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目的:我们之前进行过商品化及非商品化噬菌体实验检测耐利福平(RMP)结核(TB)的诊断准确性和操作特点的分析,此文章的目的是基于更多的研究来更新前一次分析。设计及结果:我们运用二元随机效果回归模型和分层综合接受者工作特征曲线(HSROC),对检测实验的准确性进行了系统回顾及Meta分析。评估的实验包括:FASTPlaqueTM、噬菌体荧光素报告(LRP)实验、室内噬菌体扩增实验。利福平检测的敏感性及特异性是主要分析指标。结果:通过更新文献搜索及分析,共有31篇研究(3085个标本)纳入此meta分析中。与室内扩增实验相比(敏感性变异范围为88%～100%,特异性变异范围为84%～100%),商品化试剂盒的指示值变化范围较大(敏感性变异范围为81%～100%,特异性变异范围为73%～100%)。LRP实验诊断的准确性一直很稳定,8项研究中7项敏感性为100%,4项特异性为100%。仅对准确性估计不能获得商品化试剂盒其他重要问题的分析,例如:污染率和不能得到确定结果的比例,直接检测病人标本的利福平耐药率时这2个率分别为3%和36%(平均值为20%)。结论:噬菌体技术需要进一步发展,以获得最多的诊断率并降低技术失误。一旦技术的问题得到解决,应得到对病人预后的影响和成本效益分析,为决策提供证据以得到大规模使用。
OBJECTIVE: We previously conducted an analysis of the diagnostic accuracy and operational characteristics of rifampicin (RMP) tuberculosis (TB) using both commercial and non-commercial phage assays. The purpose of this article is to update the previous study based on more studies analysis. Design and Results: We conducted a systematic review and meta-analysis of the accuracy of the test using binary random effects regression model and hierarchical integrated receiver operating characteristic curve (HSROC). The experiments evaluated included FASTPlaqueTM, phage luciferin reporter (LRP) experiments, and in vivo phage amplification experiments. The sensitivity and specificity of rifampin test are the main analysis indicators. RESULTS: A total of 31 studies (3085 specimens) were included in this meta-analysis by updating the literature search and analysis. Compared with indoor amplification experiments (sensitivity ranged from 88% to 100%, specificity ranged from 84% to 100%), the indicated range of commercial kit ranged widely (sensitivity range was 81% ~ 100%, the specific range of variation is 73% ~ 100%). The accuracy of LRP experimental diagnostics has been consistently stable, with seven of the eight studies 100% sensitive and four specific 100%. For example, the contamination rate and the proportion of unidentifiable results can not be obtained only for the estimation of accuracy, and the rates of rifampicin resistance in the direct detection of the patient samples are 3% and 36% (average 20%). Conclusion: Phage technology needs further development to achieve the highest diagnostic rates and reduce technical errors. Once the technical problems have been solved, the prognosis of patients should be affected and cost-benefit analysis, to provide evidence for decision-making for large-scale use.