结核分枝杆菌耐利福平诊断试验的系统评价

目的采用Meta分析的方法评价LiPA和phage-based assays法检测结核分枝杆菌耐利祸平诊断试验的准确性：方法通过检索PubMed、EMbase、CBMWeb、CSJD、CJFD数据库和其他方式广泛收集文献：根据QUADAS质量评价标准评价纳入文献的质量，用Meta-Disc软件对其敏感度、特异度、阳性似然比、阴性似然比等进行合并分析，并进行异质性检验，对无异质性的研究绘制SROC曲线。结果最终纳入42篇文献：（1）LiPA法检测结核分支杆菌耐利福平时，7个研究以BACTEC460法为参考，合并敏感度0.98，合并特异度0.98，SROC（AUC）=0.9924；6个研究以proportion法为参考，合并敏感度0.97，合并特异度1.00，SROC（AUC）=0.9961；3个研究以BACTEC460、Proportion法作为参考，合斤敏感度0.92，合并特异度0.98，SROC（AUC）=0.9842；（2）噬菌体扩增法（商用）检测结核分枝杆菌耐利福平的7个研究，以BACTEC460、Proportion法为参考，合并敏感度0.95，合并特异度0.95，SROC（AUC）=0.9842，（3）噬菌体扩增法（内部的）检测结核分支杆菌耐利福平的7个研究，以BACTEC460、比例法、绝对浓度法和电阻率法为参考，其合并敏感度0.98，合并特异度0.98，SROC（AUC）=0.9949；（4）光素酶噬菌体报告技术检测结核分枝杆菌耐利福平的7个研究，以BACTEC460、比例法、绝对浓度法为参考，其合并敏感度0.98，合并特异度0.98，SROC（AUC）=0.9788。结论现有研究证实：（1）采用分离培养时，噬菌体检测法存检洲结核分枝杆菌耐利福平方面具有较高的敏感度和特异度，在提高耐多药结核病诊断准确性方面具有潜力、（2）LiPA任检测结俊分枝杆菌耐利福平方面也具有较高的敏感度和特异度，但直接应用临床标本检测时敏感度似乎稍有下降一上述结果尚需更多设计严谨、科学的临床试验进一步证实。

Diagnostic Value of LiPA and Phage-Based Assays for Rifampicin Resistance in Mycobacterium Tuberculosis:A Systematic Review

Objective To evaluate the diagnostic accuracy of LiPA and phage-based assays in detecting rifampicin resistance in Mycobacterium tuberculosis.Methods A fully recursive literature search was conducted in PUBMED,EMBASE,CBMWeb,CSJD and CJFD.QUADAS items were used to evaluate the quality of the included studies.Meta-disc software was used to handle data from the included studies.SEN,SPE and SROC were used to assess the diagnostic accuracy of every individual diagnostic test.Results A total of 42 studies were included finally.(1)LiPA for detection of rifampicin resistant Mycobacterium tuberculosis:7 studies took BACTEC 460 assay as the reference test,and meta-analysis showed that the summary SEN=0.98,summary SPE=0.98,SROC(AUC)=0.9924;6 studies chose proportion assay as the reference test,and meta-analysis showed that the summary SEN=0.97,summary SPE=1.00,SROC(AUC)=0.9961;and 3 studies took both BACTEC 460 assay and proportion assay as the reference tests,and meta-analysis showed that the summary SEN=0.92,summary SPE=0.98,SROC(AUC)=0.9842.(2)Seven studies detected the rifampicin resistant Mycobacterium tuberculosis using Phage amplification assays(Commercial),taking BACTEC 460 assay and proportion assay as the reference tests.Meta-analysis showed that the summary SEN=0.95,summary SPE=0.95,SROC(AUC)= 0.9842.(3)Seven studies detected the rifampicin resistant Mycobacterium tuberculosis using Phage amplification assays(in-house),taking BACTEC 460 assay,proportion assay and absolute concentration as the reference tests.Meta-analysis showed that the summary SEN=0.98,summary SPE=0.98,SROC(AUC)=0.9949.(4)Seven studies detected the rifampicin resistant Mycobacterium tuberculosis using Luciferase reporter phage assays(In-house),taking BACTEC 460 assay,proportion assay and absolute concentration as the reference tests.Meta-analysis showed that the summary SEN= 0.98,summary SPE=0.98,SROC(AUC)=0.9788.Conclusion Current research confirms that Phage assay is a highly sensitive and specific test for the detection of rifampicin resistance in culture isolates and has a potential in improving the diagnostic accuracy of all diagnostic tests in detecting the rifampicin resistant Mycobacterium tuberculosis.LiPA is also a highly sensitive and specific test for the detection of rifampicin resistance,but the sensitivity appears to relatively decrease when it was used directly on clinical specimens.The results mentioned above need to be further confirmed by more high-quality studies.