Management of curable sexually-transmitted infections (STI) such as Chlamydia can be revolutionized by highly sensitive nucleic acid testing that is deployable at the point-of-care (POC). Here we report the development of a mobile nucleic acid amplification testing (mobiNAAT) platform utilizing a mobile phone and droplet magnetofluidics to deliver NAAT in a portable and accessible format. By using magnetic particles as a mobile substrate for nucleic acid capture and transport, fluid handling is reduced to particle translocation on a simple magnetofluidic cartridge assembled with reagents for nucleic acid purification and amplification. A mobile phone user interface operating in tandem with a portable Bluetooth-enabled cartridge-processing unit facilitates process integration. We tested 30 potentially Chlamydia trachomatis (CT)-infected patients in a hospital emergency department and confirmed that mobiNAAT showed 100% concordance with laboratory-based NAAT. Concurrent evaluation by a nontechnical study coordinator who received brief training via an embedded mobile app module demonstrated ease of use and reproducibility of the platform. This work demonstrates the potential of mobile nucleic acid testing in bridging the diagnostic gap between centralized laboratories and hospital emergency departments.
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D.J.S. designed and manufactured the cartridge and the mobiNAAT prototype, co-designed and developed the mobile user interface, designed the experiments and wrote the manuscript. P.A. developed the mobile user interface and data analysis software, performed the experiments, analyzed the data and assisted in prototype design. L.C. designed and optimized the assay, performed the experiments, analyzed the data and assisted in the prototype design. C.G. and J.H. conceived and coordinated patient sample collection, tested with the gold standard assay and wrote the manuscript. Y.H.H. and R.R. prepared the IRB application, facilitated prototype evaluation at the emergency department and provided insightful discussion for user interface design. M.L. received the samples and performed the assays in the emergency department using the mobiNAAT platform. T.H.W. conceived the project, provided overall guidance and wrote the manuscript with contribution from all authors. 2ff7e9595c
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