摘要
目的:探讨Gene Xpert MTB/RIF技术在川东基层医疗机构中对结核病(TB)的早期诊断价值。方法:收集2020年3月至2021年2月遂宁市中心医院收治的疑似TB患者送检的标本368份,分别采用抗酸染色法、荧光定量聚合酶链式反应(PCR)法、Gene Xper t MTB/RIF技术与固体培养法对标本进行检测,比较四种检测方法的阳性检出率,并以固体培养法的检测结果为金标准,分析Gene Xpert MTB/RIF技术对结核分枝杆菌(MTB)的检测效能;以比例法药敏试验结果为金标准,分析Gene Xpert MTB/RIF技术对利福平耐药性的检测效能。结果:用抗酸染色法、荧光定量PCR法、Gene Xpert MTB/RIF技术、固体培养法对368份标本进行检测的阳性检出率分别为14.13%、34.24%、49.46%、50.82%。采用Gene Xp ert M TB/RIF技术对368份标本进行检测的阳性检出率高于荧光定量PCR法和抗酸染色法,差异有统计学意义(P<0.05)。采用固体培养法对368份标本进行检测的阳性检出率略高于Gene Xpert MTB/RIF技术,但差异无统计学意义(P>0.05)。以固体培养法的检测结果为金标准,发现采用Gene Xpert MTB/RIF技术检测疑似TB患者送检标本中MTB的敏感度为96.79%、特异度为99.45%,阳性预测值为99.45%,阴性预测值为96.77%,二者的符合率为98.10%,Kappa值为0.961。以比例法药敏试验结果为金标准,发现采用Gene Xpert MTB/RIF技术检测疑似TB患者送检标本利福平耐药性的敏感度为88.89%,特异度为99.71%,阳性预测值为96.00%,阴性预测值为99.13%,二者的符合率为98.91%,Kappa值为0.884。结论:采用Gene Xpert MTB/RIF技术检测MTB和利福平耐药性的敏感度高、特异度好且对生物安全要求较低,适合在川东生物安全防护薄弱的基层医疗机构推广使用。
Objective:To investigate the value of Gene Xpert MTB/RIF in t he early diagnosis of tuberculosis(TB)in primary medical institutions in eastern Sichuan.Methods:A total of 368 specimens were collected from suspected TB patients admitted to Suining Central Hospital from March 2020 to February 2021.Acid-fast staining,fluorescence quantitative polymerase chain reaction(PCR),Gene Xpert MTB/RIF technology and solid culture method were used to detect the specimens,and the positive detection rates of the four detection methods were compared.The detection efficiency of Gene Xpert MTB/RIF for Mycobacterium tuberculosis(MTB)was analyzed by using solid culture method as the gold standard.To analyze the efficacy of Gene Xpert MTB/RIF technology in detecting rifampicin resistance with the results of proportional susceptibility test as the gold standard.Results:The positive detection rates of 368 samples detected by acid-fast staining,fluorescence quantitative PCR,Gene Xpert MTB/RIF technology and solid culture method were 14.13%,34.24%,49.46%and 50.82%,respectively.The positive detection rate of 368 samples detected by Gene Xpert MTB/RIF technique was higher than that of fluorescence quantitative PCR and acid-fast staining,and the difference was statistically significant(P<0.05).The positive detection rate of 368 specimens detected by solid culture method was slightly higher than that by Gene Xpert MTB/RIF technique,but the difference was not statistically significant(P>0.05).Taking the solid culture method as the gold standard,it was found that the sensitivity,specificity,positive predictive value and negative predictive value of Gene Xpert MTB/RIF for detecting MTB in the samples of suspected TB patients were 96.79%,99.45%,99.45%and 96.77%,respectively.The coincidence rate of the two was 98.10%.The Kappa value was 0.961.Taking the results of drug sensitivity test by proportional method as the gold standard,it was found that the sensitivity,specificity,positive predictive value and negative predictive value of Gene Xpert MTB/RIF in detecting rifampicin resistance of samples from suspected TB patients were 88.89%,99.71%,96.00%and 99.13%,respectively.The coincidence rate of the two was 98.91%.The Kappa value was 0.884.Conclusion:Gene Xpert MTB/RIF technology has high sensitivity,good specificity and low biosafety requirements for the detection of MTB and rifampicin resistance,which is suitable for popularization and use in primary medical institutions with weak biosafety protection in eastern Sichuan.
作者
王翠
王芬
刘家瑞
WANG Cui;WANG Fen;LIU Jiarui(Suining Central Hospital,Suining 629000,Sichuan,China)
