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Abstract：
The Metagenomics next-generation sequencing (mNGS) and GeneXpert MTB/RIF assay (Xpert) exhibited a sensitivity for tuberculosis (TB) diagnostic performance. Research that directly compared the clinical performance of ddPCR analysis, mNGS, and Xpert in mycobacterium tuberculosis complex (MTB) infection has not been conducted.
The study aimed to evaluate the diagnostic performance of ddPCR compared to mNGS and Xpert for the detection of MTB in multiple types of clinical samples. The final clinical diagnosis was used as the reference standard.
Out of 236 patients with suspected active TB infection, 217 underwent synchronous testing for tuberculosis using ddPCR, Xpert, and mNGS on direct clinical samples. During follow-up, 100 out of 217 participants were diagnosed with MTB infection. Compared to the clinical final diagnosis, ddPCR produced the highest sensitivity of 99% compared with mNGS (86%) and Xpert (64%) for all active MTB cases.
Twenty-two Xpert-negative samples were positive in mNGS tests, which confirmed the clinical diagnosis results from ddPCR and clinical manifestation, radiologic findings. Thirteen mNGS-negative samples were positive in ddPCR assays, which confirmed the clinical final diagnosis.ddPCR provides a higher sensitive compared to Xpert and mNGS for MTB diagnosis, as defined by the high concordance between ddPCR assay and clinical final diagnosis.
The study aimed to evaluate the diagnostic performance of ddPCR compared to mNGS and Xpert for the detection of MTB in multiple types of clinical samples. The final clinical diagnosis was used as the reference standard.
Out of 236 patients with suspected active TB infection, 217 underwent synchronous testing for tuberculosis using ddPCR, Xpert, and mNGS on direct clinical samples. During follow-up, 100 out of 217 participants were diagnosed with MTB infection. Compared to the clinical final diagnosis, ddPCR produced the highest sensitivity of 99% compared with mNGS (86%) and Xpert (64%) for all active MTB cases.
Twenty-two Xpert-negative samples were positive in mNGS tests, which confirmed the clinical diagnosis results from ddPCR and clinical manifestation, radiologic findings. Thirteen mNGS-negative samples were positive in ddPCR assays, which confirmed the clinical final diagnosis.ddPCR provides a higher sensitive compared to Xpert and mNGS for MTB diagnosis, as defined by the high concordance between ddPCR assay and clinical final diagnosis.
摘要：
■宏基因组学下一代测序（mNGS）和GeneXpertMTB/RIF测定（Xpert）表现出对结核病（TB）诊断性能的敏感性。直接比较ddPCR分析的临床性能的研究，mNGS,和Xpert在结核分枝杆菌复合体（MTB）感染中尚未进行。
■该研究旨在评估ddPCR与mNGS和Xpert相比在多种类型的临床样品中检测MTB的诊断性能。最终的临床诊断被用作参考标准。
■在236例疑似活动性结核感染患者中，217人使用ddPCR进行了结核病同步检测，Xpert,和直接临床样本上的mNGS。随访期间,217名参与者中有100名被诊断为MTB感染。与临床最终诊断相比，对于所有活性MTB病例，ddPCR与mNGS（86％）和Xpert（64％）相比产生了99％的最高灵敏度。
■22个Xpert阴性样本在mNGS测试中呈阳性，从ddPCR和临床表现证实了临床诊断结果，放射学发现。13份mNGS阴性样本在ddPCR检测中呈阳性，这证实了临床最终诊断。与Xpert和mNGS相比，ddPCR对MTB诊断具有更高的灵敏度，由ddPCR检测和临床最终诊断之间的高度一致性定义。
■该研究旨在评估ddPCR与mNGS和Xpert相比在多种类型的临床样品中检测MTB的诊断性能。最终的临床诊断被用作参考标准。
■在236例疑似活动性结核感染患者中，217人使用ddPCR进行了结核病同步检测，Xpert,和直接临床样本上的mNGS。随访期间,217名参与者中有100名被诊断为MTB感染。与临床最终诊断相比，对于所有活性MTB病例，ddPCR与mNGS（86％）和Xpert（64％）相比产生了99％的最高灵敏度。
■22个Xpert阴性样本在mNGS测试中呈阳性，从ddPCR和临床表现证实了临床诊断结果，放射学发现。13份mNGS阴性样本在ddPCR检测中呈阳性，这证实了临床最终诊断。与Xpert和mNGS相比，ddPCR对MTB诊断具有更高的灵敏度，由ddPCR检测和临床最终诊断之间的高度一致性定义。
