沙门氏菌能力验证样品的研制及其应用

Preparation of quality control samples of Salmonella and their application in the proficiency test

目的研制沙门氏菌分离培养及血清分型能力验证样品,并应用于沙门氏菌的能力验证。方法能力验证样品包括5瓶,其中3瓶阳性,2瓶阴性。阴性样品仅含有背景细菌,阳性样本在背景菌的基础上添加有沙门氏菌,3件阳性样品分别含有不同的血清型沙门氏菌。为防止数据串通,将参试实验室随机分成5组,每组实验室获得的质控样组合不同。为进行沙门氏菌能力验证样品评价,随机抽取冻干质控样品20瓶,参照本次能力验证推荐的GB 4789.4-2010对样品进行均匀性检验,阳性样品至少检出1种血清型沙门氏菌,阴性对照样品应不得检出沙门氏菌。将沙门氏菌能力验证样品分别在-30、4、25和37℃下储藏28 d监测其储藏稳定性。结果沙门氏菌的质控样在均匀性、储藏稳定性和运输稳定性均能满足质控样使用的要求。在166家实验室反馈结果中,123家结果评定为满意,占74.1%;28家结果为不满意,占16.9%;15家结果评定为可疑,占9.0%。结论沙门氏菌的能力验证样品可以满足此次能力验证的需求,本次能力验证可以真实的反应参试单位的检测水平。

Objective To develop proficiency testing samples of Salmonella serotype for isolation and culture and apply the samples in the proficiency test. Methods The proficiency testing samples included 5 samples, including 3 positive samples and 2 negative samples. Negative samples only contained background bacteria. Salmonella was added to 3 positive samples on the basis of background bacteria, and 3 positive samples contained 3 different serotypes of Salmonella. In order to avoid collusion, participant laboratories were randomly divided into 5 groups, and obtained different combinations of quality control samples. To evaluate the ability of Salmonella proficiency test samples, 20 bottles of freeze-dried quality control samples were randomly selected, and inspected the uniformity with reference to the recommended standard of GB 4789.4 2010, and then positive samples were detected at least 1 kind of Salmonella serotype, negative control samples should be not detected. Salmonella proficiency test samples were respectively stored at ？30, 4, 25 and 37 ℃ for 28 d to evaluate the storage stability. Results Salmonella quality control sample results in uniformity, stability, and storage stability of transport could meet the requirements of the quality control sample used. In 166 laboratories＇ feedback results, 123 were rated as satisfactory results, accounting for 74.1%; 28 were rated as unsatisfactory results, accounting for 16.9%; 15 were rated as suspicious results, accounting for 9.0%. Conclusion The samples can meet the requirements of the proficiency test and the proficiency test can reflect the real testing capacity of the laboratory.