Claims for Patent: 9,658,225

Summary for Patent: 9,658,225

Title:	Automated immunoanalyzer system for performing diagnostic assays for allergies and autoimmune diseases
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.
Inventor(s):	Van Cleve; Mark David (Long Beach, CA), Reid; Taylor Addison (Carlsbad, CA), Trondle; Linda Marie (Irvine, CA), Hung; Victoria (San Diego, CA), Luo; Yi (Long Beach, CA), Rieger; Dennis Edwin (Hermosa Beach, CA), McMenamy; Evan Phillip (Los Alamitos, CA), Raghavan; Nanditha (Costa Mesa, CA), Reliford; Morkoah Blay (Anaheim, CA), Canfield; Douglas John (Ludington, MI), Taine; Elaine Grace (Anaheim, CA), Sinson; Edsel Lawrence Noche (Chino Hills, CA), Vande Wetering; Scott William (Long Beach, CA), Taylor; Teri (Irvine, CA), Knox; Travis (Long Beach, CA), Cuaresma Jacalne; Fran Zylo (Anaheim, CA), Weston; James (East Lothian, GB), Bao-Guey Chan; Jennifer (San Francisco, CA), Ortega; Stephanie TuVi (Santa Ana, CA), Schell; Rachel Sarah (Torrance, CA), Diamond; Ronald Norman (Anaheim Hills, CA), Gann; Steve Michael (Huntington Beach, CA), Hall; Eric Darnell (Garden Grove, CA), Hwang; Tae Ho (Brea, CA), Morton; John Lewis (Canyon Lake, CA), Moskalev; Anatoly (Irvine, CA), Stack; Marinela Gombosev (San Clemente, CA), Sargeant; Bruce Alan (Orange, CA), Forshager; Michelle Fredrika (Vancouver, WA), Chua; Vanessa Camille (Chino Hills, CA), Wilson; Kylie (Indianapolis, IN)
Assignee:	Hycor Biomedical, LLC (Indianapolis, IN)
Application Number:	14/215,720
Patent Claims:	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.

Details for Patent 9,658,225

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Csl Behring Ag	CARIMUNE, CARIMUNE NF, PANGLOBULIN, SANDOGLOBULIN	immune globulin intravenous (human)	For Injection	102367	07/27/2000		2033-03-15
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	07/26/2007		2033-03-15
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10/02/2009		2033-03-15
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	02/07/2013		2033-03-15
Bio Products Laboratory	GAMMAPLEX	immune globulin intravenous (human)	Injection	125329	09/17/2009		2033-03-15