不确定的 HIV-1 PCR 结果的解释受不断变化的垂直传播预防方案的影响。

Interpretation of indeterminate HIV-1 PCR results are influenced by changing vertical transmission prevention regimens.

机构信息

Division of Medical Virology, Department of Pathology, National Health Laboratory Service and Stellenbosch University, Cape Town, South Africa.

Family Clinical Research Unit and Department of Pediatrics and Child Health, Stellenbosch University and Tygerberg Children's Hospital, Cape Town, South Africa.

出版信息

J Clin Virol. 2017 Oct;95:86-89. doi: 10.1016/j.jcv.2017.08.013.

DOI:10.1016/j.jcv.2017.08.013

PMID:28898704

Abstract

BACKGROUND

Suppression of HIV by antiretroviral drugs may be one of the reasons that indeterminate HIV-1 PCR results are obtained from testing HIV-exposed infants. This complicates the early identification of infected infants, potentially delaying initiating treatment early. There is uncertainty as to how different vertical HIV transmission prevention regimens (VTP) affect the rate and predictive value of indeterminate PCR results.

OBJECTIVES

To investigate rates of indeterminate PCR results, outcomes of subsequent samples and the predictive value of an indeterminate PCR for a later positive result in the setting of intensifying VTP in the Western Cape province of South Africa.

STUDY DESIGN

Retrospective laboratory data analysis. Diagnostic PCR data of a public health laboratory from June 2009 to October 2014 was analysed and categorised by South African VTP regimens. First indeterminate HIV-1 PCRs in patients younger than 12 months were linked with follow-up HIV-1 PCRs and/or serological tests. Linked results sets were analysed by PCR amplification characteristics and subsequent patient outcome.

RESULTS

Over intensified VTP regimens, the rate of indeterminate and positive PCRs decreased significantly (5.6-3.2% and 2.4-0.4%, respectively; both p<0.001). Most notably, significantly more patients with indeterminate results had positive PCRs on subsequent samples during WHO Option B+ use compared to older regimens (64.1% vs. 14.7%, p<0.001) at a median 28days later.

CONCLUSIONS

Indeterminate HIV PCRs, although decreasing in frequency with Option B+, should be regarded with a high index of suspicion for being representative of true HIV-1 infections. Additional virological testing is required to arrive at a definitive diagnosis.

摘要

背景

抗逆转录病毒药物抑制 HIV 可能是从检测 HIV 暴露婴儿中获得不确定的 HIV-1 PCR 结果的原因之一。这使得确定感染婴儿变得复杂，可能会延迟早期开始治疗。不同的垂直 HIV 传播预防方案（VTP）如何影响不确定 PCR 结果的发生率和预测值尚不确定。

目的

在南非西开普省强化 VTP 的情况下，调查不确定 PCR 结果的发生率、后续样本的结果以及不确定 PCR 对以后阳性结果的预测价值。

研究设计

回顾性实验室数据分析。对公共卫生实验室 2009 年 6 月至 2014 年 10 月的诊断 PCR 数据进行分析，并按南非 VTP 方案进行分类。将 12 个月以下的患者首次出现不确定的 HIV-1 PCR 与后续的 HIV-1 PCR 和/或血清学检测结果进行关联。通过 PCR 扩增特征和随后的患者结局分析关联结果集。

结果

在强化 VTP 方案下，不确定和阳性 PCR 的发生率显著下降（分别为 5.6%-3.2%和 2.4%-0.4%，均<0.001）。值得注意的是，在使用世卫组织 B+方案期间，与较旧方案相比（64.1% vs. 14.7%，p<0.001），更多的不确定结果患者在随后的样本中出现阳性 PCR，中位数为 28 天。