Microfluidic tool box as technology platform for hand-held diagnostics.
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 < or = 1 microm 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 A(1c) 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 microm with geometries for stopping and starting the flow of blood, urine, or buffer; vented chambers for metering and splitting 100 nL to 30 microL; 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 microm.


CONCLUSIONS
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.
Pugia
Michael J
MJ
Diagnostic Division, Bayer Healthcare LLC, Tarrytown, NY, USA. michael.pugia.b@bayer.com
Blankenstein
Gert
G
Peters
Ralf-Peter
RP
Profitt
James A
JA
Kadel
Klaus
K
Willms
Thomas
T
Sommer
Ronald
R
Kuo
Hai Hang
HH
Schulman
Lloyd S
LS
D001786:Blood Glucose / Q000032:analysis; D004867:Equipment Design; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation; D046210:Microfluidic Analytical Techniques / Q000295:instrumentation* / Q000379:methods*; D044085:Microfluidics / Q000295:instrumentation* / Q000379:methods*; D019095:Point-of-Care Systems; D012680:Sensitivity and Specificity; D013499:Surface Properties; D016482:Urinalysis / Q000295:instrumentation
D001786:Blood Glucose; D006442:Glycated Hemoglobin