Background: Detecting pathogens is crucial for management of pneumonia. Chips for Complicated Infection Detection (CCID), based on isothermal amplification technology and microfluidic technology, can simultaneously detect multi-target nucleic acid of 174 pathogens within 50 minutes.

Aims: To evaluate the diagnostic value of CCID in detecting pneumonia pathogens.

Methods: This study was conducted at nine hospitals in China from January 2021 to September 2022. Respiratory samples from adult pneumonia patients were collected to evaluate the diagnostic value of CCID.

Results: A total of 245 patients were included, with 73.1% being elderly. The overall positive and negative percent agreements between CCID and conventional microbiological tests (CMT) for pathogen detection were 90.0% and 38.1%, respectively. CCID  identified pathogenic microbes in 78.0%  patients and CMT in 57.1% patients (p<0.001). 38.8% patients were diagnosed as mixed infections with at least two pathogens by CCID. Bacterial infections identified by CCID accounted for 44.1% of 245 patients, with top 3 being Pseudomonas aeruginosa, Klebsiella pneumoniae, and Enterococcus faecium, respectively. K. pneumoniae was the most common pathogen in elderly patients, with a significantly higher prevalence compared to non-elderly patients (p=0.0011). Among 197 patients who had used antibiotics before sample collection, the positive rate of CCID was significantly higher than that of CMT (p<0.001).

Conclusion: CCID is effective in detecting pathogen of pneumonia and has promising clinical application prospect.

This work was supported by National Key R&D Program of China (2020YFC2005401).