Lateral flow assays using two dimensional test and control signal readout patterns
First Claim
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1. A test device for detecting an analyte in a liquid sample, 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 said liquid sample flows laterally along said matrix, flow of said liquid sample 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, and:
- 1) after a liquid sample containing no analyte or an analyte below detection level flows laterally along said test device and passes said plurality of reagent dots, said plurality of reagent dots form two separate two-dimensional signal features A and B, and said feature A, feature B or a combination thereof, viewed from a direction substantially parallel or opposite to the liquid sample flow direction, indicates that a test is properly conducted and said sample contains no analyte or the analyte below detection level;
or2) after a liquid sample containing an analyte at or above detection level flows laterally along said test device and passes said plurality of reagent dots, said plurality of reagent dots;
a) form one discernible feature that is one of said features A and B, form additional signal feature C that obscures the other of said features A and B to form an obscured feature D, and said discernible feature from features A and B or a combination of said discernible feature from features A and B and said obscured feature D, viewed from a direction substantially parallel or opposite to the liquid sample flow direction, indicates that a test is properly conducted; and
b) form at least one additional two-dimensional signal feature E, and a combination of said discernible feature from features A and B and said feature E, viewed from a direction substantially perpendicular to the liquid sample flow direction, indicates that said sample contains said analyte at or above detection level.
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Abstract
The present invention relates to novel lateral flow devices using two dimensional features, preferably, uniform two dimensional test and control signal readout patterns, and the methods for detecting an analyte using the lateral flow devices.
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Citations
26 Claims
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1. A test device for detecting an analyte in a liquid sample, 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 said liquid sample flows laterally along said matrix, flow of said liquid sample 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, and:
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1) after a liquid sample containing no analyte or an analyte below detection level flows laterally along said test device and passes said plurality of reagent dots, said plurality of reagent dots form two separate two-dimensional signal features A and B, and said feature A, feature B or a combination thereof, viewed from a direction substantially parallel or opposite to the liquid sample flow direction, indicates that a test is properly conducted and said sample contains no analyte or the analyte below detection level;
or2) after a liquid sample containing an analyte at or above detection level flows laterally along said test device and passes said plurality of reagent dots, said plurality of reagent dots; a) form one discernible feature that is one of said features A and B, form additional signal feature C that obscures the other of said features A and B to form an obscured feature D, and said discernible feature from features A and B or a combination of said discernible feature from features A and B and said obscured feature D, viewed from a direction substantially parallel or opposite to the liquid sample flow direction, indicates that a test is properly conducted; and b) form at least one additional two-dimensional signal feature E, and a combination of said discernible feature from features A and B and said feature E, viewed from a direction substantially perpendicular to the liquid sample flow direction, indicates that said sample contains said analyte at or above detection level. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
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10. A test device for detecting an analyte in a liquid sample, 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 said liquid sample flows laterally along said matrix, flow of said liquid sample 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, and:
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1) after a liquid sample containing no analyte or an analyte below detection level flows laterally along said test device and passes said plurality of reagent dots, said plurality of reagent dots form two separate two-dimensional signal features A and B, said feature A, feature B or a combination thereof, viewed from a direction substantially parallel or opposite to the liquid sample flow direction, indicates that a test is properly conducted and said sample contains no analyte or the analyte below detection level;
or2) after a liquid sample containing an analyte at or above detection level flows laterally along said test device and passes said plurality of reagent dots, said plurality of reagent dots; a) form two separate two-dimensional signal features A and B and an additional signal feature C, said feature A, feature B or a combination thereof, viewed from a direction substantially parallel or opposite to the liquid sample flow direction, indicates that a test is properly conducted, and a combination of one or both of said features A and B and said feature C, viewed from a direction substantially parallel or opposite to the liquid sample flow direction, generates a signal that aids interpretation of the test result; and b) form at least one additional two-dimensional signal feature E, and a combination of at least one of said features A and B and said feature E, viewed from a direction substantially perpendicular to the liquid sample flow direction, indicates that said sample contains said analyte at or above detection level. - View Dependent Claims (11, 12, 13, 14, 15, 16)
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Specification