ARCHITECT C16000全自动生化分析仪检测血清胱抑素C的性能评价

目的 对ARCHITECT C16000全自动生化分析仪检测血清胱抑素C(Cys C)的分析性能进行评价.方法 根据相关标准,验证ARCHITECT C16000全自动生化分析仪检测血清Cys C的精密度、正确度、分析测量范围、临床可报告范围、抗干扰性能、生物参考区间.结果 低水平质控品、高水平质控品及混合血清标本的批...

Evaluation of the performance of ARCHITECT C16000 automatic biochemical analyzer in detecting serum cystatin C

Objective To evaluate the analytical performance of the ARCHITECT C16000 automatic biochemical analyzer in detecting serum cystatin C(Cys C).Methods According to relevant standards,verified the precision,accuracy,analysis and measurement range,clinical reportable range,anti-interference performance and biological reference interval of serum Cys C detected by ARCHITECT C16000 automatic biochemical analyzer.Results The intra-assay coefficient of variation(CV)of low level quality control,high level quality control and mixed serum samples were less than 1/4 total allowable error of the external quality assessment(6.25%),and the inter-assay CV were less than 1/3 total allowable error of the external quality assessment(8.33%),and were less than manufacturer standard(10.00%).The absolute value of the relative deviation between the detection value and the target value of the 5 levels calibrators were less than 1/2 total allowable error of the external quality assessment(12.50%).The detection results of the reference system and the system to be evaluated were consistent.The linear regression equation between the measured value and the expected value was Y=1.000 X+0.094,r=0.9991,r≥0.975,and the slope was 0.97—1.03,the analysis and measurement range of Cys C was 0.14—9.91 mg/L.The maximum acceptable dilution of Cys C was 20 times,and the upper limit of clinical reportable range was 198.20 mg/L.The absolute value of the relative deviation between the detection values of the samples containing different levels of free bilirubin,conjugated bilirubin,hemoglobin,chyle and the control samples were less than the manufacturer standard(10.00%).In the validation of biological reference interval,Cys C detection results beyond the reference interval were less than 10.00%,which passed the validation.Conclusion The performance of ARCHITECT C16000 automatic biochemical analyzer in the detection of Cys C meets the clinical requirements,and can be used in clinic.