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评价 Genmark ePlex® 和 QIAstat-Dx® 呼吸道病原体检测 panels 在检测下呼吸道标本中细菌靶标的性能。

Evaluation of the Genmark ePlex® and QIAstat-Dx® respiratory pathogen panels in detecting bacterial targets in lower respiratory tract specimens.

机构信息

Department of Medical Microbiology, Leiden University Medical Center, PO Box 9600, Leiden, 2300 RC, The Netherlands.

Department of Medical Microbiology, University Medical Center Utrecht, Utrecht, The Netherlands.

出版信息

BMC Microbiol. 2021 Aug 26;21(1):236. doi: 10.1186/s12866-021-02289-w.

DOI:10.1186/s12866-021-02289-w
PMID:34445973
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8390116/
Abstract

BACKGROUND

The ePlex® and QIAstat-Dx® respiratory pathogen panels detect multiple respiratory pathogens, mainly viruses but also Legionella pneumophila, Mycoplasma pneumoniae and Bordetella pertussis. The assays have been marketed for use in nasopharyngeal swab specimens. For diagnosing bacterial pneumonia, lower respiratory tract (LRT) specimens are indicated. Aim of this study was to evaluate the performance of these syndromic panels for these three bacterial targets in samples from the LRT. Fifty-six specimens were collected from our repositories, five negative samples and fifty-one samples which had been previously tested positive with the routine diagnostic real-time PCR assays for Legionella spp. (N = 20), Bordetella spp. (N = 16) or M. pneumoniae (N = 15).

RESULTS

The QIAstat-Dx Respiratory Panel V2 (RP) assay detected all of the L. pneumophila and B. pertussis positive samples but only 11/15 (73.3 %) of the M. pneumoniae targets. The ePlex Respiratory Pathogen Panel (RPP) assay detected 10/14 (71.4 %) of the L. pneumophila targets, 8/12 (66.7 %) of the B. pertussis positive samples and 13/15 (86.7 %) of the M. pneumoniae targets.

CONCLUSIONS

No false-positive results were reported for all three bacterial pathogens by both assays. The clinical performance of both assays depended highly on the bacterial load in the sample and the type of specimen under investigation.

摘要

背景

ePlex®和 QIAstat-Dx®呼吸道病原体检测 panel 可检测多种呼吸道病原体,主要是病毒,但也包括嗜肺军团菌、肺炎支原体和百日咳博德特氏菌。这些检测方法已被推向市场,用于检测鼻咽拭子样本。对于细菌性肺炎的诊断,需要使用下呼吸道(LRT)样本。本研究旨在评估这些综合征检测 panel 对 LRT 样本中这三种细菌靶标的性能。从我们的存储库中收集了 56 个样本,其中 5 个为阴性样本,51 个样本先前使用常规诊断实时 PCR 检测法针对军团菌属(N=20)、博德特氏菌属(N=16)或肺炎支原体(N=15)呈阳性。

结果

QIAstat-Dx 呼吸道 Panel V2 (RP) 检测法检测到了所有嗜肺军团菌和百日咳博德特氏菌阳性样本,但只检测到了 15 个肺炎支原体目标中的 11 个(73.3%)。ePlex 呼吸道病原体检测 panel (RPP) 检测法检测到了 14 个嗜肺军团菌目标中的 10 个(71.4%)、12 个百日咳博德特氏菌阳性样本中的 8 个(66.7%)和 15 个肺炎支原体目标中的 13 个(86.7%)。

结论

两种检测方法均未报告所有三种细菌病原体的假阳性结果。两种检测方法的临床性能高度依赖于样本中的细菌载量和所研究的样本类型。

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