MALDI-TOF MS验证与综合评价
Validation and Comprehensive Evaluation of MALDI-TOF MS
王艺凯 1侯颖 1杨帆 2任宇捷 1杨菲 1李运涛 3邱烨 1刘鑫1
作者信息
- 1. 中国海关科学技术研究中心 北京 100026
- 2. 二连海关技术中心 二连浩特 011100
- 3. 北京融智优普生物科技有限公司 北京 100026
- 折叠
摘要
基质辅助激光解吸电离飞行时间质谱(Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry,MALDI-TOF MS)在微生物鉴定方面具有快速高通量分析和高灵敏度等优点,被广泛应用于医疗诊断、生物防御、环境监测和食品质量控制等相关领域.MALDI-TOF MS与PCR技术结合,能够实现高通量的核苷酸位点分析.为了确保其在应用中的可靠性和准确性,建立一套完善的验证与综合评价方案对其进行性能评价至关重要.本文通过参考现有MALDI-TOF MS标准并结合核酸检测的特殊性,建立了该类型设备的验评方案,提出了包含质量测定范围、准确性、分辨率、稳定性等基本性能验证指标和准确性、灵敏度、重复性、抗干扰性等应用性能验证技术指标.依据以上指标,对QuanNUA型MALDI-TOF MS进行验评,验评方案方便易行且无须专业的计量设备,普通的分子生物学实验室就能够对MALDI-TOF MS进行系统和全面验评.该验评方案可为MALDI-TOF MS用于核酸鉴定性能评价提供参考.
Abstract
Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry(MALDI-TOF MS)is renowned for its rapid and high-throughput analysis capabilities,as well as high sensitivity in microbial identification,which has led to its widespread application in various fields such as medical diagnostics,biodefense,environmental monitoring,and food quality control.The combination of MALDI-TOF MS and PCR technology can achieve high-throughput nucleotide site analysis.To ensure its reliability and accuracy in these applications,establishing a comprehensive validation and evaluation scheme for performance assessment is crucial.This paper,by referencing existing MALDI-TOF MS standards and considering the particularities of nucleic acid detection,has developed a verification scheme for this type of equipment.It proposes basic performance verification indicators including mass measurement range,accuracy,resolution,and stability,as well as application performance verification technical indicators such as accuracy,sensitivity,repeatability,and interference resistance.Based on these indicators,the QuanNUA type MALDI-TOF MS was evaluated,and the evaluation scheme is convenient and practical without the need for specialized metrological equipment,allowing general laboratories to conduct systematic and comprehensive evaluation of MALDI-TOF MS.This validation and evaluation scheme can provide a reference for assessing the performance of MALDI-TOF MS in nucleic acid identification.
关键词
基质辅助激光解吸电离飞行时间质谱/性能评价/核酸检测Key words
Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry(MALDI-TOF MS)/performance evaluation/nucleic acid detection引用本文复制引用
出版年
2024
NETL
NSTL
万方数据