Ibrahim Maryanne, Moyo Sikhulile, Mohammed Terence, Mupfumi Lucy, Gaseitsiwe Simani, Maswabi Kenneth, Ajibola Gbolahan, Gelman Rebecca, Batlang Oganne, Sakoi Maureen, Auletta-Young Chloe, Makhema Joseph, Lockman Shahin, Shapiro Roger L
*Harvard Medical School, Doris Duke International Clinical Research Fellowship, Boston, MA; †David Geffen School of Medicine, University of California, Los Angeles, CA; ‡Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; §Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA; ‖Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, MA; and ¶Division of Infectious Disease, Brigham and Women's Hospital, Boston, MA.
J Acquir Immune Defic Syndr. 2017 Aug 15;75(5):e128-e131. doi: 10.1097/QAI.0000000000001384.
HIV point-of-care (POC) testing allows for early infant HIV diagnosis and treatment, but POC accuracy at birth and in the setting of antiretroviral prophylaxis for the prevention of mother-to-child HIV transmission is unknown.
We evaluated the Cepheid Xpert HIV-1 Qual POC test against the Roche Taqman HIV-1 DNA polymerase chain reaction (PCR) platform using dried blood spots from 15 HIV-infected and 75 HIV-exposed uninfected newborns. These infants were screened for HIV at <96 hours of life at 5 hospital maternity wards in Botswana; all infants received postexposure antiretroviral prophylaxis with single-dose nevirapine and zidovudine, and most mothers received 3-drug antiretroviral therapy in pregnancy and at delivery.
Fourteen of the 15 PCR positive samples tested positive by Cepheid POC, yielding a sensitivity of 93.3% (95% confidence interval: 68.1 to 99.8). Baseline viral load among positive infants ranged from <40 to >10,000,000 copies/mL, with a median of 2403 copies/mL. The HIV RNA for the infant with false-negative POC testing was 1661 copies/mL. Of note, 2 infants with low HIV RNA (<40 and 272 copies/mL) were correctly identified as HIV positive by Cepheid POC. All the 75 PCR-negative samples tested negative by Cepheid POC, yielding a specificity of 100% (95% confidence interval: 96.1 to 100).
Our study demonstrates high sensitivity and specificity for the Cepheid POC assay in the first week of life despite early infection and antiretroviral prophylaxis. This platform may be a useful approach for adding early infant HIV diagnosis to current testing programs.
人类免疫缺陷病毒（HIV）即时检测（POC）有助于早期诊断和治疗婴儿HIV感染，但在出生时以及在用于预防母婴HIV传播的抗逆转录病毒药物预防治疗情况下，POC检测的准确性尚不清楚。
我们使用来自15名HIV感染新生儿和75名HIV暴露未感染新生儿的干血斑，将赛沛Xpert HIV-1 Qual POC检测与罗氏Taqman HIV-1 DNA聚合酶链反应（PCR）平台进行了比较。这些婴儿在博茨瓦纳的5家医院产科病房出生后96小时内接受了HIV筛查；所有婴儿均接受了单剂量奈韦拉平和齐多夫定的暴露后抗逆转录病毒药物预防治疗，大多数母亲在孕期和分娩时接受了三联抗逆转录病毒治疗。
15份PCR阳性样本中有14份经赛沛POC检测呈阳性，灵敏度为93.3%（95%置信区间：68.1%至99.8%）。阳性婴儿的基线病毒载量范围为<40至>10,000,000拷贝/毫升，中位数为2403拷贝/毫升。POC检测为假阴性的婴儿的HIV RNA为1661拷贝/毫升。值得注意的是，2名HIV RNA水平较低（<40拷贝/毫升和272拷贝/毫升）的婴儿经赛沛POC检测被正确鉴定为HIV阳性。所有75份PCR阴性样本经赛沛POC检测均为阴性，特异性为100%（95%置信区间：96.1%至100%）。
我们的研究表明，尽管存在早期感染和抗逆转录病毒药物预防治疗，赛沛POC检测在出生后第一周仍具有高灵敏度和特异性。该平台可能是在当前检测项目中增加婴儿HIV早期诊断的一种有用方法。
