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 Constant volume chemical analysis test device

Details
Inventors: Daffern, George M.; Thompson, Tracy N.;
Assignee:
Primary Examiner: Warden; Robert J.
Assistant Examiner: Johnston; Jill
Attorney, Agent or Firm: Walker; William B.

The multilayer test devices of this invention comprise, in order, (a) an absorbent layer; (b) a waterproof barrier layer; and (c) a quickly absorbent reagent layer having a determinate volume. The absorbent and barrier layers each include an aperture functionally aligned for application of a test sample through the absorbent and barrier layers and onto the surface of the reagent layer. The reagent layer contains one or more reagents which produce a detectable species in the presence of an analyte. The reagent layer preferably comprises an asymmetrical filter, which localizes cellular components of the test sample at or near the surface of the filter, while facilitating saturation of the filter by non-cellular sample components. Preferred embodiments of the test devices include devices for testing glucose, alcohol, cholesterol, or other analytes in whole blood.

DETAILED DESCRIPTION The present invention provides a test device for a bodily fluid comprising, in sequential contact, an absorbent layer, a barrier layer, and a reagent matrix layer having a defined saturation volume, wherein the absorbent and barrier layers each includes an opening for applying a test sample directly onto the reagent layer.
In one embodiment, a support is provided on a side of the reagent layer opposite the dosing surface.
In an especially preferred embodiment, the support layer includes an aperture which permits contact between the lower layer of the reagent matrix layer and the atmosphere.
In another embodiment, the reagent layer may be substantially enclosed, with the proviso that the barrier and absorbent layers include openings exposing a substantial portion of the reagent layer to the atmosphere.
In a preferred embodiment, the dosing surface of the reagent matrix layer constitutes a means for retaining cellular components.
One preferred embodiment comprises a test device and method for determining glucose in a whole blood sample.
Other preferred embodiments are test devices and methods for cholesterol and alcohol determination in whole blood samples.



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