雅培i2000化学发光仪替代冲洗缓冲液的评价

Evaluation of domestic alternative wash buffer in Abbott i2000 Chemo-luminescence analyzer

目的:对雅培i2000化学发光仪国产替代缓冲液进行评估。方法:(1)使用国产替代冲洗缓冲液进行17个项目不同水平的质控品检测并进行结果分析。(2)依据美国临床实验室标准化委员会(NCCLS)EP9-A2文件要求,通过TSH、HBcAb两个检测项目,就原厂冲洗缓冲液和国产冲洗缓冲液进行比对试验,偏差分析评估。结果:(1)使用国产替代冲洗缓冲液测量17个项目不同水平的质控品,结果全部合格。(2)得出线形回归方程,检测项目促甲状腺激素(TSH)为y=0.9737x+0.0357,r=0.999;乙肝核心抗体(HBcAb)为y=0.9878x-0.057,r=0.998。两种冲洗缓冲液对测量结果无显著性差异。结论:国产缓冲液具有替代原厂配套缓冲液的可能性。

Objective：To evaluate the domestic alternative wash buffer in Abbott i2000 chemo -luminescence analyzer.Methods：（1）Quality control materials of 17 items are tested with i2000 chemo-luminescence analyzer using domestic alternative wash buffer instead of the original buffer,and all of the results are analyzed.（2） According to National Committee for Clinical Laboratory Standards（NCCLS） EP9-A2 document,TSH and HBcAb levels of patient samples are test to compare domestic alternative wash buffer with the original equipment wash buffer.Results：（1） All of results of the quality control materials about 17 items are satisfied.（2） Regression equations of TSH is y=0.9915x-0.0452（r=0.9999）,and regression equations of HBcAb is y = 0.9878x-0.057（r=0.998）.The test results show that there are no significant differences between domestic alternative wash buffer and original equipment wash buffer.Conclusion：Domestic alternative wash buffer can be used instead of original equipment wash buffer.