Comprehensive Performance Verification of the Mindray
MN
2880 System in Detecting Respiratory Virus Nucleic Acids
Jinliang Chen, Lianying Zeng, Hao Huang, Peisong Chen ABSTRACT
Objective
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.
Methods
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.
Results
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,
Conclusion
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.