Rapid diagnostic tests (RDTs) offer valuable diagnostic information in a quick, easy-to-use and low-cost format. While RDTs are one of the most commonly used tools for in vitro diagnostic testing, they require the collection of a blood sample, which is painful, poses risks of infection and can lead to complications. We introduce a blood-free point-of-care diagnostic test for the rapid detection of protein biomarkers in dermal interstitial fluid (ISF). This device consists of a lateral flow immunochromatographic assay (LFIA) integrated within a microfluidic skin patch. ISF is collected from the skin using a microneedle array and vacuum-assisted extraction system integrated in the patch, and transported through the lateral flow strip via surface tension. Using this skin patch platform, we demonstrate in situ detection of anti-tetanus toxoid IgG and SARS-CoV-2 neutralizing antibodies, which could be accurately detected in human ISF in <20 min. We envision that this device can be readily modified to detect other protein biomarkers in dermal ISF, making it a promising tool for rapid diagnostic testing.

中文翻译：

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基于侧向层析的皮肤贴剂，用于快速检测人体真皮间质液中的蛋白质生物标志物


快速诊断检测 （RDT） 以快速、易于使用和低成本的形式提供有价值的诊断信息。虽然 RDT 是体外诊断测试最常用的工具之一，但它们需要采集血液样本，这很痛苦，有感染风险，并可能导致并发症。我们引入了一种无血即时诊断测试，用于快速检测真皮间质液 （ISF） 中的蛋白质生物标志物。该装置由集成在微流体皮肤贴片中的侧向流免疫层析测定 （LFIA） 组成。ISF 使用集成在贴片中的微针阵列和真空辅助提取系统从皮肤中收集，并通过表面张力通过侧向流条带运输。使用这个皮肤贴剂平台，我们展示了抗破伤风类毒素 IgG 和 SARS-CoV-2 中和抗体的原位检测，可以在 <20 分钟内在人 ISF 中准确检测到。我们设想该设备可以很容易地进行修改以检测皮肤 ISF 中的其他蛋白质生物标志物，使其成为快速诊断测试的有前途的工具。