幽门螺杆菌感染的血清学诊断：对一种市售酶联免疫吸附测定法（ELISA）检测IgG的评估。

Serodiagnosis of Helicobacter pylori infection: an evaluation of a commercially available ELISA-IgG.

作者信息

van de Wouw B A, de Boer W A, Jansz A R, Staals A P, Roymans R T

机构信息

Department of Internal Medicine, Sint Joseph Ziekenhuis, Veldhoven, Netherlands.

出版信息

Neth J Med. 1995 Dec;47(6):272-7. doi: 10.1016/0300-2977(95)00104-2.

DOI:10.1016/0300-2977(95)00104-2

PMID:8569932

Abstract

BACKGROUND

Our aim was to evaluate a commercially available ELISA (Pyloriset IgG, Orion diagnostica, Imphos B.V.) for detection of serum IgG antibodies to Helicobacter pylori.

METHODS

Serum samples were taken from 154 Dutch patients. As a reference method several biopsy specimens were taken from different gastric areas for histological analysis, bacterial culture and direct urease testing. The sensitivity, specificity, positive and negative predictive values of the Pyloriset IgG were calculated as compared to the reference method.

RESULTS

Of 154 patients 126 were found to be H. pylori positive (82%), 28 were H. pylori negative (18%). Using a cut-off value at a titre of 500 U/l (as advised by the manufacturer) we found a sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of 81, 89, 97 and 51%, respectively. Lowering the cut-off value to 350 U/l and excluding patients aged above 70 years optimalized the performance of the Pyloriset IgG to a sensitivity, specificity, PPV and NPV of 92, 96, 99 and 72%, respectively. In the subgroup of 54 patients under the age of 45 years a sensitivity, specificity, PPV and NPV of 92, 100, 100 and 82% was found.

CONCLUSIONS

The Pyloriset IgG is a simple and accurate method for detecting H. pylori infection in dyspeptic Dutch patients. The performance of this assay is improved by lowering the cut-off value (test becomes predominantly more sensitive) and excluding older patients (test becomes predominantly more specific). Therefore serology might eventually replace endoscopy or breath tests in the detection of H. pylori infection, especially in the younger age groups.

摘要

背景

我们的目的是评估一种市售的酶联免疫吸附测定法（Pyloriset IgG，奥立安诊断公司，Imphos B.V.）用于检测幽门螺杆菌血清IgG抗体。

方法

从154名荷兰患者中采集血清样本。作为参考方法，从不同胃区域采集多个活检标本进行组织学分析、细菌培养和直接尿素酶检测。将Pyloriset IgG的敏感性、特异性、阳性和阴性预测值与参考方法进行比较计算。

结果

154名患者中，126名被发现幽门螺杆菌阳性（82%），28名幽门螺杆菌阴性（18%）。使用制造商建议的500 U/l滴度作为临界值，我们发现敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）分别为81%、89%、97%和51%。将临界值降至350 U/l并排除70岁以上患者，可使Pyloriset IgG的性能优化至敏感性、特异性、PPV和NPV分别为92%、96%、99%和72%。在45岁以下的54名患者亚组中，发现敏感性、特异性、PPV和NPV分别为92%、100%、100%和82%。