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Methods and Devices for Detecting Kidney Damage

Inactive Publication Date: 2011-03-17
MYRIAD RBM INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0007]The present invention provides methods and devices for diagnosing, monitoring, or determining kidney damage in a mammal. In particular, the present invention provides methods

Problems solved by technology

Because compounds in circulation are concentrated in the kidney up to 1000-fold relative to the plasma concentration, the kidney is especially vulnerable to injury due to exposure to toxic compounds.
In the pharmaceutical industry, drug-induced kidney injury is a major cause for delay during the development of candidate drugs.
However, these diagnostic tests typically detect only late signs of kidney damage and provide little information as to the location of kidney damage.
Other diagnostic tests such as kidney tissue biopsies or CAT scans have the advantage of enhanced sensitivity to earlier stages of kidney damage, but these tests are also generally costly, slow, and / or invasive.

Method used

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  • Methods and Devices for Detecting Kidney Damage
  • Methods and Devices for Detecting Kidney Damage
  • Methods and Devices for Detecting Kidney Damage

Examples

Experimental program
Comparison scheme
Effect test

example 1

Least Detectable Dose and Lower Limit of Quantitation of Assay for Analytes Associated with Renal Disorders

[0102]To assess the least detectable doses (LDD) and lower limits of quantitation (LLOQ) of a variety of analytes associated with renal disorders, the following experiment was conducted. The analytes measured were alpha-1 microglobulin (A1M), beta-2 microglobulin (B2M), calbindin, clusterin, CTGF, cystatin C, GST-alpha, KIM-1, NGAL, osteopontin (OPN), THP, TIMP-1, TFF-3, and VEGF.

[0103]The concentrations of the analytes were measured using a capture-sandwich assay using antigen-specific antibodies. For each analyte, a range of standard sample dilutions ranging over about four orders of magnitude of analyte concentration were measured using the assay in order to obtain data used to construct a standard dose response curve. The dynamic range for each of the analytes, defined herein as the range of analyte concentrations measured to determine its dose response curve, is presented ...

example 2

Precision of Assay for Analytes Associated with Renal Disorders

[0110]To assess the precision of an assay used to measure the concentration of analytes associated with renal disorders, the following experiment was conducted. The analytes measured were alpha-1 microglobulin (A1M), beta-2 microglobulin (B2M), calbindin, clusterin, CTGF, cystatin C, GST-alpha, KIM-1, NGAL, osteopontin (OPN), THP, TIMP-1, TFF-3, and VEGF. For each analyte, three concentration levels of standard solution were measured in triplicate during three runs using the methods described in Example 1. The percent errors for each run at each concentration are presented in Table 3 for all of the analytes tested:

TABLE 3Precision of Analyte AssayAverageRun 1Run 2Run 2InterrunconcentrationErrorError ErrorErrorAnalyte(ng / mL)(%)(%)(%)(%)Calbindin4.0626133653272811603Clusterin4.449263951682291302CTGF1.210174142.5191914141875139GST-alpha3.91475101613710114211668KIM-10.035205130.3245282.90574VEGF65101614534921275,397113149β-2...

example 3

Linearity of Assay for Analytes Associated with Renal Disorders

[0112]To assess the linearity of an assay used to measure the concentration of analytes associated with renal disorders, the following experiment was conducted. The analytes measured were alpha-1 microglobulin (A1M), beta-2 microglobulin (B2M), calbindin, clusterin, CTGF, cystatin C, GST-alpha, KIM-1, NGAL, osteopontin (OPN), THP, TIMP-1, TFF-3, and VEGF. For each analyte, three concentration levels of standard solution were measured in triplicate during three runs using the methods described in Example 1. Linearity of the assay used to measure each analyte was determined by measuring the concentrations of standard samples that were serially-diluted throughout the assay range. The % recovery was calculated as observed vs. expected concentration based on the dose-response curve. The results of the linearity analysis are summarized in Table 4.

TABLE 4Linearity of Analyte AssayExpectedObservedRecoveryAnalyteDilutionconcentra...

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PUM

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Abstract

Methods and devices for diagnosing, monitoring, or determining kidney damage in a mammal are described. In particular, methods and devices for diagnosing, monitoring, or determining kidney damage using measured concentrations of a combination of three or more analytes in a test sample taken from the mammal are described.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims the priority of U.S. provisional application Ser. No. 61 / 327,389, filed Apr. 23, 2010, and U.S. provisional application Ser. No. 61 / 232,091, filed Aug. 7, 2009, each of which is hereby incorporated by reference in its entirety and is related to U.S. patent application Ser. Nos. [Not Yet Assigned], entitled Methods and Devices for Detecting Obstructive Uropathy and Associated Disorders, Computer Methods and Devices for Detecting Kidney Damage, Devices for Detecting Renal Disorders, Methods and Devices for Detecting Kidney Transplant Rejection, Methods and Devices for Detecting Diabetic Nephropathy and Associated Disorders, and Methods and Devices for Detecting Glomerulonephritis and Associated Disorders, Attorney Docket Nos. 060075-, filed on the same date as this application, the entire contents of which are incorporated herein by reference.FIELD OF THE INVENTION[0002]The invention encompasses methods and devices f...

Claims

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Application Information

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IPC IPC(8): C40B30/04
CPCG01N33/6893G01N2800/34Y10T436/147777G01N33/566G01N33/5302G01N2333/47G01N2333/4703G01N2333/4706G01N2333/4725G01N2333/4727G01N2333/475G01N2333/52G01N2333/70503G01N2333/70539G01N2333/765G01N2333/775G01N2333/8139G01N2333/8146G01N2333/82G01N2333/91177G01N2800/347G01N2800/52G01N2800/56G01N2800/60
Inventor LABRIE, SAMUEL T.MAPES, JAMES P.MCDADE, RALPH L.EISINGER, DOMINICBALLARD, KARRI L.SPAIN, MICHAEL D.
Owner MYRIAD RBM INC
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