Isothermal amplification technology, Point-of-care testing instrument, Respiratory pathogen detection, Respiratory tract infection, Medicine (General), R5-920, Chemistry, QD1-999

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.