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一项回顾性观察研究,评估 mNGS 检测的应用,以考察两家学术医学中心的诊断管理的作用。

A retrospective observational study of mNGS test utilization to examine the role of diagnostic stewardship at two academic medical centers.

机构信息

Department of Pathology, University of Utah, Salt Lake City, Utah, USA.

ARUP Laboratories, Salt Lake City, Utah, USA.

出版信息

J Clin Microbiol. 2024 Sep 11;62(9):e0060524. doi: 10.1128/jcm.00605-24. Epub 2024 Aug 20.

Abstract

UNLABELLED

Given the cost and unclear clinical impact of metagenomic next-generation sequencing (mNGS), laboratory stewardship may improve utilization. This retrospective observational study examines mNGS results from two academic medical centers employing different stewardship approaches. Eighty mNGS orders [54 cerebrospinal fluid (CSF) and 26 plasma] were identified from 2019 to 2021 at the University of Washington (UW), which requires director-level approval for mNGS orders, and the University of Utah (Utah), which does not restrict ordering. The impact of mNGS results and the relationship to traditional microbiology orders were evaluated. Nineteen percent (10/54) of CSF and 65% (17/26) of plasma studies detected at least one organism. Compared to CSF results, plasma results more frequently identified clinically significant organisms (31% vs 7%) and pathogens not detected by traditional methods (12% vs 0%). Antibiotic management was more frequently impacted by plasma versus CSF results (31% vs 4%). These outcome measures were not statistically different between study sites. The number and cumulative cost of traditional microbiology tests at UW were greater than Utah for CSF mNGS testing (UW: 46 tests, $6,237; Utah: 26 tests, $2,812; < 0.05) but similar for plasma mNGS (UW: 31 tests, $3,975; Utah: 21 tests, $2,715; = 0.14). mNGS testing accounted for 30%-50% of the total microbiology costs. Improving the diagnostic performance of mNGS by stewardship remains challenging due to low positivity rates and difficulties assessing clinical impact. From a fiscal perspective, stewardship efforts should focus on reducing testing in low-yield populations given the high costs of mNGS relative to overall microbiology testing expenditures.

IMPORTANCE

Metagenomic next-generation sequencing (mNGS) stewardship practices remain poorly standardized. This study aims to provide actionable insights for institutions that seek to reduce the unnecessary usage of mNGS. Importantly, we highlight that clinical impact remains challenging to measure without standardized guidelines, and we provide an actual cost estimate of microbiology expenditures on individuals undergoing mNGS.

摘要

目的

鉴于宏基因组下一代测序(mNGS)的成本和不明确的临床影响,实验室管理可能会改善其利用率。本回顾性观察研究考察了两所学术医疗中心采用不同管理方法的 mNGS 结果。2019 年至 2021 年,华盛顿大学(UW)共进行了 80 项 mNGS 检测(54 项脑脊液 [CSF] 和 26 项血浆),该大学对 mNGS 检测订单要求主任级别的批准,而犹他大学(Utah)则不限制检测订单。评估了 mNGS 结果的影响及其与传统微生物学检测订单的关系。54 项 CSF 检测中有 19%(10/54)和 26 项血浆研究中检测到至少一种病原体。与 CSF 结果相比,血浆结果更频繁地发现具有临床意义的病原体(31%对 7%)和传统方法未检测到的病原体(12%对 0%)。血浆结果对抗生素管理的影响比 CSF 结果更频繁(31%对 4%)。这些结果在两个研究地点之间没有统计学差异。UW 进行 CSF mNGS 检测的传统微生物学检测数量和累计成本均高于 Utah(UW:46 项检测,6237 美元; Utah:26 项检测,2812 美元;<0.05),但进行血浆 mNGS 检测的数量和累计成本相似(UW:31 项检测,3975 美元; Utah:21 项检测,2715 美元;=0.14)。mNGS 检测占总微生物学检测费用的 30%-50%。由于阳性率低且难以评估临床影响,通过管理来提高 mNGS 的诊断性能仍然具有挑战性。从财政角度来看,鉴于 mNGS 相对于整体微生物学检测支出的高成本,管理工作应侧重于减少低产出人群的检测。

意义

宏基因组下一代测序(mNGS)管理实践仍未得到很好的标准化。本研究旨在为寻求减少 mNGS 不必要使用的机构提供切实可行的见解。重要的是,我们强调,在没有标准化指南的情况下,临床影响仍然难以衡量,并且我们提供了正在进行 mNGS 的个体的微生物学检测支出的实际成本估算。

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