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快速综合征聚合酶链反应检测时代痰标本显微镜质量评估的诊断效用

The diagnostic utility of microscopic quality assessment of sputum samples in the era of rapid syndromic PCR testing.

作者信息

Markussen Dagfinn Lunde, Ebbesen Marit, Serigstad Sondre, Knoop Siri Tandberg, Ritz Christian, Bjørneklett Rune, Kommedal Øyvind, Jenum Synne, Ulvestad Elling, Grewal Harleen M S

机构信息

Emergency Care Clinic, Haukeland University Hospital , Bergen, Norway.

Department of Clinical Science, Bergen Integrated Diagnostic Stewardship Cluster, Faculty of Medicine, University of Bergen , Bergen, Norway.

出版信息

Microbiol Spectr. 2023 Sep 29;11(5):e0300223. doi: 10.1128/spectrum.03002-23.

Abstract

This prospective study assessed the value of initial microscopy evaluation of sputum samples submitted for rapid syndromic PCR-based testing. Bacterial detections by the BioFire FilmArray Pneumonia Panel in 126 high- and 108 low-quality sputum samples, based on initial microscopy evaluation in samples from patients with lower respiratory tract infections were compared. We found that high-quality samples had a higher proportion of bacterial detections compared to low-quality samples ( = 0.013). This included a higher proportion of detections of bacteria deemed clinically relevant by predefined criteria (70% and 55%, = 0.016), as well as a higher proportion of detections of (36% and 20%, = 0.010). High-quality samples also had more detections of bacteria with high semi-quantitative values. The study found no significant difference between high- and low-quality samples in the proportions of samples with a single species of bacteria detected, samples with a bacteria treated by the clinician, samples with detection of a proven etiology of community-acquired pneumonia by predefined criteria, the number of bacterial species detected, or the detection of , , or . The results showed that 40% (95% CI 35%-47%) of the bacterial detections would have been missed if only high-quality samples were analyzed. This included 41% (27%-56%) of detections of , 33% (23%-45%) of detections of , 42% (28%-58%) of detections of , and 37% (23%-54%) of detections of . These findings suggest that all sputum samples submitted for rapid syndromic PCR testing should be analyzed, regardless of initial microscopy quality assessment. (This study has been registered at ClinicalTrials.gov under registration no. NCT04660084.) IMPORTANCE Microscopic quality assessment of sputum samples was originally designed for sputum culture, and its applicability in today's workflow, which includes syndromic PCR testing, may differ. Addressing this crucial gap, our study emphasizes the need to optimize the use and workflow of syndromic PCR panels, like the BioFire FilmArray Pneumonia plus (FAP plus), in microbiology laboratories. These advanced PCR-based tests offer rapid and comprehensive pathogen detection for respiratory infections, yet their full potential remains uncertain. By comparing bacterial detections in high- and low-quality sputum samples, we underscore the importance of including low-quality samples in testing. Our findings reveal a significant proportion of potentially clinically relevant bacterial detections that would have been missed if only high-quality samples were analyzed. These insights support the efficient implementation of syndromic PCR panels, ultimately enhancing patient care and outcomes.

摘要

这项前瞻性研究评估了提交用于基于快速症候群聚合酶链反应(PCR)检测的痰标本初始显微镜评估的价值。比较了BioFire FilmArray肺炎检测板在126份高质量和108份低质量痰标本中的细菌检测情况,这些标本来自下呼吸道感染患者,基于标本的初始显微镜评估。我们发现,与低质量标本相比,高质量标本的细菌检测比例更高(P = 0.013)。这包括根据预定义标准被认为具有临床相关性的细菌检测比例更高(分别为70%和55%,P = 0.016),以及肺炎链球菌的检测比例更高(分别为36%和20%,P = 0.010)。高质量标本中半定量值高的细菌检测也更多。该研究发现,在检测到单一细菌种类的标本比例、临床医生已治疗过细菌的标本比例、根据预定义标准检测到社区获得性肺炎已证实病因的标本比例、检测到的细菌种类数量,或检测到金黄色葡萄球菌、肺炎克雷伯菌或鲍曼不动杆菌方面,高质量和低质量标本之间没有显著差异。结果显示,如果仅分析高质量标本,40%(95%置信区间35%-47%)的细菌检测将会遗漏。这包括30%(27%-56%)的肺炎链球菌检测、33%(23%-45%)的金黄色葡萄球菌检测、42%(28%-58%)的肺炎克雷伯菌检测以及37%(23%-54%)的鲍曼不动杆菌检测。这些发现表明,所有提交用于快速症候群PCR检测的痰标本都应进行分析,无论其初始显微镜质量评估如何。(本研究已在ClinicalTrials.gov注册,注册号为NCT04660084。)重要性 痰标本的显微镜质量评估最初是为痰培养设计的,其在当今包括症候群PCR检测的工作流程中的适用性可能有所不同。为填补这一关键空白,我们的研究强调了在微生物实验室中优化症候群PCR检测板(如BioFire FilmArray肺炎加项检测板(FAP加项))的使用和工作流程的必要性。这些先进的基于PCR的检测方法可为呼吸道感染提供快速且全面的病原体检测,但其全部潜力仍不确定。通过比较高质量和低质量痰标本中的细菌检测情况,我们强调了在检测中纳入低质量标本的重要性。我们的发现揭示,如果仅分析高质量标本,将会遗漏很大一部分可能具有临床相关性的细菌检测。这些见解支持了症候群PCR检测板的有效实施,并最终改善患者护理和治疗结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/438c/10581175/98c1c40664ae/spectrum.03002-23.f001.jpg

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