Technau Karl-Günter, Kuhn Louise, Coovadia Ashraf, Carmona Sergio, Sherman Gayle
Empilweni Services and Research Unit, Department of Paediatrics & Child Health, Rahima Moosa Mother and Child Hospital, Faculty of Health Sciences, University of the Witwatersrand, South Africa.
Gertrude H. Sergievsky Center, College of Physicians and Surgeons, and Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.
J Int AIDS Soc. 2017 Apr 10;20(1):21436. doi: 10.7448/IAS.20.01/21436.
Timely diagnosis is necessary to avert early death in HIV-infected neonates. Birth PCR testing may improve early identification and facilitate access to care. We implemented a birth HIV diagnosis programme in Johannesburg, South Africa and present successes and challenges of the first two and a half years of operation.
Between June 2014 and December 2016, we sought to identify all HIV-exposed births and offer newborn HIV PCR testing before discharge after delivery. The programme identified newly delivered women who had tested positive during pregnancy and provided post-partum HIV antibody testing for women without recent negative results. HIV-positive women were required to consent for neonatal birth testing and asked to return a week later to obtain their results. Neonatal venous blood was sampled and tested at the national laboratory using Roche COBAS® TaqMan® HIV-1 Qualitative Test (Version 2.0). Non-negative results triggered active follow-up for confirmatory testing and appropriate treatment.
Of 30,591 women with live births, 6864 (22.4%) were known to be HIV positive and an additional 221 women (1.4% of those tested) were identified during maternal postnatal testing. Of 7085 HIV-positive women, 6372 (89.9%) were interviewed and agreed to data collection, 6358 (99.8%) consented to birth testing for 6467 neonates and a blood sample was collected for 6377 (98.6%). If tested, 6210 (97.4%) tested negative, 91 (1.4%) positive, 57 (0.9%) revealed errors and 19 (0.3%) were indeterminate . Seven of the 19 neonates with indeterminate results and one with initial error result were found to be infected on subsequent testing yielding an intrauterine transmission rate of 1.6% (95% CI: 1.3-1.9). Sixteen (16%) of 99 infected infants were born to women (n = 221) identified during postnatal testing. With active outreach, 95/99 (96%) infected infants were initiated on antiretroviral therapy. Of 6261 neonates with negative results, 3251 (52%) returned to receive their test results.
Our programme successfully achieved high coverage and uptake of birth PCR testing and was able, with active tracking, to start almost all identified HIV-infected neonates on antiretroviral therapy. Implementation required additional staff for counselling, quality control and outreach. Return for negative results was low and neonates with indeterminate results required multiple repeat tests.
及时诊断对于避免感染艾滋病毒的新生儿过早死亡至关重要。出生时进行聚合酶链反应（PCR）检测可能会改善早期识别并促进获得治疗。我们在南非约翰内斯堡实施了一项出生时艾滋病毒诊断计划，并介绍了该计划头两年半运作中的成功经验和挑战。
在2014年6月至2016年12月期间，我们试图识别所有接触过艾滋病毒的新生儿，并在分娩后出院前为其提供新生儿艾滋病毒PCR检测。该计划识别出在孕期检测呈阳性的新分娩妇女，并为近期检测结果未呈阴性的妇女提供产后艾滋病毒抗体检测。艾滋病毒呈阳性的妇女被要求同意进行新生儿出生检测，并被要求一周后返回获取检测结果。采集新生儿静脉血并在国家实验室使用罗氏COBAS® TaqMan® HIV-1定性检测（版本2.0）进行检测。非阴性结果引发积极的后续确认检测和适当治疗。
在30591名有活产婴儿的妇女中，已知6864名（22.4%）艾滋病毒呈阳性，另外在产妇产后检测中识别出221名妇女（占检测者的1.4%）。在7085名艾滋病毒呈阳性的妇女中，6372名（89.9%）接受了访谈并同意进行数据收集，6358名（99.8%）同意为6467名新生儿进行出生检测，采集了6377名（98.6%）新生儿的血样。如果进行检测，6210名（97.4%）检测结果为阴性，91名（1.4%）为阳性，57名（0.9%）显示检测错误，19名（0.3%）结果不确定。19名结果不确定的新生儿中有7名以及1名最初检测错误的新生儿在后续检测中被发现感染，宫内传播率为1.6%（95%置信区间：1.3 - 1.9）。99名感染婴儿中有16名（16%）的母亲是在产后检测中被识别出的妇女（n = 221）。通过积极的宣传推广，95/99（96%）的感染婴儿开始接受抗逆转录病毒治疗。在6261名检测结果为阴性的新生儿中，3251名（52%）返回获取检测结果。
我们的计划成功实现了出生PCR检测的高覆盖率和高接受率，并且通过积极追踪，几乎能够让所有确诊感染艾滋病毒的新生儿开始接受抗逆转录病毒治疗。实施该计划需要额外的工作人员进行咨询、质量控制和宣传推广。阴性结果返回率较低，结果不确定的新生儿需要多次重复检测。
