Multicenter evaluation of the Acaruiter Respiratory Panel for diagnosis of respiratory tract infections in Chinese children

Respiratory tract infection represents the most frequent infectious disease afflicting children worldwide. This study was to evaluate the performance of Acaruiter Respiratory Panel (fluorescent PCR) in the detection of respiratory tract infection pathogens in children. Clinical trials were conducted in three representative pediatric hospitals in Shanghai, Chengdu, and Beijing. With reference to another widely used multiplex assay and first-generation sequencing, the sensitivity, specificity, accuracy, and consistency coefficient kappa (kappa) value of the assay were evaluated to verify the accuracy and effectiveness in the detection of clinical respiratory pathogens, so as to objectively evaluate the clinical performance and application value of Acaruiter Respiratory Panel (fluorescent PCR). A total of 1,540 samples were screened in this clinical trial project, of which 1,404 were valid samples. Based on the comprehensive analysis of the clinical trial data of 1,404 effective samples, the detection ability of Acaruiter Respiratory Panel (fluorescent PCR) for various pathogens compared with the results of clinical diagnosis, the positive percent agreement was 97.04%-100%, the negative percent agreement was 99.31%-100%, the total percent agreement was 99.36%-100%, and the kappa value was 0.982-1.000, which had good consistency and high accuracy.

Automated summary

This study evaluated the performance of Acaruiter Respiratory Panel (fluorescent PCR) in detecting respiratory tract infection pathogens in children. The results showed that it has good consistency, high accuracy, and high positive and negative agreement percentages.