罗氏COBAS6000全自动电化学发光免疫分析仪性能验证

Performance verification of Roche COBAS 6000 automatic electrochemiluminescence immunoassay analyzer

目的按ISO15189要求对罗氏COBAS 6000全自动电化学发光免疫分析仪的性能进行验证。方法对甲胎蛋白(alpha-fetoprotein,AFP)的精密度、准确度、临床可报告范围(clinical reportable range,CRR)、分析测量范围(analytical measurement range,AMR)、参考区间进行验证实验。结果批内精密度变异系数(coefficient variation,CV)高低值分别为3.28%和3.46%;日间精密度CV高低值分别为4.39%和5.13%,均小于厂家提供的CV(10%)。相对偏差为0.862%,小于5%。分析测量范围为0.80-1 200 ng/ml,参考区间为0-20.00 ng/ml,临床可报告范围为0-60 000 ng/ml。结论罗氏COBAS 6000全自动电化学发光免疫分析仪的性能与厂家提供的资料基本一致,故可用其进行临床标本的检验工作,所得结果具有可信性。

Objective To test and verify the system performance of Roche COBAS 6000 automatic electrochemiluminescence immunoassay analyzer according to the requirements of ISO15189.Methods Verification experiments were taken to measure the precision,accuracy,clinical reportable range（CRR）,analytical measurement range（AMR）,reference interval of alpha-fetoprotein（AFP）.Results The high and low values of coefficient variation（CV）of inter-assay were 3.28% and 3.46%,and those of between-day precision were 4.39% and 5.13%,which were all less than the CV provided by the manufacturer（10%）.Relative bias was 0.862%.Analytical measurement range was 0.80-1 200 ng/ml,the reference interval was 0-20.00 ng/ml,and the clinical reportable range was 0-60 000 ng/ml.Conclusion The basic performances of Roche COBAS6000 automatic electrochemiluminescence immunoassay analyzer are consistent with the data provided by the manufacturer,so it can be used to inspect the clinical samples and the results are credible.