自配免疫洗液在罗氏电化学发光免疫分析系统中的应用研究

Study on application of self-made immune cleaning solution in Roche electrochemiluminescence immune analysis systems

目的采用自配免疫洗液(三丙胺清洗液、电池检测清洗液)替代进口原装洗液在罗氏电化学发光免疫系统中的应用。方法自配免疫洗液与罗氏原装洗液执行性能测试,按罗氏E601电化学发光全自动免疫分析仪的操作说明书进行免疫洗液的准确性、测量范围和免疫样本检测。结果采用罗氏E601电化学发光全自动免疫分析仪对自配、原装免疫洗液的甲胎蛋白(AFP)、人绒毛膜促性腺激素加β片段(β-hCG)、三碘甲状腺原氨酸(T3)、促甲状腺激素(TSH)水平进行测定并比较其检验准确性,两者的检验准确性比较差异无统计学意义(P>0.05);选取最低值和最高值的标本测量范围,对自配、原装免疫洗液的测量范围进行比较,差异无统计学意义(P>0.05);细菌培养统计细菌数无明显变化。结论自配免疫洗液可替代罗氏进口原装洗液在罗氏电化学发光免疫分析系统上使用,其准确度高、稳定性好。

Objective To investigate the application of self-made immune cleaning solution（tripropylamine cleaning fluid,cell detection cleaning fluid）instead of the imported original cleaning solution in Roche electrochemiluminescence immune systems.Methods The execution performance of self-made immune cleaning solution and imported original cleaning solution was tested.The accuracy,immunity sample examination and measurement range of immune cleaning solution were conducted according to the operating manual of Roche E601 electrochemical luminescence automatic analyzer.Results The levels of alpha-fetoprotein（AFP）,β-human chorionic gonadotropin（β-HCG）,triiodothyronine（T3）and thyroid-stimulating hormone（TSH）were measured by the Roche E601 electrochemical luminescence automatic analyzer with the two kinds of cleaning solution.The detection accuracies between them had no statistical difference（P〉0.05）;The sample measurement ranges of lowest value and highest value were selected for conducting the comparison,the difference had no statistical significance（P〉0.05）;the bacterial count by bacterial culture statistics had no obvious change.Conclusion The self-made immune cleaning solution can replace imported original cleaning solution to be used in the Roche electrochemiluminescence immune system with high accuracy and good stability.