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

Abstract

ObjectivesThe 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. MethodsThe 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. ResultsThe 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. ConclusionsRTisochip-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.