Test strip for detection of analyte and methods of use
First Claim
1. A reagent test strip comprising:
- a. a top support layer comprising a sample aperture;
b. a membrane comprising a reagent system for indicating the concentration of a target;
c. a spreading layer;
d. a bottom support layer comprising a measuring port in substantial alignment or approximate alignment with said sample aperture;
wherein said membrane is affixed to said top support layer;
further wherein said membrane is positioned between said top support layer and said bottom support layer;
further wherein said spreading layer is positioned above said top support layer and in substantial or approximate alignment with said sample aperture; and
further wherein a fluid applied to said spreading layer, passes through said sample aperture and contacts said membrane.
4 Assignments
0 Petitions
Accused Products
Abstract
One aspect of the present invention is a reagent test strip that includes: a) a top support layer including a sample aperture; b) a membrane that includes a reagent system for indicating the concentration of a target; c) a spreading layer; d) a bottom support layer including a measuring port in substantial alignment or approximate alignment with the sample aperture. Preferably, the membrane is affixed to the top support layer. Preferably, the membrane is positioned between the top support layer and the bottom support layer. Preferably, the spreading layer is positioned above the top support layer and in substantial or approximate alignment with the sample aperture. Preferably, a fluid applied to the spreading layer, passes through the sample aperture and contacts the membrane.
226 Citations
31 Claims
-
1. A reagent test strip comprising:
-
a. a top support layer comprising a sample aperture;
b. a membrane comprising a reagent system for indicating the concentration of a target;
c. a spreading layer;
d. a bottom support layer comprising a measuring port in substantial alignment or approximate alignment with said sample aperture;
wherein said membrane is affixed to said top support layer;
further wherein said membrane is positioned between said top support layer and said bottom support layer;
further wherein said spreading layer is positioned above said top support layer and in substantial or approximate alignment with said sample aperture; and
further wherein a fluid applied to said spreading layer, passes through said sample aperture and contacts said membrane. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 24, 25, 26, 27, 28, 29, 30, 31)
a. applying a fluid suspected of comprising a target to the reagent test strip of claim 1;
b. detecting the reflectance of said membrane through said measuring port; and
c. determining the presence or concentration of said target.
-
-
25. A method of determining the presence or concentration of a target in a sample according to claim 24 wherein the step of determining the presence or concentration comprises measuring the absorbance of a chromophore.
-
26. A method of determining the concentration of a target in a sample comprising the steps of:
-
a. detecting a dry strip reading from the reagent test strip of claim 1;
b. running a preprogrammed threshold loop instruction;
c. detecting a first reflectance measurement;
d. running a preprogrammed kinetic loop instruction;
e. determining the presence or concentration of the target;
wherein said threshold loop instruction comprises the steps of;
detecting a threshold comparison measurement;
comparing said threshold comparison measurement to a predetermined threshold value;
repeating the loop until said threshold comparison measurement is less than or equal to said predetermined threshold value;
further wherein a fluid suspected of including a target is applied during the step of running said threshold loop instruction;
further wherein said kinetic loop instruction comprises the steps of;
detecting a second reflectance measurement;
comparing said first reflectance measurement to said second reflectance measurement;
ending the loop if said comparison is less than or equal to a predetermined cutoff value;
replacing the value of said first reflectance measurement with the value of said second reflectance measurement; and
repeating the loop.
-
-
27. A method according to claim 26 wherein the step of determining the presence or concentration of said target comprises calculating the concentration using said second reflectance measurement.
-
28. A method of determining the concentration of a target in a sample comprising the steps of:
-
a. detecting a dry strip reading from the reagent test strip of claim 1;
b. running a preprogrammed threshold loop instruction;
c. detecting a first reflectance measurement;
d. running a preprogrammed kinetic loop instruction;
e. running a consecutive comparison instruction;
e. determining the presence or concentration of the target;
wherein said threshold loop instruction comprises the steps of;
detecting a threshold comparison measurement;
comparing said threshold comparison measurement to a predetermined threshold value;
repeating the loop until said threshold comparison measurement is less than or equal to said predetermined threshold value;
further wherein a fluid suspected of including a target is applied during the step of running said threshold loop instruction;
further wherein said kinetic loop instruction comprises the steps of;
detecting a second reflectance measurement;
comparing said first reflectance measurement to said second reflectance measurement;
ending the loop if said comparison is less than or equal to a predetermined cutoff value;
replacing the value of said first reflectance measurement with the value of said second reflectance measurement; and
repeating the loop;
further wherein said consecutive comparison instruction comprises the steps of;
detecting a third reflectance measurement;
comparing said second reflectance measurement to said third reflectance measurement;
ending the consecutive comparison instruction if said comparison is less than or equal to said predetermined cutoff value;
replacing the value of said first reflectance measurement with the value of said third reflectance measurement; and
returning to the step of running a kinetic loop instruction.
-
-
29. A method of determining the concentration of a target in a sample comprising the steps of:
-
a. detecting a dry strip reading from the reagent test strip of claim 1;
b. running a preprogrammed threshold loop instruction;
c. beginning a predetermined time point such that a fixed time point may be reached;
d. detecting a first reflectance measurement;
e. running a preprogrammed kinetic loop instruction;
f. determining the presence or concentration of the target;
wherein said threshold loop instruction comprises the steps of;
detecting a threshold comparison measurement;
comparing said threshold comparison measurement to a predetermined threshold value;
repeating the loop until said threshold comparison measurement is less than or equal to said predetermined threshold value;
further wherein a fluid suspected of including a target is applied during the step of running said threshold loop instruction;
further wherein said kinetic loop instruction comprises the steps of;
detecting a second reflectance measurement;
comparing said first reflectance measurement to said second reflectance measurement;
ending the loop if said second reflectance measurement is less than or equal to a predetermined cutoff value or if said fixed time point is reached;
replacing the value of the first reflectance measurement with the value of the second reflectance measurement; and
repeating the loop.
-
-
30. A method of determining the concentration of a target in a sample comprising the steps of:
-
a. detecting a dry strip reading from the reagent test strip of claim 1;
b. running a preprogrammed threshold loop instruction;
c. beginning a predetermined time point such that a fixed time point may be reached;
d. detecting a first reflectance measurement;
e. running a preprogrammed kinetic loop instruction;
f. running a consecutive comparison instruction;
f. determining the presence or concentration of the target;
wherein said threshold loop instruction comprises the steps of;
detecting a threshold comparison measurement;
comparing said threshold comparison measurement to a predetermined threshold value;
repeating the loop until said threshold comparison measurement is less than or equal to said predetermined threshold value;
further wherein a fluid suspected of including a target is applied during the step of running said threshold loop instruction;
further wherein said kinetic loop instruction comprises the steps of;
detecting a second reflectance measurement;
comparing said first reflectance measurement to said second reflectance measurement;
ending the loop if said second reflectance measurement is less than or equal to a predetermined cutoff value or if said fixed time point is reached;
replacing the value of the first reflectance measurement with the value of the second reflectance measurement; and
repeating the loop;
further wherein said consecutive comparison instruction comprises the steps of;
detecting a third reflectance measurement;
comparing said second reflectance measurement to said third reflectance measurement;
ending the consecutive comparison instruction if said comparison is less than or equal to said predetermined cutoff value or if said fixed time point is reached;
replacing the value of said first reflectance measurement with the value of said third reflectance measurement; and
returning to the step of running a kinetic loop instruction.
-
-
31. A method of determining the concentration of a target in a sample comprising the stops of:
-
a. detecting a dry strip reading from the reagent test strip of claim 1;
b. running a preprogrammed threshold loop instruction;
a. beginning a predetermined time point such that a fixed time point may be reached;
d. determining the presence or concentration of a target in a sample when said fixed time point is reached;
wherein said threshold loop instruction comprises;
detecting a threshold comparison value;
comparing said threshold comparison value to a predetermined threshold value;
repeating the loop until said threshold comparison value is less than or equal to said predetermined threshold value; and
further wherein a fluid inspected of including a target is applied during the step of running said threshold loop instruction.
-
-
23. A reagent test strip comprising:
-
a. a top support layer comprising a sample aperture;
b. a membrane comprising a reagent system for indicating the concentration of a target;
c. at least one spacer able to reduce contact between said membrane and a surface; and
wherein said membrane is positioned below said top support layer and in substantial alignment or approximate alignment with said sample aperture.
-
Specification