Chey W D, Murthy U K, Linscheer W, Barish C, Riff D, Rubin H, Safdi M, Schwartz H, Shah U, Wruble L, El-Zimaity H M
University of Michigan, Ann Arbor, USA.
Am J Gastroenterol. 1998 Jan;93(1):16-9. doi: 10.1111/j.1572-0241.1998.016_c.x.
To evaluate a new whole blood serology test (Hp Chek; ChemTrak) that detects IgG antibodies to Helicobacter pylori.
The study was conducted at 10 sites within the United States. Patients undergoing upper endoscopy for dyspepsia were recruited for enrollment. Those treated for H. pylori infection within a year of endoscopy and those who had regularly used proton pump inhibitors, bismuth compounds, or antibiotics within a month of endoscopy were not eligible. During endoscopy, specimens were obtained from the corpus and antrum for histological examination, which was performed by a single experienced pathologist. The Hp Chek was tested using whole blood and serum. Serum was also tested with a reference enzyme-linked immunosorbent assay (ELISA) at a centralized location. Test characteristics for the Hp Chek and ELISA were calculated using histology as the "gold standard."
Two hundred eighty-seven patients (140 women and 147 men; mean age 53 +/- 6 yr) were enrolled. The Hp Chek was easy to perform and yielded results 9 min after inoculation of the test cassette with whole blood or serum. When the Hp Chek used with whole blood was compared with histology as the gold standard, the sensitivity was 88%, specificity 85%, positive predictive value 83%, negative predictive value 90%, and percent agreement 86%. There were no statistically significant differences among the results obtained with the Hp Chek using whole blood, the Hp Chek using serum, or reference ELISA.
The Hp Chek whole blood serology test was easy to perform and rapid and yielded performance characteristics comparable to those of a reference ELISA or the Hp Chek used with serum.
评估一种检测幽门螺杆菌IgG抗体的新型全血血清学检测方法（Hp Chek；ChemTrak）。
该研究在美国的10个地点进行。招募因消化不良接受上消化道内镜检查的患者。在内镜检查前一年内接受过幽门螺杆菌感染治疗的患者以及在内镜检查前一个月内经常使用质子泵抑制剂、铋化合物或抗生素的患者不符合入选标准。在内镜检查期间，从胃体和胃窦获取标本进行组织学检查，由一位经验丰富的病理学家进行操作。使用全血和血清对Hp Chek进行检测。血清也在一个集中地点用参考酶联免疫吸附测定法（ELISA）进行检测。以组织学作为“金标准”计算Hp Chek和ELISA的检测特征。
共招募了287名患者（140名女性和147名男性；平均年龄53±6岁）。Hp Chek操作简便，在向检测盒中接种全血或血清后9分钟即可得出结果。当将使用全血的Hp Chek与作为金标准的组织学进行比较时，灵敏度为88%，特异性为85%，阳性预测值为83%，阴性预测值为90%，一致性百分比为86%。使用全血的Hp Chek、使用血清的Hp Chek或参考ELISA所获得的结果之间无统计学显著差异。
Hp Chek全血血清学检测方法操作简便、快速，其性能特征与参考ELISA或使用血清的Hp Chek相当。
