摘要
目的制备长期使用且稳定性好的人类免疫缺陷病毒（HIV）抗体弱阳性质控血清。方法以正常人阴性血清按不同稀释倍数1∶2、1∶4、1∶8、1∶16、1∶32等比例梯度稀释HIV抗体阳性血清;以2种厂家提供不同批号的检测试剂,采用酶联免疫吸附试验（ELISA）双抗原夹心法对HIV抗体弱阳性质控血清进行连续6个月检测,以此对HIV抗体弱阳性质控血清稳定性进行评价。结果以吸光度值/临界值（S/CO）2.0~3.0为参考标准,确定本实验室HIV抗体弱阳性质控血清的最佳稀释度为1∶16（其S/CO值为3.01,CV为5.88%）;且该质控血清在不同检测试剂使用稳定性较好（其S/CO范围为2.52~2.80,CV范围为4.14%~8.97%）;HIV抗体弱阳性质控血清连续6个月检测结果 CV范围为4.34%~9.52%（CV〈10%）。结论自制HIV抗体弱阳性质控血清具有良好的稳定性和精密度,可作为临床常规HIV抗体检测的质控血清。
Objective To prepare the weakly positive randox of human immunodeficieney virus （HIV） antibody with long - term use and good stability. Methods The the positive serum of HIV antibody was diluted with normal human negative serum by grads 1 ： 2, 1 ： 4, 1 ： 8, 1 ： 16, and 1 ： 32; with two detection reagents in two different lot numbers from two different manufactures, the weakly positive randox of HIV antibody was continuously detected for 6 months by the double antigen sandwich method of en- zyme - linked immunosorbent assay（ELISA）. Results Regarding S/CO value between 2.＇0 to 3.0 as the reference standard, the optimal diluting multiple of weakly positive randox of HIV antibody was assured to be 1 ： 16（the value of S/CO is 3.01, the coefficient of variation（CV） is 5.88% ） ; The randox possessed a good stability in different detection reagents（ the S/CO value ranged from 2.52 to 2.80, and the CV is 4.14% - 8.97% ）. In the detection results of weakly positive randox of HIV antibody with 6 continous months, CV ranged from 4. 34% to 9.52% （ CV 〈 10% ）. Conclusion The prepared weakly positive randox of HIV antibody possessed good stability and precision, which was fit for the randox in clinical routine HIV antibody test.
出处
《中国卫生检验杂志》
北大核心
2014年第21期3092-3093,共2页
Chinese Journal of Health Laboratory Technology
基金
南京市科技计划项目(201303019)
南京市科技发展计划项目(201308041)
关键词
人类免疫缺陷病毒抗体
质控血清
制备
Human immunodeficiency virus （HIV） antibody
Randox
Preparation
