Sample preparation presents a major challenge in point-of-care (POC) diagnostic assays, including ones requiring whole blood as the starting specimen. This study presents an integrated sample preparation device – which we call PRECISE – that performs both plasma separation and nucleic acid extraction, enabling streamlined sample preparation from whole blood requiring only a commercially available blood collection tool and a syringe, and no other external equipment or electricity. Plasma separation is performed using a dual-membrane filter (which filters out blood components while limiting membrane clogging) integrated into the cartridge, and nucleic acid extraction is performed by users moving magnets (to mix the samples, and along a guided track). The plasma filtration demonstrated recovery on par with lab-based centrifugation, and the extraction module showed performance similar to benchtop-based magnetic bead extraction. A sample-to-result demonstration on 50 μL of whole blood spiked with virions of hepatitis C virus (HCV), operating the PRECISE cartridge in 16 minutes followed by benchtop PCR, showed a limit of detection (∼6770 IU mL⁻¹) on the order of the minimal requirements of target product profile for POC HCV detection. Future work on the PRECISE cartridge, building on POC accessibility and fast sample preparation demonstrated in this work, may enable detection of bloodborne pathogens from whole-blood specimens collected at the POC.

中文翻译：

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用于从全血中分离和核酸提取的集成设备，用于血源性病原体的即时检测


样品制备是即时 （POC） 诊断分析的主要挑战，包括需要全血作为起始样本的分析。本研究提出了一种集成的样品制备设备（我们称之为 PRECISE），该设备可同时执行血浆分离和核酸提取，只需市售的采血工具和注射器即可简化全血样品制备，无需其他外部设备或电力。使用集成在柱中的双膜过滤器（过滤掉血液成分，同时限制膜堵塞）进行血浆分离，核酸提取由用户移动磁铁进行（用于混合样品，并沿着导向轨道）。血浆过滤的回收率与基于实验室的离心相当，萃取模块的性能与基于台式的磁珠萃取相似。对 50 μL 加标丙型肝炎病毒 （HCV） 病毒粒子的全血进行样品到结果演示，在 16 分钟内操作 PRECISE 小柱，然后进行台式 PCR，结果显示检测限 （∼6770 IU ^mL-1） 与 POC HCV 检测的目标产品概况的最低要求相同。PRECISE 卡夹的未来工作以 POC 可及性和本研究中展示的快速样品制备为基础，可能能够从 POC 采集的全血样本中检测血源性病原体。