IP Library Granted Patent US 9,658,225
Granted Patent B2
US 9,658,225 · App. 14/215,720 · Granted May 23, 2017

Automated immunoanalyzer system for performing diagnostic assays for allergies and autoimmune diseases

Inventors: Mark David Van Cleve (Long Beach, CA); Taylor Addison Reid (Carlsbad, CA); Linda Marie Trondle (Irvine, CA); Victoria Hung (San Diego, CA); Yi Luo (Long Beach, CA); Dennis Edwin Rieger (Hermosa Beach, CA); Evan Phillip McMenamy (Los Alamitos, CA); Nanditha Raghavan (Costa Mesa, CA); Morkoah Blay Reliford (Anaheim, CA); Douglas John Canfield (Ludington, MI); Elaine Grace Taine (Anaheim, CA); Edsel Lawrence Noche Sinson (Chino Hills, CA); Scott William Vande Wetering (Long Beach, CA); Teri Taylor (Irvine, CA); Travis Knox (Long Beach, CA); Fran Zylo Cuaresma Jacalne (Anaheim, CA); James Weston (East Lothian, GB); Jennifer Bao-Guey Chan (San Francisco, CA); Stephanie TuVi Ortega (Santa Ana, CA); Rachel Sarah Schell (Torrance, CA); Ronald Norman Diamond (Anaheim Hills, CA); Steve Michael Gann (Huntington Beach, CA); Eric Darnell Hall (Garden Grove, CA); Tae Ho Hwang (Brea, CA); John Lewis Morton (Canyon Lake, CA); Anatoly Moskalev (Irvine, CA); Marinela Gombosev Stack (San Clemente, CA); Bruce Alan Sargeant (Orange, CA); Michelle Fredrika Forshager (Vancouver, WA); Vanessa Camille Chua (Chino Hills, CA); Kylie Wilson (Indianapolis, IN)
Assignee: Hycor Biomedical, LLC
G01N33/564G01N21/645G01N21/6428G01N21/76G01N33/5306G01N33/54326G01N33/54393G01N33/569G01N33/582G01N33/6854G01N33/6893G01N35/0098G01N35/1011G01N2021/6484G01N2035/0453G01N2035/1062G01N2201/062G01N2201/08G01N2333/4703G01N2333/62G01N2333/78G01N2800/24Y10T436/119163
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Quick Facts
Patent No.
US 9,658,225
App. No.
14/215,720
Granted
May 23, 2017
Kind
B2
Abstract

A quantitative method for performing an automated diagnostic assay, comprising: incubating a capture reagent with a streptavidin-coated medium to form a solid phase complex; washing the solid phase complex to remove excess capture reagent; incubating the solid phase complex with a serum sample to form an immune complex; washing the immune complex to remove any unbound sample; incubating the immune complex with a conjugate to create an immune-conjugate complex; washing the immune-conjugate complex to remove any unbound conjugate; introducing a substrate capable of generating a quantifiable response; and calibrating the response generated from introducing the substrate.

Claims (28)

1. A quantitative method for performing an automated diagnostic assay, comprising:

dispensing a quantity of streptavidin-conjugated universal fluorescent-labeled magnetic microparticles into a reaction cuvette within a reaction rotor of an immunoanalyzer instrument using a first pipettor;

measuring a first fluorescent signal associated with the quantity of streptavidin-conjugated universal fluorescent-labeled magnetic microparticles through an optics pipette;

selecting a capture reagent suitable for performing the diagnostic assay;

dispensing the capture reagent into the reaction cuvette using the first pipettor;

incubating the capture reagent with the quantity of streptavidin-conjugated universal fluorescent-labeled magnetic microparticles to form a solid phase complex in the reaction cuvette;

washing the solid phase complex to remove excess capture reagent;

dispensing a serum sample into the reaction cuvette using a second pipettor;

incubating the solid phase complex with the serum sample to form an immune complex;

washing the immune complex to remove any unbound sample;

dispensing a conjugate into the reaction cuvette using a third pipettor;

incubating the immune complex with the conjugate to form an immune-conjugate complex;

washing the immune-conjugate complex to remove any unbound conjugate;

introducing a substrate capable of generating a quantifiable response using the third pipettor;

transferring the substrate and immune-conjugate complex from the reaction rotor to an optics box using the optics pipette by aspirating the substrate and immune-conjugate complex from the reaction cuvette into the optics pipette;

measuring a second fluorescent signal associated with the transferred material through the optics pipette and calculating a ratio of the first fluorescent signal to the second fluorescent signal to obtain a bead retention ratio;

measuring a chemiluminescent signal in the transferred material;

determining the response generated from introducing the substrate; and

adjusting the quantifiable response for bead retention by: adjusting the quantified chemiluminescent signal by the bead retention ratio to calculate a reported value;

wherein one or more of the washing steps include washing the solid phase, immune, and/or immune-conjugate complexes by magnetically sequestering the solid phase, immune, and/or immune-conjugate complexes being washed within a confined area of a reaction cuvette; wherein the step of incubating the capture reagent with the streptavidin-conjugated universal fluorescent-labeled magnetic microparticles comprises incubating the streptavidin-conjugated universal fluorescent-labeled magnetic microparticles with a biotinylated capture reagent; wherein the step of incubating the capture reagent with the streptavidin-conjugated universal fluorescent-labeled magnetic microparticles includes incubating the capture reagent that is retained in a suspension by a reagent diluent comprising about 25% human serum albumin (HSA); wherein the step incubating the immune complex with a conjugate comprises incubating the immune complex that is retained in a suspension by a conjugate diluent comprising about 2-5% polyethylene glycol; and wherein horseradish peroxidase (HRP) is used as an indirect label when washing the immune complex to remove unbound sample.

2. The method of claim 1 , wherein the step of incubating the solid phase complex with the serum sample comprises binding an allergen-specific human immunoglobulin E (IgE) present in the serum sample to a biotinylated capture reagent.

3. The method of claim 1 , wherein the step of incubating the solid phase complex with the serum sample comprises binding an autoimmune-specific human immunoglobulin G (IgG), an autoimmune-specific human immunoglobulin M (IgM) or an autoimmune-specific human immunoglobulin A (IgA) present in the serum sample to a biotinylated capture reagent.

4. The method of claim 1 , wherein the capture reagent is derived from the biotinylation of a purified allergen, protein, enzyme or antibody.

5. The method of claim 1 , wherein the capture reagent is derived from the biotinylation of an allergen extract comprised of a multiplicity of allergens.

6. The method of claim 1 , wherein the capture reagent exists as an amalgam of multiple biotinylated capture reagents selected from purified allergens, proteins, enzymes, antibodies and allergen extracts.

7. The method of claim 1 , wherein the step of transferring the substrate and immune-conjugate complex to the optics box comprises using an automated pipette arm with a reusable optics pipette tip to aspirate the sample.

8. The method of claim 1 , further comprising entering the first and second fluorescence signals and chemiluminescence signal into an algorithm to generate a bead retention adjusted relative light unit signal.

9. The method of claim 8 , further comprising comparing the generated bead retention adjusted relative light unit signal to a calibration curve relative light unit signal.

Assignments (10)
RELEASE OF SECURITY INTEREST Recorded May 9, 2022
From: GPB DEBT HOLDINGS II, LLC
To: HYCOR BIOMEDICAL, LLC.
Reel/Frame 059870/0604 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 8, 2016
From: GANN, STEVEN MICHAEL; HALL, ERIC DARNELL; HWANG, TAE HO; MORTON, JOHN LEWIS; MOSKALEV, ANATOLY; STACK, MARINELA GOMBOSEV; SARGEANT, BRUCE ALAN; FORSHAGER, MICHELLE FREDRIKA; DIAMOND, RONALD NORMAN
To: HYCOR BIOMEDICAL, LLC.
Reel/Frame 038843/0461 →
CHANGE OF NAME Recorded Jan 29, 2016
From: VAN CLEVE, MARK DAVID
To: HYCOR BIOMEDICAL, LLC.
Reel/Frame 037651/0378 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 30, 2015
From: DIAMOND, RONALD NORMAN; GANN, STEVE MICHAEL; HALL, ERIC DARNELL; HWANG, TAE HO; MORTON, JOHN LEWIS; MOSKALEV, ANATOLY; STACK, MARINELA GOMBOSEV; SARGEANT, BRUCE ALAN; FORSHAGER, MICHELLE FREDRIKA
To: HYCOR BIOMEDICAL, LLC.
Reel/Frame 037385/0851 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 28, 2015
From: REID, TAYLOR ADDISON; TRONDLE, LINDA MARIE
To: HYCOR BIOMEDICAL, LLC.
Reel/Frame 037366/0398 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 22, 2015
From: RIEGER, DENNIS EDWIN
To: HYCOR BIOMEDICAL, LLC.
Reel/Frame 037349/0479 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2015
From: HUNG, VICTORIA; LUO, YI; WESTON, JAMES
To: HYCOR BIOMEDICAL, LLC.
Reel/Frame 037339/0984 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 17, 2015
From: TAINE, ELAINE GRACE
To: HYCOR BIOMEDICAL, LLC.
Reel/Frame 037319/0944 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 15, 2015
From: MCMENAMY, EVAN PHILLIP; RAGHAVAN, NANDITHA; RELIFORD, MARKOAH BLAY; CANFIELD, DOUGLAS JOHN; NOCHE SINSON, EDSEL LAWRENCE; VANDE WETERING, SCOTT WILLIAM; TAYLOR, TERI; KNOX, TRAVIS; CUARESMA JACALNE, FRAN ZYLO; CHAN, JENNIFER BAO-GUEY; ORTEGA, STEPHANIE TUVI; SCHELL, RACHEL SARAH; WILSON, KYLIE; CHUA, VANESSA CAMILLE
To: HYCOR BIOMEDICAL, LLC.
Reel/Frame 037296/0364 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 27, 2015
From: VAN CLEVE, MARK DAVID
To: HYCOR BIOMEDICAL, INC.
Reel/Frame 035726/0398 →
Continuity (3)
Provisional Application 61791879 · Mar 15, 2013
Provisional Application 61791295 · Mar 15, 2013
Related Publication 20140274784A1 · Sep 18, 2014