Test strip and fixture

• US 4,790,979 A
• Filed: 08/29/1986
• Issued: 12/13/1988
• Est. Priority Date: 08/29/1986
• Status: Expired due to Term

• Current Assignee: Home Diagnostics Incorporated, Jack L. Aronowitz
• Original Assignee: Technimed Corporation
• Inventors: Aronowitz, Jack L., Terminiello, Louis
• Primary Examiner(s): Richman, Barry S.
• Assistant Examiner(s): Johnston, Jill
• Application Number:
  US06/901,603
• Time in Patent Office: 837 Days
• Field of Search: 422/56, 422/58, 128/770, 128/771, 436/169, 436/170
• US Class Current: 422/410
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387

Abstract

A test strip is disclosed which provides for transport and separation of heterogenous fluid samples. This test strip can be used for analysis of whole blood by reflectance measurement. This test strip, which can be especially adapted for use in a disposable blood sampling fixture, comprises two functional components: (1) a wicking element for reception of the whole blood sample and transport of the sample to a dry chemistry reagent system, and (2) a porous membrane which has been impregnated with a dry chemistry reagent system specific for analysis of an analyte within the whole blood sample. A barrier layer is provided between the wicking layer and the porous membrane to preclude contact therebetween. In the preferred embodiments of this invention, an aperture is cut or formed in the barrier layer to allow for the flow of sample for the wick to the surface of the porous membrane. Such transport of sample does not, however, involve or contemplate physical between the wick and the membrane in the area of the aperture. This test strip is suitable for use in a disposable fixture designed for self collection and testing of the whole blood sample for one or more constituents (i.e. glucose).

Claims

1. A self-contained analytical element for conducting an analysis of a heterogeneous fluid sample suspected of containing an analyte of interest comprising:

a test strip consisting essentially of two functional components, each of said functional components being maintained in spaced apart relationship and out of fluid contact with one another by a fluid impermeable barrier layer;

a first functional component of said test strip comprising an essentially planar wicking element for reception of the heterogeneous fluid sample and transport of the heterogeneous sample to a sample receptive surface of a porous membrane which has been impregnated with a dry chemistry reagent system;

a second functional component comprising an essentially planar porous membrane which has been impregnated with a dry chemistry reagent system specific for analysis of an analyte within the heterogeneous fluid sample, said membrane having a sample receptive surface of sufficient density to selectively exclude substantial penetration of suspended or dissolved matter of the sample which can

interfere or mask the reaction of the analyte with the reagent system in the membrane, while allowing the remainder of the sample to be freely absorbed; and

a fluid impermeable barrier layer located between the wicking element and the sample receptive surface of said porous membrane for maintaining said wicking element out of fluid contact with said receptive surface, said barrier layer having at least one aperture for confinement of a pool of sample on the sample receptive surface of the porous membrane, the size and shape of said aperture permitting flow of the heterogeneous fluid sample from the wicking element to the sample receptive surface of the membrane and roughly corresponding to an analysis site.

2. The self-contained analytical element of claim 1, wherein the surface of the wicking element which is contiguous with the barrier layer is modified to facilitate the flow of sample from the wicking element to the sample receptive surface of the porous membrane, said modification involving the placement of a series of channels or cuts in the surface of said wicking element in the area corresponding to the aperture of the barrier layer.

3. The self-contained analytical element of claim 1, wherein the heterogenous fluid sample is whole blood and the wicking element is transportive of the whole blood sample to the sample receptive surface of the porous membrane.

4. The self-contained analytical element of claim 3, wherein the dry chemistry reagent system is specific for the manifestation of glucose in whole blood.

5. In a disposable fixture adapted for use in a portable self-test monitor designed for detection of constituents of whole blood, the disposable test fixture being provided with a test strip and means for inflicting a puncture wound sufficient to draw blood, the improvement comprising:

a test strip consisting essentially of two functional components, each of said functional components being maintained in spaced apart relationship and out of fluid contact with one another by a fluid impermeable barrier layer;

(a) a first functional component of said test strip comprising an essentially planar wicking element for reception of the whole blood sample and transport of the whole blood sample to a dry chemistry reagent system;

(b) a second functional component comprising an essentially planar porous membrane which has been impregnated with a dry chemistry reagent system specific for analysis of a constituent within the blood sample, said membrane having a sample receptive surface of sufficient density to selectively exclude substantial penetration of cellular components of the blood into the membrane while allowing fluid components to be freely absorbed; and

(c) a fluid impermeable barrier layer comprising an essentially planar element, located between the wicking element and the sample receptive surface of said porous membrane, for maintaining said wicking element out of fluid contact with said receptive surface, said barrier layer having at least one aperture, for confinement of a pool of blood on the sample receptive surface of the porous membrane, the size and shape of said aperture permitting flow of the whole blood from the wicking element to the sample receptive surface of the membrane and roughly corresponding to an analysis site which is defined in terms of the field of view of a photo-optical read station of said monitor.

6. The improvement of claim 5, wherein the dry chemistry reagent system is specific for the manifestation of glucose in the whole blood sample.

7. The improvement of claim 5, wherein the surface of the wicking element which is contiguous with the barrier layer is modified to facilitate the flow of the whole blood sample from the wicking element to the sample receptor surface of the porous membrane, and modification involving the placement of a series of channels or cuts in the surface of said wicking element in the area corresponding to the aperture of the barrier layer.