酶检测）具有非常好的一致性。临床试验标识符为 NCT03060746（治疗前）和 NCT03060733（治疗后）。
