免疫增强透射比浊法测定超敏C-反应蛋白的方法学评价

Particle enhanced immunoturbidimetic assay of high sensitive C-reactive protein

目的 :对免疫增强透射比浊法在全自动生化分析仪上测定超敏C 反应蛋白 (Hs CRP)的方法进行评价。方法 :检测该方法的分析范围、最低检测限、精密度、抗干扰能力及参考范围。结果 :免疫增强透射比浊法测定Hs CRP的分析范围为 0 .12 5～ 12 .5mg/L ,最低检测限为 0 .115mg/L ,批内、批间精度分别为 0 .89%和0 .90 %;本实验室Hs CRP的参考范围为 0 .2 0～ 2 .6 0mg/L。结论 :免疫增强的透射比浊法在全自动生化分析仪上测定Hs CRP的方法具有敏感性高、稳定性好、方便快速的优点 ,适宜于在临床推广应用。

Objective To evaluate the particle enchanced immunoturbidimetic assay of high sensitive C-reactive protein by the automated chemistry analyzer (Hitachi 7170A). Methods The detection limit of quantification,measurement range,precision,interference and reference interval were assessed.Results The measurement range of the method was from 0.125 to 12.5 mg/L.The detection limitation was 0.115 mg/L. The internal and external accuracy were 0.89% and 0.90% respectively.The reference range of the assay was from 0.20 mg/L to 2.60 mg/L.Conclusion The particle enhanced immunoturbidimetic assay is sensitive and stable, and can be used in clinical diagnosis.