早期婴儿 HIV-1 PCR 循环阈值预测婴儿出生时的病毒载量。
Early infant diagnosis HIV-1 PCR cycle-threshold predicts infant viral load at birth.
机构信息
Centre for HIV and STIs, National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa; Department of Medical Virology, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.
Centre for HIV and STIs, National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa; School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
出版信息
J Clin Virol. 2019 May;114:21-25. doi: 10.1016/j.jcv.2019.03.009. Epub 2019 Mar 18.
BACKGROUND
HIV-1 viral load (VL) has been found to be an independent predictor for disease progression among untreated HIV-infected children. However, qualitative polymerase chain reaction (PCR) assays are routinely used for early infant diagnosis (EID).
OBJECTIVES
To predict HIV-1 VL at birth using qualitative EID real-time PCR cycle-threshold (Ct) values.
STUDY DESIGN
This study was a secondary analysis of results from a cohort of intrauterine HIV-1 infected neonates. Neonates were enrolled at Rahima Moosa Mother & Child Hospital in Johannesburg, South Africa between June 2014 and November 2017. Laboratory EID HIV-1 PCR testing was performed at birth using COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test v2.0 (EID CAP/CTM). Some infants had simultaneous EID point-of-care (POC) testing using Xpert HIV-1 Qualitative assay (EID Xpert). Neonates with a confirmed HIV-1 detected EID result and plasma HIV-1 RNA VL test were included in this analysis. Bland-Altman analysis was used to determine extent of agreement between Ct values of both EID assays. Multivariable linear regression models adjusting for time between EID and VL testing were used to describe the association between EID Ct values and VL and to predict VL at given EID Ct values.
RESULTS
Among 107 HIV-1 infected neonates included in the study, 59 had POC EID testing. Median VL was 28 400 copies per millilitre (cps/ml) (IQR: 1 918-218 358) - two neonates had VL < 100 cps/ml prior to antiretroviral therapy initiation. There was good correlation between Ct values of both EID assays (Spearman correlation coefficient 0.9, 95% CI: 0.8-1.0). The limits of agreement between EID CAP/CTM and Xpert Ct values were 4-11 cycles. For every one cycle increase in Ct value there was 0.3 log RNA decrease (95% CI: -0.3 to -0.2) for both EID assays. An EID CAP/CTM Ct value ≤ 23 and an EID Xpert Ct value ≤ 31 predicted a VL of > 5.0 log cps/ml in 82.2% (95% CI: 73.9-88.3) and 84.7% (95% CI: 73.7-91.8) of cases, respectively.
CONCLUSION
EID Ct values at birth predict VL and accurately identify infants with VL > 5.0 log cps/ml.
背景
HIV-1 病毒载量（VL）已被发现是未接受治疗的 HIV 感染儿童疾病进展的独立预测因素。然而，定性聚合酶链反应（PCR）检测通常用于早期婴儿诊断（EID）。
目的
使用定性 EID 实时 PCR 循环阈值（Ct）值预测出生时的 HIV-1 VL。
研究设计
本研究是对约翰内斯堡 Rahima Moosa 母婴医院收治的宫内 HIV-1 感染新生儿队列研究结果的二次分析。2014 年 6 月至 2017 年 11 月期间，在南非约翰内斯堡的 Rahima Moosa 母婴医院招募了新生儿。实验室 EID HIV-1 PCR 检测在出生时使用 COBAS AmpliPrep/COBAS TaqMan HIV-1 定性测试 v2.0（EID CAP/CTM）进行。一些婴儿同时进行了基于点的 EID 检测（POC），使用 Xpert HIV-1 定性检测（EID Xpert）。本分析纳入了确认 HIV-1 检测结果和血浆 HIV-1 RNA VL 检测的 HIV-1 阳性新生儿。Bland-Altman 分析用于确定两种 EID 检测的 Ct 值之间的一致性程度。使用调整了 EID 和 VL 检测之间时间的多变量线性回归模型来描述 EID Ct 值与 VL 之间的关联，并预测特定 EID Ct 值下的 VL。
结果
在纳入本研究的 107 名 HIV-1 感染新生儿中，59 名进行了 POC EID 检测。中位 VL 为 28400 拷贝/毫升（IQR：1918-218358）-两名新生儿在开始抗逆转录病毒治疗前 VL<100 拷贝/ml。两种 EID 检测的 Ct 值之间有很好的相关性（Spearman 相关系数 0.9，95%CI：0.8-1.0）。EID CAP/CTM 和 Xpert Ct 值之间的一致性界限为 4-11 个周期。对于 Ct 值的每一个周期增加，两种 EID 检测的 RNA 减少 0.3 log（95%CI：-0.3 至-0.2）。EID CAP/CTM Ct 值≤23 和 EID Xpert Ct 值≤31 分别在 82.2%（95%CI：73.9-88.3）和 84.7%（95%CI：73.7-91.8）的病例中预测 VL>5.0 log cps/ml。
结论
出生时的 EID Ct 值可预测 VL，并能准确识别 VL>5.0 log cps/ml 的婴儿。
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