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在坦桑尼亚，艾滋病毒暴露新生儿出生时和第 6 周前使用 Xpert 即时检测的准确性和操作特征。

Accuracy and Operational Characteristics of Xpert Human Immunodeficiency Virus Point-of-Care Testing at Birth and Until Week 6 in Human Immunodeficiency Virus-exposed Neonates in Tanzania.

机构信息

National Institute for Medical Research, Mbeya Medical Research Center, Tanzania.

Division of Infectious Diseases and Tropical Medicine, University Hospital, LMU Munich.

出版信息

Clin Infect Dis. 2019 Feb 1;68(4):615-622. doi: 10.1093/cid/ciy538.

DOI:10.1093/cid/ciy538
PMID:29961841
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6355822/
Abstract

BACKGROUND

Point-of-care (PoC) systems for early infant diagnosis (EID) may improve timely infant human immunodeficiency virus (HIV) management. Experiences within African public health settings are limited.

METHODS

We evaluated the accuracy and operational feasibility of the Xpert HIV-1 Qual for PoC-EID testing, using fresh blood and dried blood spots (DBS) samples at obstetric health facilities in Tanzania at birth and at postpartum weeks 1, 2, 3, and 6 in HIV-exposed infants. Test results were confirmed using TaqMan DBS HIV-deoxyribonucleic acid and/or plasma HIV-ribonucleic acid (RNA) testing.

RESULTS

At week 6, 15 (2.5%) out of 614 infants were diagnosed with HIV; 10 (66.7%) of them at birth (median HIV-RNA 4570 copies/mL). At birth, the Xpert-PoC and Xpert-DBS were 100% sensitive (95% confidence intervals: PoC, 69.2-100%; DBS, 66.4-100%) and 100% specific (PoC, 92.1-100%; DBS, 88.4-100%). By week 3, 5 infants with intra/postpartum HIV-infection (median HIV-RNA 1 160 000 copies/mL) were all correctly diagnosed by Xpert. In 2 cases, Xpert-PoC testing correctly identified HIV-infection when DBS tests (Xpert and TaqMan) were negative, suggesting a greater sensitivity. In 2 infants with confirmed HIV at birth, all tests were negative at week 6, possibly because of viral suppression under nevirapine prophylaxis. Problems were reported in 183/2736 (6.7%) of Xpert-PoC tests, mostly related to power cuts (57.9%).

CONCLUSIONS

We demonstrated excellent Xpert HIV-1 Qual performance and good operational feasibility for PoC-EID testing at obstetric health facilities. Week 6 sensitivity issues were possibly related to nevirapine prophylaxis, supporting additional birth PoC-EID testing to avoid underdiagnosis.

CLINICAL TRIALS REGISTRATION

NCT02545296.

摘要

背景

即时护理（PoC）系统可用于婴儿早期艾滋病毒（HIV）诊断，这有助于及时管理婴儿的 HIV 感染。在非洲公共卫生环境中的经验有限。

方法

我们评估了 Xpert HIV-1 Qual 在坦桑尼亚产科保健设施中的新鲜血液和干血斑（DBS）样本的准确性和操作性，用于在婴儿出生时以及在产后第 1、2、3 和 6 周时对 HIV 暴露婴儿进行检测。使用 TaqMan DBS HIV 脱氧核糖核酸和/或血浆 HIV-核糖核酸（RNA）检测对检测结果进行了确认。

结果

在第 6 周时，614 名婴儿中有 15 名（2.5%）被诊断为 HIV 感染；其中 10 名（66.7%）在出生时（中位 HIV-RNA 4570 拷贝/ml）。出生时，Xpert-PoC 和 Xpert-DBS 的敏感性均为 100%（95%置信区间：PoC，69.2-100%；DBS，66.4-100%），特异性均为 100%（PoC，92.1-100%；DBS，88.4-100%）。到第 3 周时，5 名围产期 HIV 感染的婴儿（中位 HIV-RNA 1 160 000 拷贝/ml）均通过 Xpert 正确诊断。在 2 例中，Xpert-PoC 检测在 DBS 检测（Xpert 和 TaqMan）阴性时正确识别出 HIV 感染，表明其具有更高的敏感性。在出生时 HIV 感染确诊的 2 名婴儿中，所有检测在第 6 周均为阴性，这可能是由于齐多夫定预防治疗抑制了病毒。在 2736 次 Xpert-PoC 检测中（6.7%），报告了 183 次检测出现问题，主要与停电有关（57.9%）。

结论

我们在产科保健设施中证明了 Xpert HIV-1 Qual 即时护理（PoC）检测的出色性能和良好的操作性。第 6 周敏感性问题可能与齐多夫定预防治疗有关，支持在出生时进行额外的即时护理（PoC）检测，以避免漏诊。

临床试验注册

NCT02545296。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f2a4/6355822/6ce7ce8c9221/ciy53801.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f2a4/6355822/6ce7ce8c9221/ciy53801.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f2a4/6355822/6ce7ce8c9221/ciy53801.jpg

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