校准验证在自建生化检测系统的应用

摘要

目的应用病人血清验证自建的日立7170A生化检测系统在线性范围内校准的稳定性及测定结果的准确性,明确校准验证在自检生化检测系统的作用.方法比较16个生化检测项目在可溯源的罗氏Modular PI生化检测系统和自建的日立7170A生化检测系统上测得的结果,以可溯源的罗氏Modular PI生化检测系统所测值为靶值,通过绘制线性回归图及百分差异图对自建的日立7170A生化检测系统进行可接受判断分析.结果自建的日立7170A生化检测系统测定ALT、AST、ALB、UA、Crea、Urea、GLU、LDH、GGT、ALP、TC、TG、钙、磷等14个分析物的校准有效,CK和HDL-C校准无效.结论应用病人血清对自建生化检测系统进行校准验证的方法实用、有效.%Objective To identify calibration verification function in self-developed biochemical testing system by using the serum of patients to verify the stability of calibration and accuracy of testing result of the self-developed Hitachi 7170A biochemical analyzer. Methods Compared the 16 items results tested in the traceable Roche Modular PI biochemical analyzer and the self-developed Hitachi 7170A biochemical analyzer, and then took these results tested in the traceable Roche Modular PI biochemical analyzer as target values, and analyzed the acceptable of the self-developed Hitachi 7170A biochemical analyzer by drawing linear regression graph and the percentage difference plot. Results The calibration results of ALT, AST, ALB, UA, Crea, Urea, GLU, LDH, GGT, ALP, TC, TG and calcium tested in self-developed Hitachi 7170A biochemical analyzer are effective, CK and HDL-C are not effective. Conclusion Calibration verification is practical and effective by using the serum of patients to the self-developed biochemical detection system.