Claims for Patent: 10,739,262

Summary for Patent: 10,739,262

Title:	Automated immunoanalyzer system for performing diagnostic assays for autoimmune and infectious diseases
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.
Inventor(s):	Van Cleve; Mark David (Long Beach, CA), Taine; Elaine Grace (Anaheim, CA), Canfield; Douglas John (Ludington, MI), Ortega; Stephanie TuVi (Santa Ana, CA), Reid; Taylor Addison (Carlsbad, CA)
Assignee:	HYCOR Biomedical, LLC (Indianapolis, IN)
Application Number:	15/482,508
Patent Claims:	1. A method for performing an automated diagnostic immunoassay for an autoimmune disease comprising: measuring an initial fluorescent signal associated with a quantity of streptavidin-conjugated fluorescent-labeled magnetic microparticles in a reaction cuvette for the immunoassay process, wherein the reaction cuvette contains a labeled immune-conjugate, prior to washing a labeled immune-conjugate complex in the reaction cuvette, wherein the labeled immune-conjugate complex includes a biotinylated autoantigen, the streptavidin-conjugated fluorescent-labeled magnetic microparticles, a patient antibody, and a conjugate; measuring a final fluorescent signal associated with the quantity of streptavidin-conjugated fluorescent-labeled magnetic microparticles in the reaction cuvette containing the labeled immune-conjugate complex and a chemiluminescent signal associated with the labeled immune-conjugate complex after equilibrium is reached; calculating a ratio of the final fluorescent signal to the initial fluorescent signal to obtain a bead retention ratio; and adjusting a quantifiable response for bead retention by adjusting the chemiluminescent signal by the bead retention ratio to calculate a reported value. 2. The method of claim 1, wherein the biotinylated autoantigen includes an autoantigen selected from aggrecan, alanyl-tRNA syntetase (PL-12), alpha beta crystallin, alpha fodrin (Sptan 1), alpha-actinin, .alpha.1 antichymotrypsin, .alpha.1 antitripsin, .alpha.1 microglobulin, alsolase, aminoacyl-tRNA synthetase, an amyloid, an annexin, an apolipoprotein, aquaporin, bactericidal/permeability-increasing protein (BPI), .beta.-globin precursor BP1, .beta.-actin, .beta.-lactoglobulin A, .beta.2-glycoprotein I, .beta.2-microglobulin, a blood group antigen, C reactive protein (CRP), calmodulin, calreticulin, cardiolipin, catalase, cathepsin B, a centromere protein, chondroitin sulfate, chromatin, collagen, a complement component, cytochrome C, cytochrome P450 2D6, cytokeratins, decorin, dermatan sulfate, DNA, DNA topoisomerase I, elastin, Epstein-Barr nuclear antigen 1 (EBNA1), elastin, entaktin, an extractable nuclear antigen, Factor I, Factor P, Factor B, Factor D, Factor H, Factor X, fibrinogen, fibronectin, formiminotransferase cyclodeaminase (LC-1), gliadin and amidated gliadin peptides (DGPs), gp210 nuclear envelope protein, GP2 (major zymogen granule membrane glycoprotein), glycoprotein gpIIb/IIIa, glial fibrillary acidic protein (GFAP), glycated albumin, glyceraldehyde 3-phosphate dehydrogenase (GAPDH), haptoglobin A2, heat shock proteins, hemocyanin, heparin, a histone, histidyl-tRNA synthetase (Jo-1), hyaluronidase, immunoglobulins, insulin, insulin receptor, an integrin, interstitial retinol-binding protein 3, intrinsic factor, Ku (p70/p80), lactate dehydrogenase, laminin, liver cytosol antigen type 1 (LC1), liver/kidney microsomal antigen 1 (LKM1), lysozyme, melanoma differentiation-associated protein 5 (MDAS), Mi-2 (chromodomain helicase DNA binding protein 4), a mitochondrial protein, muscarinic receptors, myelin-associated glycoprotein, myosin, myelin basic protein, myelin oligodendrocyte glycoprotein, myeloperoxidase (MPO), rheumatoid factor (IgM anti-IgG), neuron-specific enolase, nicotinic acetylcholine receptor .alpha. chain, nucleolin, a nucleoporin, nucleosome antigen, PM/Scl100, PM/Scl 75, pancreatic .beta.-cell antigen, pepsinogen, peroxiredoxin 1, phosphoglucose isomerase, phospholipids, phosphotidyl inositol, platelet derived growth factors, polymerase beta (POLB), potassium channel KIR4.1, proliferating cell nuclear antigen (PCNA), proteinase-3, proteolipid protein, proteoglycan, prothrombin, recoverin, rhodopsin, ribonuclease, a ribonucleoprotein, ribosomes, a ribosomal phosphoprotein, RNA, an Sm protein, Sp100 nuclear protein, SRP54 (signal recognition particle 54 kDa), selectin, smooth muscle proteins, sphinomyelin, streptococcal antigens, superoxide dismutase, synovial joint proteins, T1F1 gamma collagen, threonyl-tRNA synthetase (PL-7), tissue transglutaminase, thyroid peroxidase, thyroglobulin, thyroid stimulating hormone receptor, transferrin, triosephosphate isomerase, tubulin, tumor necrosis alpha, topoisomerase, U1-small nuclear ribonucleoprotein (U1-snRNP) 68/70 kDa, U1-snRNP A, U1-snRNP C, U-small nuclear ribonucleoprotein-associated proteins B and B' (U-snRNP B/B'), ubiquitin, vascular endothelial growth factor, vimentin, and vitronectin. 3. The method of claim 1, wherein the autoantigen is amyloid beta, amyloid P, annexin II, annexin V, apolipoproteins ApoB, apolipoproteins ApoE, apolipoproteins ApoE4, apolipoproteins ApoJ, aquaporin AQP1, aquaporin AQP2, aquaporin AQP3, aquaporin AQP4, Rh blood group antigens, I blood group antigens, ABO blood group antigens, CENP-A, CENP-B, collagen type I, collagen type II, collagen type III, collagen type IV, collagen type V, collagen type VI, complement components C1q, complement components C3, complement components C3a, complement components C3b, complement components C4, complement components C5, complement components C6, complement components C7, complement components C8, complement components C9, double stranded DNA, single stranded DNA, extractable nuclear antigen Ro, extractable nuclear antigen La, extractable nuclear antigen Sm, extractable nuclear antigen RNP, extractable nuclear antigen Scl-70, extractable nuclear antigen Jo1, fibrinogen IV, fibrinogen S, Hsp60, HSP70, histone H1, histone H2A, histone H2B, histone H3, histone H4, integrin .alpha.1.beta.1, integrin .alpha.2.beta.1, integrin .alpha.3.beta.1, integrin .alpha.4.beta.1, integrin .alpha.5.beta.1, integrin .alpha.6.beta.1, integrin .alpha.7.beta.1, integrin .alpha.L.beta.2, integrin .alpha.M.beta.2, integrin .alpha.IIb.beta.3, integrin .alpha.V.beta.1, integrin .alpha.V.beta.3, integrin .alpha.V.beta.5, integrin .alpha.V.beta.6, integrin .alpha.V.beta.8, integrin .alpha.6.beta.3, integrin .alpha.1.beta.1, Ku p70/p80, mitochondrial protein M1, mitochondrial protein M2, mitochondrial protein M3, mitochondrial protein M4, mitochondrial protein M5, mitochondrial protein M6, mitochondrial protein M7, mitochondrial protein M8, mitochondrial protein M9, mitochondrial protein BCOADC-E2, mitochondrial protein OGDC-E2, mitochondrial protein PDC-E2, Nup62, rheumatoid factor IgM anti-IgG, ribonucleoprotein Ro, ribonucleoprotein La, ribonucleoprotein snRNP, ribonucleoprotein scRNP, ribosomal phosphoprotein P0, ribosomal phosphoprotein P1, ribosomal phosphoprotein P2, double stranded RNA, single stranded RNA, Sm protein SmB, Sm protein SmB', Sm protein SmD1, Sm protein SmD2, Sm protein SmD3, Sm protein SmF, Sm protein SmG, or Sm protein SmN. 4. The method of claim 1, wherein the conjugate includes horseradish peroxidase (HRP). 5. The method of claim 1, wherein the patient antibody is from a serum sample. 6. The method of claim 1, wherein the patient antibody is from a plasma sample. 7. The method of claim 1, further comprising transferring the labeled immune-conjugate complex to an optics box, wherein the final fluorescent signal and the chemiluminescent signal are quantified. 8. The method of claim 7, wherein the step of transferring the labeled immune-conjugate complex to the optics box comprises using an automated pipette arm with a reusable pipette tip. 9. The method of claim 1, further comprising: measuring fluorescence within an optics box to determine bead retention; and measuring chemiluminescence within the optics box to detect a generated relative light unit signal. 10. The method of claim 9, further comprising entering the fluorescence and chemiluminescence measurements into an algorithm to generate a bead retention adjusted relative light unit signal. 11. The method of claim 10, further comprising comparing the generated bead retention adjusted relative light unit signal to a calibration curve relative light unit signal. 12. The method of claim 1, further comprising incubating the biotinylated autoantigen with the quantity of streptavidin-conjugated fluorescent-labeled magnetic microparticles to form a solid phase complex. 13. The method of claim 12, wherein the step of incubating the biotinylated autoantigen with the quantity of streptavidin-conjugated fluorescent-labeled magnetic microparticles includes a reaction diluent including human serum albumin (HSA). 14. The method of claim 12, further comprising incubating an immune complex formed from the solid phase complex and a biological sample with a conjugate to form an immune-conjugate complex. 15. The method of claim 14, wherein the biological sample includes the patient antibody. 16. The method of claim 14, wherein an autoimmune-specific human immunoglobulin G (IgG), an autoimmune-specific human immunoglobulin M (IgM), or an autoimmune-specific human immunoglobulin A (IgA) binds to a biotinylated capture reagent. 17. The method of claim 14, wherein the step of incubating the immune complex with the conjugate comprises incubating with a conjugate diluent including polyethylene glycol.

Details for Patent 10,739,262

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	May 05, 2004		2037-04-07
Bausch & Lomb Incorporated	VITRASE	hyaluronidase	Injection	021640	December 02, 2004		2037-04-07
Amphastar Pharmaceuticals, Inc.	AMPHADASE	hyaluronidase	Injection	021665	October 26, 2004		2037-04-07
Akorn, Inc.	HYDASE	hyaluronidase	Injection	021716	October 25, 2005		2037-04-07
Csl Behring Ag	CARIMUNE, CARIMUNE NF, PANGLOBULIN, SANDOGLOBULIN	immune globulin intravenous (human)	For Injection	102367	July 27, 2000		2037-04-07
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	July 26, 2007		2037-04-07