全自动生化分析仪反应杯状况敏感指标评判的研究

Study on the sensitive indicators of estimating reaction cell status in Roche Cobas 8000 biochemistry analyzer

目的:探讨全自动生化分析仪反应杯状况的敏感性指标,为实验室及时、合理地更换反应杯提供指导。方法:采用全自动生化分析仪检测新鲜混合血清中的天冬氨酸氨基转移酶(AST)、葡萄糖(GLU)、α羟丁酸脱氢酶(HBDH)、γ谷氨酰转肽酶(GGT)以及白蛋白(ALB),每个项目检测10次,以获得各项目对照值。将施污染项目(A)和受污染项目(B)分别配对检测,进行携带污染筛查实验;确认候选组合后将项目A检测1次,项目B连续检测3次。更换新反应杯后再次按携带污染确认实验的方式,验证候选评判指标。结果:检测数据与对照值相比,ALB会导致AST的绝对偏差(测定值为26.20 U/L)和相对偏差(89.60%)均低于允许范围,且更换新反应杯后,此组合通过验证试验。结论:ALB与AST的携带污染组合试验可作为评判反应杯状况正常与否的敏感指标,使实验室能够较早地识别反应杯状况的异常,从而避免因比色杯异常引入至检验过程中的医疗风险。

Objective： To explore the sensitive indicators of reflecting the reaction cells status in automated biochemistry analyzer, and provide a guidance for timely and reasonable replacement reaction cells in laboratory. Methods： Firstly, AST, GLU, HBDH, GGT, and ALB tests in the fresh and mixed serum were run separately for the standard values. Secondly, the carryover screening experiments were conducted to pair the proposed pollution item（A） and the proposed polluted item（B） profiles. Thirdly, the candidate paired profiles were run the preliminary confirmation experiments. Specifically, the item A was run 1 time, and subsequently item B was run 3 times. This profile would be used as a candidate evaluation indicator when the absolute deviation or the relative deviation was beyond the range. Finally, after replacing the new reaction cells, the carryover experiment was run again in order to confirm the candidate paired profiles. Quantitative data were represented as MEAN＋SD, and were statistically analyzed by SPSS. Results： Comparing with the standard, ALB resulted in that the AST absolute deviation（measured value is 26.20 U/L） and the relative deviation（89.60%） were lower than the allowable ranges as a pollution item. Meanwhile, this ALB and AST paired profile also passed the verification experiment after the reaction cells were changed. Conclusion： ALB and AST paired carryover profile could evaluate the reaction cells status as a sensitive indicator. The abnormal status of reaction cell could be more early recognized in laboratory so as to avoid that medical risk was introduced into examination processes.