Department of Medicine, University of California, San Francisco (UCSF), San Francisco, CA.
Abbott Rapid Diagnostics, Pomona, CA.
J Acquir Immune Defic Syndr. 2020 Jun 1;84(2):149-152. doi: 10.1097/QAI.0000000000002322.
Therapeutic drug monitoring measures antiretroviral adherence more accurately than self-report but has not been available at the point-of-care (POC) until now. We compare a novel POC test for urine tenofovir to laboratory-based enzyme-linked immunosorbent assay (ELISA) testing in diverse patient populations urine pre-exposure prophylaxis (PrEP).
Urine samples were analyzed using ELISA and the POC lateral flow immunoassay (LFA) test from 2 cohorts of PrEP users taking tenofovir disoproxil fumarate/emtricitabine: the Partners PrEP Study, which recruited Kenyan and Ugandan heterosexual men and women, and the IBrEATHe Study, which recruited US transgender women and men using gender-affirming hormone therapy.
We calculated the sensitivity, specificity, and accuracy of the POC test compared with ELISA at a cutoff of 1500 ng/mL.
Overall, 684 urine samples were tested from 324 participants in the 2 cohorts. In Partners PrEP, 454 samples from 278 participants (41% women) were tested with a median age of 33 years. In IBrEATHe, 231 samples from 46 individuals (50% transwomen) were tested with a median age of 31 years. Comparison of the LFA read-out to ELISA yielded 100% sensitivity [97.5% one-sided confidence interval (CI) = 99.3%], 98.3% specificity (95% CI = 95.2% to 99.7%), and 99.6% accuracy (95% CI = 98.7% to 99.9%).
The sensitivity, specificity, and accuracy of a novel POC test for urine tenofovir all exceeded 98% when compared with a laboratory-based ELISA method when tested in diverse patient populations. Given the LFA's high accuracy and expected low cost, this POC test is a promising tool to support antiretroviral adherence that could be widely scalable to real-world clinical settings.
与自我报告相比，治疗药物监测更能准确地衡量抗逆转录病毒的依从性，但直到现在，这种方法在即时检测点（POC）都不可用。我们比较了一种新的 POC 检测尿液替诺福韦的方法与实验室酶联免疫吸附测定（ELISA）检测不同人群使用替诺福韦二吡呋酯/恩曲他滨进行尿液暴露前预防（PrEP）的情况。
使用 ELISA 和 POC 侧向流动免疫测定（LFA）测试从两个 PrEP 使用者队列的尿液样本：合作伙伴 PrEP 研究，招募肯尼亚和乌干达的异性恋男女；以及 IBrEATHe 研究，招募使用性别肯定激素治疗的美国跨性别女性和男性。
我们计算了 POC 检测在 1500ng/ml 截止值时与 ELISA 检测相比的敏感性、特异性和准确性。
总体而言，从两个队列的 324 名参与者中检测了 684 个尿液样本。在合作伙伴 PrEP 中，278 名参与者的 454 个样本（41%为女性）进行了测试，中位年龄为 33 岁。在 IBrEATHe 中，46 名参与者的 231 个样本（50%为跨性别女性）进行了测试，中位年龄为 31 岁。LFA 读数与 ELISA 比较的结果为 100%的敏感性[97.5%单侧置信区间（CI）=99.3%]，98.3%的特异性（95%CI=95.2%至 99.7%）和 99.6%的准确性（95%CI=98.7%至 99.9%）。
与实验室 ELISA 方法相比，当在不同人群中检测时，一种新的 POC 检测尿液替诺福韦的方法的敏感性、特异性和准确性均超过 98%。鉴于 LFA 的高准确性和预期的低成本，这种 POC 检测是一种很有前途的支持抗逆转录病毒依从性的工具，可以广泛扩展到现实临床环境。
