The lab-on-a-chip (LOC) field has witnessed an excess of new technology concepts, especially for the point-of-care (POC) applications. However, only few concepts reached the POC market often because of challenging integration with pumping and detection systems as well as with complex biological assays. Recently, a new technology termed SIMPLE was introduced as a promising POC platform due to its features of being self-powered, autonomous in liquid manipulations, cost-effective and amenable to mass production. In this paper, we improved the SIMPLE design and fabrication and demonstrated for the first time that the SIMPLE platform can be successfully integrated with biological assays by quantifying creatinine, biomarker for chronic kidney disease, in plasma samples. To validate the robustness of the SIMPLE technology, we integrated a SIMPLE-based microfluidic cartridge with colorimetric read-out system into the benchtop Creasensor. This allowed us to perform on-field validation of the Creasensor in a single-blind study with 16 plasma samples, showing excellent agreement between measured and spiked creatinine concentrations (ICC: 0.97). Moreover, the range of clinically relevant concentrations (0.76-20 mg/dL), the sample volume (5 μL) and time-to-result of only 5 min matched the Creasensor performance with both lab based and POC benchmark technologies. This study demonstrated for the first time outstanding robustness of the SIMPLE in supporting the implementation of biological assays. The SIMPLE flexibility in liquid manipulation and compatibility with different sample matrices opens up numerous opportunities for implementing more complex assays and expanding its POC applications portfolio.

中文翻译：

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Creasensor：用于血浆中肌酐检测的简单技术

芯片实验室 ​​(LOC) 领域见证了大量新技术概念，尤其是针对即时 (POC) 应用。然而，由于与泵和检测系统以及复杂的生物测定的集成具有挑战性，因此只有少数概念进入 POC 市场。最近，一项名为 SIMPLE 的新技术被引入作为一种有前途的 POC 平台，因为它具有自供电、液体操作自主、成本效益高且适合大规模生产的特点。在本文中，我们改进了 SIMPLE 的设计和制造，并首次证明了 SIMPLE 平台可以通过量化血浆样本中的肌酐（慢性肾病的生物标志物）成功地与生物检测相结合。为了验证 SIMPLE 技术的稳健性，我们将带有比色读出系统的基于 SIMPLE 的微流体墨盒集成到台式 Creasensor 中。这使我们能够在 16 个血浆样本的单盲研究中对 Creasensor 进行现场验证，显示测量的和加标的肌酐浓度之间具有极好的一致性（ICC：0.97）。此外，临床相关浓度范围 (0.76-20 mg/dL)、样品体积 (5 μL) 和仅 5 分钟的出结果时间与基于实验室和 POC 基准技术的 Creasensor 性能相匹配。这项研究首次证明了 SIMPLE 在支持生物检测实施方面的出色稳健性。