补体分子C1q免疫透射比浊法的方法学评价  

Evaluation of the Immunity Transmission Turbidimetry Method in the Measurement of C1q

作　　者：高玲[1] 冯品宁[1] 姚真荣[1] 颜绵生[1] 邝永晴[1] 

机构地区：[1]中山大学附属第一医院医学检验部,广东广州510080

出　　处：《热带医学杂志》2013年第2期192-195,共4页Journal of Tropical Medicine

摘　　要：目的对C1q检测试剂盒进行方法学初步评价。方法根据美国临床和实验室标准协会颁布的《定量临床检验方法的初步评价批准指南》第2版(EP10-A2)提供的方法,按特定的顺序连续测定来自中山大学附属第一医院低、中、高浓度的病人标本5d,对该试剂盒检测方法的性能进行初步评价。结果当C1q低、中、高浓度的血清的靶值分别为98.02、194.28、290.54mg/L时,C1q测定的线性回归方程为Y=1.012X+5.072,相关系数为0.997;绝对偏差分别是3.41、13.97、5.87mg/L;总不精密度(CV%)分别为2.43%、7.06%、5.28%。结论 C1q检测试剂盒检测方法的线性、偏倚和抗交叉污染能力均达到EP10-A2文件标准,符合临床应用要求。中值和高值的总不精密度提示超出可接受范围,需要进一步进行评估。Objective To evaluate the performance of the a Clq testing kit produced by a Shanghai Beijia company. Methods The precision,accuracy,linearity and anti-interference ability were evaluated according to the EP10-A2 document issued by CLSI. The samples with low,middle and high levels of Clq from the patients of 1st affiliated hospital of Zhongshan University were tested. Results The multiple regression equation derived from the testing of the Clq kit was Y=l.012X＋5.072, r2=0.997. The absolute bias for samples with low （98.02 mg/L）,middle （194.28 mg/L） and high （290.54 mg/L） levels of Clq were 3.41 mg/L, 13.97 rag/L, and 5.87 mg/L, respectively. The CV% for these 3 groups of samples were 2.43%, 7.06%, and 5.28%, respectively. Conclusions Linearity, bias and sample carry-over of the Clq testing kit were up to the EP10-A2 standard.The midle and high level of imprecision should be studied in the future.

关 键 词：补体分子C1q EP10-A2 试剂盒评价 

分 类 号：R392.9[医药卫生—免疫学]