Womens Health and HIV Research Unit, Department of Obstetrics and Gynaecology, Nelson R Mandela School of Medicine, University of KwaZulu-Natal, South Africa.
J Clin Virol. 2012 Jun;54(2):180-4. doi: 10.1016/j.jcv.2012.02.021. Epub 2012 Mar 22.
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.
We evaluated the Determine(®) 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.
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(®) v2.0 PCR test was used to quantify HIV-viral copies in women with incident HIV-infections.
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.
The Combo RT does not identify AHI but is superior to 3rd generation tests in detecting HIV antibody responses.
目前在资源有限的环境中使用的第三代快速 HIV 检测无法检测急性 HIV 感染（AHI）。已知它们在“窗口期”过后或晚期才能检测到 HIV 感染。在妊娠早期及早发现艾滋病毒感染，可增加机会启动抗逆转录病毒预防措施，以防止艾滋病毒母婴传播。
我们评估了第四代检测试剂 Determine(®) HIV1/2 Ag/Ab Combo 快速检测（Combo RT），它与两种第三代检测试剂（SENSA-HIV1/2/0 三线检测、SD-Bioline）比较，用于检测妊娠期间 HIV 感染的早期情况。
在一项队列研究中，我们检测了 32 名随后在产前就诊时发生血清转换的孕妇（新发感染）的血浆样本、189 名在基线时 HIV 检测阳性的孕妇（既往感染）和 32 名在随后的产前就诊时仍 HIV 阴性的孕妇的样本。我们使用第三代（仅检测抗体）和第四代（检测抗体/抗原）快速 HIV 检测试剂对样本进行检测。采用 HIV-1 NucliSENSEasyQ(®) v2.0 PCR 检测对新发 HIV 感染女性的 HIV 病毒载量进行定量。
在 32 名（56.3%）女性（新发感染）中，有 18 人（88.9%）在基线时检测到可检测的病毒载量，她们的 Combo RT 检测均呈抗体反应。32 个标本均未在 Combo RT 的抗原成分上呈反应。在血清转换前，Combo RT 检测 HIV 感染的敏感性和特异性分别为 59.4%（95%CI 40.6-76.3）和 96.9%（95%CI 83.8-99.9）。如果将 Combo RT 用作筛查检测（基线），则可检测到所有 HIV 感染的 94.0%，而第三代检测试剂的检出率为 85.5%。
Combo RT 不能检测急性 HIV 感染，但在检测 HIV 抗体反应方面优于第三代检测试剂。
