Point-of-Care Testing and Molecular Diagnostics: Miniaturization Required

Turnaround time for molecular diagnostic tests is critical in detecting infectious agents, in determining a patient's ability to metabolize a drug or drug class, and in detecting minimal residual disease. These applications would benefit from the development of a point-of-care device for nucleic acid extraction, amplification, and detection. The ideal device would have a low cost per test, use a disposable unit use device for all steps in the assay, be portable, and provide a result that requires no interpretation. The creation of such a device requires miniaturization of current technologies and the use of microfluidics, microarrays, and small-diameter capillary tubes to reduce reagent volumes and simplify heat conduction by convection during nucleic acid amplification. This ideal device may be available in 3 to 5 years and will revolutionize and expand the global availability of molecular diagnostic assays.