Back to results
US 9,804,154 B2Granted
Rapid test for urine albumin and urine creatinine
AssigneeEpinex Diagnostics, Inc.
InventorsWing T. Liu, Thien-Toan Tran, John Scott, Thomas Lee, Srishti Prasad, Azra Zaidi
Life of this patent
Estimating the term…
Abstract
Disclosed herein is an immunochromatographic system for measuring albumin and creatinine in a urine sample and a reader that detects signals from the test cassette, calculates, and displays the results for albumin concentration, creatinine concentration, and albumin-creatinine ratio.
Claims20
A device for determining an albumin-creatinine-ratio in a human sample comprising:
- a test cassette comprising a test strip, wherein the test strip consists of:
- a single sample application pad containing a sample well disposed on a solid support;
- a conjugate pad having disposed therein a creatinine-specific conjugate and an albumin-specific conjugate;
- a lateral flow membrane;
- a creatinine-specific test region in which the creatinine-specific conjugate which has not been bound by creatinine present in the sample is retained by a creatinine-specific immobilization agent associated with the membrane and creatinine-bound creatinine-specific conjugate is not retained by the creatinine-specific test region;
- a creatinine-specific control region in which the creatinine-bound creatinine-specific conjugate is retained by a creatinine conjugate-specific immobilization agent associated with the membrane in the creatinine-specific control region;
- an albumin-specific test region in which the albumin-specific conjugate which has not been bound by albumin present in the sample is retained by an albumin-specific immobilization agent associated with the membrane and albumin-bound albumin-specific conjugate is not retained by the albumin-specific test region;
- an albumin-specific control region in which the albumin-bound albumin-specific conjugate is retained by an albumin conjugate-specific immobilization agent associated with the membrane in the albumin-specific control region;
- a reservoir;
- and a measurement device to determine the concentration of albumin in the sample, the concentration of creatinine in the sample, and the albumin-creatinine-ratio, wherein said concentration of albumin is directly proportional to a diminution of signal from maximal in the albumin-specific test region and wherein said concentration of creatinine is directly proportional to a diminution of signal from maximal in the creatinine-specific test region.
7 more elements
A device for determining an albumin-creatinine-ratio in a human sample comprising:
- (1) a test cassette comprising:
- (a) a single sample application pad containing a sample well disposed on a solid support;
- (b) a conjugate pad having disposed therein a creatinine-specific conjugate and an albumin-specific conjugate;
- (c) a lateral flow membrane;
- and
- (d) two test strips, wherein
- (i) a first test strip comprises a first conjugate pad comprising a creatinine-specific test region in which the creatinine-specific conjugate which has not been bound by creatinine present in the sample is retained by a creatinine-specific immobilization agent associated with the membrane and creatinine-bound creatinine-specific conjugate is not retained by the creatinine-specific test region and a creatinine-specific control region in which the creatinine-bound creatinine-specific conjugate is retained by a creatinine conjugate-specific immobilization agent associated with the membrane in the creatinine-specific control region;
- and a first reservoir;
- and
- (ii) a second test strip comprises a second conjugate pad comprising an albumin-specific test region in which the albumin-specific conjugate which has not been bound by albumin present in the sample is retained by an albumin-specific immobilization agent associated with the membrane and albumin-bound albumin-specific conjugate is not retained by the albumin-specific test region;
- an albumin-specific control region in which the albumin-bound albumin-specific conjugate is retained by an albumin conjugate-specific immobilization agent associated with the membrane in the albumin-specific control region;
- and a second reservoir;
- wherein the first test strip and the second test strip are arranged in configuration parallel, opposite to each other, or at an angle to each other such that the first test strip and the second test strip share a single sample application pad;
- and
- (2) a measurement device to determine the concentration of albumin in the sample, the concentration of creatinine in the sample, and the albumin-creatinine-ratio, wherein said concentration of albumin is directly proportional to a diminution of signal from maximal in the albumin-specific test region and wherein said concentration of creatinine is directly proportional to a diminution of signal from maximal in the creatinine-specific test region.
12 more elements
Dependencies are inferred from the claim text.