外部质量控制调查,用于识别微生物,使用矩阵辅助激光脱/离子化飞行时间质谱法
Kazuyuki Sogawa1, Azumi Fujinaga2, Hajime Okumura3
1Department of Biochemistry, School of Life and Environmental Science, Azabu University.
Journal of microorganism control
|March 20, 2024
概括
评估了使用矩阵辅助激光吸附/电离飞行时间质谱法 (MALDI-TOF MS) 进行细菌鉴定的外部准确性控制. 使用分数值开发的程序证明了在临床实验室的质量控制中有用.
科学领域:
- 微生物学 微生物学
- 分析化学 分析化学
- 医学诊断 医学诊断 医学诊断
背景情况:
- 矩阵辅助激光脱/离子化飞行时间质谱法 (MALDI-TOF MS) 是一种已被批准作为医疗器械的既定细菌识别方法.
- 目前,基于质谱的细菌类型的外部质量控制范围有限.
- 需要标准化程序来确保MALDI-TOF MS在临床环境中的准确性和可靠性.
研究的目的:
- 评估一种新的外部精度控制检查的可行性和有效性,用于使用MALDI-TOF的细菌类型.
- 通过标准化的准确性控制程序来评估两个MALDI-TOF MS系统 (MALDI Biotyper和VITEK MS/PRIME) 的性能.
- 验证在常规实验室诊断中用于外部质量评估的得分值的使用.
主要方法:
- 在228个机构使用既定程序测试了E. faecium和S. maltophilia的细菌样本.
- 通过MALDI生物型和VITEK MS/PRIME生成的得分值被记录和分析.
- 应用了一个标准化的协议,以确保对外部质量控制的一致的数据收集.
主要成果:
- 马尔迪生物型为*E. faecium*产生了2.43±0.08的评分值,为*S. maltophilia*产生了2.38±0.08的评分值.
- 维特克MS/PRIME对*E. faecium*和*S. maltophilia*都表现出高准确度,得分值为99.9±0.0.
- 开发的程序为外部准确性控制提供了一致和可靠的数据.
结论:
- 开发的程序对于使用MALDI-TOF MS.进行细菌识别的外部准确性控制的评估是有效的.
- 评分值作为质量保证的有价值指标,用于基于质谱的微生物鉴定.
- 这些程序的实施可以提高临床微生物学实验室中MALDI-TOF MS的可靠性.
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