转基因食品定量检测方法的验证

Verification of the quantitative method for GMO foods

按欧盟联合研究中心(Joint Reaserch Center,JRC)的欧盟网络转基因实验室(European Network of GMO laboratories,ENGL)方法验证工作组编制的指南文件的要求,对《GB/T 19495.5—2004转基因产品检测核酸定量PCR检测方法》进行方法验证。分别验证了脱氧核糖核酸(deoxyribonucleic acid,DNA)提取质量,方法的准确度、重复性和相对定量限4个指标。经过验证,选用的DNA提取试剂盒提取质量合格;检测值在可接受参考值的±25%内,准确度良好;相对可重复性标准偏差均小于25%,重复性良好;相对定量限为0.1%转基因含量。依照指南对国标进行了验证,结果证明该指南在实验室进行方法验证中具有指导性作用。

According to the requirements of Guidance document from the European Network of GMO laboratories （ENGL） of JRC, ＂GB/T 19495.5--2004 Detection of genetically modified organisms and derived products--Quanti- tative PCR methods based on nucleic acid＂ including four typical indexes, DNA extraction, accuracy, repeatability and LOQrel, was verified. After verification, DNA extraction kit was qualified. The trueness was within ± 25% of the accepted reference value. RSDr 〈 25. LOQrel was 0.1% GMO content. The verification on the national standard confirms that the guidance is applicable for method verification in laboratory.