PFI-TT: Development of Point-of-Care Biochips for the Rapid and Sensitive Detection of Multiple Respiratory Pathogens

这一创新-技术转化伙伴关系(PFI-TT)项目的广泛影响/商业潜力源于对一种低成本、护理点(POC)微流控设备的迫切需求，该设备可在资源匮乏的弱势人群中快速检测多种呼吸道病原体(如百日咳和肺炎)。例如，全世界估计有2410万百日咳病例，每年约有160,700名儿童死于百日咳。新的微流控设备可以在护理地点提供低成本、快速和准确的多种呼吸道病原体检测，使百日咳和肺炎球菌肺炎能够在一小时内在医生办公室、学校、农村地区和发展中国家等不同地点检测到。在护理点(POC)进行快速病原体检测可以显著降低儿童和老年人的死亡率。微流控装置还有可能检测各种其他病原体，如食源性病原体和SARS-CoV-2。因此，这项技术的翻译发展对社会和商业的影响可能会影响全球健康。该项目的主要目的是开发一种低成本的微流控设备原型，与特定和敏感的DNA测试技术相结合，用于在护理地点快速准确地检测脆弱人群中的多种常见呼吸道病原体(即百日咳杆菌和肺炎链球菌)。传统的病原体检测方法要么耗时长，要么需要昂贵而笨重的仪器，限制了它们在低资源环境中的应用。这种方法是基于低成本的纸/聚合物混合微流控装置上的集成环路介导的等温放大(LAMP)。DNA扩增和针对每个病原体目标的六个引物分别确保了高检测灵敏度和高准确度，而肉眼无需仪器的检测将仪器要求降至最低。在便携式微流控设备上集成LAMP进一步增强了其POC测试能力。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Partnerships for Innovation - Technology Translation (PFI-TT) project stems from the critical need for a low-cost, point-of-care (POC) microfluidic device for the rapid detection of multiple respiratory pathogens (such as whooping cough and pneumonia) in vulnerable people in low-resource settings. For instance, there are an estimated 24.1 million cases of pertussis worldwide, and about 160,700 deaths per year from whooping cough in children. The new microfluidic device can provide low-cost, rapid, and accurate detection of multiple respiratory pathogens at the point of care, enabling detection of whooping cough and pneumococcal pneumonia within one hour at various venues such as physicians’ offices, schools, rural areas, and developing nations. Rapid pathogen detection at the point of care (POC) can significantly reduce mortality in children and the elderly. The microfluidic device also has the potential to detect a variety of other pathogens such as foodborne pathogens and SARS-CoV-2. Hence, the societal and commercial impacts of the translational development of this technique may impact global health. This project is primarily intended to develop a low-cost microfluidic device prototype integrated with specific and sensitive DNA testing techniques for the rapid and accurate detection of multiple common respiratory pathogens (i.e., B. pertussis and S. pneumonia)in vulnerable people at the point of care. Conventional pathogen detection methods either take a long time or require costly and bulky instruments, limiting their applications for low-resource settings. This approach is based on integrated loop-mediated isothermal amplification (LAMP) on a low-cost paper/polymer hybrid microfluidic device. DNA amplification and six primers specific to each pathogen target ensure high detection sensitivity and high accuracy, respectively, while the instrument-free detection by the naked eye minimizes instrumentation requirements. The integration of LAMP on a portable microfluidic device further enhances its capability for POC testing.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.