IP Library › Granted Patent US 12,584,929
Granted Patent B2
US 12,584,929 · App. 17/359,060 · Granted Mar 24, 2026

Composition and methods for assessing sensitivity and specificity of antibody detection reagents

Inventor: James Charles Zimring (Seattle, WA)
Assignee: Bloodworks
G01N33/80C07K16/2896G01N33/53G01N33/6854
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Quick Facts
Patent No.
US 12,584,929
App. No.
17/359,060
Granted
Mar 24, 2026
Kind
B2
Abstract

Compositions and methods which are useful for determining the sensitivity and specificity of antibody detection reagents are disclosed.

Claims (24)

1 . A method to determine the specificity and sensitivity of an anti-human globulin antibody, the method comprising:

a) binding the anti-human globulin antibody to a panel of human antibodies, wherein the human antibodies within the panel are of different Ig isoallotypes of IgG1, IgG2, IgG3, or IgG4 and comprise:

a heavy chain comprising:

complementarity determining region (CDR) 1 of SEQ ID NO: 120,

CDR2 of SEQ ID NO: 121, and

CDR3 of SEQ ID NO: 122; and

a light chain comprising:

CDR1 of SEQ ID NO: 123,

CDR2 of SEQ ID NO: 124, and

CDR3 of QQS, and

b) detecting the binding of the anti-human globulin antibody to the human antibodies of the panel, thus determining the specificity and sensitivity of the anti-human globulin antibody to each of the different Ig isoallotypes of IgG1, IgG2, IgG3, or IgG4.

2 . The method of claim 1 , wherein the human antibodies comprise heavy chains comprising SEQ ID NOs: 10 or 12.

3 . The method of claim 1 , wherein the human antibodies comprise light chains comprising SEQ ID NOs: 14 or 16.

4 . The method of claim 1 , wherein the human antibodies are IgG.

5 . The method of claim 1 , wherein the different Ig isoallotypes are selected from:

the group consisting of IgG1-01, IgG1-03, IgG1-05, IgG1-07, IgG1-08, IgG1-01v2, and IgG1-04v2;

the group consisting of IgG2-01, IgG2-02, IgG2-04, and IgG2-06;

the group consisting of IgG3-01, IgG3-03, IgG3-04, IgG3-06, IgG3-08, IgG3-09, IgG3-11, IgG3-12, IgG3-13, IgG3-14, IgG3-15, IgG3-16, IgG3-17, IgG3-18, and IgG3-19; or

the group consisting of IgG4-01, IgG4-02, and IgG4-03.

6 . The method of claim 1 , wherein the human antibodies are IgA, IgM, IgE, or IgD.

7 . The method of claim 1 , wherein the human antibodies bind to an antigen with an affinity constant (K D ) of less than 1×10 −8 M.

8 . The method of claim 1 , wherein the method is performed using a fluorescence activated cell sorting (FACS) assay, a gel testing assay, a tube testing assay, or a solid phase testing assay.

9 . The method of claim 1 , wherein the panel of human antibodies comprises at least two isoallotypes of IgG1, at least two isoallotypes of IgG2, at least two isoallotypes of IgG3, and at least two isoallotypes of IgG4.

10 . The method of claim 1 , wherein the panel of human antibodies comprises 29 isoallotypes of IgG1, IgG2, IgG3, and IgG4.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 20, 2021
From: ZIMRING, JAMES CHARLES
To: BLOODWORKS
Reel/Frame 056913/0476 →
Continuity (4)
Continuation 15762532
Provisional Application 62368069 · Jul 28, 2016
Provisional Application 62232310 · Sep 24, 2015
Related Publication 20210356479A1 · Nov 18, 2021
References Cited (30)
US 10253109B2 · Zimring · 2019 [cited by applicant]
US 20130288387A1 · Blancher et al. · 2013 [cited by applicant]
US 20140038210A1 · Essig · 2014 [cited by examiner]
US 20150037819A1 · Blancher et al. · 2015 [cited by applicant]
US 20190049471A1 · Zimring · 2019 [cited by applicant]
WO WO2012162068A2 · 2012 [cited by applicant]
Dean L. Blood Groups and Red Cell Antigens [Internet]. Bethesda (MD): National Center for Biotechnology Information (US); 2005. Chapter 8, The Kell blood group. Available from: https://www.ncbi.nlm.nih.gov/books/NBK2270… [cited by examiner]
Boyland, et al., “Delayed hemolytic transfusion reaction caused by anti-Fyb in a splenectomized patient,” Transfusion, vol. 22, No. 5, 1982, p. 402. [cited by applicant]
Campbell, et al., “Molecular cloning of the B-CAM cell surface glycoprotein of epithelial cancers: a novel member of the immunoglobulin superfamily,” Cancer Res., vol. 54, No. 22, 1994, pp. 5761-5765. [cited by applicant]
Chaudhuri, et al., “Detection of Duffy antigen in the plasma membranes and caveolae of vascular endothelial and epithelial cells of nonerythroid organs,” Blood, vol. 89, No. 2, 1997, pp. 701-712. [cited by applicant]
Daniels et al., “Causes of fetal anemia in hemolytic disease due to anti-K,” Transfusion, vol. 43, No. 1, 2003, pp. 115-116. [cited by applicant]
Daniels, et al., “International Society of Blood Transfusion Committee on Terminology for Red Cell Surface Antigens: Cape Town report,” Vox Sanguinis, vol. 92, No. 2007, pp. 250-253. [cited by applicant]
El Nemer, et al., “Organization of the human LU gene and molecular basis of the Lu(a)/Lu(b) blood group polymorphism,” Blood, vol. 89, No. 12, 1997, pp. 4608-4616. [cited by applicant]
Goodrick et al., “Haemolytic disease of the fetus and newborn due to anti-Fy(a) and the potential clinical value of Duffy genotyping in pregnancies at risk,” Transfusion Medicine , vol. 7, No. 4, 1997, pp. 301-304. [cited by applicant]
Hendrickson, et al., “Recipient inflammation affects the frequency and magnitude of immunization to transfused red blood cells,” Transfusion, vol. 46 No. 9, 2006, pp. 1526-1536. [cited by applicant]
Inderbitzen, et al., “An example of HDN probably due to anti-Lua,” Transfusion, vol. 22, No. 6, 1982, p. 542. [cited by applicant]
International Preliminary Report on Patentability Dated Apr. 5, 2018 in International Application No. PCT/US16/53311, 9 pages. [cited by applicant]
Iwamoto, et al., “Genomic organization of the glycoprotein D gene: Duffy blood group Fya/Fyb alloantigen system is associated with a polymorphism at the 44-amino acid residue,” Blood, vol. 85, No. 3, 1995, pp. 622-626. [cited by applicant]
Iwamoto, et al., “Identification of a novel exon and spliced form of Duffy mRNA that is the predominant transcript in both erythroid and postcapillary venule endothelium,” Blood, vol. 87, No. 1, 1996, pp. 378-385. [cited by applicant]
Lee, “Molecular basis of Kell blood group phenotypes,” Vox Sanguinis, vol. 73, No. 1, 1997, pp. 1-11. [cited by applicant]
Mallinson, et al., “Mutations in the erythrocyte chemokine receptor (Duffy) gene: the molecular basis of the Fya/Fyb antigens and identification of a deletion in the Duffy gene of an apparently healthy individual with t… [cited by applicant]
Office Action Dated Jul. 14, 2020 for U.S. Appl. No. 15/762,532, 8 pages. [cited by applicant]
Parsons, et al., “The Lutheran blood group glycoprotein, another member of the immunoglobulin superfamily, is widely expressed in human tissues and is developmentally regulated in human liver,” PNAS, vol. 92, No. 12, 19… [cited by applicant]
Ridgwell et al., “Production of soluble recombinant proteins with Kell, Duffy and Lutheran blood group antigen activity, and their use in screening human sera for Kell, Duffy and Lutheran antibodies,” Transfus. Med., vo… [cited by applicant]
Russo, et al., “Expression of Kell blood group protein in nonerythroid tissues,” Blood, vol. 96, No. 1, 2000, pp. 340-346. [cited by applicant]
Sosler, et al., “The prevalence of immunization to Duffy antigens in a population of known racial distribution,” Transfusion, vol. 29, No. 6, 1989, pp. 505-507. [cited by applicant]
Search Report and Written Opinion Dated Apr. 7, 2017 for International Application No. PCT/US2016/053311, 19 pages. [cited by applicant]
Tournamille, et al., “Molecular basis and PCR-DNA typing of the Fya/fyb blood group polymorphism,” Human Genetics, vol. 95, No. 4, 1995, pp. 407-410. [cited by applicant]
Vaughan, et al., “Inhibition of erythroid progenitor cells by anti-Kell antibodies in fetal alloimmune anemia,” N. Engl. J. Med., vol. 338, No. 12, 1998, pp. 798-803. [cited by applicant]
Vescio, et al., “Hemolytic disease of the newborn caused by anti-Fyb,” Transfusion, vol. 27, No. 4, 1987, p. 366. [cited by applicant]