Guanbin Zhang , Xiaoying Lin , Wenkun Mu , Jun Luo , Yiyuan Xu , Chicheng Song , Jiang Li
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Application of a clamshell isothermal nucleic acid amplification analyzer in the detection of lower respiratory tract bacteria
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.
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.
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