Lateral flow assays using two dimensional features
First Claim
1. A test device, which device comprises a plurality of reagent dots on a matrix, wherein at least two of said reagent dots do not overlap and are sufficiently spaced apart from each other so that when a liquid flows laterally along said matrix, flow of said liquid to, through and/or around one of said two reagent dots does not substantially affect flow of said liquid sample to, through and/or around said other reagent dot, each of said two reagent dots is neither a reagent line across the entire width of said matrix in a direction perpendicular to the direction of said liquid flow nor a complete circle of a reagent line circulating the center or sample or liquid application site of said test device, and after a liquid flows laterally along said test device and passes said at least two reagent dots, detectable signals are formed at said at least two reagent dots to provide for flow control information, and:
- 1) to function as an internal control;
or2) to provide for internal calibration information for said test device;
or3) to function as an internal control and to provide for internal calibration information for said test device, andwhereinsaid internal calibration information is for quantification of an analyte,said flow control information allows internal calibration within said test device for perturbation in test results caused by variability in flow rate or flow pattern laterally across the surface and/or along the length of a flow field, andat least a quarter, a third, half of or all said reagent dots have a diameter of about 0.1-1 μ
m, 1-10 μ
m, 10-50 μ
m, 51-100 μ
m, 101-200 μ
m, 201-300 μ
m, or 301-400 μ
m.
1 Assignment
0 Petitions
Accused Products
Abstract
The present invention relates to novel lateral flow devices using two dimensional features, preferably, uniform two dimensional test and control features, to provide flow control information, to function as an internal control and/or to provide internal calibration information for the test device. The present invention also relates to methods for using the lateral flow devices to provide flow control information, to function as an internal control and/or to provide internal calibration information for the test device.
-
Citations
22 Claims
-
1. A test device, which device comprises a plurality of reagent dots on a matrix, wherein at least two of said reagent dots do not overlap and are sufficiently spaced apart from each other so that when a liquid flows laterally along said matrix, flow of said liquid to, through and/or around one of said two reagent dots does not substantially affect flow of said liquid sample to, through and/or around said other reagent dot, each of said two reagent dots is neither a reagent line across the entire width of said matrix in a direction perpendicular to the direction of said liquid flow nor a complete circle of a reagent line circulating the center or sample or liquid application site of said test device, and after a liquid flows laterally along said test device and passes said at least two reagent dots, detectable signals are formed at said at least two reagent dots to provide for flow control information, and:
-
1) to function as an internal control;
or2) to provide for internal calibration information for said test device;
or3) to function as an internal control and to provide for internal calibration information for said test device, and wherein said internal calibration information is for quantification of an analyte, said flow control information allows internal calibration within said test device for perturbation in test results caused by variability in flow rate or flow pattern laterally across the surface and/or along the length of a flow field, and at least a quarter, a third, half of or all said reagent dots have a diameter of about 0.1-1 μ
m, 1-10 μ
m, 10-50 μ
m, 51-100 μ
m, 101-200 μ
m, 201-300 μ
m, or 301-400 μ
m. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
-
Specification