CLIAMDK: A Modular Smartphone Platform Matching Plate Reader Performance for Chemiluminescent Immunoassay Development
Wood, C. S.; Abele, S. M.; Alsbach, J.; Gervalla, A.; Meinel, D. M.; Cuny, A. P.
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The development of chemiluminescent immunoassays (CLIAs) is a complex and iterative process that relies on costly laboratory infrastructure, limiting its accessibility and application across healthcare settings and disease areas. Here, we detail the CLIA Mobile Development Kit (CLIAMDK) a modular, mobile, and inexpensive platform to assess image sensors, smartphones and data processing workflows for CLIA development. For its demonstration, we developed two CLIAs targeting renin and aldosterone, key biomarkers for diagnosing primary aldosteronism. The results from our performance study, including 50 patient samples, demonstrate the potential of our platform in a real-world scenario. We found that the performance of our mobile reader platform is comparable to that of a state-of-the-art plate reader, with a Lower Limit-of-Detection (LLoD) approaching 41 femtomolar. We envision that our platform will help accelerate CLIA development, make it more accessible, and lay the foundations for novel, distributed, yet highly sensitive diagnostic tests.
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