NEW YORK – Researchers at Florida Atlantic University are progressing on a project to create a highly sensitive molecular diagnostic system for HIV self testing. With their recent Phase II funding only slightly delayed by new National Institutes of Health funding policies, the team expects to soon prototype its disposable microfluidic device on clinical samples as part of its path toward commercialization.

纽约——佛罗里达大西洋大学的研究人员正在推进一个项目，旨在开发一种用于艾滋病毒自我检测的高灵敏度分子诊断系统。由于美国国立卫生研究院的新资助政策，他们最近的第二阶段资金略有延迟，但团队预计很快将在临床样本上对其一次性微流体设备进行原型设计，作为其商业化进程的一部分。

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。

Waseem Asghar, a biomedical engineer at FAU and principal investigator on the project, said in an interview that, to his knowledge, there is no molecular HIV self-test currently commercially available in the US or elsewhere. His group hopes to change that with a RT-LAMP testing platform

FAU的生物医学工程师、该项目的首席研究员瓦西姆·阿什加尔在一次采访中表示，据他所知，目前美国或其他地方尚无商业化的分子HIV自我检测方法。他的团队希望利用RT-LAMP检测平台来改变这一现状。

The team was granted a two-year Phase II award of $1.3 million from the NIH's National Institute of Allergy and Infectious Disease division to assess accuracy of a prototype device with clinical HIV samples collected by collaborators at Emory University and the University of Virginia.

该团队获得了美国国立卫生研究院 (NIH) 下属的国家过敏与传染病研究所提供的为期两年、价值 130 万美元的第二阶段奖励，用于评估由埃默里大学和弗吉尼亚大学合作者收集的临床 HIV 样本的原型设备的准确性。

Viral load can be astronomical in the first few weeks following an HIV infection, until the body mounts an immune response, and can rise again in cases where patients are on suppressive medication and acquire treatment resistance.

在感染艾滋病毒后的最初几周内，病毒载量可能会非常高，直到身体产生免疫反应，并且在患者服用抑制性药物并产生耐药性的情况下可能再次上升。

Rapid lateral flow assays detecting HIV antibodies are most effective about three weeks after infection, while viral antigen tests can be used slightly earlier. Tests that detect viral RNA, on the other hand, can be extremely sensitive, in part because they amplify these relatively rare targets.

快速侧向流动检测法在感染后大约三周检测HIV抗体最为有效，而病毒抗原检测可以稍早使用。另一方面，检测病毒RNA的测试可以非常敏感，部分原因是它们放大了这些相对稀有的目标。

Nitika Pant Pai, an HIV researcher at McGill University in Montreal who was not involved with the FAU research, said that antigen-based p24 tests are relatively inexpensive and can detect HIV infection within a window between about 18 days and 45 days after exposure, while antibody-based tests can be used between about 23 days to 90 days after exposure..

麦吉尔大学蒙特利尔分校的艾滋病毒研究员尼蒂卡·潘特·派伊没有参与佛罗里达大西洋大学的研究，她表示，基于抗原的p24测试相对便宜，可以在暴露后大约18天到45天的窗口期内检测出艾滋病毒感染，而基于抗体的测试则可以在暴露后大约23天到90天内使用。

However, molecular detection with nucleic acid amplification RNA tests 'is the key to identifying infection early,' she said, and is effective within a window of between 10 days and 33 days.

然而，她说：“使用核酸扩增RNA检测进行分子检测是早期识别感染的关键”，在10天至33天的窗口期内有效。

Early detection can prevent spread of HIV during a period when viral load is high, and can also connect patients to care sooner, which has potential benefits to their long-term health.

早期发现可以在病毒载量高的时期防止艾滋病毒的传播，还可以让患者更早得到治疗，这对他们的长期健康有潜在的好处。

Unfortunately, unlike antibodies — which can be found in saliva and other samples — HIV viral RNA is almost exclusively found in blood. And therein lies a major problem for self-test developers.

然而，与抗体不同——抗体可以在唾液和其他样本中找到——HIV病毒RNA几乎只存在于血液中。这就是自测工具开发者面临的一个主要问题。

Asghar said that with more than 1 billion red blood cells in a milliliter of human blood, the virus is miniscule and rare by comparison. Centrifugation is required to isolate virus for testing in the lab, he said, but very few people have lab-grade centrifuges in their homes.

阿斯加尔说，人类血液中每毫升有超过10亿个红细胞，相比之下，病毒微小且罕见。他说，实验室需要通过离心来分离病毒以进行测试，但很少有人在家里拥有实验室级别的离心机。

The FAU team's solution involves magnetic actuation within the microfluidic chip, such that the test can be sample-in, answer-out, requiring very minimal user manipulation.

FAU团队的解决方案涉及在微流控芯片内进行磁驱动，使得测试可以实现样品进、结果出，需要用户的操作极少。

The issue of centrifugation has also been noted in an

离心问题也已经被注意到在

HIV Medicine

艾滋病药物

study published earlier this year. An assay from Cepheid called Xpert HIV VL showed great promise, reviewers said, but its use at the point of care in rural areas was hampered by the need for centrifugation. They also noted that centralized lab tests are expensive and results turnaround can take up to two months in rural areas of some countries..

今年早些时候发表的一项研究。评审人员表示，Cepheid公司的Xpert HIV VL检测方法展现了巨大的潜力，但其在农村地区即时医疗中的应用因需要离心操作而受到阻碍。他们还指出，集中式实验室测试费用昂贵，在一些国家的农村地区，结果反馈可能需要长达两个月的时间。

Portable platforms are also expensive, McGill's Pai said, adding that to her knowledge there are no point-of-care single-use devices available for molecular HIV testing.

麦吉尔大学的派伊表示，便携式平台也很昂贵，并补充说据她所知，目前还没有用于分子艾滋病毒检测的即时单次使用设备可用。

'It is the next frontier in testing for sure,' she said. However, from her perspective, it is critical to determine assay performance in the context of anti-retroviral drug treatment, and to make sure the limit of detection is low.

“这确实是检测的下一个前沿领域，”她说道。然而，从她的角度来看，关键在于确定在抗逆转录病毒药物治疗背景下检测方法的表现，并确保检测下限足够低。

'The proof of this test will be realized when it is evaluated in a field setting under various temperature conditions,' Pai said.

“这项测试的验证将在不同温度条件下的实地环境中进行评估时实现，”Pai说。

The FAU assay is expected to cost approximately $5 per test. Asghar and his colleagues validated their test system development last year in a study published in

FAU检测预计每次测试的成本约为5美元。阿什加尔和他的同事在去年发表的一项研究中验证了他们的测试系统开发。

Biosensors

生物传感器

, describing an automated RT-LAMP-based microfluidic chip that combines the RNA isolation, purification, and amplification steps with a visual readout.

，描述了一种基于自动RT-LAMP的微流控芯片，该芯片结合了RNA分离、纯化和扩增步骤，并具有可视化读数功能。

And, in a study published last year in

而且，在去年发表的一项研究中

Viruses

病毒

, the team showed it could detect SARS-CoV-2 within 40 minutes from saliva and nasopharyngeal samples. The team has also previously shown its approach could be used to detect

，该团队展示了它可以在40分钟内从唾液和鼻咽样本中检测到SARS-CoV-2。该团队之前还展示过其方法可用于检测

Zika

寨卡

and

和

hepatitis C

丙型肝炎

viruses.

病毒。

Self-testing is a critical piece of HIV prevention, control, and patient management. The only self-test approved by the US Food and Drug Administration currently is an immunoassay approved in 2012 from OraSure.

自我检测是艾滋病预防、控制和患者管理的关键部分。目前，唯一获得美国食品和药物管理局批准的自我检测方法是OraSure公司于2012年获批的一种免疫测定法。

Pai and her colleagues recently

派和她的同事最近

described

描述

an app called HIVSmart! that could enhance the accuracy of HIV self-tests like OraSure's. However, she said her team isn't currently in discussions with industry to integrate the app, although it is keen for it to be taken up by governmental agencies scaling HIV testing globally.

一款名为HIVSmart!的应用程序，可以提高类似OraSure的HIV自我检测的准确性。然而，她说她的团队目前并未与业界讨论整合该应用程序，尽管她非常希望全球推广HIV检测的政府机构能够采用它。

Other HIV molecular self-tests are also potentially on the horizon. For example, a research team at Pennsylvania State University has developed a point-of-care testing

其他HIV分子自测试剂盒也有可能在不久的将来出现。例如，宾夕法尼亚州立大学的一个研究团队已经开发出一种即时检测方法

system

系统

using RT-LAMP that is also being

使用同样正在被使用的RT-LAMP

developed

开发

for HIV viral load monitoring from whole blood. This team also developed a novel de-clogging

用于从全血中监测 HIV 病毒载量。该团队还开发了一种新型的去堵塞技术

mechanism

机制

that enables them to adapt a glass nanopore device to the native buffers required for point-of-care RT-LAMP testing.

这使得他们能够将玻璃纳米孔装置适应于即时护理RT-LAMP测试所需的天然缓冲液。

Still, although a

不过，虽然

review

审查

published in February was a recent example of the consensus that accurate POC HIV RNA tests 'could leapfrog fourth-generation POC assays,' these tests remain unavailable for routine use.

今年2月发表的文章是共识的一个最新例子，即准确的POC HIV RNA测试“可以跨越式超越第四代POC测试”，但这些测试仍未被用于常规用途。

Meanwhile, there are a handful of point-of-care or near-patient molecular diagnostic test systems for HIV viral load monitoring either commercially available or in development, according to a 2019 evaluation in

同时，根据2019年的一项评估，目前市面上已有或正在开发一些用于HIV病毒载量监测的床旁或近患者分子诊断测试系统。

Clinical Microbiology Reviews

临床微生物学评论

. These included Abbott's m-PIMA, formerly known as the Alere q HIV-1/2 Detect, Danaher's Cepheid Xpert HIV-1 Viral Load, the SAMBA I PSQ and SAMBA II WBSQ from Diagnostics for the Real World, and the TrueNat HIV Viral Load from MolBio Diagnostics.

这些仪器包括雅培的m-PIMA（前身为Alere q HIV-1/2 Detect）、丹纳赫的Cepheid Xpert HIV-1病毒载量、Diagnostics for the Real World公司的SAMBA I PSQ和SAMBA II WBSQ，以及MolBio Diagnostics公司的TrueNat HIV病毒载量。

Global health HIV

全球健康 HIV

strategies

策略

through 2030 developed by the World Health Organization include encouraging genomic approaches — especially those that can be applied to other pathogens — as well as self-testing options that can take HIV testing and patient monitoring to communities and remote areas.

通过2030年世界卫生组织制定的目标包括鼓励基因组学方法——特别是那些可以应用于其他病原体的方法——以及可以将HIV检测和患者监测推广到社区和偏远地区的自我检测选项。

HIV testing cost is a critical barrier in low- and middle-income countries, however. According to a

然而，艾滋病毒检测成本是低收入和中等收入国家的关键障碍。根据一项研究

survey

调查

by researchers at Johns Hopkins University published in 2023, this is also increasingly true for high-income countries. The survey also revealed that test sensitivity was more important than cost for practitioners in LMICs as well as HICs, although both groups said they would compromise on sensitivity if it would reduce cost.

2023年由约翰霍普金斯大学的研究人员发表，高收入国家也是如此。 调查还显示，对于中低收入国家以及高收入国家的从业者来说，测试灵敏度比成本更重要，但两组人员都表示，如果可以降低成本，他们愿意在灵敏度上作出妥协。

'Low cost should remain a strong consideration during assay development and may be critical to adoption and access in all settings,' the authors concluded..

“低成本应始终作为检测方法开发过程中的重要考虑因素，且可能是所有环境中推广和获取的关键所在，”作者总结道。

In addition to qualitative HIV testing, the FAU team aims to develop a quantitative test in the future and is also adapting its system for other infectious diseases, Asghar said. The team currently has a preliminary patent on the system and hopes to commercialize it through collaboration with industry..

阿斯加尔说，除了定性 HIV 检测外，FAU 团队未来还旨在开发定量检测方法，并正在调整其系统以适应其他传染病。该团队目前对该系统拥有初步专利，并希望与业界合作将其商业化。