Metering technique for lateral flow assay devices
First Claim
1. A diagnostic test kit for detecting the presence of an analyte within a test sample, the test kit comprising a lateral flow assay device that includes a membrane, wherein a metering channel is formed in the membrane that has a width that is the same or substantially equal to the width of the membrane, the depth of the metering channel being from about 0.1 to about 800 micrometers, and further wherein the membrane defines a detection zone that is located downstream from the metering channel.
2 Assignments
0 Petitions
Accused Products
Abstract
A diagnostic test kit for detecting an analyte residing in a test sample is provided. The kit employs a lateral flow device that contains a membrane. A metering channel is formed in the membrane that is capable of delivering a controlled volume of the test sample to a detection zone upon initiation of the assay. Such a metering channel is particularly effective for embodiments in which the test sample has a relatively low volume, such as less than about 100 microliters, in some embodiments less than about 25 microliters, and in some embodiments, less than about 10 microliters. For example, whole blood drops obtained from patients with a lancet from low-pain areas (due to reduced nerve endings than finger), such as the forearm, thigh, or other alternate sites, may have a volume of from about 0.1 to about 5 microliters. Despite their low volume, the present inventors have discovered that the blood drops may still be accurately analyzed for the presence of an analyte using lateral flow detection techniques.
127 Citations
16 Claims
- 1. A diagnostic test kit for detecting the presence of an analyte within a test sample, the test kit comprising a lateral flow assay device that includes a membrane, wherein a metering channel is formed in the membrane that has a width that is the same or substantially equal to the width of the membrane, the depth of the metering channel being from about 0.1 to about 800 micrometers, and further wherein the membrane defines a detection zone that is located downstream from the metering channel.
-
4. (canceled)
-
16-33. -33. (canceled)
Specification