ADCCLIA400全自动板式发光免疫分析仪性能评价

Performance evaluation of ADC CLIA 400 automatic plate immunoassay analyzer

目的对ADCCLIA400全自动板式发光仪检测甲胎蛋白AFP和癌胚抗原CEA的方法学评价。方法按照美国临床实验室标准化委员会（CLSI）方法学评价系列文件，对ADC电化学发光仪检测AFP、CEA的批内精密度、批问精密度、分析测量线性范围和回收实验进行评价，并与厂商声明的性能和有关质量标准进行比较。结果该仪器批内精密度、批问精密度、分析测量线性范围和回收实验结果与厂商提供性能相符。结论ADC400全自动板式发光免疫分析仪的主要分析性能符合质量目标要求，可满足临床检测需要。

Objective To evaluate the performance of ADC CLIA 400 automatic plate luminescence to test al- pha fetoprotein（AFP）and carcinoembryonic antigen（ CEA） result. Methods The indexes of AFP,CEA were detected according to the U. S. Committee for Standardization Clinical Laboratory（CLSI）methodology evaluated a series of documents. Results The instrument assay precision,inter-assay precision,analytical measurement range of linear and recycling vendors accorded with the prescriptive range. Conclusion The performance of ADC CLIA 400 automatic plate luminescence is relable and suitable for clinical laboratory to use.