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摘要: 目的:比较全自动酶免分析仪操作法(以下称全自动法)和手工操作法检测HBsAg结果的差异。方法:用相同批号HBsAg ELISA试剂盒分别对80份标本用手工和全自动方法检测HBsAg,比较2种方法测定结果的一致性;用2种方法分别对同一份阳性质控血清重复测定20孔,进行批内重复性检测并比较其差异性;用已知含量阳性质控血清,按原倍血清1∶2、1∶4、1∶8、1∶16、1∶32、1∶64、1∶128稀释,检测手工操作法与全自动酶免分析仪操作法线性并比较其差异性;计算相关系数、直线回归方程和2种方法之间的预期偏差。结果:2种方法阳性检出率一致性好;在测定结果和精密度差异有统计学意义(P<0.01);全自动酶免分析系统和手工操作方法具有良好的相关性,测定结果在本实验室具有可比性;2种操作方法测定结果存在差异,有一定的预期偏差。结论:自动分析仪测定结果稳定性、精密度、准确性好。当全自动酶联免疫分析系统出现故障时,手工操作可以作为应急替代全自动酶联免疫分析系统进行检测;但要避免采用滴加试剂的方式。手工替代应急操作出现检测结果位于临界值附近,处于"灰区"不易判定时,需要考虑2种操作方法间的预期偏差,确保检测结果的准确稳定。
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关键词:
- 全自动酶联免疫分析仪 /
- 手工操作方法 /
- 方法对比 /
- 预期偏差
Abstract: Objective:To compare the differences of results between automatic ELISA system (hereinafter referred to as automatic method) and manual method (In add liquid process is divided into direct adding reagent and the trace pipette in two ways ). Method:Using the same batch number HBsAg ELISA kit,HBsAg of 80 specimens were separately detected with manual and automatic method,and the consistency of the results of two methods was compared.One positive quality control serum was repeated measurements of 20 holes as repeatability tests by two methods,and their differences were compared.In accordance with the known concentration of positive quality control serum,the linear of automatic and manual methods were detected by 1∶2,1∶4,1∶8,1∶16,1∶32,1∶64,1∶128 dilution,and their differences were compared.The correlation coefficient,linear regression equations and expected deviation between the two methods were calculated.Result:The positive detection rate of these two methods was good consistency and there was a significant difference in determination results and precision (P<0.01).Automatic ELISA system and manual method had good correlation.The determination results were comparable in this laboratory.There were some differences and a certain expected deviation between two methods in the determination results.Conclusion:The results of automatic method would have high stability,precision and accuracy.When the automatic ELISA system occurred failure,manual operation could be served as emergency and replacement of automatic method for testing,but it should be avoided using adding reagents way.When the test results were in critical value or in the "gray area" that hard to determine by manual operation,expectation bias must be considered between the two methods to ensure the result accuracy and stability.-
Key words:
- automatic ELISA system /
- manual operation /
- method comparison /
- expected deviation
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[1] 张传宝,张克坚.方法对比及偏差评估的方法--介绍NCCL S文件EP92A[C].临床实验室质量管理文件汇编,2002:169-185.
[2] 周艳萍,倪诗强,黄勇.酶联免疫吸附试验"灰区"结果探讨[J].检验医学与临床,2008,7(5):876-877.
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