[用于幽门螺杆菌感染血清学诊断的4种商业免疫酶测定法的评估]

[Assessment of 4 commercial immunoenzymatic assays for the serologic diagnosis of Helicobacter pylori infection].

作者信息

Juncal A R, Garea M T, Cid A, Peñalver M D, Vázquez R, Montero E, Rajo M C, Jato A M, López J M

机构信息

Servicio de Microbiología, Hospital General de Galicia, Santiago de Compostela.

出版信息

Enferm Infecc Microbiol Clin. 1998 Apr;16(4):185-9.

PMID:9646563

Abstract

BACKGROUND

The aim of this study was to evaluate four commercial tests for the serologic diagnosis of infection by Helicobacter pylori based on the detection of IgG class antibodies versus this microorganism.

METHODS

Four commercial kits were analyzed based on the ELISA method in serum samples of 48 patients admitted for digestive endoscopy. The data of the serologic tests were compared with those provided by the culture, the histologic observation and the urease test of gastric biopsy specimens. The calculation of seroprevalence of anti-H. pylori antibodies in serum of 60 asymptomatic subjects was carried out.

RESULTS

The seroprevalence of infection by H. pylori in an asymptomatic population of between 18 to 78 years of age was 58.33%. A sensitivity of 94.3% and a specificity of 88.9% were observed with the Pyloriset EIA-G test. The positive predictive value (PPV) was 92.2% and the negative predictive value (NPV) 91.5%. With the Chemifarma commercial kit the sensitivity was 78.8% and the specificity 100% with a PPV of 100% and NPV of 76.7%. Plate showed a sensitivity of 85.3% and a specificity of 87.5% with a PPV of 90% and a NPV of 80.76%. Milenia had a sensitivity of 80% and a specificity of 66.7% and a PPV of 77% and a NPV of 70.7%.

CONCLUSIONS

The usefulness of the serologic tests for the diagnosis of Helicobacter pylori infection is herein confirmed with the test evaluated showing a high sensitivity and specificity as well as high predictive values.

摘要

背景

本研究的目的是评估四种基于检测抗幽门螺杆菌IgG类抗体的商业检测方法用于幽门螺杆菌感染的血清学诊断。

方法

基于酶联免疫吸附测定（ELISA）方法对48例因消化内镜检查入院患者的血清样本进行了四种商业试剂盒分析。将血清学检测数据与胃活检标本的培养、组织学观察及尿素酶试验结果进行比较。计算了60名无症状受试者血清中抗幽门螺杆菌抗体的血清阳性率。

结果

18至78岁无症状人群中幽门螺杆菌感染的血清阳性率为58.33%。Pyloriset EIA-G检测的灵敏度为94.3%，特异性为88.9%。阳性预测值（PPV）为92.2%，阴性预测值（NPV）为91.5%。使用Chemifarma商业试剂盒时，灵敏度为78.8%，特异性为100%，PPV为100%，NPV为76.7%。Plate检测的灵敏度为85.3%，特异性为87.5%，PPV为90%，NPV为80.76%。Milenia检测的灵敏度为80%，特异性为66.7%，PPV为77%，NPV为70.7%。