School of Chemistry, Faculty of Exact Sciences, Tel Aviv University, Tel Aviv69978, Israel.
Department of Materials Science and Engineering, the Iby and Aladar Fleischman Faculty of Engineering, Tel Aviv University, Tel Aviv69978, Israel.
ACS Nano. 2022 Sep 27;16(9):13800-13813. doi: 10.1021/acsnano.2c01793. Epub 2022 Aug 25.
Protein biomarkers' detection is of utmost importance for preventive medicine and early detection of illnesses. Today, their detection relies entirely on clinical tests consisting of painful, invasive extraction of large volumes of venous blood; time-consuming postextraction sample manipulation procedures; and mostly label-based complex detection approaches. Here, we report on a point-of-care (POC) diagnosis paradigm based on the application of intradermal finger prick-based electronic nanosensors arrays for protein biomarkers' direct detection and quantification down to the sub-pM range, without the need for blood extraction and sample manipulation steps. The nanobioelectronic array performs biomarker sensing by a rapid intradermal prick-based sampling of proteins biomarkers directly from the capillary blood pool accumulating at the site of the microneedle puncture, requiring only 2 min and less than one microliter of a blood sample for a complete analysis. A 1 mm long microneedle element was optimal in allowing for pain-free dermal sampling with a 100% success rate of reaching and rupturing dermis capillaries. Current common micromachining processes and top-down fabrication techniques allow the nanobioelectronic sensor arrays to provide accurate and reliable clinical diagnostic results using multiple sensing elements in each microneedle and all-in-one direct and label-free multiplex biomarkers detection. Preliminary successful clinical studies performed on human volunteers demonstrated the ability of our intradermal, in-skin, blood extraction-free detection platform to accurately detect protein biomarkers as a plausible POC detection for future replacement of today's invasive clinical blood tests. This approach can be readily extended in the future to detect other clinically relevant circulating biomarkers, such as miRNAs, free-DNAs, exosomes, and small metabolites.
蛋白质生物标志物的检测对于预防医学和疾病的早期发现至关重要。如今,它们的检测完全依赖于临床测试,包括从静脉中抽取大量血液的痛苦、有创的提取过程;耗时的提取后样本处理程序;以及主要基于标签的复杂检测方法。在这里,我们报告了一种基于应用基于皮内手指刺破的电子纳米传感器阵列的即时诊断(POC)诊断范式,用于直接检测和定量蛋白质生物标志物,其检测下限低至亚皮摩尔范围,而无需进行血液提取和样本处理步骤。纳米生物电子阵列通过快速的基于皮内刺破的方法从积聚在微针穿刺部位的毛细血管血液池中直接采样来进行生物标志物感测,仅需 2 分钟,并且仅需不到 1 微升的血液样本即可完成完整分析。1 毫米长的微针元件是最佳的,可实现无痛的真皮采样,成功率为 100%,可达到并刺破真皮毛细血管。目前常见的微加工工艺和自上而下的制造技术允许纳米生物电子传感器阵列使用每个微针中的多个感测元件和一体式直接、无标记的多重生物标志物检测,提供准确和可靠的临床诊断结果。在人类志愿者中进行的初步成功临床研究表明,我们的无需皮肤内提取血液的皮内、皮肤内检测平台能够准确检测蛋白质生物标志物,作为未来替代当今有创临床血液测试的可行即时检测方法。该方法将来可以很容易地扩展到检测其他临床相关的循环生物标志物,如 miRNA、游离 DNA、外泌体和小分子代谢物。