2种快速检测技术在结核分枝杆菌利福平耐药性检测中的应用评价

Application evaluation of the two rapid detection technologies in the detection of rifampin resistance in Mycobacterium tuberculosis

目的探讨噬菌体扩增技术和基因芯片技术在结核分枝杆菌(MTB)利福平耐药性检测中的应用价值。方法应用噬菌体法和基因芯片法直接检测380份痰样本,分析MTB对利福平的耐药性,同时对痰样本进行BACTEC MGIT 960培养,并用培养法对培养菌株做药敏试验,对3种方法检测的药敏结果进行比较。涂片阴性培养阳性样本,用临床分离株进行以上3种方法利福平耐药性检测并比较结果。对与培养法结果不一致的样本进行DNA测序。结果以培养法为参考方法,噬菌体法的综合灵敏度、特异度、准确度分别为87.8%(36/41)、94.1%(95/101)、92.3%(131/142);基因芯片法的综合灵敏度、特异度、准确度分别为82.9%(34/41)、96.0%(97/101)、92.3%(131/142),2种检测方法的综合灵敏度、特异度和准确度差异均无统计学意义(χ2=0.391、χ2=0.421、χ2=0,P>0.05)。结论本次研究显示噬菌体法和基因芯片法检测结核分枝杆菌利福平耐药性均有较高的灵敏度、特异度和准确度,具有准确、快速的特点,在结核病快速诊疗领域有较好的应用前景。

Objective To evaluate the value of phage amplification technology and gene chip technology in detection of rifampin resistance in mycobaeterium tuberculosis（MTB）. Methods 380 cases of sputum specimens were determined by phage amplifi- cation technology and gene chip technology, analysis of rifampin resistance in mycobacterium tuberculosis, the sputum speci- mens were cultured by BACTEC MGIT 960 and culture method was used to drug sensitivity test, result comparison of the three detecting methods in detection of rifampin resistance in mycobaeterium tuberculosis. Clinical isolates of smear negative and posi- tive culture were determined by the three detecting methods and results comparison of rifampin resistance. Corresponding the culture method, the inconsistent samples were conducted for DNA sequencing. Results Comprehensive sensitivity, specificity and degree of accuracy of phage amplification technology were 87.8% （36/41）, 94.1% （95/101） and 92.3% （131/142）. Comprehensive sensitivity, specificity and degree of accuracy of Gene chip technology were 82.9% （34/41）, 96.0% （97/101） and 92.3 % （131/142）. The comprehensive sensitivity, specificity and degree of accuracy of two detecting methods was not sta- tistically significant （x^2 = 0.391, x^2 = 0. 421, x^2 = 0, P 〉 0.05 ）. Conclusion The research shows that phage amplification technology and gene chip technology in detection of rifampin resistance in Mycobacterium tuberculosis both have high sensitivity, specificity and degree of accuracy; and the method is characterized by rapidness and accuracy. There is a good application pros- pect of tuberculosis diagnosis and treatment.