同型半胱氨酸检测试剂与厂家声明的一致性验证  

Conformance verification of the homocysteine assay kit and manufacturer's description

作　　者：朱薇[1] 王丽娜[1] 王静[1] 葛君琍 

机构地区：[1]宝鸡市中心医院,陕西宝鸡721008

出　　处：《中国卫生检验杂志》2016年第1期41-42,53,共3页Chinese Journal of Health Laboratory Technology

基　　金：国家高技术研究发展863课题子课题(2014AA022304)

摘　　要：目的对同型半胱氨酸检测试剂进行验证,确定其分析性能是否与厂家声明一致。方法根据EP-15中生化定量检测试剂性能验证方案,对同型半胱氨酸试剂的准确度、精密度、线性范围、分析灵敏度、特异性进行系统评估。结果准确度低值偏差为5.24%,高值偏差为1.84%,偏差<10%;重复性标准差为0.182 4,变异系数为1.838 6%,偏差<10%;线性回归方程:y=63.790x+3.3442,r2=0.998 3;分析物灵敏度均值为-0.057 5,标准差为0.132,灵敏度为0.338 5;血清中分别加入特异性干扰物,测定结果偏差最大为8.17%,最小为-2.78%,正负偏差均<10%。结论北京九强公司生产的同型半胱氨酸检测试剂在测定准确度、精密度、线性范围、灵敏度、特异性方面与厂家声明的一致性良好,各项性能指标符合临床和实验室规范的要求。Objective To research the consistency between the practical detection result of Homocysteine （Hcy） assay kit and its manufacturers description. Methods According to the verification program on the biochemical properties of the quantitative detection reagents in EP - 15, to systematically verify the reagent accuracy, precision, linear range, sensitivity and specificity. Results The accuracy deviation of analyses at low level was 5.24%, while at high level was 1.84%, both were lower than 10%. The precision deviation of precision Was 0. 182 4, and the coefficient of variation（CV） was 1. 838 6%, which was less than 10%. The linear regression equation ：y = 63. 790x ＋ 3. 344 2, r^2 =0. 998 3; the mean sensitivity of analyte was -0.057 5, with the standard deviation of 0. 132, the sensitivity of 0.338 5, and the deviation less than 10%. Specific disruptors were added in serum ,the maximum deviation of the test results was 8.17%, the minimum was -2.78%, and both the positive and negative deviation 〈 10%. Conclusion Performance of precision, linearity and interference testing of the homocysteine assay kit produced by Jiu Qiang Company has the consistency with its description, and can fulfill the requirements of clinical and laboratory.

关 键 词：同型半胱氨酸 准确度 精密度 线性范围 灵敏度 特异性 一致性 

分 类 号：R446.1[医药卫生—诊断学]