Evaluation of a 4th generation rapid HIV test for earlier and reliable detection of HIV infection in pregnancy
Evaluation of a 4th generation rapid HIV test for earlier and reliable detection of HIV infection in pregnancy
复制标题
DOI：
10.1016/j.jcv.2012.02.021
复制
发表时间：
2012-06-01
影响因子：
8.8
通讯作者：
Chuturgoon, Anil
中科院分区：
文献类型：
--
作者：
Chetty, Vani;Moodley, Dhayendre;Chuturgoon, Anil
背景：目前在资源有限的环境中使用的第三代快速HIV检测不能检测急性HIV感染（AHI）。已知它们可以在“窗口期”之后或后期发现艾滋病毒感染。在怀孕早期检测到HIV感染事件增加了启动抗逆转录病毒预防的机会，以防止母婴传播HIV。（Combo RT），第4代测试对比两个第3代测试（SENSA-HIV 1/2/0 Tri-line，SD-Bioline）用于妊娠期HIV感染的早期检测。在一项队列研究中，对32名在随后的产前访视中发生血清转化的孕妇的血浆样本进行了检测。（意外感染），来自189名基线时艾滋病毒检测呈阳性的妇女的样本（已确诊感染），并对32名在后续产前检查中保持艾滋病毒血清阴性的妇女的样本进行了第三代检测（仅抗体检测）和第四代（抗体/抗原检测）快速HIV检测。HIV-1 NucliSENSEasyQ（R）v2.0 PCR检测用于定量发生HIV感染的女性中的HIV病毒拷贝。（56.3%）（意外感染）有可检测的病毒拷贝（基线）; 16（88.9%）32份标本均未对Combo RT的抗原组分产生反应。Combo RT检测血清转换前HIV感染的特异性分别为59.4%（95% CI 40.6-76.3）和96.9%（95% CI 83.8-99.9）。如果用作筛查测试（基线），Combo RT可检测到94.0%的所有HIV感染，而第三代测试可检测到85.5%。结论：Combo RT不能识别AHI，但在检测HIV抗体方面优于第三代测试，但具有上级。(C)2012爱思唯尔有限公司版权所有。
Background: Currently used 3rd generation rapid HIV-tests in resource-limited settings do not detect acute HIV-infections (AHI). They are known to detect HIV-infections after or late in the "window period". Detecting incident-HIV infections early in pregnancy increases opportunities for initiating antiretroviral prophylaxis to prevent mother-to-child transmission of HIV.Objectives: We evaluated the Determine (R) HIV1/2 Ag/Ab Combo Rapid Test (Combo RT), a 4th generation test against two 3rd generation tests (SENSA-HIV1/2/0 Tri-line, SD-Bioline) for early detection of HIV-infection in pregnancy.Study design: In a cohort study, plasma samples from 32 pregnant women who seroconverted at a subsequent antenatal visit (incident-infection), samples from 189 women who tested HIV positive at baseline (established-infections) and samples from 32 women remaining HIV-seronegative at a subsequent antenatal visit were tested with 3rd generation (antibody detection only) and 4th generation (antibody/antigen detection) rapid HIV tests. The HIV-1 NucliSENSEasyQ (R) v2.0 PCR test was used to quantify HIV-viral copies in women with incident HIV-infections.Results: Eighteen of 32 (56.3%) women (incident-infections) had detectable viral copies (baseline); 16 (88.9%) were antibody reactive with the Combo RT. None of the 32 specimens were reactive on the antigen component of the Combo RT. The sensitivity and specificity of the Combo RT in detecting HIV infections prior to seroconversion is 59.4% (95% CI 40.6-76.3) and 96.9% (95% CI 83.8-99.9) respectively. The Combo RT detected 94.0% of all HIV-infections if used as a screening test (baseline) compared to 85.5% detected by 3rd generation tests.Conclusions: The Combo RT does not identify AHI but is superior to 3rd generation tests in detecting HIV antibody responses. (C) 2012 Elsevier B.V. All rights reserved.