8种第3代和4种第4代人免疫缺陷病毒抗体诊断试剂的比较

Comparative evaluation of eight third generation and four fourth generation anti-HIV diagnostic reagents

目的分析第3代和第4代HIV抗体诊断试剂间以及同一代各种试剂间的差异。方法用8种第3代试剂和4种第4代试剂分别检测989份人免疫缺陷病毒（HIV）阴性样品、185份HIV-1核酸阳性样品、HIV抗体第一代国际参考品以及9套BBI阳转血清，并判定检测结果。结果第4代试剂对HIV感染的检出时间普遍早于第3代试剂，但不同的第4代试剂的检出时间并不相同，不同的第3代试剂在HIV抗体的检出时间方面没有明显的差别。各种试剂检测不同基因型的能力不同，尤其国产试剂检测HIV-10组和HIV-2的能力普遍较差。结论本研究为试剂质量的进一步提高提供了实验数据。

Objective To evaluate the differences between the third and the fourth generations of anti-HIV assays, and different kits within the same generation. Methods A total of 989 HIV-negative samples, 185 samples positive for HIV-1 RNA, 1 st-generation international references of HIV antibodies and samples from 9 sets of BBI seroconversion panels were detected by 8 kits of the third generation and 4 kits of the fouIth. Results The fourth generation kits can detect HIV infection earlier than the third generation kits. However, the detected days of HIV infection with different kits of the fourth generation were different whilst no significant differences were found with different kits of the third generation. Furthermore, the capacity of detecting samples with different genotypes for different reagents was different, especially the capacity of domestic reagents on detecting HIV-10 group and HIV-2 samples was relatively weak. Conclusion These data provided information to improve the quality of anti-HIV diagnostic reagents further.