ArticleJournal of clinical laboratory analysis2026
An Evaluation of a Molecular Point-of-Care Testing System Designed for Early Diagnosis of Mycoplasma pneumoniae and Respiratory Syncytial Virus Infections.
Article in Journal of clinical laboratory analysis, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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14 authors.
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Abstract
backgroundMycoplasma 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.
methodsOropharyngeal 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.
resultsFor 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.
conclusionsThe 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.
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