Triple-mode point-of-care diagnostics for high-risk human papillomavirus in urine

IF 10.61 Q3 Biochemistry, Genetics and Molecular Biology

Biosensors and Bioelectronics: X Pub Date : 2025-07-07 DOI:10.1016/j.biosx.2025.100658

Duc Anh Thai , Jing Liu , Angel Gutierrez Ruiz , Yuqian Zhang , Marina Walther-Antonio , Yuguang Liu

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Abstract

Human papillomavirus (HPV) screening is crucial for early diagnosis and prevention of cervical cancer, yet fast and convenient HPV detection remains challenging, especially in resource-limited areas. Herein, we developed a nucleic acid test named SSMG-LAMP, which combined loop-mediated isothermal amplification (LAMP) with an engineered DNA indicator (SYBR Safe – Malachite Green) for the point-of-care diagnosis of high-risk HPV strains (HPV 16 and 18) in urine. The assay can be completed within 45 min, including DNA extraction, SSMG-LAMP reaction, and signal readout using a simple, portable system. This system enabled the triple-mode detection of DNA targets using colorimetry, fluorometry, and electrochemistry, and can detect as low as 10 copies μL⁻¹ HPV DNA. As a preliminary validation, we used SSMG-LAMP for a blind test of 16 clinical urine samples to detect HPV 16 and 18, and results showed a sensitivity of >80 % and specificity of up to 96.2 %, with a 95 % confidence interval. This triple-mode HPV detection strategy holds potential for point-of-care cervical cancer screening in low-resource settings.

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尿中高危人乳头瘤病毒的三模式即时诊断

人乳头瘤病毒（HPV）筛查对于宫颈癌的早期诊断和预防至关重要，但快速方便的HPV检测仍然具有挑战性，特别是在资源有限的地区。在此，我们开发了一种名为SSMG-LAMP的核酸检测方法，将环介导的等温扩增（LAMP）与工程DNA指示剂（SYBR Safe -孔雀石绿）相结合，用于尿中高危HPV毒株（HPV 16和18）的即时诊断。该分析可在45分钟内完成，包括DNA提取、SSMG-LAMP反应和信号读取，使用简单的便携式系统。该系统能够使用比色法、荧光法和电化学对DNA靶标进行三模式检测，并且可以检测低至10拷贝μL−1的HPV DNA。作为初步验证，我们使用SSMG-LAMP对16份临床尿液样本进行盲检，检测HPV 16和18，结果显示敏感性为80%，特异性高达96.2%，置信区间为95%。这种三模式HPV检测策略在低资源环境中具有即时宫颈癌筛查的潜力。

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来源期刊

Biosensors and Bioelectronics: X Biochemistry, Genetics and Molecular Biology-Biophysics

CiteScore

4.60

自引率

0.00%

发文量

166

审稿时长

54 days

期刊介绍： Biosensors and Bioelectronics: X, an open-access companion journal of Biosensors and Bioelectronics, boasts a 2020 Impact Factor of 10.61 (Journal Citation Reports, Clarivate Analytics 2021). Offering authors the opportunity to share their innovative work freely and globally, Biosensors and Bioelectronics: X aims to be a timely and permanent source of information. The journal publishes original research papers, review articles, communications, editorial highlights, perspectives, opinions, and commentaries at the intersection of technological advancements and high-impact applications. Manuscripts submitted to Biosensors and Bioelectronics: X are assessed based on originality and innovation in technology development or applications, aligning with the journal's goal to cater to a broad audience interested in this dynamic field.