Analyte detection device and process

Details Analyte detection device and process Analyte detection device and process

1995-03-06

2001-02-20

Soderquist, Arlen (Department: 1743)

Chemistry: analytical and immunological testing

Biological cellular material tested

C422S051000, C422S051000, C435S014000, C435S022000, C435S026000, C436S071000, C436S095000, C436S166000, C436S169000, C436S170000, C436S177000

Reexamination Certificate

active

06190918

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a device and a process for detecting an analytes in a biological fluid. A device comprises a separating matrix for separating an analyte from a sample fluid, where the separating matrix contains HEPES buffer. A process comprises applying a sample fluid to a device having a separating matrix and then detecting an analyte in the sample using detection means in a detection layer adjacent to the separating matrix.
DESCRIPTION OF THE BACKGROUND ART
There is a need in the end point detection art for devices and methods that allow for the rapid, accurate determination of analyte (e.g., glucose, triglyceride, cholesterol, etc.) concentration in very small sample volumes of biological fluid. The need for a device using small sample volumes is particularly relevant to the detection of blood glucose because of the difficulty and inconvenience of obtaining blood samples from subjects.
Currently available such devices include ACCUCHEK EASY TEST STRIPS™ and ACCUTREND® (Boehringer Mannheim Corp.). Those devices are multilayer reagent systems characterized by the absence of a buffering agent in the separation or filtration layer.
Buffer is commonly added to the composition present in a detection layer for the purpose of controlling the pH of the reagent composition present in said layer. The use of buffers for this purpose is described, for example, in U.S. Pat. No. 5,116,763.
The present invention provides a detection device having a HEPES-impregnated separation matrix, which HEPES serves to reduce the time needed for analyte detection. Unexpectedly, HEPES speeds up the end point determination in the detection layer. Other buffers do not demonstrate the same benefit.
BRIEF SUMMARY OF THE INVENTION
In one aspect, the present invention contemplates a device for detecting an analyte in a biological fluid sample, which device comprises:
a) a separation matrix containing HEPES; and
b) means for detecting an analyte, which detection means is vertically adjacent to the separation matrix and substantially coincident with that matrix such that analyte can move from the separation matrix to the detection means.
The amount of HEPES present is between 70 and 150 millimolar and preferably between 80 and 100 millimolar.
A detection means is preferably a matrix containing chemical reagents that interact with the analyte to generate a detectable signal. A preferred detection means for glucose is a synthetic membrane containing ATP, NAD, hexokinase, glucose-6-phosphate dehydrogenase, diaphorase and an indicator.
In a preferred embodiment, the separation matrix is a glass fiber filter. More preferably, the glass fiber filter has a sample application side adjacent to the cover portion and a reagent side adjacent to the detection means, whereby the glass fibers at the reagent side are shorter than the glass fibers at the application side.
The separation matrix can contain an aggregation-promoting substance that promotes aggregation of colloidal particles or cells or a surface active agent such as a non-hemolytic surfactant.
Preferably, the biological fluid is extracellular fluid and, more preferably, the fluid is blood.
A detection device can further comprise (1) a base portion having a transparent window, which base portion is situated such that the detection means is vertically adjacent to the base portion and at least partially coincident with the transparent window and (2) a cover portion having an aperture, which cover portion is vertically adjacent to the separation matrix.
Preferably, the transparent window in the base portion is made of glass or plastic such as polycarbonate.
In a preferred aspect, therefore, the present invention contemplates a device for detecting glucose in a biological fluid, which device comprises:
a) a plastic base portion having a polycarbonate clear window:
b) means for detecting glucose vertically adjacent to the base portion and at least partially coincident with the window, which detection means comprises a matrix containing ATP, NAD, hexokinase, glucose-6-phosphate dehydrogenase, diaphorase and an indicator;
c) a separation matrix containing HEPES vertically adjacent to the detection means and substantially coincident with that detection means; and
d) a cover portion having an aperture, which cover portion is vertically adjacent to the separation matrix and which aperture is coincident with the separation matrix.
In yet another preferred aspect, the present invention contemplates a process of detecting an analyte in a biological fluid, which process comprises the steps of:
a) providing an analyte detection device comprising:
i) a separation matrix containing HEPES; and
ii) means for detecting the analyte, which detection means is vertically adjacent to the separation matrix and substantially coincident with that matrix such that analyte can move from the separation matrix to the detection means;
b) applying a sample of the biological fluid to the separation matrix of the detection device;
c) maintaining the detection device for a time period sufficient for analyte to traverse the separation matrix, enter the detection matrix and for generation of a signal indicative of the presence of analyte; and
d) detecting the signal and thereby the presence of analyte.
In another preferred embodiment, the biological fluid is blood and the separation matrix contains an aggregation-promoting substance and a surface acting agent.


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