Comprehensive Performance Verification of the Mindray MN2880 System in Detecting Respiratory Virus Nucleic Acids

To verify the clinical performance of the Mindray MN2880 system for simultaneous detection of SARS-CoV-2, influenza A virus (IAV), influenza B virus (IBV), and respiratory syncytial virus (RSV) nucleic acids.

According to the CNAS-GL039:2019 and CNAS-GL037:2019 requirements for molecular diagnostic verification, we comprehensively evaluated the Mindray MN2880 multiplex respiratory virus assay across seven critical performance parameters: clinical concordance, limit of detection (LoD), repeatability, precision, cross-reactivity/interference resistance, daily QC, and contamination control.

The Mindray MN2880 system demonstrated high diagnostic concordance with the reference method, with total percent agreements of 99.51% (95% CI: 99.00%-99.76%) for SARS-CoV-2, 99.93% (95% CI: 99.60%-99.99%) for IAV, and 100% for both IBV and RSV, and achieved clinically verified limits of detection (LoD: SARS-CoV-2 at 100 copies/mL, IAV/IBV/RSV at 200 copies/mL). Analytical precision was confirmed through 100% detection across negative/low/medium/high concentration panels with ≤ 3% CV for repeatability (Ct values) and ≤ 5% CV for inter-run precision. The assay exhibited 100% specificity against 6 clinically relevant pathogens, including Human Rhinovirus, parainfluenza virus, adenovirus, Mycoplasma pneumoniae, Haemophilus influenzae, and Staphylococcus aureus, with no observed cross-reactivity. Moreover, the MN2880 system demonstrated robust interference resistance (100% detection of weakly-positive samples spiked with seven interferents), stable daily QC performance (100% valid controls across 115 consecutive runs), and 100% contamination prevention.

The MN2880 system satisfies key analytical benchmarks required for diagnostic use in respiratory virus multiplex testing, with performance verified against CNAS-GL039:2019 and CNAS-GL037:2019 standards.