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

Abstract

ABSTRACT 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 ( κ ) 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. IMPORTANCE Compared to multiplex PCR assays that are available in the Chinese market, the Acaruiter Respiratory Panel (fluorescent PCR) covers a wider range of pathogens including eight viruses, five bacteria, Mycoplasma pneumoniae and Chlamydia pneumoniae , and has high accuracy and effectiveness in the detection of pathogens. This is the first study to evaluate the performance of the Acaruiter Respiratory Panel. This regent may be a promising assay for comprehensive testing for respiratory pathogens from nasopharyngeal swab specimens in Chinese children.