EP0436897A2
Expired / Lapsed
EP
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Device and method of separating and assaying whole blood
Assignee: Bayer Corp
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Filing: 1990-12-20
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Granted: —
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Expires: 2010-12-20
Abstract
Abstract A device and method of separating the cellular components of whole blood from plasma or serum and assaying the plasma or serum for a soluble constituent. The device includes a filter pad, that separates the cellular components of whole blood from the serum or plasma, in releasable contact with a test pad, that assays the serum or plasma for a particular soluble constituent. The filter pad, contaminated with the cellular components, is detachable from the plasma or serum-saturated test pad, thereby eliminating assay interference by the cellular components of whole blood. The method includes contacting the whole blood with a test device including a filter pad comprising a suitable carrier matrix optionally incorporating a lectin, a thrombin, or a mixture thereof, such that the cellular components of the whole blood are separated from the plasma or serum as the blood permeates through the filter pad. The essentially cell-free plasma or serum then saturates a test pad that is in releasable contact with the filter pad. After the plasma or serum saturates the test pad, the filter pad is detached from the test pad, and the exposed test pad is examined for a qualitative or quantitative response to a particular soluble constituent of the whole blood.
Inventors
- 👤 Brian R. Barkes
- 👤 Helen M. Clements
- 👤 Thomas A. Magers
- 👤 Margaret F. Means
- 👤 A. Christopher Skjold
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-11-07 03:30
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/525; G01N33/526; C; C12; C12Q; C12Q1/00; C12Q1/60; G01N33/70; G01N33/92
Claims Analysis
Total Claims: 10
Claim 1
Independent Claim
187 words
An analyte test device that separates cellular and particulate components from a liquid test sample and that determines the presence or concentration of a soluble component of the liquid test sample comprising: a support strip; a test pad secured to the support strip, the test pad comprising a substrate material incorporating an indicator reagent composition that undergoes a detectable change in response to the soluble component of the liquid test sample when in contact with the liquid test sample; a filter pad of sufficient size to separate the cellular and particulate components from the liquid test sample, the filter pad being disposed in releasable contact with the test pad and so positioned that the liquid test sample first contacts the filter pad; and a removable securing means secured to the filter pad and to the support strip to dispose the filter pad in releasable contact with the test pad, whereby separating the securing means from the support strip disconnects the filter pad from the test pad to expose the test pad for examination of the detectable change in response to the soluble component of the test sample.
Claim 2
Dependent Claim
14 words
The analyte test device of claim 1 wherein the biological sample is whole blood.
Claim 3
Dependent Claim
49 words
The analyte test device of claim 1 wherein the filter pad comprises a carrier matrix selected from the group consisting of silica gel, alumina, diatomaceous earth, filter paper, chromatographic paper, glass fiber, cellulose acetate, polyvinyl chloride, polyacrylamide, polyacrylate, polyurethane, crosslinked dextran, polyethylene, polypropylene, polyvinylidene fluoride, polysulfone and combinations thereof.
Claim 4
Dependent Claim
31 words
The analyte test device of claim 1 wherein the filter pad comprises a carrier matrix having a pore size in the range of from about 0.1 micron to about 50 microns.
Claim 5
Dependent Claim
20 words
The analyte test device of claim 1 wherein the filter pad has a thickness of at least about 1 mm.
Claim 6
Independent Claim
169 words
A device for separating plasma or serum from a biological fluid and for detecting a soluble constituent of the plasma or serum comprising a filter pad to remove the cellular and particulate components of the biological sample upon contact therewith, and a test pad containing a suitable indicator reagent composition in a sufficient quantity for interaction with a soluble constituent of the plasma or serum to produce a detectable change in the test pad upon contact with the serum or plasma, the filter pad being so positioned that the biological fluid first contacts the filter pad to remove the cellular and particulate components of the biological fluid and the test pad being disposed in releasable contact with the filter pad and so positioned that the interaction between the soluble constituent of the plasma or serum and the indicator reagent composition is detected without substantial interference from the cellular and particulate components separated by the filter pad after the filter pad is disconnected from releasable contact with the test pad.
Claim 7
Independent Claim
133 words
A device for separating plasma or serum from an undiluted whole blood sample comprising a filter pad to separate the cellular and particulate components from the sample in the area of the filter pad while allowing a quantity of the plasma or serum portion of the whole blood sample to flow completely through the filter pad in undiluted form separate from the cellular and particulate components of the whole blood sample into a test pad, the test pad disposed in releasable contact with the filter pad and including a suitable indicator reagent composition to assay for a particular soluble constituent of the serum or plasma, whereby disconnecting the filter pad from the test pad exposes the test pad for examination of a response to the particular soluble constituent of the serum or plasma.
Claim 8
Independent Claim
104 words
A method of separating plasma or serum from an undiluted whole blood sample comprising contacting the undiluted whole blood sample with a filter pad of a device to separate and retain the cellular and particulate components of the undiluted whole blood sample in the filter pad while allowing a quantity of the plasma or serum portion of the undiluted whole blood sample to flow through the filter pad of the device into a hydrophilic pad of the device that is in releasable contact with the filter pad, then disconnecting the filter pad from the hydrophilic pad to expose the plasma or serum-containing hydrophilic pad.
Claim 9
Independent Claim
158 words
A method of separating plasma or serum from a whole blood sample and testing the plasma or serum for a predetermined soluble constituent comprising contacting the whole blood with a filter pad to separate and retain the cellular and particulate components from the whole blood thereby separating the plasma or serum from the cellular components of the whole blood; allowing the separated plasma or serum to contact a test pad containing a suitable testing reagent for the soluble constituent of the plasma or serum, the test pad being in releasable contact with the filter pad for contact of the separated serum or plasma with the test pad to produce an interaction between the predetermined soluble constituent and the testing reagent of the test pad resulting in a detectable change in the test pad; detaching the filter pad from releasable contact with the test pad to expose the test pad; and detecting the detectable change in the test pad.
Claim 10
Independent Claim
304 words
A method of determining the presence or concentration of a specific soluble constituent in a biological fluid comprising: (a) contacting a test device with the biological fluid, the test device comprising: a support strip; a reagent test pad secured to the support strip, the reagent test pad comprising a substrate material incorporating an indicator reagent composition that undergoes a detectable change in response to the specific soluble constituent of the biological fluid when in contact with the biological fluid; a filter pad capable of separating cellular and particulate components from the biological fluid, the filter pad being disposed in releasable contact with the reagent test pad and so positioned that the biological sample first contacts the filter pad; and a removable securing means secured to the filter pad and to the support strip to dispose the filter pad in releasable contact with the reagent test pad, whereby separating the securing means from the support strip disconnects the filter pad from the reagent test pad to expose the reagent test pad for examination of the detectable change in response to the specific soluble constituent of the biological sample; (b) allowing a sufficient time for the biological sample to permeate the filter pad to effect separation of the cellular and particulate components of the biological sample and for a liquid portion of the biological fluid to contact the reagent test pad; (c) disconnecting the filter pad including the cellular and particulate components of the biological sample from the reagent test pad including the liquid portion of the biological fluid and detaching the filter pad from the test device to expose the reagent test pad; and (d) determining the presence or concentration of the specific soluble constituent from the detectable change of the indicator reagent composition in response to the specific soluble constituent in the biological fluid.
References Cited (Backward Citations)
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