C 反应蛋白冰冻混合人血清定值校准品的制备研究

Preparation of the mixed serum calibrators for C-reactive protein

目的：制备3个水平C反应蛋白（ CRP ）的定值校准品。方法按国家标准物质技术规范的要求，选择感染疾病检测阴性、无肉眼溶血、脂血、黄疸的体检者或患者血清，按CRP浓度水平分成低、中、高3组，分别混匀、过滤除菌、分装。采用单因素方差分析检验其均匀性、直线回归分析检验其稳定性，通过国际标准物质，采用颗粒增强免疫散射比浊法为CRP定值，评估不确定度。结果（1）均匀性检验中CL、CM、CH三组血清的Ubb分别为0、0.125、0，Ur分别为0.046、0.213、0.785，Ubb均﹤Ur；F值分别为0.803、1.686、0.966，P值均﹥0.05，差异无统计学意义，说明均匀性良好。（2）稳定性研究中室温条件下F 值分别为0.609、0.259、1.557；冷藏条件下 F 值分别为1.217、4.583、0.893，P值均﹥0.05，说明血清CRP在室温、冷藏条件下至少稳定3、30 d。（3）3个水平的CRP定值结果分别为（2.64±0.14）、（31.17±0.63）、（73.85±1.74） mg／L。结论3个水平冰冻混合人血清CRP定值校准品均匀、稳定、定值可靠，可用于临床检测系统的校准评价。

Objective To prepare serum calibrators for CRP measurement.Methods Fresh serum without infectious diseases , hemolysis, lipemia and choloplania were collected and divided into 3 groups, low, medium, and high, according to the CRP concentration.Each serum pool was mixed , filtered, sterilized and aliquoted.The materials were tested for homogeneity and stability.The values of the CRP was assigned by particle enhanced immunonephelpmetry , and calibrated with international reference materials.The expanded uncertainty was evaluated.Results The materials were tested to be homogeneous （Ubb﹤Ur, P＆gt;0.05） with Ubb values being 0, 0.125, 0, Ur values being 0.046, 0.213, 0.785, and F values being 0.803, 1.686, 0.966 in CL, CM, CH groups respectively.Stability study, where F values are 0.609, 0.259, and 1.557 at 22-25℃, 1.217, 4.583, and 0.893 at 2-8℃（P＆gt;0.05）, showed that the materials were stable for at least 3 days at 22-25 ℃or 30 days at 2-8 ℃, respectively.The certified values of the 3 levels materials for CRP were （ 2.64 ＆#177;0.14 ） , （ 31.17 ＆#177;0.63 ） , （ 73.85 ＆#177;1.74 ） mg/L, respectively.Conclusion The calibrators prepared for serum CRP measurement were homogeneous , stable and accurately assigned and can be used to calibrate the CRP measure system.