应用CLSIEP10-A2文件初步评价细胞角蛋白19片段（CYFRA21-1）试剂盒性能

Preliminary Evaluation of chemiluminescence immunoassay system in detecting CYFRA21-1 by CLSI EP10-A2

目的利用美国临床实验室标准化协会（CLSI）EP10-A2文件初步评价细胞角蛋白19片段（CYFRA21-1）试剂盒的临床应用性能。方法按照CLSIEP10-A2文件规定，按中、高、低、中、中、低、低、高、高、中的顺序连续测定各浓度样本，连续5d。计算测定结果的偏差、总不精密度、截距、斜率、非线性、携带污染和漂移。结果低、中、高浓度CYFRA21-1样本偏差分别为-0．03、0．5和-0．26ng／mL；总不精密度分别为4．79％、1．42％、1．68o．4；截距、斜率、非线性、携带污染、漂移分别为一0．450、0．994、0．325、0．000、-0．011（-4．6〈t〈4．6，P〉0．01）。结论211试剂盒准确度、精密度良好，均在允许范围内，线性良好，携带污染率低，稳定性较好，试剂性能可满足临床应用要求。

Objeetive To detect CYFRA21-1 kit preliminary performance in serum of chemiluminescence immunosaaay system according to the CLSI guideline EP10-A2. Methods Three level of samples were analyzed in a run according to the specific sequence of Mid, Hi, Low, Mid, Mid, Low, Low, Hi, Hi, Mid for 5days. Estimation of the effects of intercept, Slope, nonlinearity, sam- ple carry-over and linear drift. Results The low,middle,high samples bais of quantitative clinical laboratory methods of CYFRA21- 1 were -0.03,0.5%,-0.26 ng/mL, total imprecision of them were 4.79%, 1.42%, 1.68%. The indexes of intercept, slope, non linearity, carryover rate,linear drift were -0. 450,0. 994,0. 325,0. 000 ,-0. 011 （-4.6〈t〈4.6, P〉0.01）.accorded with the prescriptive range. Conclusion The indexes of intercept, slope, non linearity, carryover rate, linear drift accorded with the prescriptive range. The performance of CYFRA21-1 kit reliable and suitable for clinical laboratory to use.