Method and kit for detecting the early onset of renal tubular cell injury
First Claim
1. A method for the detection of a renal tubular cell injury in a mammal, including an ischemic renal injury and a nephrotoxic injury, comprising the steps of:
- 1) obtaining a urine sample from a mammalian subject;
2) contacting the urine sample with an antibody for a renal tubular cell injury biomarker, the biomarker comprising NGAL, to allow formation of a complex of the antibody and the biomarker; and
3) detecting the antibody-biomarker complex.
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Accused Products
Abstract
A method and kit for detecting the early onset of renal tubular cell injury, utilizing NGAL as an early urinary biomarker. NGAL is a small secreted polypeptide that is protease resistant and consequently readily detected in the urine following renal tubule cell injury. NGAL protein expression is detected predominantly in proximal tubule cells, in a punctate cytoplasmic distribution reminiscent of a secreted protein. The appearance NGAL in the urine is related to the dose and duration of renal ischemia and nephrotoxemia, and is diagnostic of renal tubule cell injury and renal failure. NGAL detection is also a useful marker for monitoring the nephrotoxic side effects of drugs or other therapeutic agents.
113 Citations
29 Claims
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1. A method for the detection of a renal tubular cell injury in a mammal, including an ischemic renal injury and a nephrotoxic injury, comprising the steps of:
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1) obtaining a urine sample from a mammalian subject;
2) contacting the urine sample with an antibody for a renal tubular cell injury biomarker, the biomarker comprising NGAL, to allow formation of a complex of the antibody and the biomarker; and
3) detecting the antibody-biomarker complex. - View Dependent Claims (2, 3, 4, 5)
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6. A method of monitoring the effectiveness of a treatment for a renal tubular cell injury, comprising the steps of:
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1) providing a treatment to a mammalian subject experiencing a renal tubular cell injury;
2) obtaining at least one post-treatment urine sample from the subject; and
3) detecting for the presence of a biomarker for the renal tubular cell injury in the post-treatment urine sample. - View Dependent Claims (7, 8, 9, 10, 11)
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12. A kit for use in detecting the presence of an immediate or early onset biomarker for a renal tubular cell injury, including an ischemic renal injury and a nephrotoxic injury, in the urinary fluid of a subject, comprising:
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1) a means for acquiring a quantity of a urine sample;
2) a media having affixed thereto a capture antibody capable of complexing with a biomarker for a renal tubular cell injury, the biomarker comprising NGAL; and
3) an assay for the detection of a complex of the biomarker and the capture antibody. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21)
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- 22. A competitive enzyme linked immunosorbent assay (ELISA) kit for determining the status of a renal tubular cell injury, including an ischemic renal injury and a nephrotoxic injury, of a mammalian subject, comprising a first antibody specific to NGAL to detect its presence in a urine sample of the subject.
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24. A method of identifying the extent of a renal tubular cell injury, including an ischemic renal injury and a nephrotoxic injury, caused by an event, comprising the steps of:
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1) obtaining at least one urine sample from a mammalian subject;
2) detecting in the urine sample the presence of a biomarker for a renal tubular cell injury; and
3) determining the extent of the renal tubular cell injury based on the time for onset of the presence of the biomarker in the urine sample, relative to the time of the event. - View Dependent Claims (25, 26, 27)
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28. A method for the detection of a renal tubular cell injury, including an ischemic renal injury and a nephrotoxic injury, in a mammal, comprising the steps of:
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1) obtaining a urine sample comprising up to 1 milliliter of the first urine from a mammalian subject;
2) contacting the urine sample with an antibody for a biomarker for a renal tubular cell injury, to allow formation of a complex of the antibody and the biomarker; and
3) detecting the antibody-biomarker complex. - View Dependent Claims (29)
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Specification