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Objective: Respiratory disease is a rapidly growing global health issue that impacts the quality of living of tens of millions of people around the world. Neutrophil elastase (NE) represents a key inflammatory biomarker and has previously been demonstrated to have the capability of predicting exacerbation risk related to respiratory diseases. This paper utilises a low-cost Point of Care (PoC) approach using Lateral Flow Assays (LFAs) to provide quantitative measurement of active NE in a patient&#x2019;s sputum. Methods and procedures: The main aim of this study is to develop a quantitative platform using a Complementary Metal-Oxide-Semiconductor (CMOS) to image the LFAs and with an adaptable image analysis algorithm to measure a target biomarker concentration. This result could be used to monitor a patient&#x2019;s health and quality of living. In the paper, NE is used as the target biomarker to determine if the patient is suffering from a high risk of exacerbations. Results: The results presented in the paper indicate the CMOS reader approach is promising for rapid and low-cost PoC devices, with the current system able to provide quantitative trends of NE concentrations as low as 100 ng/ml and is comparable to a research-based laboratory lateral flow reader. Conclusion: The image analysis algorithm used in the CMOS reader can estimate the minimum NE concentration of 250 ng/ml to indicate the high-risk category for exacerbations from respiratory illnesses with the same accuracy as expensive a research-based laboratory reader but by using low-cost components and onboard image analysis. Clinical impact: The image analysis algorithm is evaluated to analyse LFAs with NE biomarker to determine the patient in a high-risk category for exacerbations. The device communicates the analysis result to medical professionals for daily historical logging for daily health monitoring without regular hospital appointments. The low-cost approach of the proposed system and image analysis approach can be adapted to analyse different biomarkers for other health concerns including multiplex LFAs without additional hardware in the reader design.

Point-of-Care Monitoring of Respiratory Diseases Using Lateral Flow Assay and CMOS Camera Reader