Clinical Evaluation of a Novel Digital Microfluidic Based Point-of-care Test Platform for Detection of SARS-Cov-2 and Influenza A/B

Respiratory pathogens, such as SARS-CoV-2 and influenza A/B, can cause severe illnesses in susceptible individuals. This research evaluated a novel digital microfluidic point-of-care testing platform designed to detect 23 pathogens, comparing its performance to conventional laboratory-based nucleic acid tests. The platform integrates nucleic acid extraction and amplification processes for rapid detection with only 2 minutes of hands-on time. Performance assays demonstrated that the platform has high sensitivity (87%-100%) and specificity (99%-100%) for the detection of the evaluated 3 viruses. Additionally, the platform can be adapted for the detection of other respiratory pathogens, aiding in the early diagnosis of respiratory diseases, identifying the source of an outbreak or epidemic, and curbing the spread of the disease.