Comprehensive Performance Verification of the Mindray MN2880 System in Detecting Respiratory Virus Nucleic Acids
- 1Department of Medical Laboratory Chaozhou People's Hospital Affiliated to Shantou University Medical College Chaozhou Guangdong China
- 2Department of Laboratory Medicine People's Hospital of Boluo County Huizhou Guangdong China
- 3Department of Laboratory Medicine The First Affiliated Hospital, Sun Yat‐Sen University Guangzhou Guangdong China
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, 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.
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.
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BibTeX
@article{chen2026comprehensive,
title = {{Comprehensive Performance Verification of the Mindray MN2880 System in Detecting Respiratory Virus Nucleic Acids}},
author = {Jinliang Chen and Lianying Zeng and Hao Huang and Peisong Chen},
journal = {Journal of Clinical Laboratory Analysis},
year = {2026},
month = oct,
doi = {10.1002/jcla.70390},
url = {https://doi.org/10.1002/jcla.70390},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Comprehensive Performance Verification of the Mindray MN2880 System in Detecting Respiratory Virus Nucleic Acids
AU - Jinliang Chen
AU - Lianying Zeng
AU - Hao Huang
AU - Peisong Chen
PY - 2026
DA - 2026/10/25
JO - Journal of Clinical Laboratory Analysis
DO - 10.1002/jcla.70390
UR - https://doi.org/10.1002/jcla.70390
AB - 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, 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. 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.
SN - 0887-8013
SN - 1098-2825
ER -