Electrochemical methods and devices for amending urine samples for immunosensor detection
First Claim
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1. A device configured to perform an immunoassay for a target analyte in an amended urine sample, the device comprising:
- a first region comprising reagents for of amending a urine sample, wherein the reagents comprise a water soluble protein for blocking non-specific binding of immunoglobulins at a sensor and a buffer; and
a second region comprising;
(i) a capture molecule capable of binding to the target analyte bound to a conjugate molecule labeled with an enzyme to form an immunocomplex, and (ii) the sensor comprising at least one electrode configured to detect the immunocomplex and determine a concentration of the target analyte in the amended urine sample,wherein the first region is configured to provide a dissolved concentration of the water soluble protein within the amended urine sample in a range of about 0.02 to 225 mg/mL; and
wherein the reagents further comprise a scavenger for reducing non-specific current generation from electroactive species at the at least one electrode.
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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.
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Citations
24 Claims
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1. A device configured to perform an immunoassay for a target analyte in an amended urine sample, the device comprising:
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a first region comprising reagents for of amending a urine sample, wherein the reagents comprise a water soluble protein for blocking non-specific binding of immunoglobulins at a sensor and a buffer; and a second region comprising;
(i) a capture molecule capable of binding to the target analyte bound to a conjugate molecule labeled with an enzyme to form an immunocomplex, and (ii) the sensor comprising at least one electrode configured to detect the immunocomplex and determine a concentration of the target analyte in the amended urine sample,wherein the first region is configured to provide a dissolved concentration of the water soluble protein within the amended urine sample in a range of about 0.02 to 225 mg/mL; and wherein the reagents further comprise a scavenger for reducing non-specific current generation from electroactive species at the at least one electrode. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A device configured to perform an immunoassay for a target analyte in an amemded urine sample, the device comprising:
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a first region comprising reagents for amending a urine sample, wherein the reagents comprise a water soluble protein for blocking non-specific binding of immunoglobulins at a sensor and a buffer; a capture molecule capable of binding to the target analyte to form an immunocomplex; a second region comprising the sensor comprising at least one electrode configured to detect the immunocomplex and determine a concentration of the target analyte in the amended urine sample; and a third region comprising a limited wash solvent capable of being delivered to the second region to wash the amended urine sample from the second region, wherein the first region is configured to provide a dissolved concentration of the water soluble protein within the amended urine sample in a range of about 0.02 to 225 mg/mL; and wherein the reagents further comprise a scavenger for reducing non-specific current generation from electroactive species at the at least one electrode.
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13. A device configured to perform an immunoassay for a target analyte in an amended urine sample, the device comprising:
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a first region comprising reagents for amending a urine sample, wherein the reagents comprise a water soluble protein for blocking non-specific binding of immunoglobulins at a sensor and a buffer; a capture molecule capable of binding to the target analyte to form an immunocomplex; and a second region comprising the sensor comprising at least one electrode configured to detect the immunocomplex and determine a concentration of the target analyte in the amended urine sample, wherein the first region is configured to provide a dissolved concentration of the water soluble protein within the amended urine sample in a range of about 0.02 to 225 mg/mL; and wherein the reagents further comprise urease for reducing a urea concentration of the urine sample below a preselected urea threshold. - View Dependent Claims (14, 15, 16, 17, 18)
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19. A device configured to perform an immunoassay for a target analyte in an amended urine sample, the device comprising:
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a first region comprising reagents for amending a urine sample, wherein the reagents comprise a water soluble protein for blocking non-specific binding of immunoglobulins at a sensor and a buffer; a second region comprising the sensor comprising;
(i) a capture molecule capable of binding to the target analyte to form an immunocomplex, and (ii) at least one electrode configured to detect the immunocomplex and determine a concentration of the target analyte in the amended urine sample; anda third region comprising a limited wash solvent capable of being delivered to the second region to wash the amended urine sample from the second region, wherein the first region is configured to provide a dissolved concentration of the water soluble protein within the amended urine sample in a range of about 0.02 to 225 mg/mL; and wherein the reagents further comprise urease for reducing a urea concentration of the urine sample below a preselected urea threshold. - View Dependent Claims (20, 21, 22, 23, 24)
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Specification