Abstract
Microfluidics is facing critical challenges in the quest of miniaturizing, integrating, and automating in vitro diagnostics, including the increasing complexity of assays, the gap between the macroscale world and the microscale devices, and the diverse throughput demands in various clinical settings. Here, a “3D extensible” microfluidic design paradigm that consists of a set of basic structures and unit operations was developed for constructing any application-specific assay. Four basic structures—check valve (in), check valve (out), double-check valve (in and out), and on–off valve—were designed to mimic basic acts in biochemical assays. By combining these structures linearly, a series of unit operations can be readily formed. We then proposed a “3D extensible” architecture to fulfill the needs of the function integration, the adaptive “world-to-chip” interface, and the adjustable throughput in the X, Y, and Z directions, respectively. To verify this design paradigm, we developed a fully integrated loop-mediated isothermal amplification microsystem that can directly accept swab samples and detect Chlamydia trachomatis automatically with a sensitivity one order higher than that of the conventional kit. This demonstration validated the feasibility of using this paradigm to develop integrated and automated microsystems in a less risky and more consistent manner.
Highlights
Since its inception, microfluidics has demonstrated a tremendous potential to revolutionize the field of in vitro diagnostics (IVDs)
Instead of developing isolated microfluidic systems, the implementation of a microfluidic platform, which comprises a combinable set of basic unit operations, is a much easier and less risky approach to translate in vitro diagnostic assays to the microchip format [9,10,11]
To elucidate and verify this design paradigm, we developed a fully integrated loop-mediated isothermal amplification microsystem with “sample-in-answer-out” capacity, adjustable throughput, and higher sensitivity compared with commercial kit
Summary
Microfluidics has demonstrated a tremendous potential to revolutionize the field of in vitro diagnostics (IVDs). Microfluidic IVD systems are believed to offer numerous advantages, such as portability, low cost, automation, and “sample-to-answer” capability, which could enable rapid, sensitive, and quantitative analyses of multiple targets by consuming minimal amounts of samples [1,2] These microfluidic systems should be able to play vital roles in nucleic acid amplification tests (NATs) where the operation process is complicated and the prevention of contamination is a critical concern [3,4]. To elucidate and verify this design paradigm, we developed a fully integrated loop-mediated isothermal amplification (iLAMP) microsystem with “sample-in-answer-out” capacity, adjustable throughput, and higher sensitivity compared with commercial kit. This example validated the feasibility of using this universal design paradigm to develop fully integrated and automated microfluidic systems in an easier, less risky, and more consistent manner
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