自建半胱氨酸蛋白酶抑制剂C检测系统的方法学评价

Pital in the evaluation of the unclosed detection system of cystatin C

目的:遵循ISO 15189的规定,对自建开放系统半胱氨酸蛋白酶抑制剂C(Cystatin C)的分析性能进行方法学评价。方法:参照CLSI文件,对亚能Cystatin C试剂盒进行方法学评价,包括精密度、分析测量范围、准确度、干扰试验以及参考区间的调查。结果:CystatinC在浓度1.22mg/L和4.08mg/L时,总不精密度分别为5.81%和2.06%,均小于7.5%。分析测量范围为0.88～7.41mg/L。甘油三酯<10mmol/L、血红蛋白<10g/L、总胆红素<300mg/L时,亚能Cystatin C检测不受影响。通过准确度评价,亚能Cystatin C试剂检测结果与Dade的测定结果呈明显相关(r=0.986),且在医学决定水平亚能Cystatin C的系统误差小于CLIA’88的允许范围。以年龄50岁对Cystatin C的参考区间进行分组,50岁以下年龄组的Cystatin C参考区间为0.63～1.07mg/L,50岁以上年龄组Cystatin C的参考区间为0.61～1.49mg/L。结论:亚能Cystatin C试剂精密度、分析测量范围、抗干扰、准确度符合临床要求。临床实验室在建立或引进新的检验项目必须进行系统的方法学评价以验证检测系统的有效性和完整性。

Objective： To evaluated the performance of the unclosed detection system of cystatin C,according to the ISO 15189.Methods： Referring to the evaluation protocols approved by CLSI,we evaluate the precision,analytical measurement range,interference,accuracy of the YA NENG cystatin C reagents,and surveyed the distribution of the cystatin C.Results： The total CV of two levels of QC was less than 7.5%.Analytical measurement range was 0.88～7.41mg/L.Triglyceride（10mmol/L）,haemoglobin（10g/L）,bilirubin（300mg/L） in the sample had no significant interference in the assay.The assay had good correlation with the Dade BNⅡPENIA（r=0.986）,and there were no significant deviation between two systems at the medical decide levels.The reference interval of cystatin C was 0.63～1.07mg/L under the age of 50 and 0.61～1.49mg/L above the age of 50.Conclusions： The main performance of the unclosed detection system of cystatin C are good enough to be used in clinical diagnosis and research.The clinical laboratory must evaluate each item to meet the clinical needs.