一种便携快速微流芯片PCR仪性能评价

Performance evaluation of a portable rapid microfluidic chip PCR instrument

中文关键词:  便携快速微流芯片PCR仪  性能评价  沙门氏菌  大肠杆菌

英文关键词:portable rapid microfluidic chip PCR instrument  performance evaluation  Salmonella  Escherichia coli

中文摘要:

      目的 评价一种便携快速微流芯片PCR仪的主要性能指标。方法 按照RB/T 160-2017《分析化学仪器设备验证与综合评价指南》、SN/T 2102.2-2008《食源性病原体PCR检测技术规范第2部分: PCR仪性能试验要求》等相关标准制定的评价指标及要求, 选取标准菌株鼠伤寒沙门氏菌ATCC14028、肠炎沙门氏菌ATCC13076和大肠埃希氏菌O157:H7 ATCC43895食源性致病菌为检测目标物, 对便携快速微流芯片PCR仪的基线噪声、检测低限、线性、精密度、样品检测及重复性进行验证实验。结果 检测基线稳定、线性拟合相关系数r>0.98, 精密度均小于5%, 满足YY/T 1173-2010《聚合酶链反应分析仪》的要求。结论 基线噪声、检测低限、线性、精密度、样品检测及重复性6个指标可以有效的评价便携快速微流芯片PCR仪。

英文摘要:

      Objective To evaluate the main performance indicators of the portable rapid microfluidic chip PCR instrument. Methods According to evaluation indicators and requirements of RB/T 160-2017 Guidelines for the validation and comprehensive evaluation of analytical chemical instruments, SN/T 2102.2-2008 Technical specifications for PCR deteCtion of foodborne pathogens, Part 2: Performance requirements for PCR instruments, standard strains of Salmonella typhimurium ATCC14028, Salmonella enteritidis ATCC13076 and Escherichia coli O157:H7 ATCC43895 were seleCted as deteCtion targets, and the baseline noise, deteCtion low limit, linearity, precision, sample deteCtion and repeatability of portable rapid microfluidic chip PCR instrument were tested. Results The baseline stability was determined, the linear fitting correlation coefficient r>0.98, and the precision were less than 5%, which met the requirements of YY/T 1173-2010 Polymerase chain reaCtion analyzer. Conclusion Baseline noise, deteCtion low limit, linearity, precision, sample deteCtion and repeatability can effeCtively evaluate the portable rapid microfluidic chip PCR instrument.