背景:宏基因组下一代测序(mNGS)可以提高病原体在血流感染或败血症中的诊断效率。当用于可疑感染的早期诊断时,对mNGS测试的临床影响知之甚少。在这里,我们的主要目的是评估利用血液样本进行mNGS早期诊断可疑感染的临床疗效。以及评估其在指导抗菌治疗决策方面的潜力。
方法:在本研究中,纳入212名在疑似感染早期接受血液mNGS检测的成年住院患者。比较mNGS试验和血培养的诊断效能,分析mNGS对临床护理的影响。
结果:在我们的研究中,血mNGS总检出率明显高于培养法(74.4%vs.12.1%,配对mNGS测试和血液培养中的P<0.001)。血流感染(107,67.3%)是我们患者所有疾病的最大组成部分,单血样亚组的检出率与多类型样品亚组的检出率相似。在187名抱怨发烧的患者中,在仅出现发热的病例中使用血液标本或其他标本时,mNGS的诊断效能没有差异.同时,当患者出现除发烧以外的其他症状时,在同时采集疑似感染部位标本和血液的病例中,mNGS的表现更优.在mNGS结果的指导下,70.3%(149/212)的治疗方案改变,在住院时间较早的病例中,平均住院天数明显缩短。
结论:在这项研究中,我们强调了血液mNGS在有轻度和非特异性症状的早期感染患者中的重要性.血mNGS可以作为常规实验室检查的补充,应尽快实施,以指导临床医生及时有效地进行相应的抗感染治疗。此外,合并来自疑似感染部位的同期样本可以改善疾病诊断和预后.进一步的研究需要在大规模临床试验中更好地验证,以优化诊断方案,并进行成本效用分析。
BACKGROUND: Metagenomic next-generation sequencing (mNGS) could improve the diagnosed efficiency of pathogens in bloodstream infections or sepsis. Little is known about the clinical impact of mNGS test when used for the early diagnosis of suspected infections. Herein, our main objective was to assess the clinical efficacy of utilizing blood samples to perform mNGS for early diagnosis of suspected infections, as well as to evaluate its potential in guiding antimicrobial therapy decisions.
METHODS: In this study, 212 adult hospitalized patients who underwent blood mNGS test in the early stage of suspected infections were enrolled. Diagnostic efficacy of mNGS test and blood culture was compared, and the clinical impact of mNGS on clinical care was analyzed.
RESULTS: In our study, the total detection rate of blood mNGS was significantly higher than that of culture method (74.4% vs. 12.1%, P < 0.001) in the paired mNGS test and blood culture. Blood stream infection (107, 67.3%) comprised the largest component of all the diseases in our patients, and the detection rate of single blood sample subgroup was similar with that of multiple type of samples subgroup. Among the 187 patients complained with fever, there was no difference in the diagnostic efficacy of mNGS when blood specimens or additional other specimens were used in cases presenting only with fever. While, when patients had other symptoms except fever, the performance of mNGS was superior in cases with specimens of suspected infected sites and blood collected at the same time. Guided by mNGS results, therapeutic regimens for 70.3% cases (149/212) were changed, and the average hospitalized days were significantly shortened in cases with the earlier sampling time of admission.
CONCLUSIONS: In this study, we emphasized the importance of blood mNGS in early infectious patients with mild and non-specific symptoms. Blood mNGS can be used as a supplement to conventional laboratory examination, and should be performed as soon as possible to guide clinicians to perform appropriate anti-infection treatment timely and effectively. Additionally, combining the contemporaneous samples from suspected infection sites could improve disease diagnosis and prognoses. Further research needs to be better validated in large-scale clinical trials to optimize diagnostic protocol, and the cost-utility analysis should be performed.