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一种用于快速传染病检测的简化即时检验解决方案。

A streamlined POCT solution for rapid infectious disease detection.

作者信息

Xie Yaping, Yu Yan, Huang Shuaiwu, Wan Liangcheng, Wu Chang, Yin Chiwei, Li Jianjun, Ling Jiangang, Dai Lizhong

机构信息

Research and Development Department, Sansure Biotech Inc., Changsha, 410125, China.

出版信息

Sci Rep. 2025 Apr 21;15(1):13739. doi: 10.1038/s41598-025-97155-4.


DOI:10.1038/s41598-025-97155-4
PMID:40258873
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12012083/
Abstract

Point-of-care testing (POCT) plays a crucial role in infectious disease screening due to its rapid detection and portability. However, current POCT systems face challenges such as lengthy sample preparation time, complex nucleic acid extraction, and limited real-time data transmission, extending patient waiting time. This study presents iPonatic, an integrated POCT system with a quantitative dropper for efficient sample addition, a low-cost cartridge utilizing one-step rapid nucleic acid release technology, and real-time data synchronization via a cloud platform. Patients can receive test reports within 30 min. The system was validated for both respiratory and sexually transmitted pathogens, showing consistent [Formula: see text] values with standard quantitative PCR. Clinical validation on 1159 samples demonstrated an AUC above 0.98 for all targets, with sensitivity exceeding 95% and specificity reaching 100%. iPonatic is ideal for primary healthcare, epidemic response, and resource-limited settings. It offers an efficient solution to enhance diagnostics and reduce patient waiting time, supporting timely responses to public health needs.

摘要

即时检测(POCT)因其快速检测和便携性在传染病筛查中发挥着关键作用。然而,当前的POCT系统面临着诸如样本制备时间长、核酸提取复杂以及实时数据传输受限等挑战,从而延长了患者等待时间。本研究展示了iPonatic,这是一种集成的POCT系统,它具有用于高效加样的定量滴管、采用一步快速核酸释放技术的低成本试剂盒以及通过云平台进行实时数据同步。患者可在30分钟内收到检测报告。该系统针对呼吸道和性传播病原体均得到验证,与标准定量PCR显示出一致的[公式:见正文]值。对1159份样本的临床验证表明,所有目标的曲线下面积(AUC)均高于0.98,灵敏度超过95%,特异性达到100%。iPonatic非常适合基层医疗、疫情应对和资源有限的环境。它提供了一种高效的解决方案,以加强诊断并减少患者等待时间,支持对公共卫生需求的及时响应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba4b/12012083/1efd7631a216/41598_2025_97155_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba4b/12012083/bf74b6f1ef3f/41598_2025_97155_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba4b/12012083/eed99e7562fb/41598_2025_97155_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba4b/12012083/d8eba13f4fd6/41598_2025_97155_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba4b/12012083/f9dd9235c029/41598_2025_97155_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba4b/12012083/e9e8ee68f160/41598_2025_97155_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba4b/12012083/1efd7631a216/41598_2025_97155_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba4b/12012083/bf74b6f1ef3f/41598_2025_97155_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba4b/12012083/eed99e7562fb/41598_2025_97155_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba4b/12012083/d8eba13f4fd6/41598_2025_97155_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba4b/12012083/f9dd9235c029/41598_2025_97155_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba4b/12012083/e9e8ee68f160/41598_2025_97155_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba4b/12012083/1efd7631a216/41598_2025_97155_Fig6_HTML.jpg

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[1]
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本文引用的文献

[1]
Forty Years of Molecular Diagnostics for Infectious Diseases.

J Clin Microbiol. 2022-10-19

[2]
Fingerpick Blood-Based Nucleic Acid Testing on A USB Interfaced Device towards HIV self-testing.

Biosens Bioelectron. 2022-8-1

[3]
Multiplex digital PCR with digital melting curve analysis on a self-partitioning SlipChip.

Analyst. 2022-2-14

[4]
Tools and Techniques for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)/COVID-19 Detection.

Clin Microbiol Rev. 2021-6-16

[5]
Triboelectric Effect Enabled Self-Powered, Point-of-Care Diagnostics: Opportunities for Developing ASSURED and REASSURED Devices.

Micromachines (Basel). 2021-3-22

[6]
Internet of medical things (IoMT)-integrated biosensors for point-of-care testing of infectious diseases.

Biosens Bioelectron. 2021-5-1

[7]
Fully integrated microfluidic devices for qualitative, quantitative and digital nucleic acids testing at point of care.

Biosens Bioelectron. 2021-4-1

[8]
Current and Future Point-of-Care Tests for Emerging and New Respiratory Viruses and Future Perspectives.

Front Cell Infect Microbiol. 2020-4-29

[9]
IoT PCR for pandemic disease detection and its spread monitoring.

Sens Actuators B Chem. 2020-1-15

[10]
Recent progress, challenges, and prospects of fully integrated mobile and wearable point-of-care testing systems for self-testing.

Chem Soc Rev. 2020-2-26

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