雅培I4000检测乙肝表面抗原的性能评价

Evaluation of architect I4000 for determining HBsAg

目的对雅培I4000全自动化学发光免疫分析仪检测乙肝表面抗原(HBsAg)的分析性能进行验证。方法根据实验室认可准则,对雅培I4000检测的乙肝表面抗原进行精密度、正确度、线性及仪器比对验证。结果雅培I4000检测乙肝表面抗原精密度、正确度、线性及仪器比对等均符合要求。结论雅培I4000检测乙肝表面抗原性能完全满足预期的临床应用要求。

Objective To verify the determining HBs Ag of ARCHITECT I4000 chemiluminescence immunoassay analyzer. Methods According to laboratory accreditation criteria,the precision、accuracy、liner range and comparison were verified for the test of HBs Ag performed on ARCHITECT I4000 chemiluminescence immunoassay analyzer.Results The precision、accuracy、liner range and comparison were all acceptable. Conclusion The test of HBs Ag performed on ARCHITECT I4000 chemiluminescence immunoassay analyzer could fully meet the reqirements in clinical application.