Clinical Evaluation of a Rapid Reciprocal-Flow PCR Assay and Real-Time PCR Assay with Quenching Probe for Detection of Mycobacterium tuberculosis Complex.

IF 4.2 2区生物学 Q2 MICROBIOLOGY Microorganisms Pub Date : 2025-01-17 DOI:10.3390/microorganisms13010201

Kosuke Kosai, Keisuke Matsumoto, Takahisa Ishikawa, Yasuhide Kawamoto, Norihiko Akamatsu, Kenji Ota, Fujiko Mitsumoto-Kaseida, Norihito Kaku, Hiroo Hasegawa, Koichi Izumikawa, Hiroshi Mukae, Katsunori Yanagihara

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Abstract

This study investigated the diagnostic efficiencies of two assays for the detection of Mycobacterium tuberculosis complex: (1) the reciprocal-flow real-time polymerase chain reaction (PCR)-based GeneSoC assay and (2) the real-time PCR based GENECUBE MTB assay with quenching probe. These assays were performed for stored clinical samples and results were compared with the confirmed results based on culture and COBAS TaqMan MTB assay. A total of 53 samples (20 confirmed positives and 33 confirmed negatives) were included in the performance analysis. The GeneSoC assay showed concordance in all 53 samples, regardless of specimen type, while the GENECUBE MTB assay showed concordance in 19 of the 20 confirmed positive samples and all 33 confirmed negative samples. The overall agreement was 100.0% for the GeneSoC assay and 98.1% for the GENECUBE MTB assay. Positive and negative percent agreements were 100.0% each for the GeneSoC assay and 95.0% and 100.0%, respectively, for the GENECUBE MTB assay. Both the GeneSoC and GENECUBE MTB assays exhibited excellent performance in detecting M. tuberculosis complex. The GeneSoC assay is useful for independent assays of individual samples, whereas the GENECUBE MTB assay is suitable for batch assays of multiple samples.

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快速往复PCR和实时荧光定量PCR猝灭探针检测结核分枝杆菌复合体的临床评价

本研究考察了两种检测结核分枝杆菌复合体的方法的诊断效率：(1)基于往复流实时聚合酶链反应（PCR）的GeneSoC法和(2)基于实时PCR的淬火探针GENECUBE MTB法。对储存的临床样本进行这些检测，并将结果与基于培养和COBAS TaqMan MTB检测的确认结果进行比较。共有53份样本（20例确诊阳性，33例确诊阴性）被纳入绩效分析。GeneSoC检测在所有53个样本中显示一致性，无论标本类型如何，而GENECUBE MTB检测在20个确诊阳性样本中的19个和所有33个确诊阴性样本中显示一致性。GeneSoC检测的总体一致性为100.0%，GENECUBE MTB检测的总体一致性为98.1%。GeneSoC检测的阳性率和阴性率分别为100.0%，GENECUBE MTB检测的阳性率和阴性率分别为95.0%和100.0%。GeneSoC和GENECUBE MTB检测方法在检测结核分枝杆菌复合体方面均表现出优异的性能。GeneSoC测定法适用于单个样品的独立测定，而GENECUBE MTB测定法适用于多个样品的批量测定。

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来源期刊

Microorganisms Medicine-Microbiology (medical)

CiteScore

7.40

自引率

6.70%

发文量

2168

审稿时长

20.03 days

期刊介绍： Microorganisms (ISSN 2076-2607) is an international, peer-reviewed open access journal which provides an advanced forum for studies related to prokaryotic and eukaryotic microorganisms, viruses and prions. It publishes reviews, research papers and communications. Our aim is to encourage scientists to publish their experimental and theoretical results in as much detail as possible. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced. Electronic files and software regarding the full details of the calculation or experimental procedure, if unable to be published in a normal way, can be deposited as supplementary electronic material.