Abstract：
OBJECTIVE: Metagenomic next-generation sequencing (mNGS) provided promising supports to rapid pathogen diagnosis. However, summary of scientific application strategy based on clinical practice study is still necessary for enhancing clinical benefits.
METHODS: We conducted a retrospective analysis of 775 samples from patients with suspected infectious diseases (IDs). Based on final diagnosis, diagnostic performance, clinical relevance and clinical impact of mNGS among various clinical settings were assessed, and influencing factors were deeply explored.
RESULTS: 84.26 % tests were clinically relevant; sample, but not sequencing, was the influencing factor. 40.77 % tests contributed to positive clinical impact, while 0.13 % and 59.10 % to negative and no impact respectively. mNGS utility in patients with IDs, definite infection site, BALF and CSF contributed to higher positive impacts. Days of empirical treatment before sampling ≤ 5 in ICU and ≤ 2 or between 11 and 20 in non-ICU, and reporting in 2 days brought about higher clinical benefit rates. Characteristic pathogen spectrum between ICU and non-ICU cases were revealed.
CONCLUSIONS: Our findings highlighted clinical benefits from mNGS varied among different clinical settings, and elucidated choices on patients, samples, sampling and reporting time were four key factors. Rational strategy should be concerned to promote scientific application of mNGS and better improve clinical value.
METHODS: We conducted a retrospective analysis of 775 samples from patients with suspected infectious diseases (IDs). Based on final diagnosis, diagnostic performance, clinical relevance and clinical impact of mNGS among various clinical settings were assessed, and influencing factors were deeply explored.
RESULTS: 84.26 % tests were clinically relevant; sample, but not sequencing, was the influencing factor. 40.77 % tests contributed to positive clinical impact, while 0.13 % and 59.10 % to negative and no impact respectively. mNGS utility in patients with IDs, definite infection site, BALF and CSF contributed to higher positive impacts. Days of empirical treatment before sampling ≤ 5 in ICU and ≤ 2 or between 11 and 20 in non-ICU, and reporting in 2 days brought about higher clinical benefit rates. Characteristic pathogen spectrum between ICU and non-ICU cases were revealed.
CONCLUSIONS: Our findings highlighted clinical benefits from mNGS varied among different clinical settings, and elucidated choices on patients, samples, sampling and reporting time were four key factors. Rational strategy should be concerned to promote scientific application of mNGS and better improve clinical value.
摘要：
目的：宏基因组下一代测序（mNGS）为快速病原体诊断提供了有希望的支持。然而,在临床实践研究的基础上总结科学的应用策略对提高临床效益仍有必要。
方法：我们对775例疑似感染性疾病患者的样本进行了回顾性分析。根据最终诊断，诊断性能,评估了mNGS在各种临床环境中的临床相关性和临床影响，并对影响因素进行了深入的探讨。
结果：84.26%的测试与临床相关；样本，但不是测序，是影响因素。40.77%的测试有助于积极的临床影响，而分别为0.13%和59.10%的负面影响和无影响。MNGS在ID患者中的应用，明确的感染部位，BALF和CSF产生了更高的积极影响。ICU采样前经验治疗天数≤5天，非ICU采样前经验治疗天数≤2天或11-20天，和2天报告带来了更高的临床获益率。揭示了ICU和非ICU病例之间的特征病原体谱。
结论：我们的发现强调了mNGS的临床益处因不同的临床环境而异，并阐明了患者的选择，样品,抽样和报告时间是四个关键因素。应重视合理的策略，以促进mNGS的科学应用，更好地提高临床价值。
方法：我们对775例疑似感染性疾病患者的样本进行了回顾性分析。根据最终诊断，诊断性能,评估了mNGS在各种临床环境中的临床相关性和临床影响，并对影响因素进行了深入的探讨。
结果：84.26%的测试与临床相关；样本，但不是测序，是影响因素。40.77%的测试有助于积极的临床影响，而分别为0.13%和59.10%的负面影响和无影响。MNGS在ID患者中的应用，明确的感染部位，BALF和CSF产生了更高的积极影响。ICU采样前经验治疗天数≤5天，非ICU采样前经验治疗天数≤2天或11-20天，和2天报告带来了更高的临床获益率。揭示了ICU和非ICU病例之间的特征病原体谱。
结论：我们的发现强调了mNGS的临床益处因不同的临床环境而异，并阐明了患者的选择，样品,抽样和报告时间是四个关键因素。应重视合理的策略，以促进mNGS的科学应用，更好地提高临床价值。
