The feasibility of modified HIV and antiretroviral drug testing using self-collected dried blood spots from men who have sex with men.

The feasibility of modified HIV and antiretroviral drug testing using self-collected dried blood spots from men who have sex with men.
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DOI:
10.1186/s12879-021-06110-x
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发表时间:
2021-05-05
影响因子:
3.7
通讯作者:
Masciotra S
Masciotra S
中科院分区:
医学3区
文献类型:
--
作者:
Luo W;Sullivan V;Chavez PR;Wiatrek SE;Zlotorzynska M;Martin A;Rossetti R;Sanchez T;Sullivan P;MacGowan RJ;Owen SM;Masciotra S

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在美国,与艾滋病病毒携带者(MSM)发生性行为的男性中,六分之一的人不知道自己感染了艾滋病毒。在某些情况下,获得艾滋病毒检测和病毒载量(VL)监测具有挑战性。这项研究的目的是评估以实验室为基础的艾滋病毒和抗逆转录病毒(ARV)药物测试以及VL监测作为两项自采集干血点(DBS)研究的一部分的可行性。在招募在线男男性接触者的研究中,参与者被指示用自己的手指收集DBS。第一项研究(N = 1444)中的树突状细胞用食品和药物管理局批准的艾滋病毒血清学方法进行检测。用实验室改进的血清学和VL分析进一步检测一个亚群,并用质谱仪测量ARV水平。第二项研究(N = 74)中的DBS仅用于评估VL监测。在第一项研究中,自收集的星展银行卡的回邮率为62.9%。90%的DBS卡片是在收集之日起2周内在实验室收到的,98%的卡片有足够的斑点用于一次检测。FDA批准的方案和实验室修改的方案之间的一致性很高。未检测到ARV的样本比至少含有一种ARV药物的样本具有更高的VL。在第二项研究中,70.3%的参与者退还了自己收集的DBS卡,所有人都有足够的斑点用于VL检测。在报告低ARV依从性的参与者的样本中观察到高VL。在这些研究中,男男性接触者能够收集并提供足够的DBS用于艾滋病毒检测。FDA批准的测试算法和实验室修改的测试算法执行情况类似。在家中收集的DBS可能用于HIV检测、ARV测量和监测病毒抑制。
In the US, one in six men who have sex with men (MSM) with HIV are unaware of their HIV infection. In certain circumstances, access to HIV testing and viral load (VL) monitoring is challenging. The objective of this study was to evaluate the feasibility of conducting laboratory-based HIV and antiretroviral (ARV) drug testing, and VL monitoring as part of two studies on self-collected dried blood spots (DBS). Participants were instructed to collect DBS by self-fingerstick in studies that enrolled MSM online. DBS from the first study (N = 1444) were tested with HIV serological assays approved by the Food and Drug Administration (FDA). A subset was further tested with laboratory-modified serological and VL assays, and ARV levels were measured by mass spectrometry. DBS from the second study (N = 74) were only tested to assess VL monitoring. In the first study, the mail back rate of self-collected DBS cards was 62.9%. Ninety percent of DBS cards were received at the laboratory within 2 weeks from the day of collection, and 98% of the cards had sufficient spots for one assay. Concordance between FDA-approved and laboratory-modified protocols was high. The samples with undetectable ARV had higher VL than samples with at least one ARV drug. In the second study, 70.3% participants returned self-collected DBS cards, and all had sufficient spots for VL assay. High VL was observed in samples from participants who reported low ARV adherence. In these studies, MSM were able to collect and provide adequate DBS for HIV testing. The FDA-approved and laboratory-modified testing algorithms performed similarly. DBS collected at home may be feasible for HIV testing, ARV measurement, and monitoring viral suppression.