US20100151488A1 - Rapid Test for Glycated Albumin - Google Patents

Rapid Test for Glycated Albumin Download PDF

Info

Publication number
US20100151488A1
US20100151488A1 US12/645,387 US64538709A US2010151488A1 US 20100151488 A1 US20100151488 A1 US 20100151488A1 US 64538709 A US64538709 A US 64538709A US 2010151488 A1 US2010151488 A1 US 2010151488A1
Authority
US
United States
Prior art keywords
albumin
test
glycated albumin
system
microparticles
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US12/645,387
Inventor
Henry J. Smith
Asad Zaidi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Epinex Diagnostics Inc
Original Assignee
Epinex Diagnostics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US50539203P priority Critical
Priority to PCT/US2004/031202 priority patent/WO2005031356A1/en
Priority to US10/538,392 priority patent/US7659107B2/en
Application filed by Epinex Diagnostics Inc filed Critical Epinex Diagnostics Inc
Priority to US12/645,387 priority patent/US20100151488A1/en
Assigned to EPINEX DIAGNOSTICS, INC. reassignment EPINEX DIAGNOSTICS, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SMITH, HENRY J., ZAIDI, ASAD
Publication of US20100151488A1 publication Critical patent/US20100151488A1/en
Application status is Abandoned legal-status Critical

Links

Images

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803General methods of protein analysis not limited to specific proteins or families of proteins
    • G01N33/6842Proteomic analysis of subsets of protein mixtures with reduced complexity, e.g. membrane proteins, phosphoproteins, organelle proteins
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/76Assays involving albumins other than in routine use for blocking surfaces or for anchoring haptens during immunisation
    • G01N2333/765Serum albumin, e.g. HSA
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00Chemistry: molecular biology and microbiology
    • Y10S435/805Test papers
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00Chemistry: molecular biology and microbiology
    • Y10S435/81Packaged device or kit
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00Chemistry: molecular biology and microbiology
    • Y10S435/97Test strip or test slide
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00Chemistry: molecular biology and microbiology
    • Y10S435/973Simultaneous determination of more than one analyte
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00Chemistry: molecular biology and microbiology
    • Y10S435/975Kit
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00Chemistry: analytical and immunological testing
    • Y10S436/807Apparatus included in process claim, e.g. physical support structures
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00Chemistry: analytical and immunological testing
    • Y10S436/807Apparatus included in process claim, e.g. physical support structures
    • Y10S436/808Automated or kit
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00Chemistry: analytical and immunological testing
    • Y10S436/807Apparatus included in process claim, e.g. physical support structures
    • Y10S436/81Tube, bottle, or dipstick
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00Chemistry: analytical and immunological testing
    • Y10S436/815Test for named compound or class of compounds

Abstract

A rapid immunochromatographic assay system is provided for measuring the amount of glycated albumin in a blood sample relative to the total level of albumin in the sample. The assay system is comprised of a disposable cassette that contains the test strips and testing reagents, and a measurement device that automatically reads, calculates and displays the test results over a period of time. The test cassette contains two test strips that are used to measure glycated albumin and total albumin respectively. The strips are contiguous beneath the single sample application well so that the same sample is tested simultaneously by both test strips. Part of the sample will migrate thru the glycated albumin test strip where it will react with the glycated albumin test reagents to yield a glycated albumin result, while part of the sample will migrate thru the total albumin test strip where it will react with the total albumin test reagents to yield a total albumin result. The test cassette is placed within a measuring device such as a reflectance spectrometer or fluorometer, that reads, calculates and expresses the result as the percentage of glycated albumin relative to total albumin in the sample. The results of successive testing that are performed over a period of time are stored in the instrument's memory and displayed in a numerical or graphical format so that the individual's glycated albumin levels can be monitored over time.

Description

    RELATED APPLICATIONS
  • This application is a continuation of U.S. patent application Ser. No. 10/538,392 filed Apr. 27, 2006, which is an application under Section 371 of International patent application number PCT/US2004/031202 filed Sep. 22, 2004 which in turn claims the benefit under 35 USC §119(e) to U.S. provisional patent application Ser. No. 60/505,392 filed Sep. 23, 2003, the entire contents of all of which are incorporated by reference herein.
  • FIELD OF THE INVENTION
  • This invention relates generally to medical devices for measuring levels of glycated albumin in blood from patients with diabetes. More specifically, the present invention uses lateral flow immunochromatography to measure both glycated albumin and total albumin in a single sample. Additionally the present invention provides methods for monitoring levels of glycated albumin in the blood of diabetes patients using a point-of-care assay and medical device.
  • BACKGROUND OF THE INVENTION
  • Diabetes mellitus, or diabetes, is a disease characterized by elevated levels of plasma glucose. Uncontrolled hyperglycemia is associated with increased risk of vascular disease including, nephropathy, neuropathy, retinopathy, hypertension, and death. There are two major forms of diabetes: Type 1 diabetes (or insulin-dependent diabetes) and Type 2 diabetes (or non insulin-dependent diabetes). The American Diabetes Association has estimated that approximately 6% of the world population has diabetes.
  • The goal of diabetic therapy is to maintain a normal level of glucose in the blood. The American Diabetic Association has recommended that diabetics monitor their blood glucose level at least three times a day in order to adjust their insulin dosages and/or their eating habits and exercise regimen. However, glucose tests can only measure a point in time result and do not provide an overall assessment of glycemic control over a period of time. The measurement of glycated albumin has proven to be valuable measure of the effectiveness of glycemic control over the preceding 2-3 weeks. The basis for measuring glycated albumin depends on the nonenzymatic glycosylation of albumin and is directly proportional to the level of glucose in plasma over a period of time. The half-life of albumin in plasma is 2-3 weeks and as glycosylation occurs at a constant rate over time the level of glycated albumin provides a measure of the average blood glucose level over the preceding two to three weeks.
  • Frequent monitoring of the individual's glycated albumin would provide an accurate assessment of overall effectiveness of glycemic control in the individual.
  • Current methodology for performing tests for glycated albumin are complex to perform or require expensive instrumentation and are generally performed in laboratories. It would be advantageous to develop a simplified point-of-care assay that could be utilized in a doctor's office or by the patient and there is intensive research to develop such a test.
  • The present invention describes a simplified point-of-care assay that utilizes disposable test strips and a reusable measuring instrument.
  • SUMMARY OF THE INVENTION
  • The present invention is directed to medical devices and methods for monitoring levels of glycated albumin in the blood of diabetes patients using a point-of-care assay and medical device. Specifically, the present invention uses lateral flow immunochromatography to measure both glycated albumin and total albumin in a single sample.
  • In an embodiment of the present invention, an immunochromatographic system is provided for measuring glycated albumin in a blood sample comprising a first test strip that measures glycated albumin and a second test strip that measures total albumin; and a measurement device that reads, calculates and displays the result as the percentage of glycated albumin compared to total albumin in the sample.
  • In another embodiment of the present invention, the first test strip is comprised of microparticles coated with a first antibody to glycated albumin and an immobilization agent covalently bound to the membrane strip. The immobilization agent is a second antibody to glycated albumin or phenyl boronic acid.
  • In alternative embodiments of the present invention the first and second antibodies to glycated albumin are individually monoclonal or polyclonal antibodies. The polyclonal antibodies may be the whole antiserum, the IgG fraction or the purified antibody.
  • In an embodiment of the present invention, the microparticles of the first test strip are selected from the group consisting of colloidal gold particles, latex particles, polystyrene particles, acrylic particles or other solid phase microparticles. Additionally the size of the microparticles can vary from approximately 5 nm to approximately 50 nm in diameter.
  • In another embodiment of the present invention, the second test strip is comprised of microparticles coated with a first antibody to albumin and an second antibody to albumin covalently bound to the membrane strip.
  • In an embodiment of the present invention, the first and second antibodies to albumin are individually monoclonal or polyclonal antibodies. The polyclonal anti-albumin antibodies may be the whole antiserum, the IgG fraction or the purified antibody.
  • In an embodiment of the present invention, the microparticles of the second test strip are selected from the group consisting of colloidal gold particles, latex particles, polystyrene particles, acrylic particles or other solid phase microparticles. Additionally the size of the microparticles can vary from approximately 5 nm to approximately 50 nm in diameter.
  • In another embodiment of the present invention the microparticles of either of the first or second test strips can have particle size diameters of 10 nm, 20 nm, 30 nm and 40 nm.
  • In yet another embodiment of the present invention, the microparticles of either the first or second test strip can either colored or tagged with a fluorescent compound.
  • In an embodiment of the present invention, the first test strip and the second test strip may be arranged in parallel; or opposite to each other; or at an angle to each other. Additionally the first test strip and the second test strip are enclosed in a rigid cassette.
  • In an embodiment of the present invention the measurement device is a reflectance spectrometer comprising: a reflectance detector for measuring the glycated albumin test result; a reflectance detector for measuring the glycated albumin control band; a reflectance detector for measuring the total albumin test result; a reflectance detector for measuring the total albumin control band; an internal computer chip for measurement and calculation; a liquid crystal display; an external port to transfer data to an external computer and/or printer; a battery and/or an external power source; and a rigid external case with an aperture for inserting the test cassette.
  • In an embodiment of the present invention the measurement device is a fluorometer composed comprising: a fluorescence detector for measuring the glycated albumin test result; a fluorescence detector for measuring the glycated albumin control band; a fluorescence detector for measuring the total albumin test result; a fluorescence detector for measuring the total albumin control band; an internal computer chip for measurement and calculation; a liquid crystal display; an external port to transfer data to an external computer and/or printer; a battery and/or an external power source; and a rigid external case with an aperture for inserting the test cassette.
  • In another embodiment of the present invention the measurement device further comprises an internal memory chip capable of storing one or more than one test result.
  • In yet another embodiment of the present invention, the measurement device can display one or more than one test result on the measurement device's liquid crystal display in numerical format or in graphical format. Additionally the test results can be transferred to an external computer or printer.
  • In an embodiment of the present invention, a method of monitoring glycated albumin using a point-of-care assay is provided comprising: depositing a drop of blood into a sample well of an immunochromatography system test cassette; transferring said blood into the sample application pad thereby allowing blood plasma to pass into a first conjugate pad of a first test strip; binding said blood plasma to anti-glycated albumin antibody-coated microparticles in said first conjugate pad; allowing blood plasma-bound anti-glycated albumin antibody-coated microparticles to migrate across said first conjugate pad to a fixed band of membrane-bound anti-glycated albumin antibody; binding said blood plasma-bound anti-glycated albumin antibody-coated microparticles to said membrane bound anti-glycated albumin antibody to form a visible band; inserting said immunochromatography system test casette into a measurement device; and providing numerical results of glycated albumin levels.
  • In an embodiment of the present invention, the method of monitoring glycated albumin using a point-of-care assay further comprises: depositing a drop of blood into a sample well of an immunochromatography system cassette; transferring said blood into the sample application pad thereby allowing blood plasma to pass into a second conjugate pad of a second test strip; binding said blood plasma to anti-total albumin antibody-coated microparticles in said second first conjugate pad; allowing blood plasma-bound anti-total albumin antibody-coated microparticles to migrate across said second conjugate pad to a fixed band of membrane-bound anti-total albumin antibody; binding said blood plasma-bound anti-total albumin antibody-coated microparticles to said membrane bound anti-total albumin antibody to form a visible band; inserting said immunochromatography system test cassette into a measurement device; and providing numerical results of total albumin levels.
  • In another embodiment of the present invention, a method of monitoring glycated albumin using a point-of-care assay is provided wherein glycated albumin levels and said total albumin levels are used to determine percent glycated albumin.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • FIG. 1 depicts a first view of the test strips made in accordance with the teachings of the present invention.
  • FIG. 2 depicts a second view of the test strips made in accordance with the teachings of the present invention.
  • FIG. 3 depicts a side view of the test strips made in accordance with the teachings of the present invention.
  • FIG. 4 depicts a reflectance spectrometer as used with the test strips made in accordance with the methods of the present invention.
  • FIG. 4 b depicts a fluorometer as used with the test strips made in accordance with the methods of the present invention.
  • FIG. 5 depicts a first view of a test strip cassette made in accordance with the teachings of the present invention.
  • FIG. 6 depicts a second view of a test strip cassette made in accordance with the teachings of the present invention.
  • FIG. 7 depicts a reflectance spectrometer and test strip as used in accordance with the methods of the present invention.
  • DESCRIPTION OF THE INVENTION
  • This invention utilizes the principle of lateral flow immunochromatography to measure both glycated albumin and total albumin. The patient's blood sample is placed in a test cassette that contains reagents to separate the plasma from the red blood cells and to perform the test. The test cassette is then inserted into a measuring instrument that reads, calculates and reports the result.
  • The rapid assay for glycated albumin is an immunochromatographic method that utilizes antibodies to glycated albumin and antibodies to total albumin on test strips. In order to measure the percent of glycated albumin to total albumin, two procedures are involved. The first procedure utilizes an immunochromatographic test strip to measure glycated albumin. The second procedure utilizes an immunochromatographic test strip to measure total albumin. Both strips are contained within a single exterior cassette (FIG. 1) that is inserted into a measuring instrument (FIG. 7) that automatically reads, calculates and displays the result.
  • Glycated Albumin Test
  • The test strip for measuring glycated albumin is shown in FIGS. 1 and 2. The test strip consists of a solid phase support (1), including but not limited to a cellulose nitrate membrane, to which antibody to glycated albumin has been fixed to the solid-phase substrate as a band (2). A sample application pad (3) contacts a conjugate pad (4) containing microparticles coated with anti-glycated albumin antibody. A control band is provided to bind excess unreacted microparticles (5) and a reservoir pad (6) is provided at the distal end of the membrane to absorb excess sample fluid. The test strip is enclosed within a rigid cassette containing a sample well and window segments to allow for visualization and measurement of the test result.
  • To perform the test a small volume of blood is placed into the sample well. The blood migrates into the sample application pad which filters and binds the red blood cells allowing the plasma to pass through into the conjugate pad where it reacts with the antibody coated microparticles. Any glycated albumin present binds to the anti-glycated albumin antibody-coated microparticles. The microparticles continue to migrate across the cellulose membrane until they come into contact with the fixed band of anti-glycated albumin antibody. Any glycated albumin bound to microparticles becomes bound to the membrane and causes the bound microparticles to form a visible band. The intensity of the band is proportional to the amount of glycated albumin bound to the microparticles. The intensity of the visible band is estimated visually by comparison to a visual standard or measured in an instrument developed for this purpose.
  • Total Albumin Test
  • The test strip for measuring total albumin is shown in FIGS. 1 and 2. It consists of a solid phase substrate (1), including but not limited to a cellulose nitrate membrane (1) to which antibody to albumin has been fixed as a band (7). A sample application pad (3) contacts a conjugate pad (8) containing microparticles coated with anti-albumin antibody. A control band (9) is provided to bind excess unreacted microparticles and a reservoir pad (6) is provided at the distal end of the membrane to absorb excess sample fluid. The test strip is enclosed within a rigid cassette containing a sample well and window segments to allow for visualization and measurement of the test result.
  • To perform the test a small volume of blood is placed into the sample well. The blood migrates from the sample application pad which filters and binds the red blood cells allowing the plasma to pass into the conjugate pad where it reacts with the antibody coated microparticles. Any albumin present binds to the anti-albumin antibody coated microparticles. The microparticles continue to migrate across the cellulose membrane until they come into contact with the fixed band of anti-albumin antibody. Any albumin bound to microparticles becomes bound to the membrane and causes the bound microparticles to form a visible band. The intensity of the band is proportional to the amount of albumin bound to the microparticles. The intensity of the visible band is estimated visually by comparison to a visual standard or measured in an instrument developed for this purpose.
  • Measuring Instrument
  • In one embodiment of this invention, the measuring instrument is a reflectance spectrophotometer that is specifically designed to measure the intensity of the glycated albumin test band on the glycated albumin test strip, the total albumin test band on the total albumin test strip, and to calculate a result from these readings. The instrument has two sets of detectors: one detector set is for measuring glycated albumin and the other detector set is for measuring total albumin. The result is then calculated according to a mathematical algorithm derived from data obtained from measurement of standards of glycated and total albumin. The result is expressed as the percent of glycated albumin compared to total albumin present.
  • Alternatively, other methods for measuring the density of the aggregated microparticles may be employed. For example, in another embodiment of the present invention, the measuring instrument may be a fluorometer that measures the fluorescence that is emitted from microroparticles that have been tagged with a fluorescent dye including, but not limited to, fluorescein or rhodamine red. In this embodiment there will be an excitatory beam of light projected onto the test bands and onto the control bands, and the emitted light from each band will be individually read by the corresponding detectors sensitive to the wavelength of the emitted light. The data reduction and reporting of the result will be as described above for the reflectance spectrophotometer.
  • EXAMPLE 1 Glycated Albumin Test
  • A blood sample, such as that obtained from a finger stick, is placed in the sample well and allowed to absorb into the sample application pad. The sample application pad is composed of porous cellulose material but other woven or porous materials including but not limited to glass fibers may be used. The sample application pad has a porosity that does not allow the passage of red blood cells but allows the passage of the plasma. Alternatively, the application pad can be treated with binding agents such as lectins that bind the red blood cells and prevent them from passage through the application membrane.
  • The filtered plasma sample then flows into a conjugate pad containing microparticles. The conjugate pad is composed of porous cellulose material but other woven or porous materials such as glass fibers may be used. The microparticles are composed of materials including, but not limited to, colloidal gold, latex particles, acrylic particles or polystyrene particles with diameters that may range from approximately 5 nm to 50 nm. Microparticles composed of other materials may also be employed and are within the scope of this invention. In alternative embodiment of the present invention, colored or fluorescent tagged microparticles can be employed to increase the sensitivity of the system.
  • In embodiments of the present invention, the microparticles are coated with either polyclonal or monoclonal antibodies to glycated albumin. The polyclonal anti-glycated albumin antibodies are prepared in immunized animals, including but not limited to rabbits, sheep, goats, or other immunized species of animals, or by monoclonal antibody techniques. Either the whole antiserum, or the IgG purified fraction, or the affinity purified antibody to glycated albumin may be employed. The methods for immunization of animals and the preparation and purification of antibody is performed according to standard laboratory procedures and are known to those skilled in the art.
  • Similarly, the methods of developing monoclonal antibodies is performed according to standard laboratory procedures and are known to those skilled in the art. The microparticles may be coated with the antibody by passive adsorption, by chemical conjugation such as covalent binding, or through binding to an intermediate agent such as to Protein A-coated microparticles. The methods for coating microparticles are performed according to standard laboratory procedures and are familiar to those skilled in the art.
  • When the test sample comes into contact with the antibody coated microparticles, the antibody will bind any glycated albumin present. The microparticles will continue to migrate across the membrane until they reach the band of anti-glycated albumin antibody fixed to the membrane. Any microparticles containing bound glycated albumin will become bound to the fixed band of anti-glycated albumin antibody to form a visible band.
  • Alternatively the membrane may be treated with chemicals known to bind glycated proteins such as phenyl boronic acids which are applied as a band to the membrane strip. Any microparticles containing bound glycated albumin will become bound to the fixed band of phenyl boronic acid to form a visible band. Independent of the method by which the glycated albumin becomes bound to the test strip, the density of the band formed will be directly proportional to the amount of glycated albumin present in the blood sample. The density of the band can be measured using a reflectance spectrometer for colored microparticles or a fluorometer for microparticles tagged with a fluorescent compound. The measurements are used to calculate the percentage of glycated albumin compared to total albumin in the blood sample.
  • In order to verify that the test strips are functioning correctly each test strip can additionally have a control band located distal to the test band. For the glycated albumin test strip this control band is composed of antibody directed against the species antibody that was used to coat the microparticles. For example, if rabbit anti-human glycated albumin antibody used to coat the microparticles, then the control band would use another species such as goat or sheep antibodies directed against rabbit IgG immunoglobulin. The antibodies in the control band bind to the excess unreacted antibody-coated microparticles that were not bound to the test band but continued to migrate across the membrane until bound by the control reagent. The intensity of the control band is measured using a reflectance spectrometer or fluorometer and the data is used to determine if the test is performing correctly.
  • EXAMPLE 2 Total Albumin Test
  • A blood sample, such as that obtained from a finger stick, is placed in the sample well and allowed to absorb into the sample application pad. The sample application pad is composed of porous cellulose material but other woven or porous materials, including but not limited to glass fibers may be used. The sample application has a porosity that does not allow the passage of red blood cells but allows the passage of the plasma. Alternatively, the application pad can be treated with binding agents such as lectins that bind the red blood cells and prevent them from passage through the application membrane.
  • The filtered plasma sample then flows into a conjugate pad containing microparticles. The conjugate pad is composed of porous cellulose material but other woven or porous materials, including but not limited to glass fibers may be used. The microparticles are composed of materials including, but not limited to, colloidal gold, latex particles, acrylic particles or polystyrene particles with diameters that may range from approximately 5 nm to 50 nm. Microparticles composed of other materials may also be employed and are within the scope of this invention. Colored or fluorescence tagged microparticles may be employed to increase the sensitivity of measurement of the result.
  • In embodiments of the present invention, the microparticles are coated with either polyclonal or monoclonal antibodies to glycated albumin. The polyclonal anti-albumin antibodies are prepared in immunized animals including but not limited to rabbits, sheep, goats, or other immunized species of animals, or by monoclonal antibody techniques. Either the whole antiserum, or the IgG purified fraction, or the affinity purified antibody to albumin may be employed. The methods for immunization of animals and the preparation and purification of antibody is performed according to standard laboratory procedures and are known to those skilled in the art. Similarly, the methods of developing monoclonal antibodies are performed according to standard laboratory procedures and are known to those skilled in the art.
  • The microparticles may be coated with the antibody by passive adsorption, by chemical conjugation such as covalent binding, or through binding to an intermediate agent such as to Protein A-coated microparticles. The methods for coating microparticles are performed according to standard laboratory procedures and are familiar to those skilled in the art.
  • When the test sample comes into contact with the antibody coated microparticles the antibody binds any albumin present. The microparticles continue to migrate across the membrane until they reach the band of anti-albumin antibody fixed to the membrane. Any microparticles containing bound albumin become bound to the fixed band of anti-albumin antibody to form a visible band. The density of the band formed is directly proportional to the amount of albumin present in the blood sample. The density of the band is measured using a reflectance spectrometer for colored microparticles or a fluorometer for microparticles tagged with a fluorescent compound. The measurements are used to calculate the percentage of glycated albumin compared to total albumin in the blood sample.
  • In order to verify that the test strips are functioning correctly each test strip has an additional band of fixed reagent located distal to the test band. For the test strip, this control band is composed of antibody directed against the species antibody that was used to coat the microparticles. For example, if rabbit anti-human albumin antibody was used to coat the microparticles then the control band uses another species such as goat or sheep antibodies directed against rabbit IgG immunoglobulin. The antibodies in the control band bind to the excess unreacted antibody coated microparticles that were not bound to the test band but continued to migrate across the membrane until bound by the control reagent. The intensity of the control band is measured using a reflectance spectrometer or fluorometer and the data is used to determine if the test is performing correctly.
  • EXAMPLE 3 The Measuring Instrument
  • The measuring instrument shown in FIG. 4 a is a reflectance spectrometer and is composed of the following components: A detector (10) calibrated to read the reflectance of the microparticles fixed to the glycated albumin band on the glycated albumin test strip; a detector (11) calibrated to read the reflectance of the microparticles fixed to the control band on the glycated albumin test strip; a detector (12) calibrated to read the reflectance of the microparticles fixed to the total albumin band on the total albumin test strip; a detector (13) calibrated to read the reflectance of the microparticles fixed to the control band on the total albumin test strip; a computing chip and electronic circuitry (14) to collect the data from the detectors and to calculate the result.
  • The calculations are based on a mathematical algorithm and a reference standard curve. The standard curve is derived from value assigned standards and the instrument is precalibrated at the manufacturing facility before it is distributed. The result is expressed as the percent of glycated albumin compared to total albumin and displayed on a liquid crystal display (15). Successive results obtained over a period of time are stored in the instrument and can be retrieved on demand and displayed in numerical format or in graphical format. Typically, the result will be displayed along with the date of the test. The user may then select to have all the previous stored test results and their date displayed, or have all the results presented as a graph so that any trends can be identified. In order to enter commands to the internal computer the instrument may contain either buttons or a keyboard on its exterior case.
  • The results can also be downloaded via an external port to an external computer and/or printed on an external printer (16). The instrument's electronics are powered by an internal battery (17) and/or external power source (18). The components are housed in a rigid exterior case (19) with a window (20) for the display monitor and an aperture (21) for inserting the test cassette.
  • Alternatively, the measuring instrument may be a fluorometer (FIG. 4 b) that measures the density of aggregated microparticles that have been tagged with a fluorescent dye such fluorescein or rhodamine. The fluorometer is composed of the following components: A detector (22) calibrated to read the fluorescence of the microparticles fixed to the glycated albumin band on the glycated albumin test strip; a detector (23) calibrated to read the fluorescence of the microparticles fixed to the control band on the glycated albumin test strip; a detector (24) calibrated to read the fluorescence of the microparticles fixed to the total albumin band on the total albumin test strip; a detector (25) calibrated to read the fluorescence of the microparticles fixed to the control band on the total albumin test strip; a computing chip and electronic circuitry (26) to collect the data from the detectors and to calculate the result. Using fluorescein tagged microparticles as an example, the excitatory beam of light (492 nm wavelength) is projected onto the test bands and onto the control bands, and the emitted light from each band is individually read by the corresponding detectors sensitive to the wavelength (518 nm) of the emitted light. Alternatively, other fluorescent compounds may be used and the wavelength of the exciting beam and the wavelength of the resulting fluorescence to be measured is adjusted accordingly.
  • The calculations are based on a mathematical algorithm and a reference standard curve. The standard curve is derived from value assigned standards and the instrument is precalibrated at the manufacturing facility before distribution. The result is expressed as the percent of glycated albumin compared to total albumin and is displayed on a liquid crystal display (27). Successive results obtained over a period of time are stored in the instrument and can be retrieved on demand and displayed in numerical format or in graphical format. Typically, the result is displayed along with the date of the test. The user may then select to have all the previous stored test results and their date displayed, or have all the results presented as a graph so that any trends can be identified. In order to enter commands to the internal computer the instrument may contain either buttons or a keyboard on its exterior case.
  • The results can also be downloaded via an external port to an external computer and/or printed on an external printer (28). The instrument's electronics are powered by an internal battery (29) and/or external power source (30). The components are housed in a rigid exterior case (31) with a window (32) for the display monitor and an aperture (33) for inserting the test cassette.
  • In one embodiment of this invention, the test cassette is designed to enclose two test strips arranged in a parallel fashion (FIG. 1) and the sample application well is constructed so that the test sample fluid can migrate across both test strips simultaneously. However, other test cassette configurations may be employed using the same principles described in this invention and are considered to be within the scope of this invention. For example, the sample application well may be centrally located with the glycated albumin test strip and the total albumin test strip pointing outward in a radial direction. FIG. 5 shows the test strips arrangement as diametrically opposite to each other and FIG. 6 shows the test strips to be at an angle to each other. In these examples the test cassette is in the shape of a rectangular or square configuration. The aperture in the measuring instrument for inserting these cassettes is adjusted to accommodate the shape of these cassettes.
  • In an embodiment of the present invention, the measuring instrument is a reflectance spectrometer which measures a particular wavelength of the light reflected from the colored microparticles. The amount of reflected light measured at the test band and control band sites is directly proportional to the density of the aggregated microparticles at each site
  • Alternatively, a fluorometer may be used as the measuring instrument. In this example, the microparticles are tagged with an internal fluorescent dye such as fluorescein or rhodamine red. The fluorescence-tagged microparticles are excited at one wavelength of light which causes them to fluoresce at a different wavelength of light. The amount of fluorescence measured at the test band and control band sites is directly proportional to the density of the aggregated microparticles at each site.
  • In another embodiment of the present invention, the measuring instrument is of small size, compact and lightweight. In general, it is similar in appearance and design to the various handheld glucometers in common usage. Such variations are cosmetic in nature and are considered to be within the scope of this invention.

Claims (19)

1-26. (canceled)
27. A system for detecting glycated albumin in a sample and determining the percent glycated albumin comprising:
a first assay measuring glycated albumin in said sample;
a second assay measuring total albumin in the same sample as said first assay;
means for calculating percent glycated albumin.
28. The system of claim 27 wherein said first assay comprises:
contacting a drop of blood with an anti-glycated albumin antibody such that glycated albumin present in said blood binds to said anti-glycated albumin antibody; and
detecting said bound glycated albumin.
29. The system of claim 27 wherein said second assay comprises:
contacting a drop of blood with an anti-albumin antibody such that albumin present in said blood binds to said anti-albumin antibody; and
detecting said bound albumin.
30. The system of claim 27 wherein said system is an immunochromatographic system.
31. The system of claim 30 wherein said immunochromatographic system for determining the percent glycated albumin in a blood sample comprises:
a first test strip that measures glycated albumin and a second test strip that measures total albumin; and
a measurement device that reads, calculates and displays the result as the percentage of glycated albumin compared to total albumin in the sample.
32. The system of claim 31, wherein said first test strip is comprised of microparticles coated with a first antibody to glycated albumin and an immobilization agent covalently bound to said test strip.
33. The system of claim 32 wherein said immobilization agent is an antibody to glycated albumin.
34. The system of claim 32 wherein said microparticles are selected from the group consisting of colloidal gold particles, latex particles, polystyrene particles, acrylic particles or other solid phase microparticles.
35. The system of claim 31 wherein said second test strip is comprised of microparticles coated with a first antibody to albumin and a second antibody to albumin covalently bound to said test strip.
36. The system of claim 35 wherein said microparticles are selected from the group consisting of colloidal gold particles, latex particles, polystyrene particles, acrylic particles or other solid phase microparticles.
37. The system of either of claim 34 or 36, wherein said microparticles may be colored or tagged with a fluorescent compound.
38. The system of claim 31 wherein the first test strip and the second test strip may be arranged in parallel; or opposite to each other; or at an angle to each other.
39. The system of claim 31 wherein the first test strip and the second test strip are enclosed in a rigid cassette.
40. The system of claim 31 wherein said measurement device is a reflectance spectrometer or a fluorometer comprising:
a detector for measuring the glycated albumin test result;
a detector for measuring the glycated albumin control band;
a detector for measuring the total albumin test result;
a detector for measuring the total albumin control band;
an internal computer chip for measurement and calculation;
a liquid crystal display;
an external port to transfer data to an external computer and/or printer;
a battery and/or an external power source; and
a rigid external case with an aperture for inserting the test cassette.
41. The system of claim 40 whereby the one or more than one test result can by displayed on said measurement device's liquid crystal display in numerical format or in graphical format.
42. The system of claim 40 further comprising an internal memory chip capable of storing one or more than one test result.
43. The system of claim 42 whereby the one or more than one test result can be transferred to an external computer or printer.
44. A method of monitoring glycated albumin using a point-of-care assay and determining a percent glycated albumin level comprising:
depositing a drop of blood into a sample well of an immunochromatography system test cassette;
transferring said blood into the sample application pad thereby allowing blood plasma to pass into a first conjugate pad of a first test strip and into a second conjugate pad of a second test strip;
binding said blood plasma to anti-glycated albumin antibody-coated microparticles in said first conjugate pad;
binding said blood plasma to anti-total albumin antibody-coated microparticles in said second first conjugate pad;
allowing blood plasma-bound antibody-coated microparticles to migrate across said conjugate pad to a fixed band of membrane-bound antibody;
binding said blood plasma-bound antibody-coated microparticles to said membrane bound antibody to form a visible band;
inserting said immunochromatography system test cassette into a measurement device;
providing numerical results of glycated albumin levels from said first test strip and total albumin levels from said second test strip; and
calculating said percent glycated albumin.
US12/645,387 2003-09-23 2009-12-22 Rapid Test for Glycated Albumin Abandoned US20100151488A1 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US50539203P true 2003-09-23 2003-09-23
PCT/US2004/031202 WO2005031356A1 (en) 2003-09-23 2004-09-22 Rapid test for glycated albumin
US10/538,392 US7659107B2 (en) 2003-09-23 2004-09-22 Rapid test for glycated albumin
US12/645,387 US20100151488A1 (en) 2003-09-23 2009-12-22 Rapid Test for Glycated Albumin

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US12/645,387 US20100151488A1 (en) 2003-09-23 2009-12-22 Rapid Test for Glycated Albumin

Related Parent Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2004/031202 Continuation WO2005031356A1 (en) 2003-09-23 2004-09-22 Rapid test for glycated albumin
US11/538,392 Continuation US20070074333A1 (en) 2005-10-05 2006-10-03 Pants with detachable frontal patch

Publications (1)

Publication Number Publication Date
US20100151488A1 true US20100151488A1 (en) 2010-06-17

Family

ID=34393012

Family Applications (2)

Application Number Title Priority Date Filing Date
US10/538,392 Active 2025-09-23 US7659107B2 (en) 2003-09-23 2004-09-22 Rapid test for glycated albumin
US12/645,387 Abandoned US20100151488A1 (en) 2003-09-23 2009-12-22 Rapid Test for Glycated Albumin

Family Applications Before (1)

Application Number Title Priority Date Filing Date
US10/538,392 Active 2025-09-23 US7659107B2 (en) 2003-09-23 2004-09-22 Rapid test for glycated albumin

Country Status (7)

Country Link
US (2) US7659107B2 (en)
EP (1) EP1664783B1 (en)
JP (2) JP2007506946A (en)
AT (1) AT509275T (en)
CA (1) CA2510277C (en)
HK (1) HK1092217A1 (en)
WO (1) WO2005031356A1 (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8292826B1 (en) 2011-06-21 2012-10-23 YofiMETER, Inc. Cocking and advancing mechanism for analyte testing device
US8333716B1 (en) 2011-06-21 2012-12-18 Yofimeter, Llc Methods for using an analyte testing device
US8961432B2 (en) 2011-06-21 2015-02-24 Yofimeter, Llc Analyte testing devices

Families Citing this family (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8445293B2 (en) 2005-02-09 2013-05-21 Rapid Pathogen Screening, Inc. Method to increase specificity and/or accuracy of lateral flow immunoassays
US20070015291A1 (en) * 2005-07-18 2007-01-18 Smith Henry J Rapid test for glycated albumin in blood
CN101261270B (en) * 2007-03-09 2012-11-07 中国人民解放军军事医学科学院微生物流行病研究所 Immunity-chromatography multiple detection test paper disk and immunity-chromatography multiple detection method
US20090042237A1 (en) * 2007-08-06 2009-02-12 Henry John Smith Aptamer based point-of-care test for glycated albumin
CN101493467A (en) * 2008-01-25 2009-07-29 上海伊思柏生物科技有限公司 Quantitative determination method for saccharified protein
EP2857525B1 (en) 2008-02-29 2019-04-10 Oxford University Innovation Limited A method of determining a suitable dosage of statin.
MX2010011176A (en) * 2008-04-09 2011-02-24 Becton Dickinson Co Sensitive immunoassays using coated nanoparticles.
US8470608B2 (en) * 2008-05-20 2013-06-25 Rapid Pathogen Screening, Inc Combined visual/fluorescence analyte detection test
US8815609B2 (en) 2008-05-20 2014-08-26 Rapid Pathogen Screening, Inc. Multiplanar lateral flow assay with diverting zone
US20110086359A1 (en) * 2008-06-10 2011-04-14 Rapid Pathogen Screening, Inc. Lateral flow assays
US8669052B2 (en) 2008-06-10 2014-03-11 Rapid Pathogen Screening, Inc. Lateral flow nucleic acid detector
US8962260B2 (en) 2008-05-20 2015-02-24 Rapid Pathogen Screening, Inc. Method and device for combined detection of viral and bacterial infections
US20090291508A1 (en) * 2008-05-20 2009-11-26 Rapid Pathogen Screening Inc. Nanoparticles in diagnostic tests
US9817001B2 (en) 2008-05-27 2017-11-14 Boston Heart Diagnostics Corporation Methods for determining LDL cholesterol treatment
WO2009152209A2 (en) * 2008-06-10 2009-12-17 Rapid Pathogen Screening, Inc. Combined visual/fluorescence analyte detection test
US8260556B2 (en) * 2008-08-21 2012-09-04 Bio-Rad Laboratories, Inc. Calibration surface method for determination on of analyte ratios
US8470541B1 (en) 2008-09-27 2013-06-25 Boston Heart Diagnostics Corporation Methods for separation and immuno-detection of biomolecules, and apparatus related thereto
US20100167306A1 (en) * 2008-12-26 2010-07-01 Henry John Smith Rapid test for glycated albumin in saliva
WO2010135574A2 (en) * 2009-05-20 2010-11-25 Relia Diagnostic Systems, Inc. Systems and methods for determining the percentage of glycated hemoglobin
US9068981B2 (en) 2009-12-04 2015-06-30 Rapid Pathogen Screening, Inc. Lateral flow assays with time delayed components
US8609433B2 (en) 2009-12-04 2013-12-17 Rapid Pathogen Screening, Inc. Multiplanar lateral flow assay with sample compressor
US8765377B2 (en) 2011-10-13 2014-07-01 Boston Heart Diagnostics Corporation Compositions and methods for treating and preventing coronary heart disease
CN103424552A (en) * 2012-05-21 2013-12-04 天津华生源科技有限公司 Test card for detecting human glycated albumin
CN102914656B (en) * 2012-07-23 2014-10-29 四川新健康成生物股份有限公司 Albumin glycated serum indirect immunofluorescence assay kit
US20160282343A1 (en) * 2012-08-15 2016-09-29 Immunolab LLC Quantitative lateral flow assay strips for quantitative analysis of an analyte, kits containing such strips and methods of manufacture and use of same
CN102879586A (en) * 2012-10-11 2013-01-16 南京基蛋生物科技有限公司 Fluorescence immunoassay quantitative detection kit of microalbuminuria, and preparation method thereof
US20140120559A1 (en) * 2012-10-26 2014-05-01 Boston Heart Diagnostics Corporation Diabetes panel
KR20140111192A (en) * 2013-03-08 2014-09-18 (주)프로테옴텍 Parallel line biochip for multiplex diagnosis
US20140273270A1 (en) 2013-03-14 2014-09-18 Polymer Technology Systems, Inc. Direct temperature measurement of a test strip
US9828624B2 (en) 2013-07-24 2017-11-28 Boston Heart Diagnostics Corporation Driving patient compliance with therapy
CN104345149A (en) * 2013-07-26 2015-02-11 深圳市艾瑞生物科技有限公司 Immunochromatography test strip for detecting glycosylated hemoglubin and preparation method thereof
CN104345150A (en) * 2013-07-26 2015-02-11 深圳市艾瑞生物科技有限公司 Glycated albumin detection immunochromatography test trip and preparation method thereof
JP2015087293A (en) * 2013-10-31 2015-05-07 日立化成株式会社 Measuring kit and measuring method of glyco-albumin
JP2015025820A (en) * 2014-11-04 2015-02-05 株式会社東芝 Optical waveguide type measurement system and measurement method for glycosylated hemoglobin
WO2016081471A1 (en) 2014-11-17 2016-05-26 Boston Heart Diagnostic Corporation Cardiovascular disease risk assessment
KR20160140186A (en) * 2015-05-29 2016-12-07 삼성전자주식회사 Strip for analysis, apparaturs and system using the strip for analysis
CN105241830A (en) * 2015-09-23 2016-01-13 广州金域医学检验中心有限公司 Glycolated serum albumin detection reagent and application thereof
WO2017072078A1 (en) * 2015-10-29 2017-05-04 Thomas Bruderer Subtractive immunoassay method and lateral flow immunochromatography assay strip for performing the method
CN105866440A (en) * 2016-05-31 2016-08-17 常州博闻迪医药科技有限公司 Detection method of glycosylated hemoglobin of blood
CN106226425B (en) * 2016-07-15 2019-04-23 首都医科大学附属北京朝阳医院 Serum glycated albumin detection method and its dedicated candidate criteria substance

Citations (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4879039A (en) * 1986-07-30 1989-11-07 Toyo Soda Manufacturing Co., Ltd. Process for measuring stable-type glycated hemoglobin in a sample
US5110745A (en) * 1989-06-01 1992-05-05 The Trustees Of The University Of Pennsylvania Methods of detecting glycated proteins
US5206144A (en) * 1985-03-29 1993-04-27 Novo Industri A/S Determination of glycated (glycosylated) hemoglobin in blood
US5223392A (en) * 1988-01-25 1993-06-29 Exocell, Inc. Monoclonal antibodies against glycated albumin, hybrid cell lines producing these antibodies, and use therefore
US5284777A (en) * 1991-03-04 1994-02-08 Isolab, Inc. Combined glycated hemoglobin and immunoturbidometric glycated albumin assay from whole blood lysate
US5470759A (en) * 1992-06-10 1995-11-28 Fujirebio, Inc. Anti-glycated hemoglobin monoclonal antibody and method for measuring glycated hemoglobin
US5478754A (en) * 1992-03-04 1995-12-26 Abbot Laboratories Determination of glycated hemoglobin by fluorescence quenching
US5506144A (en) * 1990-11-14 1996-04-09 Axis Biochemicals As Assay for glycated blood proteins
US5541117A (en) * 1992-03-05 1996-07-30 Boehringer Mannheim Gmbh Immunological method for the determination of a haemoglobin derivative
US5559041A (en) * 1989-12-18 1996-09-24 Princeton Biomeditech Corporation Immunoassay devices and materials
US5589393A (en) * 1991-06-19 1996-12-31 Abbott Laboratories Method for preparing a glycated hemoglobin solution
US5882935A (en) * 1994-10-19 1999-03-16 Fuji Photo Film Co., Ltd. Analysis element and method for analyzing glycated hemoglobin content ratio
US5962336A (en) * 1997-10-20 1999-10-05 Sun; Ming Multi-test panel
US5981298A (en) * 1995-12-13 1999-11-09 Surmodics, Inc. Immunoassay device and method
US6027907A (en) * 1995-12-14 2000-02-22 Fuji Photo Film Co., Ltd. Method for immunological determination of hemoglobin derivative and treating reagent for use therein
US6043043A (en) * 1993-04-02 2000-03-28 Bayer Corporation Method for the determination of hemoglobin adducts
US6162645A (en) * 1997-03-13 2000-12-19 Abbott Laboratories Determination of % glycated hemoglobin
US6248598B1 (en) * 1998-09-17 2001-06-19 Stuart C. Bogema Immunoassay that provides for both collection of saliva and assay of saliva for one or more analytes with visual readout
US6267722B1 (en) * 1998-02-03 2001-07-31 Adeza Biomedical Corporation Point of care diagnostic systems
US6316265B1 (en) * 1997-03-13 2001-11-13 Abbott Laboratories Determination of % glycated hemoglobin
US20020164811A1 (en) * 2001-03-14 2002-11-07 Hud Elizabeth A. Novel method for measurement of glycated hemoglobin by a rapid strip test procedure
US20020172992A1 (en) * 2001-05-16 2002-11-21 Adam Heller Method for the determination of glycated hemoglobin
US20030068830A1 (en) * 2001-01-31 2003-04-10 Mccroskey Ralph P. Methods and devices for quantitation of glycated protein
US20030073243A1 (en) * 2001-08-31 2003-04-17 Law Wai Tak Method for quantitative determination of glycated hemoglobin
US6670115B1 (en) * 1999-11-24 2003-12-30 Biotronic Technologies, Inc. Devices and methods for detecting analytes using electrosensor having capture reagent
US6670192B1 (en) * 1995-04-07 2003-12-30 Robert S. Galen Apparatus for combined assay for current glucose level and intermediate or long-term glycemic control
US20060148096A1 (en) * 2002-11-05 2006-07-06 Jina Arvind N Assay device, system and method
US20060270060A1 (en) * 2005-05-31 2006-11-30 Smith Henry J Rapid test for glycated albumin in saliva
US20070015291A1 (en) * 2005-07-18 2007-01-18 Smith Henry J Rapid test for glycated albumin in blood

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2050704T5 (en) * 1987-04-27 2004-04-16 Inverness Medical Switzerland Gmbh Immunoassays and devices for its realization.
FR2721112B1 (en) 1994-06-13 1996-08-14 Gks Technologies A quick diagnosis of any glycated molecule and setting Óoeuvre process.
US5569608A (en) 1995-01-30 1996-10-29 Bayer Corporation Quantitative detection of analytes on immunochromatographic strips
JPH09113511A (en) * 1995-10-18 1997-05-02 Kdk Corp Dry test piece for measuring glyco-albumin
EP0769697A1 (en) 1995-10-18 1997-04-23 Kyoto Daiichi Kagaku Co., Ltd. Dry test apparatus for glycated albumin determination
JP2001133457A (en) * 1999-11-05 2001-05-18 Dainabot Co Ltd Immunoanalysis device with improved stability, and method for improving its stability

Patent Citations (32)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5206144A (en) * 1985-03-29 1993-04-27 Novo Industri A/S Determination of glycated (glycosylated) hemoglobin in blood
US4879039A (en) * 1986-07-30 1989-11-07 Toyo Soda Manufacturing Co., Ltd. Process for measuring stable-type glycated hemoglobin in a sample
US5004546A (en) * 1986-07-30 1991-04-02 Toyo Soda Manufacturing Co., Ltd. Process for measuring stable-type glycated hemoglobin in a sample
US5223392A (en) * 1988-01-25 1993-06-29 Exocell, Inc. Monoclonal antibodies against glycated albumin, hybrid cell lines producing these antibodies, and use therefore
US5110745A (en) * 1989-06-01 1992-05-05 The Trustees Of The University Of Pennsylvania Methods of detecting glycated proteins
US5559041A (en) * 1989-12-18 1996-09-24 Princeton Biomeditech Corporation Immunoassay devices and materials
US5506144A (en) * 1990-11-14 1996-04-09 Axis Biochemicals As Assay for glycated blood proteins
US5284777A (en) * 1991-03-04 1994-02-08 Isolab, Inc. Combined glycated hemoglobin and immunoturbidometric glycated albumin assay from whole blood lysate
US5589393A (en) * 1991-06-19 1996-12-31 Abbott Laboratories Method for preparing a glycated hemoglobin solution
US5686316A (en) * 1991-06-19 1997-11-11 Abbott Laboratories Methods and reagents for the rapid determination of glycated hemoglobin
US5478754A (en) * 1992-03-04 1995-12-26 Abbot Laboratories Determination of glycated hemoglobin by fluorescence quenching
US5541117A (en) * 1992-03-05 1996-07-30 Boehringer Mannheim Gmbh Immunological method for the determination of a haemoglobin derivative
US5470759A (en) * 1992-06-10 1995-11-28 Fujirebio, Inc. Anti-glycated hemoglobin monoclonal antibody and method for measuring glycated hemoglobin
US6043043A (en) * 1993-04-02 2000-03-28 Bayer Corporation Method for the determination of hemoglobin adducts
US5882935A (en) * 1994-10-19 1999-03-16 Fuji Photo Film Co., Ltd. Analysis element and method for analyzing glycated hemoglobin content ratio
US6670192B1 (en) * 1995-04-07 2003-12-30 Robert S. Galen Apparatus for combined assay for current glucose level and intermediate or long-term glycemic control
US5981298A (en) * 1995-12-13 1999-11-09 Surmodics, Inc. Immunoassay device and method
US6027907A (en) * 1995-12-14 2000-02-22 Fuji Photo Film Co., Ltd. Method for immunological determination of hemoglobin derivative and treating reagent for use therein
US6162645A (en) * 1997-03-13 2000-12-19 Abbott Laboratories Determination of % glycated hemoglobin
US6316265B1 (en) * 1997-03-13 2001-11-13 Abbott Laboratories Determination of % glycated hemoglobin
US5962336A (en) * 1997-10-20 1999-10-05 Sun; Ming Multi-test panel
US6267722B1 (en) * 1998-02-03 2001-07-31 Adeza Biomedical Corporation Point of care diagnostic systems
US6248598B1 (en) * 1998-09-17 2001-06-19 Stuart C. Bogema Immunoassay that provides for both collection of saliva and assay of saliva for one or more analytes with visual readout
US6670115B1 (en) * 1999-11-24 2003-12-30 Biotronic Technologies, Inc. Devices and methods for detecting analytes using electrosensor having capture reagent
US20030068830A1 (en) * 2001-01-31 2003-04-10 Mccroskey Ralph P. Methods and devices for quantitation of glycated protein
US20020164811A1 (en) * 2001-03-14 2002-11-07 Hud Elizabeth A. Novel method for measurement of glycated hemoglobin by a rapid strip test procedure
US20020172992A1 (en) * 2001-05-16 2002-11-21 Adam Heller Method for the determination of glycated hemoglobin
US20030073243A1 (en) * 2001-08-31 2003-04-17 Law Wai Tak Method for quantitative determination of glycated hemoglobin
US6562581B2 (en) * 2001-08-31 2003-05-13 Portascience Method for quantitative determination of glycated hemoglobin
US20060148096A1 (en) * 2002-11-05 2006-07-06 Jina Arvind N Assay device, system and method
US20060270060A1 (en) * 2005-05-31 2006-11-30 Smith Henry J Rapid test for glycated albumin in saliva
US20070015291A1 (en) * 2005-07-18 2007-01-18 Smith Henry J Rapid test for glycated albumin in blood

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8292826B1 (en) 2011-06-21 2012-10-23 YofiMETER, Inc. Cocking and advancing mechanism for analyte testing device
US8333716B1 (en) 2011-06-21 2012-12-18 Yofimeter, Llc Methods for using an analyte testing device
US8333717B1 (en) 2011-06-21 2012-12-18 Yofimeter, Llc Test unit cartridge for analyte testing device
WO2012177908A1 (en) 2011-06-21 2012-12-27 Yofimeter, Llc. Test unit cartridge for analyte testing device
US8961432B2 (en) 2011-06-21 2015-02-24 Yofimeter, Llc Analyte testing devices

Also Published As

Publication number Publication date
US20060223192A1 (en) 2006-10-05
HK1092217A1 (en) 2011-11-18
EP1664783A1 (en) 2006-06-07
JP2010261961A (en) 2010-11-18
CA2510277C (en) 2012-07-24
AT509275T (en) 2011-05-15
JP2007506946A (en) 2007-03-22
JP5662704B2 (en) 2015-02-04
EP1664783B1 (en) 2011-05-11
EP1664783A4 (en) 2007-01-03
US7659107B2 (en) 2010-02-09
CA2510277A1 (en) 2005-04-07
WO2005031356A1 (en) 2005-04-07

Similar Documents

Publication Publication Date Title
US7132078B2 (en) Assay apparatus
US6436721B1 (en) Device and method for obtaining clinically significant analyte ratios
Potyrailo et al. Optical waveguide sensors in analytical chemistry: today’s instrumentation, applications and trends for future development
US6767710B2 (en) Prewetting stop flow test strip
US3973129A (en) Fluorimetric apparatus and method for analysis of body fluid
CA2528172C (en) Native analyte as reference in lateral flow assays
JP2628421B2 (en) Diagnostic test kits and methods of using the same
US5143066A (en) Optical fiber sensors for continuous monitoring of biochemicals and related method
JP2818191B2 (en) Solid phase analyzer
US6627459B1 (en) Immunoassay controls
Meadows et al. Fiber-optic biosensors based on fluorescence energy transfer
EP1899712B1 (en) Method for the determination of the concentration of a non-volatile analyte
JP3021380B2 (en) One step assay method and device for whole blood
ES2309324T3 (en) Accessible test device and method of use.
AU2004200506B2 (en) Method for Reducing Effect of Hematocrit on Measurement of an Analyte in Whole Blood, and Test Kit and Test Article Useful in the Method
CN1135389C (en) Method for testing analyte in sample and testing sheet
JP2736091B2 (en) Element and method for accurately, promptly and simply carried out bioassays
CN1145027C (en) Analytical test device and method for detecting existence of at least one kind of analyzed object in fluid sample
US6410341B1 (en) Analytical test device and method for use in medical diagnoses
EP0184600B1 (en) Method for optically ascertaining parameters of species in a liquid analyte
US4447546A (en) Fluorescent immunoassay employing optical fiber in capillary tube
JP2916637B2 (en) Diffuse spectral reflectance of the measuring device
US20020146754A1 (en) Immunochromato device and method for measuring samples using the same
US4775637A (en) An immunoassay apparatus having at least two waveguides and method for its use
CN1188217C (en) Disposable apparatus for counting blood cell

Legal Events

Date Code Title Description
AS Assignment

Owner name: EPINEX DIAGNOSTICS, INC.,CALIFORNIA

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SMITH, HENRY J.;ZAIDI, ASAD;REEL/FRAME:023703/0911

Effective date: 20060426

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION