Purpose: As human papillomavirus (HPV) is primarily responsible for the development of cervical cancer, significant efforts have been devoted to develop novel strategies for detecting and identifying HPV DNA in urine. The analysis of target DNA sequences in urine offers a potential alternative to conventional methods as a non-invasive clinical screening and diagnostic assessment tool for the detection of HPV. However, the lack of efficient approaches to isolate and directly detect HPV DNA in urine has restricted its potential clinical use. In this study, we demonstrated a novel approach of using polyethylenimine-conjugated magnetic polypyrrole nanowires (PEI-mPpy NWs) for the extraction, identification, and PCR-free colorimetric detection of high-risk strains of HPV DNA sequences, particularly HPV-16 and HPV-18, in urine specimens of cervical cancer patients. Materials and Methods: We fabricated and characterized polyethylenimine-conjugated magnetic nanowires (PEI/mPpy NWs). PEI/mPpy NWs-based HPV DNA isolation and detection strategy appears to be a cost-effective and practical technology with greater sensitivity and accuracy than other urine-based methods. Results: The analytical and clinical performance of PEI-mPpy NWs was evaluated and compared with those of cervical swabs, demonstrating a superior type-specific concordance rate of 100% between urine and cervical swabs, even when using a small volume of urine (300 µL). Conclusion: We envision that PEI-mPpy NWs provide substantive evidence for clinical diagnosis and management of HPV-associated disease with their excellent performance in the recovery and detection of HPV DNA from minimal amounts of urine samples.

中文翻译：

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多功能纳米线平台，用于从未经处理的尿液中高效分离人乳头瘤病毒DNA并直接进行无PCR的比色检测

目的：由于人类乳头瘤病毒（HPV）主要负责宫颈癌的发展，因此人们已经做出了巨大的努力来开发检测和鉴定尿液中HPV DNA的新策略。尿液中目标DNA序列的分析为常规方法提供了一种潜在的替代方法，可作为检测HPV的非侵入性临床筛查和诊断评估工具。然而，缺乏有效的方法来分离和直接检测尿液中的HPV DNA限制了其潜在的临床应用。在这项研究中，我们展示了一种使用聚乙烯亚胺共轭磁性聚吡咯纳米线（PEI-mPpy NWs）提取，鉴定和无PCR比色法​​检测HPV DNA序列高风险株（特别是HPV-16和HPV）的新方法。 HPV-18，材料和方法：我们制造并表征了聚乙烯亚胺共轭磁性纳米线（PEI / mPpy NW）。基于PEI / mPpy NWs的HPV DNA分离和检测策略似乎是一种具有成本效益和实用性的技术，比其他基于尿液的方法具有更高的灵敏度和准确性。结果：对PEI-mPpy NWs的分析和临床性能进行了评估，并与宫颈拭子进行了比较，证明即使使用少量尿液（300 µL），尿液和宫颈拭子之间的类型特异性一致性仍高达100％ ）。结论： 我们设想，PEI-mPpy NWs在从少量尿液样品中回收和检测HPV DNA方面表现出色，为HPV相关疾病的临床诊断和管理提供了实质性证据。