DIAGNOSTIC USE OF INDIVIDUAL MOLECULAR FORMS OF A BIOMARKER
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Abstract
Methods are provided of diagnosing, monitoring or determining the severity of disease or injury by measuring individual molecular forms of neutrophil gelatinase-associated lipocalin (NGAL) in bodily fluids, including the diagnosis and monitoring of acute renal injury leading to acute renal failure in a human or mammalian subject by determining the concentration of the free monomer form of NGAL.
52 Citations
54 Claims
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1-28. -28. (canceled)
- 29. A method of diagnosing, monitoring, or assessing the severity of, or immediate risk of developing, renal injury, disease, or disorder in a mammal by measuring the concentration of free neutrophil gelatinase-associated lipocalin (NGAL) monomer in a sample of bodily fluid from the mammal and comparing said concentration with a range of concentrations of at least one molecular form of said NGAL that occurs in individuals not known to be affected by said renal injury, disease, or disorder, whereby a deviation of the concentration of said NGAL monomer from the range of concentrations of said at least one molecular form of said NGAL indicates the presence of, severity of, or immediate risk of developing said renal injury, disease, or disorder.
- 45. A method of diagnosing, monitoring, or assessing the presence or severity of disease or injury to an organ, tissue, or cell type in a mammal, said disease or injury being characterized by a certain pattern of concentrations of individual molecular forms of NGAL being present in a bodily fluid from said mammal, comprising measuring the concentrations of two or more individual molecular forms of NGAL in a sample of said bodily fluid and comparing the results with the pattern of said concentrations that occur in mammals having said disease or injury, whereby the presence of a particular pattern of concentrations in said sample of bodily fluid indicates the presence or severity of the corresponding type of disease or injury in said mammal.
- 49. A method of diagnosing, monitoring, or assessing the presence or severity of systemic disease or disease or injury of an organ, tissue, or cell type in a mammal by measuring the concentration of NGAL homodimer in a sample of bodily fluid from the mammal and comparing said concentration with the range of concentrations of NGAL homodimer that occurs in individuals not known to be affected by said disease or injury, whereby a deviation of the concentration from said range indicates the presence or severity of said disease or injury.
- 51. A method of selecting a binding molecule that is capable of binding specifically to NGAL monomer comprising assaying the binding of one or more candidate binding molecules to a preparation of NGAL monomer and a preparation of NGAL homodimer, and selecting the candidate binding molecules that bind to said NGAL monomer but not to said NGAL homodimer.
- 53. A method of selecting a binding molecule that is capable of binding specifically to a NGAL homodimer comprising assaying the binding of one or more candidate binding molecules to a preparation of NGAL monomer and a preparation of NGAL homodimer, and selecting the candidate binding molecules that bind to said NGAL homodimer but not to said NGAL monomer.
Specification