IP Library › Granted Patent US 12,693,221
Granted Patent B2
US 12,693,221 · App. 16/940,947 · Granted Jul 28, 2026

Automated immunoanalyzer system for performing diagnostic assays for autoimmune and infectious 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 Zulo Cuaresma Jacaine (Anaheim, CA); James Weston (Haddington, 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); Steven 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
G01N21/645G01N21/6428G01N21/76G01N33/5306G01N33/54326G01N33/5434G01N33/54393G01N33/564G01N33/569G01N33/5695G01N33/56983G01N33/582G01N33/6854G01N33/6893G01N35/0098G01N35/1011G01N2021/6484G01N2035/0453G01N2035/1062G01N2201/062G01N2201/08G01N2333/4703G01N2333/62G01N2333/78G01N2800/24Y10T436/119163
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Quick Facts
Patent No.
US 12,693,221
App. No.
16/940,947
Filed
Jul 28, 2020
Granted
Jul 28, 2026
Kind
B2
Art Unit
1677
USPC
436/518
Abstract

A quantitative method for diagnosing an autoimmune disease or an infectious disease comprising performing an automated diagnostic assay, comprising: incubating a capture reagent with a streptavidin-coated medium to form a solid phase complex, wherein the capture reagent is a biotinylated autoantigen or infectious disease antigen; 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 (22)

1 . A method of performing a diagnostic assay, comprising:

a) combining a capture reagent-coated separation medium, wherein the separation medium comprises fluorescently-labelled particles, with an analyte-containing sample in a reaction cuvette, wherein the capture reagent has been biotinylated with PEG 12 -Biotin and the fluorescently-labelled particles have been coated with streptavidin;

b) binding luminescent labels to the separation media in proportion to a number of bound analyte molecules, to form a complex;

c) measuring an initial fluorescent signal associated with an initial quantity of the fluorescently-labelled particles;

d) washing the complex;

e) adding a luminescing reagent or substrate to the cuvette to generate a luminescent signal in proportion to the number of bound analyte molecules,

f) measuring the luminescent signal and a final fluorescent signal associated with a final quantity of the fluorescently-labelled particles in the cuvette; and

g) normalizing the luminescent signal by a ratio of initial fluorescent signal to final fluorescent signal to calculate a reported value.

2 . The method of claim 1 , wherein the fluorescently-labelled particles are magnetic.

3 . The method of claim 1 , wherein the analyte-containing sample is a serum sample.

4 . The method of claim 1 , wherein the capture reagent will be bound by analyte molecules in the analyte-containing sample.

5 . The method of claim 1 , wherein the analyte molecules are capture reagent-specific immunoglobulins.

6 . The method of claim 1 , wherein the binding of luminescent labels is mediated by a labeled anti-immunoglobulin conjugate.

7 . The method of claim 6 , wherein the labeled anti-immunoglobulin conjugate comprises an antibody, which is specific for immunoglobulin, and a luminescent label.

8 . The method of claim 7 , wherein the luminescent label is horseradish peroxidase (HRP), alkaline phosphatase (ALP), or beta galactosidase (BGAL).

9 . The method of claim 1 , wherein the capture reagent has been bound to the fluorescently-labelled particles through a biotin-streptavidin interaction.

10 . The method of claim 1 , wherein binding luminescent labels to the separation media comprises incubating a labeled anti-immunoglobulin conjugate with the capture reagent-coated separation medium.

11 . The method of claim 10 , wherein the conjugate is in a diluent including polyethylene glycol.

12 . The method of claim 1 , wherein measuring the fluorescent signals and the luminescent signal takes place within an optics box.

13 . The method of claim 1 , wherein the reported value is a bead retention adjusted relative light unit signal.

14 . The method of claim 13 , wherein the bead retention adjusted relative light unit signal is compared to a calibration curve relative light unit signal.

15 . The method of claim 1 , wherein a ratio of the final fluorescent signal to the initial fluorescent signal is used to quantify a fraction of particles that were lost during the wash step.

Assignments (6)
CHANGE OF NAME Recorded Sep 21, 2020
From: HYCOR BIOMEDICAL, INC.
To: HYCOR BIOMEDICAL, LLC
Reel/Frame 053829/0045 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2020
From: VAN CLEVE, MARK DAVID
To: HYCOR BIOMEDICAL, INC.
Reel/Frame 053829/0184 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2020
From: RIEGER, DENNIS EDWIN
To: HYCOR BIOMEDICAL, LLC
Reel/Frame 053829/0302 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2020
From: REID, TAYLOR ADDISON
To: HYCOR BIOMEDICAL, LLC
Reel/Frame 053829/0352 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2020
From: GANN, STEVEN MICHAEL; HALL, ERIC DARNELL; HWANG, TAE HO; MORTON, JOHN LEWIS; MOSKALEV, ANATOLY; STACK, MARINELA GOMBOSEV; SARGEANT, BRUCE ALAN; DIAMOND, RONALD NORMAN; FORSHAGER, MICHELLE FREDRIKA
To: HYCOR BIOMEDICAL, LLC
Reel/Frame 053829/0668 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 21, 2020
From: TRONDLE, LINDA MARIE; HUNG, VICTORIA; MCMENAMY, EVAN PHILLIP; RAGHAVAN, NANDITHA; RELIFORD, MORKOAH BLAY; LUO, YI; CANFIELD, DOUGLAS JOHN; TAINE, ELAINE GRACE; NOCHE SINSON, EDSEL LAWRENCE; VANDE WETERING, SCOTT WILLIAM; TAYLOR, TERI; KNOX, TRAVIS; CUARESMA JACAINE, FRAN ZYLO; WESTON, JAMES; BAO-GUEY CHAN, JENNIFER; TUVI ORTEGA, STEPHANIE; SCHELL, RACHEL SARAH; WILSON, KYLIE; CHUA, VANESSA CAMILLE
To: HYCOR BIOMEDICAL, LLC
Reel/Frame 053830/0320 →
Continuity (11)
Continuation 15482508 · Apr 7, 2017
Continuation 14673698 · Mar 30, 2015
Continuation In Part 14215720 · Mar 17, 2014
Continuation 15482460 · Apr 7, 2017
Continuation 14673647 · Mar 30, 2015
Continuation In Part 14215720 · Mar 17, 2014
Continuation In Part 15482537 · Apr 7, 2017
Continuation 14215720 · Mar 17, 2014
Provisional Application 61791295 · Mar 15, 2013
Provisional Application 61791879 · Mar 15, 2013
Related Publication 20200371029A1 · Nov 26, 2020
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