沙门氏菌质控样的研制及其在能力验证中的应用

目的：研制均一性和稳定性符合能力验证要求的质控样品,并将质控样品用于沙门氏菌的能力验证。方法（1）通过对沙门氏菌质控样品的储藏稳定性、运输稳定性及均一性的检验,对沙门氏菌质控样品进行评价。（2）实验室能力验证中考核方案的设计：一套考核样品包括18份沙门氏菌的质控样品,设置3个浓度水平,阴性空白对照、阳性对照、101 CFU水平和100 CFU水平。（3）防止数据串通措施：将参试实验室随机分成2组,每组实验室获得的质控样品不同；低浓度样品的结果是双盲。结果沙门氏菌的质控样品在均一性、储藏稳定性和运输稳定性均能满足质控样品使用的要求；在考核中,76家实验室有7家实验室不合格,35家实验室优秀,34家实验室合格。结论沙门氏菌的质控考核样品可以满足能力验证的需求,本次能力验证可以真实地反映参试单位的检测水平。

The Studies of the Quality Control Samples of Samonella and the Application in the Proficiency Test

Objective To prepare the quality control samples that can meet the requirements of the the proficiency test,and to apply the sample in the proficiency test.Methods （1）Evaluate the quality control sample by confirming the homogeneity,transport stability and storage stability （2）Design the laboratory proficiency testing programs：an evaluation sample including 1 8 copies of salmonella quality control samples,with three concentrations,negative control,the positive control,101 CFU levels and 100 CFU levels.（3 ） The participating laboratories were randomly divided into two groups, each group got different quality control samples. Results The quality control samples in uniformity of quality control samples,storage stability, and stability can meet the requirements of quality control samples used. There were 46.1% of the labs （35）with excellent results,44.7% （34）with qualified results and 9.2%（7）with questionable results.Conclusion The quality control sample can meet the requirements of the proficiency test and the proficiency test could reflect the real testing capacity of the laboratories.