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

• Published in: Practical laboratory medicine 2024-05, Vol.40, p.e00394-e00394, Article e00394
• Main Authors: Zhang, Guanbin, Lin, Xiaoying, Mu, Wenkun, Luo, Jun, Xu, Yiyuan, Song, Chicheng, Li, Jiang
• Format: Article
• Language: English
• Subjects: Isothermal amplification technology; Point-of-care testing instrument; Respiratory pathogen detection; Respiratory tract infection
• ISSN: 2352-5517; 2352-5517
• DOI: 10.1016/j.plabm.2024.e00394

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. 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. 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. 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. •New isothermal nucleic acid amplification instrument RTisochip-S improves functionality and appearance.•RTisochip-S fulfills the sensitivity, specificity, and repeatability requirements of the certified kit.•RTisochip-S and the reference device RTisochip-A exhibited high consistency in testing clinical specimens.