Electrochemical methods and devices for amending urine samples for immunosensor detection
AssigneeAbbott Point of Care Inc.
InventorsKatrina Di Tullio, G. Bruce Collier, John Lewis Emerson Campbell
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Abstract
The present invention is directed to methods and devices for amending undiluted and partially diluted urine samples in a manner suitable for performing immunoassays for target analytes, for example NGAL. Generally, the urine sample is treated with reagents including at least one of buffer materials, water soluble proteins, urease, and other interferent mitigants. These reagents control the pH of the urine sample in a manner suitable for immuno-binding reactions and ameliorate interferences, particularly during the detection step.
Claims20
A device configured to perform an immunoassay for a target analyte in a urine sample, the device comprising:
- a first region comprising reagents configured to amend the urine sample, wherein the reagents comprise urease and a buffer;
- and
- a second region comprising at least one electrode configured to determine a concentration of the target analyte in the amended urine sample,
- wherein the first region is configured to provide a dissolved urease enzymatic activity within the amended urine sample in a range of about 10 to 10,0000 IU/mL.
A method for performing an immunoassay for a target analyte in a urine sample, the method comprising:
- providing a test device with reagents disposed in a first region of the test device and at least one electrode disposed in a second region of the test device, wherein the reagents comprise urease and a buffer;
- amending a urine sample with the reagents such that a dissolved urease enzymatic activity within the amended urine sample is in a range of about 10 to 10,0000 IU/mL;
- and
- determining a concentration of the target analyte within the amended urine sample using the at least one electrode.
A device configured to perform an enzyme based immunoassay for a target analyte in a urine sample, the device comprising:
- a first region comprising reagents configured to amend the urine sample, wherein the reagents comprise urease and a buffer;
- a second region comprising at least one electrode configured to determine a concentration of the target analyte in the amended urine sample;
- and
- a third region configured to provide a limited wash solvent for the second region configured to wash the amended urine sample,
- wherein the first region is configured to provide a dissolved urease enzymatic activity within the amended urine sample in a range of about 10 to 10,000 IU/ml.
Dependencies are inferred from the claim text.