The diagnosis of infectious disease is typically carried out at the point-of-care (POC) using the lateral flow assay (LFA). While cost-effective and portable, LFAs often lack the clinical sensitivity and specificity required for accurate diagnoses. In response to this challenge, we introduce a new digital microfluidic (DMF) platform fabricated using a custom inkjet printing and roll-coating process that is scalable to mass production. The performance of the new devices is on par with that of traditional DMF devices fabricated in a cleanroom, with a materials cost for the new devices of only US $0.63 per device. To evaluate the usefulness of the new platform, we performed a 13-step rubella virus (RV) IgG immunoassay on the inkjet printed, roll-coated devices, which yielded a limit of detection of 0.02 IU mL^(−1), well below the diagnostic cut-off of 10 IU mL^(−1) for RV infection and immunity. We propose that this represents a breakthrough for DMF, lowering the costs to a level such that the new platforms will be an attractive alternative to LFAs for the diagnosis of infectious disease at the POC.
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机译：感染性疾病的诊断通常是在护理点（POC）上使用侧向流动测定（LFA）进行的。 LFA具有成本效益和便携性，但通常缺乏准确诊断所需的临床敏感性和特异性。为了应对这一挑战，我们推出了一种新的数字微流控（DMF）平台，该平台使用定制的喷墨印刷和辊涂工艺制造，可扩展至批量生产。新设备的性能与在无尘室中制造的传统DMF设备的性能相当，新设备的材料成本仅为每台设备0.63美元。为了评估新平台的实用性，我们在喷墨印刷的辊涂设备上进行了13步风疹病毒（RV）IgG免疫测定，检测限为0.02 IU mL ^（-1），远低于诊断RV感染和免疫的10 IU mL ^（-1）的临界值。我们建议这是DMF的一项突破，将成本降低到一定水平，以便新平台将成为LFA在POC诊断传染病方面的有吸引力的替代品。
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