摘要
目的对免疫透射比浊法测定血清特定蛋白的方法学性能进行初步评价，并与免疫散射比浊法进行比较。方法应用Roche ModularP全自动生化分析仪与Dade Behring BN Pro Spec（现为SIEMENS西门子）特定蛋白测定仪对IgG，IgA，IgM，C3，C4，CRP和hs-CRP7种血清蛋白进行初步的方法学评价，包括透射比浊法与散射比浊法的精密度分析，相关性及线性回归试验。结果①免疫透射比浊法无论是批内精密度还是批间精密度都非常好，CV均〈5％。免疫透射比浊法的精密度要优于免疫散射比浊法。②免疫透射比浊法与免疫散射比浊法从低检测范围到高检测范围，均有着良好的线性回归，斜率均接近于1，截距均接近于0。两法的r自〉0．975。③全自动生化分析仪上的线性检测功能可发现特殊样本的抗原过剩问题。④免疫透射比浊法还具有成本低，收费低，速度快等优点。结论免疫透射比浊法具有优良的精密度及分析灵敏度和检测范围，与免疫散射比浊法相关良好，系统误差较小，且更加实用和便利。
Objective To primarily evaluate the methodological performance of immunoturbidimetric assays for analysis of human serum specific proteins,and compare the differences with that of immunonephelometric assays. Methods Seven serum proteins （immunoglobulins G,A and M,complement components 3 and 4,C-reactive protein,high sensitive C-reac- tive protein）were detected by Roche Modular P automatic biochemistry analyzer and Dade Behring BN ProSpec analyzer, and primarily methodological evaluation including precision analysis of immunoturbidimetric assays and immunoneph- elometric assays,correlation and linear regression analysis of two methods was performed. Results （1）Either within-run precision or day-to-day precision of immunoturbidimetric assays was very good,coefficient of variation （CV） were both less than 5%. The precision of immunoturbidimetric assays was better than immunonephelometric assays. （2）Immunotur-bidimetrie assays and immunonephelometric assays showed good linear regression from low detection range to high detection range. The slope were all close to 1 and the intercept were all on the verge of 0. The correlation coefficient of two methods was all greater than 0. 975. （3）The linear assay function on the automatic biochemistry analyser could discover the problem about antigen excess of the specific samples. （4）There are many advantages of immunoturbidimetric assays,such as low cost,low charge and high detection speed,etc. Conclusion Immunoturbidimetric assays have excellent precision,sensitivity for analysis and measuring range. It correlated well with immunonephelometric assays and had little systematic error. Moreover,it is more practical and convenient than immunonephelometric assays.
出处
《现代检验医学杂志》
CAS
2011年第1期45-47,共3页
Journal of Modern Laboratory Medicine
关键词
免疫透射比浊法
免疫散射比浊法
方法学评价
immunoturbidimetric assays
immunonephelometric assays
methodological evaluation
