二种核酸检测法诊断幽门螺杆菌感染的临床比较

The Clinical Comparison of Two Methods Based on Nucleic Acid Detection for Diagnosis of Helicobacter Pylori Active Infection

目的:二种核酸检测法诊断幽门螺杆菌(HP)感染的临床诊断价值,用以向临床日常实践中推荐使用。方法:117例胃炎、胃溃疡和胃癌患者胃黏膜活组织标本采用HP恒温扩增-防污染核酸试纸条和实时荧光定量PCR进行HP检测,并比较二种检测方法的特异性、灵敏度等。同时以组织学染色和细菌培养二种"金标准"法作为比较。结果:二种"金标准"法诊断了HP感染的阳性66例,阴性51例;66例"金标准"检测法诊断HP阳性的标本中,其中有62例HP恒温扩增-防污染核酸试纸条检测阳性,60例实时荧光定量PCR检测阳性;51例"金标准"检测法诊断HP阴性的标本中,其中有49例HP恒温扩增-防污染核酸试纸条检测阴性,50例实时荧光定量PCR检测阴性,据此HP恒温扩增-防污染核酸试纸条检测HP的诊断敏感性为93.9%(62/66),特异性为96.1%(49/51);实时荧光定量PCR检测HP的诊断敏感性为90.9%(60/66),特异性为98.0%(50/51)。结论:HP恒温扩增-防污染核酸试纸条和实时荧光定量PCR检测技术相当,但HP恒温扩增-防污染核酸试纸条检测不需要昂贵的仪器设备,结果便于阅读,操作方法简单,适宜于作为HP感染筛查的基础。

Objective The clinical comparison of two nucleic acid detection methods for the diagnosis in patients with Helicobacter pylori（HP） active infection and diagnostic value,in order to make recommendations for daily clinical practice.Methods Using preventing contaminating nucleic acid amplification-test strip and real-time PCR to detect HP in gastric mucosa tissue in 117 patients with gastritis,gastric ulcer and gastric cancer diseases,Besides comparing to ＂gold standard＂ methods of histological staining and bacterial cultivation simultaneously.Result The positive HP infection samples detected by ＂gold standard＂ methods of the above mentioned were 66 cases,and the negative samples were 51 cases.Moreover,the positive samples detected by preventing contaminating nucleic acid amplification-test strip were 62 cases in 66 positive samples diagnosed by ＂gold standard＂ methods,and the negative samples by preventing contaminating nucleic acid amplification-test strip were 49 cases of 51 negative samples.The positive samples detected by real-time PCR were 60 cases in 66 positive samples diagnosed by ＂gold standard＂ methods,and the negative samples real-time PCR were 50 cases of 51 negative samples.In comparison with the ＂gold standard＂ methods results,the preventing contaminating nucleic acid amplification-test strip test had a sensitivity and specificity of 93.9% and 96.1%,respectively,while those for the real-time PCR test were 90.9% and 98.0%,individually.Conclusion Both the technique of preventing contaminating nucleic acid amplification-test strip and real-time PCR are equally matched.But the preventing contaminating nucleic acid amplification-test strip detection method does not require expensive equipment,the results are easy to read,simple operation,and suitable base for HP screening.