Smith Emily R, Sheahan Anna D, Heyderman Robert S, Miller William C, Wheeler Stephanie, Hudgens Michael, Nelson Julie A E, Dube Queen, Van Rie Annelies
From the *Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina; †MLW Clinical Research Programme, University of Malawi College of Medicine, Blantyre, Malawi; ‡Division of Infectious Diseases, Department of Medicine, §Department of Health Policy and Management, Gillings Schools of Global Public Health, ¶Department of Biostatistics, Gillings School of Global Public Health, and ‖Department of Microbiology and Immunology, School of Medicine, University of North Carolina, Chapel Hill, North Carolina; **Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Queen Elizabeth Central Hospital, Blantyre, Malawi; and ††Epidemiology and Social Medicine, University of Antwerp, Antwerp, Belgium.
Pediatr Infect Dis J. 2017 Apr;36(4):405-411. doi: 10.1097/INF.0000000000001384.
Timely, accurate and affordable testing algorithms at point-of-care are critical for early infant HIV diagnosis and initiation of antiretroviral therapy in the postpartum period. We aimed to assess the utility of HIV rapid tests for young, breast-fed HIV-exposed infants in resource limited, high HIV burden settings.
We collected data on the performance of 2 commonly used rapid tests (Determine and Unigold) in Malawi between 2008 and 2012 or at the University of North Carolina between 2014 and 2015. For each 3-month interval between ages 3 and 18 months, we calculated the sensitivity, specificity, positive and negative predictive values of each test compared with the HIV DNA/RNA PCR gold standard. We also assessed the utility of each rapid test to diagnose incident HIV infection during the breastfeeding period.
Among 121 HIV-exposed infants who were negative at age 6 weeks, 21 (17.2%) became infected by 18 months. At 3 months of age, both rapid tests had minimal clinical value with specificity values of 7.0% [95% confidence interval (CI): 2.3-15.7] for Determine and 19.4% (95% CI: 11.1-30.5) for Unigold. Starting at age 6 and 9 months, the Unigold test could be used as a screening tool in the follow-up of HIV-exposed infants with specificity values of 83.7% (95% CI: 74.4-89.9) and 97.7% (95% CI: 94.6-99.7), respectively. Starting at age 12 months, the type of test became less important as both tests performed well in identifying HIV-free children, although both tests failed to detect some incident HIV infections.
Updated guidelines for the use of rapid tests in young HIV-exposed children that explicitly take type of test and infant age into account are urgently needed to ensure optimal care for the 1.5 million HIV-exposed infants born annually.
即时检测时及时、准确且经济实惠的检测算法对于早期婴儿HIV诊断以及产后抗逆转录病毒治疗的启动至关重要。我们旨在评估在资源有限、HIV负担高的环境中，HIV快速检测对年轻的、母乳喂养的HIV暴露婴儿的效用。
我们收集了2008年至2012年期间在马拉维或2014年至2015年期间在北卡罗来纳大学使用的2种常用快速检测（Determine和Unigold）的性能数据。对于3至18个月龄之间的每个3个月间隔，我们计算了每种检测与HIV DNA/RNA PCR金标准相比的灵敏度、特异性、阳性和阴性预测值。我们还评估了每种快速检测在诊断母乳喂养期间新发HIV感染方面的效用。
在121名6周龄时检测为阴性的HIV暴露婴儿中，21名（17.2%）在18个月时感染。在3个月龄时，两种快速检测的临床价值都很小，Determine的特异性值为7.0%[95%置信区间（CI）：2.3 - 15.7]，Unigold的特异性值为19.4%（95%CI：11.1 - 30.5）。从6个月和9个月龄开始，Unigold检测可作为HIV暴露婴儿随访的筛查工具，特异性值分别为83.7%（95%CI：74.4 - 89.9）和97.7%（95%CI：94.6 - 99.7）。从12个月龄开始，检测类型的重要性降低，因为两种检测在识别未感染HIV的儿童方面表现都很好，尽管两种检测都未能检测到一些新发HIV感染。
迫切需要更新针对年轻HIV暴露儿童使用快速检测的指南，明确考虑检测类型和婴儿年龄，以确保每年出生的150万HIV暴露婴儿得到最佳护理。
