食品微生物检测试剂盒评价方法建立与应用

发布时间：2018-06-06 16:28

本文选题：食品 + 微生物　；参考：《中国公共卫生》2015年06期

【摘要】：目的建立实用可行的食品微生物检测试剂盒的评价方法。方法本研究以ISO 16 140为理论基础、GB 4789.10-2010为参比方法 ,从检测特异性、灵敏度、耐变性/统计学分析等方面对3M公司Petrifilm大肠埃希氏菌检测试剂盒(PEC)进行了可替代性评价。结果 PEC法对目标菌检测的特异性为84%,对非目标菌检测的特异性为100%;灵敏度检测中在25份低浓度添加样品里,PEC法的灵敏度有22份可以达到10 CFU/g,3份火腿样品的结果为阴性,国标法所有样品灵敏度均可达到10 CFU/g;耐变性评价中,PEC法在35℃/37℃、18 h/24 h耐变性条件的比较中检测结果差异均无统计学意义(P0.05);应用2种方法对添加高、中、低3个水平的大肠埃希菌的五大类样品进行测试,线性方程为y=0.942 1x+0.328 4,相关系数为0.798 9,5类样品不同方法测试结果差异均无统计学意义(P0.05);应用2种方法对30份自然样品进行检测,PEC法检测出4份阳性样品,国标法检测出6份阳性样品,2种方法阳性符合率为93.33%,差异无统计学意义(P0.05)。结论以ISO 16140为理论基础可建立一套评价方法 ,此方法可系统的对微生物检测用试剂盒的可替代性进行评价。
[Abstract]:Objective to establish a practical and feasible method for evaluating the food microorganism detection kit. Methods this study was based on ISO 16140 as the theoretical basis and GB 4789.10-2010 as the reference method to evaluate the substitutability of Petrifilm Escherichia coli detection kit (PEC) in 3M company from the aspects of specificity, sensitivity, denaturation / statistical analysis. Results the specificity of PEC method for detection of target bacteria was 84% and the specificity for detection of non target bacteria was 100%. In sensitivity detection, in 25 samples with low concentration, the sensitivity of PEC method could reach 10 CFU/g, 3 samples of ham were negative, and the sensitivity of all samples in national standard method could reach 10 CFU/g, and PEC in tolerance evaluation, PEC There was no significant difference in the test results between 35 /37 C and 18 h/24 h, and five major samples of Escherichia coli with high, middle and low 3 levels were tested with 2 methods, the linear equation was y=0.942 1x+0.328 4, and the correlation number was 0.798 9,5 samples, and the difference of the test results was no difference. Statistical significance (P0.05); 2 methods were used to detect 30 natural samples, 4 positive samples were detected by PEC, 6 positive samples were detected by the national standard method, and the positive rate of the 2 methods was 93.33%, the difference was not statistically significant (P0.05). Conclusion a set of evaluation methods can be established with ISO 16140 as the theoretical basis. The replacability of the kit was evaluated.
【作者单位】：北京出入境检验检疫局检验检疫技术中心;
【基金】：国家质量监督检验检疫总局科研项目(2013IK197)
【分类号】：R155.5

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