摘要
目的比较3家不同企业生产的HIV抗体确认试剂的检测结果。方法分别应用3家不同企业生产的HIV抗体确认试剂,检测64份经多家HIV抗体酶联免疫试剂检测不一致的样本,比较检测结果的差异,并对不确定样本的常见非特异性条带进行分析。结果 3家不同企业生产的HIV抗体确认试剂检测64份样本均为阴性或不确定,但各试剂检测为阴性和不确定样本的比例差别较大,INNO-LIATMHIVI/ⅡScore与NEWLAVBLOT1试剂、INNO-LIATMHIVⅠ/ⅡScore与HIVBLOT2.2试剂及NEWLAVBLOT1与HIVBLOT2.2试剂检测结果的符合率分别为57.8%、28.1%和48.4%,且每两家试剂检测结果之间差异均有统计学意义(P均<0.01)。最易产生不确定结果的条带主要集中在p24和p17上。结论 HIV抗体确认试剂质量差别较大,应加强其质量控制并规范检测标准。
Objective To compare the determination results by HIV antibody confirmation kits manufactured by three manufacturers. Methods Sixty-four specimens with inconsistent results by several ELISA kits for HIV antibody were confirmed by the HIV antibody confirmation kits manufactured by three manufacturers, and the results were compared, based on which the common nonspecific bands in uncertain specimens were analyzed. Results All the 64 specimens were confirmed as negative or uncertain by the HIV antibody confirmation kits manufactured by three manufacturers. However, the proportions of negative and uncertain specimens confirmed by various kits were significantly different. The coincidence rates of confirmation results by INNO-LIATM HIVⅠ / Ⅱ Score and NEW LAV BLOT 1 kits, INNO-LIATMⅠ / Ⅱ Score and HIV BLOT 2. 2 kits, and NEW LAV BLOT 1 and HIV BLOT 2. 2 kits were 57. 8%, 28. 1 and 48. 4%, respectively. Significant differences were observed between the confirmation results by various kits（P 0. 01）. Uncertain results were mainly caused by p24 and p17 bands. Conclusion The qualities of HIV antibody confirmation kits are significantly different, indicating that it is necessary to strengthen the quality control and regulate the requirements for the kits.
出处
《中国生物制品学杂志》
CAS
CSCD
2010年第8期875-877,共3页
Chinese Journal of Biologicals
基金
卫生部艾滋病防治应用性研究项目课题艾滋病防治和诊断指标的评价研究(WA-2006-04)
关键词
HIV抗体
确认试剂
符合率
HIV antibody
Confirmation kits
Coincidence rate
