实验室自动化系统的性能验证

The performance validation of laboratory automatic system

目的建立实验室自动化系统的性能验证方法，以保证检验质量。方法验证实验室免疫生化自动化系统处理样本过程中的样本信息、样本定位信息、样本状态、超出线性范围的复检、处理样本效率、样本检测结果比对、数据传输等是否符合质量要求。结果免疫生化自动化系统的样本信息能保证样本处理过程中的安全性，样本定位信息准确，样本状态如溶血、黄疸和脂血自动提示，超出线性范围自动复检，处理样本效率达到本实验室要求，样本检测结果比对在允许范围内，检测数据传输正确。结论免疫生化自动化系统经性能验证，满足质量要求，适合本实验室需要。

Objective To evaluate the performance of our laboratory automatic system to assurance quality. Methods The immune biochemical laboratory automatic system was evaluated in the process of information communication,sample location information, sample status, the re-examination when results beyond the linear range, the speed of sample process, sample results comparison,and data transmission. The performance was compared with our quality requirements. Results The sample information ensured security in the sample process, Sample location infor- mation was accurate. Sample status, such as hemolysis, jaundice and lipemia, were automatically alarmed. Samples were re-examined when results beyond the linear range. The speed of sample process achieved our laboratory requirements. The result of sample results comparison was within the allowable range. Test data communication was correct. Conclusion The performance of the immune biochemical laboratory automatic system met the quality requirements of our laboratory.