自动化免疫血液分析仪的使用前确认

Validation of automated systems for immunohematological testing before implementation

自动化免疫血液分析仪投入常规使用前必须执行方法确认。首先根据自动化系统的预期用途建立确认要求,然后对需确认的项目进行风险评估,包括识别风险因素、分析风险原因、估计风险、评价风险可接受性。确认内容包括安装确认、运行确认和性能确认。实验室只有在成功确认自动化免疫血液系统的性能后,才能用于常规检测。

The automated system for immunohematological testing should be validated before its routine implement. First, the laboratory should establish the required performance for the automated system according to the clinical application. Then the risk assessment should be conducted for those critical control points, including hazard identification, root cause analysis, risk estimation, and the risk acceptability evaluation. The validation plan should cover the installation qualification, operational qualification, and performance qualification. Only upon the validation of the automated systems for immunohematological testing is successful, can the automated system be introduced into the routine implement.