C-反应蛋白质控品的制备及应关注的问题

The preparation of C-reactive protein quality control material and related points for attention

目的制备与CRM470 C-反应蛋白(CRP)国际参考一致的CRP质控品,用作各种CRP定量检测的质量控制。方法用以CRM470 CRP为基准的进口仪器和配套试剂盒测定所配制的各种组分和状态的CRP质控品的稳定性。结果健康人血清或小牛血清为介质的CRP液态制备物稳定性最好,当CRP浓度为20 mg/L时,37℃下可以保存1个月,但CRP浓度为100 mg/L时稳定性相对较差。CRP质控品中如存在乙二胺四乙酸(EDTA)时,会影响某些CRP单抗对CRP的结合。结论CRP质控品液体状态比冻干状态稳定,CRP液体质控品以人或小牛血清作为介质的稳定性效果最好,但不能含EDTA等络合剂。

Objective To Prepare C-reactive protein （CRP） quality control material in concordance with international standard certified reference material （CRM）470 reference and used for various CRP quantitative diagnostic kit. Methods The stability at 37℃ of different ingredient for CRP quality control material was determined by reliable CRP quantitative diagnostic kit which must be consistent with international standard CRM470 CRP reference. Results Liquid CRP quality control material prepared in human or calf serum had a good stability, 20 mg/L CRP had excellent stability for a month at 37℃, but at the same time the stability of high concentration CRP （ 100 mg/L） was not so stable. In the presence of ethylenediarmine tetraacetic acid （ EDTA）, the quantitative value would decrease immediately. Conclusions The liquid CRP quality control material is more stable than the freeze-dried CRP materials and the human or calf serum is the best medium for the preparation of CRP quality control material. EDTA can not be used in CRP quality control material.