Abstract
BACKGROUND: Mycoplasma pneumoniae (MP) and respiratory syncytial virus (RSV) contribute to 15%-30% of pneumonia cases in China, yet lack rapid diagnostics. We evaluated a molecular point-of-care testing (mPOCT) system for detecting these pathogens versus RT-qPCR. METHODS: Oropharyngeal swabs from 549 patients (269 MP-suspected, 280 RSV-suspected) collected prospectively (Dec 2023-Aug 2024) were tested by RT-qPCR and mPOCT (EasyNAT). RT-qPCR positivity was defined as Ct ≤ 40, as per the kit manufacturer's instructions. Diagnostic accuracy was assessed via sensitivity, specificity, and Cohen's kappa. RESULTS: For MP detection (n = 269), mPOCT showed 97.25% sensitivity (95% CI: 91.57%-99.29%) and 98.75% specificity (95% CI: 95.09%-99.78%) with kappa = 0.96. For RSV (n = 280), sensitivity was 96.72% (95% CI: 91.31%-98.94%) and specificity 100% (95% CI: 97.04%-100%) with kappa = 0.97. Age-stratified analysis (pediatric/adult) maintained kappa > 0.90 for both pathogens. Co-infections occurred in 12.8% (14/109) of MP-positive and 17.2% (21/122) of RSV-positive samples, with > 95% mPOCT concordance except one influenza A-discordant case. CONCLUSIONS: The mPOCT system demonstrated high diagnostic accuracy comparable to RT-qPCR for MP/RSV detection, with rapid results (< 30 min). Its reliability across age groups and complex co-infections supports clinical utility for timely treatment decisions and antibiotic stewardship.