常规生化定量测定方法的校准模式探讨

Research of Calibration Model about Routine Biochemistry Quantitative Assay

目的:探讨常规生化定量测定法中应用多点校准和单点校准模式校正分析仪,对测定结果的影响并评价其差异的可接受性。方法:采用四川省迈克科技有限责任公司提供的总蛋白及葡萄糖检测试剂盒,在日立全自动生化分析仪7060C上,分别应用多点校准和单点校准模式测定系列已知浓度的样品,并进行结果比较,通过1/4总允许误差判断可接受性。结果:总蛋白单点校准和多点校准测定已知浓度的样品结果均在可接受范围内,都小于1/4总允许误差。葡萄糖的单点校准在浓度2.78mmol/L大于1/4总允许误差,不可接受。但采用多点校准多元回归模式测定已知浓度的样品结果均在可接受范围内,都小于1/4总允许误差,测定范围内标本的测定结果均较准确,且其准确度随回归拟合方次的增加而提高。结论:在常规生化定量测定法中建议采用多点校准多元回归模式取代单点校准模式,以提高临床实验室检测结果的准确性。

Objectives：To Research the effects of different calibration ways of biochemistry quantitative assay on the results and the tolerance of the differences. Methods： We cited serum total protein and glucose item, and analyzed a series of known concentration of samples by adopting multi-points and single-point calibration model respectively. Results：The result of single-point calibration model just could be applied in near calibrator concentration, and the inaccuracy would be bigger if the sample concentration was far from calibrator coneentration. But the result of multi-points calibration model was more accurate and the accuracy would become better if time of the calibration curve was increased. Conclusions： To make sure that assay result of routine biochemistry items is more accurate, we advise to adopt multi-points calibration model in place of traditional single-point calibration model.