Wityk Paweł, Terebieniec Agata, Nowak Robert, Łubiński Jacek, Mroczyńska-Szeląg Martyna, Wityk Tomasz, Kostrzewa-Nowak Dorota
Map Your DNA Ltd., Świerkowa 40, 83-330 Lniska, Poland.
Beckman Institute for Advanced Science and Technology, University of Illinois at Urbana-Champaign, Urbana, IL 61801, USA.
Sensors (Basel). 2025 Jan 9;25(2):360. doi: 10.3390/s25020360.
Biosensors are transforming point-of-care diagnostics by simplifying the detection process and enabling rapid, accurate testing. This study introduces a novel, reusable biosensor designed for direct viral RNA detection from unfiltered saliva, targeting SARS-CoV-2. Unlike conventional methods requiring filtration, our biosensor leverages a unique electrode design that prevents interference from saliva debris, allowing precise measurements. The biosensor is based on electrochemical principles, employing oligonucleotide probes immobilized on a hydrophobic-coated electrode, which prevents air bubbles and salt crystal formation. During validation, the biosensor demonstrated a sensitivity and specificity of 100%, accurately identifying SARS-CoV-2 in saliva samples without false positives or negatives. Cross-validation with RT-qPCR, the gold standard for COVID-19 diagnostics, confirmed the reliability of our device. The biosensor's performance was tested on 60 participants, yielding 12 true positive results and 48 true negatives, aligning perfectly with RT-qPCR outcomes. This reusable, easy-to-use biosensor offers significant potential for point-of-care applications in various healthcare settings, providing a fast, efficient, and cost-effective method for detecting viral infections such as COVID-19. Its robust design, minimal sample preparation requirements, and multiple-use capability mark a significant advancement in biosensing technology.
生物传感器正在通过简化检测过程并实现快速、准确的检测来改变即时诊断。本研究介绍了一种新型的可重复使用生物传感器，该传感器专为从未经过滤的唾液中直接检测病毒RNA而设计，目标是严重急性呼吸综合征冠状病毒2（SARS-CoV-2）。与需要过滤的传统方法不同，我们的生物传感器利用独特的电极设计来防止唾液碎片的干扰，从而实现精确测量。该生物传感器基于电化学原理，采用固定在疏水涂层电极上的寡核苷酸探针，可防止气泡和盐晶体形成。在验证过程中，该生物传感器的灵敏度和特异性均达到100%，能准确识别唾液样本中的SARS-CoV-2，无假阳性或假阴性结果。与2019冠状病毒病诊断的金标准逆转录定量聚合酶链反应（RT-qPCR）进行交叉验证，证实了我们设备的可靠性。该生物传感器对60名参与者进行了测试，得出12个真阳性结果和48个真阴性结果，与RT-qPCR结果完全一致。这种可重复使用、易于使用的生物传感器在各种医疗环境中的即时应用具有巨大潜力，为检测如2019冠状病毒病等病毒感染提供了一种快速、高效且经济高效的方法。其坚固的设计、最低的样本制备要求和多次使用能力标志着生物传感技术取得了重大进展。
