Abbott Molecular Inc., 1300 E Touhy Avenue, Des Plaines, IL 60018-3315, USA.
J Virol Methods. 2011 Dec;178(1-2):216-24. doi: 10.1016/j.jviromet.2011.09.015. Epub 2011 Sep 24.
Abbott RealTime HIV-1 Qualitative is an in vitro real-time PCR assay for detecting HIV-1 nucleic acids in human plasma and dried blood spots (DBS). The assay was designed to be used in diagnosis of HIV-1 infections in pediatric and adult patients, with an emphasis on the applicability in resource-limited settings. Use of DBS facilitates specimen collection from remote areas and transportation to testing laboratories. Small sample input requirement facilitates testing of specimens with limited collection volume. The Abbott RealTime HIV-1 Qualitative assay is capable of detecting HIV-1 group M subtypes A-H, group O and group N samples. HIV-1 virus concentrations detected with 95% probability were 80 copies/mL of plasma using the plasma protocol, and 2469 copies/mL of whole blood using the DBS protocol. The assay detected HIV-1 infection in 13 seroconversion panels an average 10.5 days earlier than an HIV-1 antibody test and 4.9 days earlier than a p24 antigen test. For specimens collected from 6 weeks to 18 months old infants born to HIV-1 positive mothers, assay results using both the DBS and plasma protocols agreed well with the Roche Amplicor HIV-1 DNA Test version 1.5 (95.5% agreement for DBS and 97.8% agreement for plasma).
Abbott RealTime HIV-1 Qualitative 是一种用于检测人类血浆和干血斑（DBS）中 HIV-1 核酸的体外实时 PCR 检测方法。该检测方法旨在用于儿科和成年患者的 HIV-1 感染诊断，重点是在资源有限的环境中的适用性。使用 DBS 方便了从偏远地区采集样本并运输到检测实验室。小样本输入要求方便了对采集量有限的样本进行检测。Abbott RealTime HIV-1 Qualitative 检测方法能够检测 HIV-1 组 M 亚型 A-H、组 O 和组 N 样本。使用血浆方案，该检测方法可检测到 95%概率下 HIV-1 病毒浓度为 80 拷贝/mL 的血浆，使用 DBS 方案可检测到 2469 拷贝/mL 的全血。该检测方法在 13 个血清转换面板中平均比 HIV-1 抗体检测早 10.5 天，比 p24 抗原检测早 4.9 天检测到 HIV-1 感染。对于从 HIV-1 阳性母亲所生的 6 周到 18 个月大的婴儿采集的样本，使用 DBS 和血浆方案的检测结果与罗氏 Amplicor HIV-1 DNA Test version 1.5 非常吻合（DBS 的一致性为 95.5%，血浆的一致性为 97.8%）。
