基层医院开展GeneXpert MTB技术在结核病早期诊断中的可行性研究

Feasibility study of developing GeneXpert MTB technology in early diagnosis of tuberculosis in primary hospitals

目的探讨基层医院开展GeneXpert MTB技术应用于结核病早期诊断的可行性。方法选取2015年4月-2017年5月进入结核病定点医院诊治的300例疑似结核病患者作为对象,收集其痰液标本,选用不同方法实施MTB检测,对比分析检测结果。结果 Xpert MTB检测阳性率为28. 00%,与液体培养的28. 33%比较,差异无显著性(χ^2=0. 008,P> 0. 05),但显著高于涂片法检查的17. 00%(χ^2=10. 408,P <0. 05); Xpert MTB检测与涂片法检查比较,特异度、敏感度分别为85. 14%、92. 16%,与液体培养法比较,特异度、敏感度分别为95. 81%、90. 59%,以液体培养结果为金标准,Xpert MTB技术MTB检测敏感度、一致率分别为90. 67%、93. 87%,均高于涂片法的61. 86%、88. 72%(χ^2=4. 663、χ^2=4. 046,P <0. 05); Xpert MTB技术涂阳标本检测敏感度为97. 15%,显著高于涂阴标本的80. 74%(χ^2=4. 857,P <0. 05)。结论 Xpert MTB技术应用于结核病早期诊断具有操作简便、检测快速、实验室生物安全要求低的优点,表现出较高的敏感度、特异度以及一致率,值得在基层医院大力推广。

Objective To study the feasibility of GeneXpert MTB technology in early diagnosis of tuberculosis in primary hospitals. Methods 300 patients with suspected tuberculosis who were admitted to the designated hospital of tuberculosis from April 2015 to May 2017 were selected as subjects,and their sputum samples were collected for MTB test in different methods,and the results were compared and analyzed. Results The positive rate of Xpert MTB detection was 28. 00%,and compared with liquid culture( 28. 33%),with the difference not significant( χ^2= 0. 008,P > 0. 05),but significantly higher than the smear test( 17. 00%)( χ^2= 10. 408,P < 0. 05); compared with smear test,the specificity and sensitivity of Xpert MTB test was 85. 14%,92. 16%,respectively. Compared with liquid culture method,the specificity and sensitivity was 95. 81% and90. 59%,respectively. With liquid culture as gold standard,the sensitivity and agreement rate of MTB detection by Xpert MTB technology was 90. 67% and 93. 87%,respectively,which were higher than that of smear method( 61. 86% and 88. 72%)( χ^2= 4. 663,χ^2= 4. 046,P < 0. 05); the sensitivity of Xpert MTB technology in the test of positive samples was 97. 15%,which was significantly higher than that of the smear-negative specimens( 80. 74%)( χ^2= 4. 857,P < 0. 05). Conclusion Xpert MTB technology has the advantages of simple operation,rapid detection and low bio-safety requirements in laboratory in the early diagnosis of tuberculosis. It shows high sensitivity,specificity and consistency rate,and it is worthy of promotion in primary hospitals.