Roche电化学发光免疫分析系统发光缓冲液和清洗液配制及应用

目的研制Roche1010/2010电化学发光免疫分析系统发光缓冲液和清洗液。方法用自配的发光缓冲液和清洗液代替原装ProCell和CleanCell液,利用Roche原装试剂和定标液在Roche1010/2010仪器上检测相同标本,考察准确度、精密度、灵敏度和检测最大范围并与原装试剂对比分析。结果分别测定代表几种不同方法的7个项目,并与原装试剂比较,二者结果差异无统计学意义(P>0.05),相关系数(r)均>0.98,日内、日间重复性二者均接近,自配试剂放置12个月后,与原装试剂差异无统计学意义(P>0.05),r均>0.98。结论自制试剂与原装试剂检测结果差异无统计学意义,适合临床应用。

Preparation and application of luminescence buffer and wash buffer for Roche electro-chemiluminescence systems

Objective To prepare the luminescence buffer and wash buffer for Roche electro-chemiluminescence 1010/2010 systems.Methods The accuracy,precision and the most measuring range of the prepared homogenous reagents were compared with the imported original reagents replacing with the original ProCell and CleanCell with luminescence buffer and wash buffer at Roche electro-chemiluminescence 1010/2010 systems.Results 7 different items were measured comparatively.All the mean values approached those of the original reagents,and showed no significant difference(P>0.05),r>0.98,CVs were near each other.The prepared reagents were stable after stored for 12 months.Conclusion The prepared homogenous luminescence buffer and wash buffer shows no significant difference in the results compared with the imported original reagents.It can be used for Roche electro-chemiluminescence 1010/2010 systems.