Kang Hee Jung, Yoo Kyeong Ha, Kim Han Sung, Cho Hyoun Chan
Department of Laboratory Medicine, Hallym University College of Medicine, Anyang, Korea.
Korean J Lab Med. 2006 Feb;26(1):39-44. doi: 10.3343/kjlm.2006.26.1.39.
In order to reduce the diagnostic window period between the time of human immunodeficiency virus (HIV) infection and serological diagnosis, new fourth generation screening assays which detect HIV p24 antigen and specific antibody simultaneously have been developed. In this study, we evaluated the performance of a new fourth generation assay.
We compared a new fourth generation assay, Architect HIV Ag/Ab combo, with another fourth generation assay AxSYM HIV Ag/Ab combo and a third generation assay, AxSYM HIV 1/2 gO for their performance. The assays were evaluated using 3 HIV seroconversion panels, 305 sera of healthy subjects and 100 sera of patients with HBsAg or anti-HCV antibodies. Within-run and total coefficient variations of the three screening assays were analyzed for the evaluation of precision.
Architect HIV Ag/Ab combo shortened the window period by 8.7+/-2.1 days relative to AxSYM HIV 1/2 gO and 2.0+/-2.0 days relative to AxSYM HIV Ag/Ab combo in seroconversion panels. Architect HIV Ag/Ab combo presented the best performance in precision among the three reagents; total CV for positive control was 3.6%, 9.6% and 4.6% for Architect HIV Ag/Ab combo, AxSYM HIV Ag/Ab combo and AxSYM HIV 1/2 gO, respectively. Specificities of three assays were not different in this study.
HIV Ag/Ab combined assays reduced the diagnostic window as compared to the third generation screening assays, enabling an earlier diagnosis of HIV infection. A new fourth generation assay, Architect HIV Ag/Ab combo presents a better performance than AxSYM HIV Ag/Ab combo, showing improved seroconversion sensitivity and precision.
为了缩短人类免疫缺陷病毒（HIV）感染时间与血清学诊断之间的诊断窗口期，已开发出同时检测HIV p24抗原和特异性抗体的新型第四代筛查检测方法。在本研究中，我们评估了一种新型第四代检测方法的性能。
我们比较了一种新型第四代检测方法（Architect HIV Ag/Ab组合检测法）与另一种第四代检测方法（AxSYM HIV Ag/Ab组合检测法）以及一种第三代检测方法（AxSYM HIV 1/2 gO）的性能。使用3个HIV血清转化样本组、305份健康受试者血清和100份乙肝表面抗原（HBsAg）或丙肝抗体（抗-HCV）阳性患者的血清对这些检测方法进行评估。分析三种筛查检测方法的批内和总变异系数以评估精密度。
在血清转化样本组中，相对于AxSYM HIV 1/2 gO，Architect HIV Ag/Ab组合检测法将窗口期缩短了8.7±2.1天，相对于AxSYM HIV Ag/Ab组合检测法缩短了2.0±2.0天。在三种试剂中，Architect HIV Ag/Ab组合检测法的精密度最佳；阳性对照的总变异系数分别为：Architect HIV Ag/Ab组合检测法为3.6%，AxSYM HIV Ag/Ab组合检测法为9.6%，AxSYM HIV 1/2 gO为4.6%。在本研究中，三种检测方法的特异性无差异。
与第三代筛查检测方法相比，HIV Ag/Ab联合检测法缩短了诊断窗口期，能够更早地诊断HIV感染。一种新型第四代检测方法（Architect HIV Ag/Ab组合检测法）的性能优于AxSYM HIV Ag/Ab组合检测法，在血清转化敏感性和精密度方面有所提高。
