化学发光法弱阳性质控品的制备及应用评价  

Preparation and Application Evaluation of Weak Positive Quality Control Products by Chemiluminescence Method

作　　者：肖杰 陈亚琴 韩小玲 XIAO Jie;CHEN Yaqin;HAN Xiaoling(Department of Clinical Laboratory,Aier Eye Hospital,Wuhan University,Wuhan Hubei 430060,China)

机构地区：[1]武汉大学附属爱尔眼科医院检验科,湖北武汉430060

出　　处：《中国卫生标准管理》2024年第1期23-26,共4页China Health Standard Management

摘　　要：目的探讨自制弱阳性质控品在室内质控应用中的可行性。方法收集武汉大学附属爱尔眼科医院传染性4项指标[乙型肝炎表面抗原(hepatitis B surface antigen,HBsAg)、丙型肝炎抗体(hepatitis C antibody,HCV-Ab)、梅毒螺旋体特异性抗体(treponema pallidum specific antibody,TP-Ab)、人类免疫缺陷病毒抗原抗体(human immunodeficiency virus antigen antibody,HIV-Ag/Ab)]阳性患者血清,用阴性患者血清分别将以上阳性血清稀释至临界值的3倍左右作为自制弱阳性质控品,分装后存放于-20℃冰箱,评价其均一性、复溶4℃稳定性以及-20℃保存4个月稳定性,比较自制弱阳性质控品与原装雅培质控品30 d检测值。结果HBsAg、HCV-Ab、TP-Ab、HIVAg/Ab弱阳性质控品2组间检测结果比较[(0.153±0.009)IU/m L vs.(0.154±0.008)IU/m L,(3.48±0.23)S/CO vs.(3.50±0.19)S/CO,(4.27±0.22)S/CO vs.(4.24±0.18)S/CO,(3.02±0.15)S/CO vs.(3.04±0.16)S/CO],差异无统计学意义(P>0.05),均一性评价通过。自制弱阳性质控品各项目的30 d测定结果与原装质控品基本一致[(0.152±0.007)IU/m L vs.(0.154±0.008)IU/m L,(3.56±0.17)S/CO vs.(3.53±0.21)S/CO,(4.42±0.17)S/CO vs.(4.21±0.20)S/CO,(3.04±0.15)S/CO vs.(2.99±0.15)S/CO],差异均无统计学意义(P>0.05)。将复溶后的自制弱阳性质控品存放至4℃冰箱,连续测定20 d,各指标质控品的变异系数(CV)均<15%(6.58%、5.95%、5.91%、5.92%)。自制弱阳性质控品每个月结果间的差异无统计学意义(P>0.05)。结论医院自制传染性弱阳性质控品均匀性、稳定性良好,-20℃条件保存时,至少可稳定4个月,在其稳定期内能替代进口质控品用于室内质量控制。Objective To explore the feasibility of self-made weak positive quality control materials in the application of internal quality control.Methods The serum of patients with positive four infectious indicators[hepatitis B surface antigen(HBsAg),hepatitis C antibody(HCV-Ab),treponema pallidum specific antibody(TPAb),human immunodeficiency virus antigen antibody(HIV-Ag/Ab)]in Aier Eye Hospital,Wuhan University was collected.The above positive serum was diluted to about 3 times the critical value with the serum of negative patients as self-made weak positive quality control products,stored in the refrigerator at -20℃ after subpackaging,evaluated its uniformity,stability at thaw 4℃ and stability at -20℃ storage for 4 months,the 30-day test value of self-made weak positive quality control product was compared with that of original Abbott quality control product.Results The results of HBsAg,HCV-Ab,TP-Ab and HIV-Ag/Ab weakly positive quality control products were compared between the two groups[(0.153±0.009)IU/mL vs.(0.154±0.008)IU/mL,(3.48±0.23)S/CO vs.(3.50±0.19)S/CO,(4.27±0.22)S/CO vs.(4.24±0.18)S/CO,(3.02±0.15)S/CO vs.(3.04±0.16)S/CO],there were no statistical significances(P>0.05),and the homogeneity evaluation was passed.The 30 d test results of the self-made weak positive quality control products are basically consistent with the original quality control products[(0.152±0.007)IU/mL vs.(0.154±0.008)IU/mL,(3.56±0.17)S/CO vs.(3.53±0.21)S/CO,(4.42±0.17)S/CO vs.(4.21±0.20)S/CO,(3.04±0.15)S/CO vs.(2.99±0.15)S/CO],there were no statistical significances(P>0.05).The self-made weakly positive quality control products after remelting were stored in a refrigerator at 4℃,and the coefficient of variation(CV)of each index quality control product was<15%(6.58%,5.95%,5.91%,5.92%)for continuous determination for 20 days.There was no statistical significance in the results of self-made weakly positive quality control products(P>0.05).Conclusion Our self-made weakly positive infectious quality control products

关 键 词：化学发光 传染性指标 自制质控品 室内质控 均一性 稳定性 

分 类 号：R446[医药卫生—诊断学]