Devices for Detecting Renal Disorders

a technology for detecting kidney disorders and devices, which is applied in the field of devices for diagnosing, monitoring or determining renal disorders in mammals, can solve the problems of high cost of tests, and inability to detect renal disorders,

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

[0006]The present invention provides methods and devices for diagnosing, monitoring, or determining a renal disorder in a mammal. In particular, the present invention provides methods and devices for diagnosing, monitoring, or determining a renal disorder using measured concentrations of a combination of three or more analytes in a test sample taken from the mammal.

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 addition, renal disorders may also arise from secondary sources including drugs that are toxic to the kidneys and alternative disease states that cause secondary adverse effects on the kidney, such as diabetes and hypertension.
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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  • Devices for Detecting Renal Disorders
  • Devices for Detecting Renal Disorders
  • Devices for Detecting Renal Disorders

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

[0112]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.

[0113]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

[0120]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 2InterrunconcentrationRun 1ErrorRun 2ErrorAnalyte(ng / mL)Error (%)(%)Error (%)(%)Calbindin4.0626133653272811603Clusterin4.449263951682291302CTGF1.210174142.5191914141875139GST-alpha3.91475101613710114211668KIM-10.035205130.3245282.90574VEGF65101614534921275,397113149β-...

example 3

Linearity of Assay for Analytes Associated with Renal Disorders

[0122]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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Abstract

Devices for diagnosing, monitoring, or determining a renal disorder in a mammal are described. In particular, devices for diagnosing, monitoring, or determining a renal disorder 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, Methods and Devices for Detecting Kidney Damage, 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 devices fo...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): C40B40/10
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, DOMINIC P.BALLARD, KARRI L.SPAIN, MICHAEL D.
Owner MYRIAD RBM INC
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