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Clinical Chemistry 51: 1923-1932, 2005. First published July 28, 2005; 10.1373/clinchem.2005.052498
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(Clinical Chemistry. 2005;51:1923-1932.)
© 2005 American Association for Clinical Chemistry, Inc.

Oak Ridge Conference

Microfluidic Tool Box as Technology Platform for Hand-Held Diagnostics

Michael J. Pugia1,a, Gert Blankenstein2, Ralf-Peter Peters2, James A. Profitt1, Klaus Kadel2, Thomas Willms2, Ronald Sommer1, Hai Hang Kuo1 and Lloyd S. Schulman1

1 Diagnostic Division, Bayer Healthcare LLC, Tarrytown, NY.
2 microParts GmbH, Boehringer Ingelheim, Dortmund, Germany.

aAddress correspondence to this author at: Diagnostic Division, Bayer Healthcare LLC, 1884 Miles Ave., Elkhart, IN 46515-0070. E-mail michael.pugia.b{at}bayer.com.


Abstract

Background: Use of microfluidics in point-of-care testing (POCT) will require on-board fluidics, self-contained reagents, and multistep reactions, all at a low cost. Disposable microchips were studied as a potential POCT platform.

Methods: Micron-sized structures and capillaries were embedded in disposable plastics with mechanisms for fluidic control, metering, specimen application, separation, and mixing of nanoliter to microliter volumes. Designs allowed dry reagents to be on separate substrates and liquid reagents to be added. Control of surface energy to ±5 dyne/cm2 and mechanical tolerances to ≤1 µm were used to control flow propulsion into adsorptive, chromatographic, and capillary zones. Fluidic mechanisms were combined into working examples for urinalysis, blood glucose, and hemoglobin A1c testing using indicators (substances that react with analyte, such as dyes, enzyme substrates, and diazonium salts), catalytic reactions, and antibodies as recognition components. Optical signal generation characterized fluid flow and allowed detection.

Results: We produced chips that included capillary geometries from 10 to 200 µm with geometries for stopping and starting the flow of blood, urine, or buffer; vented chambers for metering and splitting 100 nL to 30 µL; specimen inlets for bubble-free specimen entry and containment; capillary manifolds for mixing; microstructure interfaces for homogeneous transfer into separation membranes; miniaturized containers for liquid storage and release; and moisture vapor barrier seals for easy use. Serum was separated from whole blood in <10 s. Miniaturization benefits were obtained at 10–200 µm.

Conclusion: Disposable microchip technology is compatible with conventional dry-reagent technology and allows a highly compact system for complex assay sequences with minimum manual manipulations and simple operation.






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Copyright © 2005 by the American Association for Clinical Chemistry.