尿液HIV-1抗体室内质控品的制备及应用  

Preparation and application of internal quality control for HIV-1 antibody in urine

作　　者：马仲慧 陈兵[1] 常浩[1] 裴丽健[1] 邢文革[1] MA Zhong-hui;CHEN Bing;CHANG Hao;PEI Li-jian;XING Wen-ge(National Center for AIDS / STD Control and Prevention, China CDC, National HIV/AIDS Reference Laboratory, Beijing 102206, China)

机构地区：[1]中国疾病预防控制中心性病艾滋病预防控制中心参比实验室,北京102206

出　　处：《中国生物制品学杂志》2018年第5期507-510,518,共5页Chinese Journal of Biologicals

摘　　要：目的制备尿液HIV-1抗体室内质控品(简称尿液室内质控品),并对其进行均一性、稳定性评价及应用,以保证实验室检测的精密度。方法用HIV-1抗体阴性尿液样本倍比稀释HIV-1抗体阳性尿液样本,采用HIV-1尿液抗体检测试剂盒(ELISA)进行检测,根据检测结果吸光度/临界值比值(S/CO)来确定呈弱反应性的尿液样本的稀释倍数,制备尿液室内质控品。采用HIV-1尿液检测试剂盒评价尿液室内质控品的均一性和稳定性。连续检测20次尿液室内质控品,建立Levy-Jennings质控图并进行分析。结果 HIV-1抗体阳性尿液样本按1∶4比例稀释后所得样本为尿液室内质控品。均一性评价中,随机抽取的20支尿液室内质控品检测结果的变异系数(CV)为15.89%;稳定性评价中,随机抽取的20支尿液室内质控品在37℃、室温、2~8℃、-20℃放置不同时间检测结果的CV分别为8.69%、17.47%、18.08%和23.04%。Levy-Jennings质控图的S/CO比值的平均值为5.54,标准差为0.48。在常规条件下,尿液室内质控品均在控;在不同反应条件下,尿液室内质控品出现告警或失控。结论制备的尿液HIV-1室内质控品的稳定性、均一性较好,可用于控制实验室尿液HIV-1抗体检测的质量。Objective To prepare the internal quality control for HIV-1 antibody in urine and evaluate its homogeneity,stability and application so as to assurance the precision of laboratory test. Methods A HIV-1 positive urine sample was2-fold serially diluted with a HIV-1 negative urine sample and determined by ELISA kit for HIV-1 antibody in urine,and the dilution ratio of sample with low-reactivity was determined according to the S/CO value of test result,based on which the internal quality control for HIV-1 antibody in urine was prepared. The homogeneity and stability of the internal quality control in urine were evaluated by the detection kit for HIV-1 antibody in urine. The internal quality control was tested for20 times,and the results were analyzed by Levy-Jennings quality control chart. Results The dilution ratio of internal quality control in urine was 1∶4. In homogeneity test,the CV of results of 20 internal quality control was 15. 89%.However,in stability test,the CVs of results of the control after storage at 37 ℃,indoor temperature,2-8 ℃ and-20 ℃ were 8. 69%,17. 47%,18. 08% and 23. 04% respectively. The mean S/CO value in Levy-Jennings quality control chart was 5. 54,with a standard deviation of 0. 48. When the tests were carried out according to the instructions for use,the results were in the control. However,when some conditions were changed,partial results were in alarm status or out of control. Conclusion The prepared internal quality control in urine showed high stability and homogeneity,which might be used for the control of quality of laboratory test for HIV-1 in urine.

关 键 词：人类免疫缺陷病毒 抗体 尿液 室内质控品 

分 类 号：R373.9[医药卫生—病原生物学] R392-33[医药卫生—基础医学]