稀释血清及 EXCEL 与 MVS 在线性验证中的应用比较研究

目的：研究稀释血清及 EXCEL 与 MVS 在线性性能验证中的应用价值。方法分别以收集到的低值混合血清和用去离子水2～3倍稀释后的低值混合血清与同一高浓度血清配制成系列浓度标本进行线性实验，实验结果分别用 EXCEL 和 MVS两个软件统计判定线性。结果3个稀释血清的实验，两个软件均判定为线性；在6个实验中，肌酐（CREA）原血清实验结果 EX-CEL 判定为线性，MVS 判定为非线性，但在决定性浓度水平，两个回归方程的结果差异分别为-2．02μmol/L 和4．23μmol/L，均小于两种浓度水平下 CLIA′88最大允许误差（26．52μmol/L 和39．78μmol/L）的1/9，其余5个实验两种统计软件均判定为线性。结论对低值血清用去离子水适当稀释不影响线性性能验证；在线性性能验证中，EXCEL 可以满足验证需要，MVS 对线性的判定更为严格。

Comparative study on application of diluted serum and EXCEL and MVS in linear validation

Objective To study the application value of diluted serum and EXcelland MVS in the linear performance verifica-tion.Methods The series of concentration samples were prepared by mixing the collected low value mixed serum and the low value mixed serum diluted with 2-3 times of deionized water and the same high concentration serum for conducting the linear experi-ments.The linearity of the experimental results was statistically judged by the two softwares of EXcelland MVS.Results The 3 diluted serum experiments were linear by the judgement of the two softwares;in 6 experiments,the original serum experimental re-sults of CREA were linear by the judgement of EXcelland nonlinear by the judgement of MVS,but the decisive concentration lev-els,the differences of the two regression equations were -2.02 μmol/L and 4.23 μmol/L respectively,which were less than 1/9 of CLIA′88 maximum allowable error under the two concentrations（26.52 μmol/L and 39.78 μmol/L）,the remaining 5 experiments were linear by the judgement of the two softwares.Conclusion The low value serum appropriately diluted by deionized water does not affect the linear performance verification;in the linear performance verification,EXcellcan meet the verification needs and MVS is more strict in judging linearity.