Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA.
Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA.
EBioMedicine. 2019 May;43:307-316. doi: 10.1016/j.ebiom.2019.04.023. Epub 2019 Apr 18.
Accurate laboratory diagnosis of HIV is essential to reduce the risk of HIV-positive individuals transmitting HIV-1 infection. The goal of this study was to identify and assess a panel of host derived plasma miRNAs that could to serve as a prognostic and predictive biomarker to detect early/acute HIV-1 infection.
A total of 372 microRNAs were analyzed in nine plasma samples from HIV-1 infected individuals in the early phase of infection and three healthy controls using the miRNA PCR-array. Seventeen microRNAs were selected and validated in 80 plasma samples from HIV-1 infected individuals in the early phase of infection (20 each of eclipse stage, RNA+ stage, Ag + stage, and Ag + Ab+ stage of HIV-1 patients) and 25 healthy controls. Using the validation study results a plasma miRNA panel was developed and evaluated to detect early/acute HIV-1 infection in 49 blinded samples.
We identified an miRNA panel (P) containing four differentially expressed miRNAs (miR-16-5p, miR-20b-5p, miR-195-5p, and miR-223-3p) that could distinguish early HIV-1 infection from healthy controls with high AUC (1·000[1·00-1·00]), sensitivity (100%), and specificity (100%).We also found that miR-223-3p demonstrates 100% sensitivity and specificity (AUC 1·00[1·00-1·00]) and could distinguish eclipse stage of HIV-1 infection from healthy controls. To detect eclipse stage of HIV-1 infection we also developed a four-miRNA based (miR-16-5p, miR-206, let-7 g-3p, and miR-181c-3p) panel (P) with AUC 0·999 (0·995-1·000), 100% sensitivity and 95·8% specificity.
The miRNA panel, P is a potential biomarker for detecting early/acute stage of HIV-1infection and could help initiate early antiretroviral treatment, thus preventing the spread of HIV-1 infection.
准确的 HIV 实验室诊断对于降低 HIV 阳性个体传播 HIV-1 感染的风险至关重要。本研究旨在鉴定和评估一组宿主来源的血浆 miRNA，作为一种预测和预后生物标志物，以早期/急性 HIV-1 感染。
使用 miRNA PCR-array 分析了 9 名 HIV-1 感染者感染早期和 3 名健康对照者的 372 个 microRNA。从 80 名 HIV-1 感染者感染早期（每个阶段各 20 名）的血浆样本中筛选并验证了 17 个 microRNA。利用验证研究结果，开发并评估了一个血浆 miRNA 谱，以检测 49 份盲样的早期/急性 HIV-1 感染。
我们鉴定出一个 miRNA 谱（P），其中包含 4 个差异表达的 microRNA（miR-16-5p、miR-20b-5p、miR-195-5p 和 miR-223-3p），可用于区分早期 HIV-1 感染与健康对照者，AUC 为 1.000（1.00-1.00），灵敏度为 100%，特异性为 100%。我们还发现，miR-223-3p 的灵敏度和特异性均为 100%（AUC 为 1.00[1.00-1.00]），可区分 HIV-1 感染的潜伏期与健康对照者。为了检测 HIV-1 感染的潜伏期，我们还开发了一个基于 4 个 microRNA 的谱（P），包含 miR-16-5p、miR-206、let-7g-3p 和 miR-181c-3p，AUC 为 0.999（0.995-1.000），灵敏度为 100%，特异性为 95.8%。
miRNA 谱 P 是一种检测 HIV-1 早期/急性感染的潜在生物标志物，有助于启动早期抗逆转录病毒治疗，从而阻止 HIV-1 感染的传播。
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