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通过整合RNA提取和多重逆转录聚合酶链反应,在1小时内快速同时进行HIV和HCV病毒载量的自我检测。

Rapid simultaneous self-testing of HIV and HCV viral loads with integrated RNA extraction and multiplex RT-PCR in under 1 hour.

作者信息

Liu Tianyi, Politza Anthony J, Kshirsagar Aneesh, Ahamed Md Ahasan, Guan Weihua

机构信息

Department of Electrical Engineering, Pennsylvania State University, University Park, PA, 16802, United States.

Department of Biomedical Engineering, Pennsylvania State University, University Park, PA, 16802, United States.

出版信息

Biosens Bioelectron. 2025 Aug 2:117843. doi: 10.1016/j.bios.2025.117843.


DOI:10.1016/j.bios.2025.117843
PMID:40774906
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12338072/
Abstract

HIV and HCV Co-infection continues to be a significant public health problem globally especially within high-risk groups. Monitoring viral loads with precision helps direct treatment choices and measure treatment success while preventing resistance to drugs. Traditional laboratory-based testing faces limitations due to restricted accessibility and dependence on centralized facilities along with the complex process of quantifying both HIV and HCV viral loads which impedes worldwide control measures for these viruses. We developed a portable self-testing device that measures HIV and HCV viral loads from a 100 μL finger-prick blood sample at the same time. The system combines RNA extraction with rapid multiplex RT-PCR to provide semi-automated testing capabilities and generate results in under 1 h. The system extracts RNA at 80 % efficiency and employs a three-channel optical detection system that detects as low as 5 copies per reaction while delivering high sensitivity and accuracy. Validated studies found a robust connection with Bio-Rad benchtop systems (R = 0.97-0.99) which verified that detection sensitivity and accuracy matched standard laboratory testing standards. The testing device enables parallel processing of four patients which results in enhanced efficiency and access to testing services. Individuals affected by HIV/HCV co-infection can use this self-testing solution to track their viral loads on their own to enable prompt treatment changes and lower transmission risks. The technology delivers an effective self-monitoring option for viral load management through its combination of precision, portability and an easy-to-use design which advances HIV and HCV treatment outcomes.

摘要

艾滋病毒和丙型肝炎病毒合并感染在全球范围内仍然是一个重大的公共卫生问题,尤其是在高危人群中。精确监测病毒载量有助于指导治疗选择并衡量治疗效果,同时预防耐药性。传统的基于实验室的检测存在局限性,因为其可及性受限,依赖集中设施,且对艾滋病毒和丙型肝炎病毒载量进行定量的过程复杂,这阻碍了对这些病毒的全球控制措施。我们开发了一种便携式自检设备,可同时从100微升指尖采血样本中检测艾滋病毒和丙型肝炎病毒载量。该系统将RNA提取与快速多重逆转录聚合酶链反应相结合,提供半自动检测功能,并在1小时内得出结果。该系统以80%的效率提取RNA,并采用三通道光学检测系统,每个反应能检测低至5个拷贝,同时具有高灵敏度和准确性。验证研究发现与伯乐台式系统有很强的相关性(R = 0.97 - 0.99),这证实了检测灵敏度和准确性符合标准实验室检测标准。该检测设备可对四名患者进行并行处理,从而提高效率并增加检测服务的可及性。受艾滋病毒/丙型肝炎病毒合并感染影响的个体可以使用这种自检解决方案自行跟踪其病毒载量,以便及时改变治疗方案并降低传播风险。该技术通过其精确性、便携性和易于使用的设计相结合,为病毒载量管理提供了一种有效的自我监测选择,推动了艾滋病毒和丙型肝炎的治疗效果。

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本文引用的文献

[1]
Compact multiplex PCR device for HIV-1 and HIV-2 viral load determination from finger-prick whole blood in resource-limited settings.

Biosens Bioelectron. 2025-3-1

[2]
Development and validation of a portable device for lab-free versatile nucleic acid extraction.

Biotechniques. 2024-10

[3]
CRISPR-based strategies for sample-to-answer monkeypox detection: current status and emerging opportunities.

Nanotechnology. 2024-11-4

[4]
Hepatitis C virus infection and co-infection with HIV among persons who inject drugs in 10 U.S. cities-National HIV Behavioral Surveillance, 2018.

Int J Drug Policy. 2024-3-26

[5]
Sensitive and specific CRISPR-Cas12a assisted nanopore with RPA for Monkeypox detection.

Biosens Bioelectron. 2024-2-15

[6]
Compact Point-of-Care Device for Self-Administered HIV Viral Load Tests from Whole Blood.

ACS Sens. 2023-12-22

[7]
Direct-acting antiviral resistance of Hepatitis C virus is promoted by epistasis.

Nat Commun. 2023-11-17

[8]
Costing and cost-effectiveness of Cepheid Xpert HIV -1 Qual Assay using whole blood protocol versus PCR by Abbott Systems in Malawi.

J Glob Health Econ Policy. 2022

[9]
Programmable magnetic robot (ProMagBot) for automated nucleic acid extraction at the point of need.

Lab Chip. 2023-8-22

[10]
Impact of misclassified defective proviruses on HIV reservoir measurements.

Nat Commun. 2023-7-13

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