Electrochemical methods and devices for amending urine samples for immunosensor detection

摘要

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.

主权项

1. 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 to remove or reduce a urea concentration in the urine sample below a preselected urea threshold, wherein the reagents comprise urease and a buffer; and a second region comprising at least one electrode coated with a biolayer comprising an attached capture antibody configured to bind to the target analyte, which is different from that of the urea, wherein the second region is 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 10,000 IU/mL.