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.
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.
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DOI：
10.1093/cid/ciy538
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发表时间：
2019-02-01
期刊：
影响因子：
--
通讯作者：
Kroidl A
中科院分区：
文献类型：
--
作者：
Sabi I;Mahiga H;Mgaya J;Geisenberger O;Kastner S;Olomi W;Saathoff E;Njovu L;Lueer C;France J;Maboko L;Ntinginya NE;Hoelscher M;Kroidl A
Xpert HIV-1质量在坦桑尼亚卫生机构使用全血进行人类免疫缺陷病毒早期婴儿诊断（EID）检测方面表现出色。第6周EID敏感性受到影响，可能是由于奈韦拉平预防药物抑制了病毒。婴儿早期诊断（EID）的护理点（PoC）系统可以改善婴儿人类免疫缺陷病毒（HIV）的及时管理。非洲公共卫生机构的经验有限。我们评估了Xpert HIV-1质量用于PoC-EID检测的准确性和操作可行性，在坦桑尼亚的产科卫生机构使用艾滋病毒暴露婴儿出生时和产后1、2、3和6周的新鲜血液和干血点（DBS）样本。检测结果采用TaqMan DBS hiv -脱氧核糖核酸和/或血浆hiv -核糖核酸（RNA）检测。在第6周，614名婴儿中有15名（2.5%）被诊断患有艾滋病毒；出生时10例（66.7%）（中位HIV-RNA 4570拷贝/mL）。出生时，expert -PoC和expert -DBS的敏感性为100%(95%置信区间：PoC， 69.2-100%； DBS, 66.4-100%)，特异性为100% （PoC, 92.1-100%； DBS, 88.4-100%）。到第3周时，5例婴儿在产前产后感染hiv （HIV-RNA中位数为1160000拷贝/mL）均被Xpert正确诊断。在2例病例中，当DBS检测（Xpert和TaqMan）为阴性时，expert - poc检测正确地识别出hiv感染，表明其灵敏度更高。在2名出生时确诊为艾滋病毒的婴儿中，所有检测在第6周时均为阴性，可能是因为奈韦拉平预防药物抑制了病毒。在183/2736次（6.7%）的专家poc测试中报告了问题，主要与停电有关（57.9%）。我们展示了出色的Xpert HIV-1质量表现和良好的产科卫生设施PoC-EID测试的操作可行性。第6周的敏感性问题可能与奈韦拉平预防有关，支持额外的出生PoC-EID测试以避免误诊。NCT02545296
The Xpert HIV-1 Qual demonstrated excellent performance for point-of-care human immunodeficiency virus early infant diagnosis (EID) testing using whole blood at health facilities in Tanzania. EID sensitivity at week 6 was affected, possibly due to viral suppression under nevirapine prophylaxis. 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. 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. 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%). 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. NCT02545296
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影响因子：
4.5
作者：
Chatterjee, Anirban;Tripathi, Sangeeta;Ekpini, Rene
通讯作者：
Ekpini, Rene
DOI：
10.7196/samj.8322
发表时间：
2014-08-01
期刊：
SAMJ: South African Medical Journal
影响因子：
--
作者：
Mazanderani, A F Haeri;du Plessis, N M;Avenant, T
通讯作者：
Avenant, T
影响因子：
3.8
作者：
Bourne, David E.;Thompson, MaryLou;Myers, Jonny E.
通讯作者：
Myers, Jonny E.
影响因子：
3.7
作者：
Tiam, Appolinaire;Gill, Michelle M.;Guay, Laura
通讯作者：
Guay, Laura
DOI：
10.1097/qad.0b013e3283553638
发表时间：
2012-07-31
期刊：
AIDS (London, England)
影响因子：
--
作者：
Persaud D;Palumbo PE;Ziemniak C;Hughes MD;Alvero CG;Luzuriaga K;Yogev R;Capparelli EV;Chadwick EG
通讯作者：
Chadwick EG