Giang Jessica H, Basha Garoma, Thomas Katherine K, Oyaro Patrick, Chohan Bhavna H, Kingwara Leonard, Hassan Shukri A, Yongo Nashon, Wagude James, Oluoch Fredrick, Odhiambo Francesca, Oyaro Boaz, John-Stewart Grace C, Abuogi Lisa L, Patel Rena C
School of Medicine, University of Washington, Seattle, Washington, United States of America.
Department of Medicine, University of Washington, Seattle, Washington, United States of America.
PLOS Glob Public Health. 2024 Jun 24;4(6):e0003378. doi: 10.1371/journal.pgph.0003378. eCollection 2024.
Routine HIV viral load testing is important for evaluating HIV treatment outcomes, but conventional viral load testing has many barriers including expensive laboratory equipment and lengthy results return times to patients. A point-of-care viral load testing technology, such as GeneXpert HIV-1 quantification assay, could reduce these barriers by decreasing cost and turnaround time, however real-world performance is limited. We conducted a secondary analysis using 900 samples collected from participants in two studies to examine the performance of GeneXpert as point-of-care viral load compared to standard-of-care testing (which was conducted with two centralized laboratories using traditional HIV-1 RNA PCR quantification assays). The two studies, Opt4Kids (n = 704 participants) and Opt4Mamas (n = 820 participants), were conducted in western Kenya from 2019-2021 to evaluate the effectiveness of a combined intervention strategy, which included point-of-care viral load testing. Paired viral load results were compared using four different thresholds for virological non-suppression, namely ≥50, ≥200, ≥400, ≥1000 copies/ml. At a threshold of ≥1000 copies/mL, paired samples collected on the same day: demonstrated sensitivities of 90.0% (95% confidence interval [CI] 68.3, 98.8) and 66.7% (9.4, 99.2), specificities of 98.4% (95.5, 99.7) and 100% (96.5, 100), and percent agreements of 97.7% (94.6, 99.2) and 99.1% (95.0, 100) in Opt4Kids and Opt4Mamas studies, respectively. When lower viral load thresholds were used and the paired samples were collected an increasing number of days apart, sensitivity, specificity, and percent agreement generally decreased. While specificity and percent agreement were uniformly high, sensitivity was lower than expected. Non-specificity of the standard of care testing may have been responsible for the sensitivity values. Nonetheless, our results demonstrate that GeneXpert may be used reliably to monitor HIV treatment in low- and middle- income countries to attain UNAID's 95-95-95 HIV goals.
常规的HIV病毒载量检测对于评估HIV治疗效果很重要，但传统的病毒载量检测存在诸多障碍，包括昂贵的实验室设备以及向患者反馈结果的时间较长。即时检测的病毒载量检测技术，如GeneXpert HIV-1定量检测法，可通过降低成本和缩短周转时间来减少这些障碍，然而其在现实世界中的表现有限。我们进行了一项二次分析，使用从两项研究的参与者中收集的900份样本，以检验GeneXpert作为即时检测病毒载量与标准护理检测（由两个集中实验室使用传统的HIV-1 RNA PCR定量检测法进行）相比的性能。这两项研究，Opt4Kids（n = 704名参与者）和Opt4Mamas（n = 820名参与者），于2019年至2021年在肯尼亚西部进行，以评估一种联合干预策略的有效性，该策略包括即时检测病毒载量。使用四个不同的病毒学未抑制阈值，即≥50、≥200、≥400、≥1000拷贝/毫升，比较配对的病毒载量结果。在阈值≥1000拷贝/毫升时，同一天采集的配对样本：在Opt4Kids和Opt4Mamas研究中，敏感性分别为90.0%（95%置信区间[CI] 68.3，98.8）和66.7%（9.4，99.2），特异性分别为98.4%（95.5，99.7）和100%（96.5，100），一致性百分比分别为97.7%（94.6，99.2）和99.1%（95.0，100）。当使用较低的病毒载量阈值且配对样本采集间隔天数增加时，敏感性、特异性和一致性百分比通常会下降。虽然特异性和一致性百分比一直很高，但敏感性低于预期。护理标准检测的非特异性可能是导致敏感性值的原因。尽管如此，我们的结果表明，GeneXpert可可靠地用于监测低收入和中等收入国家的HIV治疗，以实现联合国艾滋病规划署的95-95-95 HIV目标。
