血站实验室酶联免疫吸附试验室内质控的实施与探讨

目的探讨血站实验室酶联免疫吸附试验（ELISA）实施统计学室内质控的可行性、质控方法、质控规则与控制目标。方法收集2006～2011年乐山市中心血站实验室实施即刻法和Levey-Jennings质控图（L-J法）室内质控的情况,统计分析室内质控结果,评价现行统计学室内质控方法,讨论ELISA室内质控的控制目标。结果即刻法和L-J法简便易行,可为ELISA实验是否在控提供客观依据,有助于提高实验室检测能力;ELISA室内质控的变异系数（CV%）,批间小于20%为控制目标。结论即刻法和L-J法等统计学质控可监控ELISA实验的精密度变化,是一种保证检测结果可靠性的有效技术手段;统计学室内质控并非ELISA质量控制的全部,作用有限,全面质量管理有赖于实验室质量体系的建立、实施、监控和持续改进。

The Implementation and Exploration of ELISA Internal Quality Control in Blood Bank Labo-ratory

Objective To explore the feasibility,quality control method,regulations and objectives of statistical quality control in ELISA experiment.Methods The IQC situations of Grubbs and Levey-Jennings applied by blood testing laboratory in Leshan Blood Bank from 2006 to 2011 were reviewed,the IQC results were statistically analyzed,the existing statistical quality control methods were evaluated and the requirements of ELISA IQC were discussed.Results Grubbs and Levey-Jennings are simple and easy to implement,can provide objective basis for judging whether ELISA is in control and improve detectability of the laboratory.When IQC is applied in ELISA,inter-assay CV% is less than 20%.Conclusion Statistical quality control methods such as Grubbs and Levey-Jennings can monitor the precision change of ELISA and they are effective and reliable techniques to ensure test results.Statistical IQC which has some limitations can not control the whole quality of ELISA.The all-sided quality control depends on the establishment,implementation,monitoring and improvement of laboratory quality system.