Application of a clamshell isothermal nucleic acid amplification analyzer in the detection of lower respiratory tract bacteria

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Practical Laboratory Medicine Pub Date : 2024-04-16 DOI:10.1016/j.plabm.2024.e00394

Guanbin Zhang , Xiaoying Lin , Wenkun Mu , Jun Luo , Yiyuan Xu , Chicheng Song , Jiang Li

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Abstract

Objectives

The clamshell isothermal nucleic acid amplification analyzer RTisochip-S, a next-generation instrument featuring improved structural design, enhanced functional integration, reduced cost, and increased portability, was assessed for its suitability in clinical respiratory pathogens detection.

Methods

The certificated detection kit for lower respiratory tract bacteria (LRTB-kit) was applied to evaluate the performance of RTisochip-S via sensitivity, specificity, and repeatability analysis. The clinical specimens, including 51 sputum specimens and 10 bronchoalveolar lavage fluid specimens, were simultaneously detected on both RTisochip-S and a certificated reference instrument (RTisochip-A) to assess the consistency.

Results

The results indicated that RTisochip-S fulfills the sensitivity, specificity, and repeatability requirements of the LRTB-Kit, and the results of clinical specimens on the two instruments were consistent.

Conclusions

RTisochip-S is satisfying the clinical detection of respiratory pathogens while enhancing portability and compactness, making it more well-suited for point-of-care testing (POCT) applications.

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蛤壳式等温核酸扩增分析仪在检测下呼吸道细菌中的应用

方法应用下呼吸道细菌认证检测试剂盒（LRTB-kit），通过灵敏度、特异性和重复性分析评估 RTisochip-S 的性能。临床标本包括 51 份痰标本和 10 份支气管肺泡灌洗液标本，同时用 RTisochip-S 和认证参考仪器（RTisochip-A）进行检测，以评估其一致性。结果结果表明，RTisochip-S 符合 LRTB-Kit 的灵敏度、特异性和重复性要求，两种仪器对临床标本的检测结果一致。

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来源期刊

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

期刊介绍： Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.