Real-world clinical impact of plasma cell-free DNA metagenomic next-generation sequencing assay.

IF 3 4区 医学 Q2 INFECTIOUS DISEASES
Ishminder Kaur, Bennett Shaw, Ashrit Multani, Christine Pham, Sanchi Malhotra, Ethan Smith, Kristina Adachi, Paul Allyn, Zackary Bango, Omer Eugene Beaird, J R Caldera, Sukantha Chandrasekaran, Lynn Chan, Rabia Cheema, Sarah Daouk, Jaime Deville, Huan Vinh Dong, Austin Fan, Omai Garner, Pryce Gaynor, Hannah Gray, Aleksandr Gorin, Sowmya Kalava, Meganne Kanatani, Andrew Karnaze, Tawny Saleh, Yamini Sharma, Stacey Stauber, Moises Vargas, Monette Veral, Drew Winston, Lauren Yanagimoto-Ogawa, Grace Aldrovandi, Karin Nielsen-Saines, Trevon Fuller, Nicholas Jackson, Daniel Uslan, Joanna Schaenman, Tara Vijayan, Ashlyn Sakona, Shangxin Yang
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引用次数: 0

Abstract

Objective: To describe the real-world clinical impact of a commercially available plasma cell-free DNA metagenomic next-generation sequencing assay, the Karius test (KT).

Methods: We retrospectively evaluated the clinical impact of KT by clinical panel adjudication. Descriptive statistics were used to study associations of diagnostic indications, host characteristics, and KT-generated microbiologic patterns with the clinical impact of KT. Multivariable logistic regression modeling was used to further characterize predictors of higher positive clinical impact.

Results: We evaluated 1000 unique clinical cases of KT from 941 patients between January 1, 2017-August 31, 2023. The cohort included adult (70%) and pediatric (30%) patients. The overall clinical impact of KT was positive in 16%, negative in 2%, and no clinical impact in 82% of the cases. Among adult patients, multivariable logistic regression modeling showed that culture-negative endocarditis (OR 2.3; 95% CI, 1.11-4.53; P .022) and concern for fastidious/zoonotic/vector-borne pathogens (OR 2.1; 95% CI, 1.11-3.76; P .019) were associated with positive clinical impact of KT. Host immunocompromised status was not reliably associated with a positive clinical impact of KT (OR 1.03; 95% CI, 0.83-1.29; P .7806). No significant predictors of KT clinical impact were found in pediatric patients. Microbiologic result pattern was also a significant predictor of impact.

Conclusions: Our study highlights that despite the positive clinical impact of KT in select situations, most testing results had no clinical impact. We also confirm diagnostic indications where KT may have the highest yield, thereby generating tools for diagnostic stewardship.

无浆细胞DNA宏基因组新一代测序测定的实际临床影响。
目的:描述市售的无浆细胞DNA宏基因组新一代测序法Karius试验(KT)的实际临床影响。方法:通过临床小组评审,回顾性评价KT的临床影响。描述性统计用于研究诊断指征、宿主特征和KT产生的微生物学模式与KT临床影响之间的关系。采用多变量logistic回归模型进一步表征较高的积极临床影响的预测因子。结果:我们评估了2017年1月1日至2023年8月31日期间941例患者中1000例独特的KT临床病例。该队列包括成人(70%)和儿科(30%)患者。总的临床影响为16%为阳性,2%为阴性,82%的病例无临床影响。在成人患者中,多变量logistic回归模型显示培养阴性心内膜炎(OR 2.3;95% ci, 1.11-4.53;P .022)和对挑剔/人畜共患/媒介传播病原体的关注(OR . 2.1;95% ci, 1.11-3.76;P .019)与KT的积极临床影响相关。宿主免疫功能低下状态与KT的积极临床影响不可靠相关(OR 1.03;95% ci, 0.83-1.29;.7806页)。在儿科患者中未发现KT临床影响的显著预测因子。微生物结果模式也是影响的重要预测因子。结论:我们的研究强调,尽管在某些情况下,KT具有积极的临床影响,但大多数测试结果没有临床影响。我们还确认了诊断适应症,其中KT可能具有最高的产量,从而产生诊断管理工具。
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来源期刊
CiteScore
6.40
自引率
6.70%
发文量
289
审稿时长
3-8 weeks
期刊介绍: Infection Control and Hospital Epidemiology provides original, peer-reviewed scientific articles for anyone involved with an infection control or epidemiology program in a hospital or healthcare facility. Written by infection control practitioners and epidemiologists and guided by an editorial board composed of the nation''s leaders in the field, ICHE provides a critical forum for this vital information.
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