Claims for Patent: 4,945,039

Summary for Patent: 4,945,039

Title:	Standard materials for measurement of immune complexes and method for measurement of immune complexes
Abstract:	A standard material for measuring immune complexes which is prepared by chemically binding immunoglobulin and/or its fragment with a complement and/or its derivative through the medium of a bifunctional reagent. By using the standard material, the standard curve which is used for measuring immune complexes existing in the blood is obtained.
Inventor(s):	Suzuki; Hideaki (Koganei, JP), Hosoda; Kenji (Kawagoe, JP), Kubota; Takaharu (Hino, JP), Fukumoto; Yuji (Hachioji, JP)
Assignee:	Teijin Limited (Osaka, JP)
Application Number:	07/060,957
Patent Claims:	1. A standard material for measuring immune complexes which is prepared by chemically binding immunoglobulin or its F(ab').sub.2 fragment or Fab' fragment from a non-immunized individual or FC fragment, with a substance selected from the group consisting of C1, C2, C3, C4, C5, C6, C7, C8, C9, C1q, C1v, C1s, C3c, C3d and Sh group containing derivatives of said C1, C2, C3, C4, C5, C6, C7, C8, or C9, through the medium of a bifunctional reagent. 2. The standard material for measuring immune complexes according to claim 1, wherein said immunoglobulin is any one of human immunoglobulin G(IgG), human immunoglobulin M(IgM), or human immunoglobulin A(IgA). 3. The standard material for measuring immune complexes according to claim 1 or claim 2, wherein said substance is C3. 4. The standard material for measuring immune complexes according to claim 1 or claim 2, wherein said substance obtained by chemically generating or introducing an SH group in or into C3. 5. The standard material for measuring immune complexes according to claim 1 wherein said bifunctional reagent is any one of dialdehyde compounds, diisocyanate compounds, diepoxy compounds, bisdiazo compounds, bismaleimide compounds, carbodiimide compounds, N-succinimidyl N-maleimidocarboxylate compounds, or N-succinimidyl pyridyldithio-carboxylate compounds. 6. The standard material for measuring immune complexes according to claim 2, wherein said bifunctional reagent is any one of dialdehyde compounds, diisocyanate compounds, diepoxy compounds, bisdiazo compounds, bismaleimide compounds, carbodiimide compounds, N-succinimidyl N-maleimido-carboxylate compounds, or N-succinimidyl pyridyldithio-carboxylate compounds. 7. The standard material for measuring immune complexes according to claim 3, wherein said bifunctional reagent is any one of dialdehyde compounds, diisocyanate compounds, diepoxy compounds, bisdiazo compounds, bismaleimide compounds, carbodiimide compounds, N-succinimidyl N-maleimido-carboxylate compounds, or N-succinimidyl pyridyldithio-carboxylate compounds. 8. The standard material for measuring immune complexes according to claim 4, wherein said bifunctional reagent is any one of dialdehyde compounds, diisocyanate compounds, diepoxy compounds, bisdiazo compounds, bismaleimide compounds, carbodiimide compounds, N-succinimidyl N-maleimido-carboxylate compounds, or N-succinimidyl pyridyldithio-carboxylate compounds. 9. In an immunoassay method for quantitatively measuring immune complexes possibly existing in a body fluid with the use of a standard curve, which is prepared for measuring immune complexes, wherein a solid phase carrier fixed with an anti- (human complement) antibody, its F(ab').sub.2, conglutinin (Kg) or combination thereof, is contacted with said body fluid and then the carrier is treated with an enzyme labeled or radio-labeled anti-(human immunoglobulin) antibody and carrying out said measurement by repeating the above technique while substituting a standard material for said body fluid to prepare said standard curve, wherein the improvement comprises using as a standard material for the preparation of said standard curve a material which is prepared by chemically binding immunoglobulin or its F(ab').sub.2, Fab' or Fc fragment with a substance selected from the group consisting of C1, C2, C3, C4, C5, C6, C7, C8, C9, C1q, C1v, C1s, C3b, C3c, C3d and SH group containing derivatives of said C1, C2, C3, C4, C5, C6, C7, C8, or C9, through the medium of a bifunctional reagent. 10. The method as claimed in claim 9, wherein said enzymelabeled or radiolabeled anti-(human immunoglobulin) antibody is a heavy chain-specific antibody. pg,11

Details for Patent 4,945,039

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		2007-07-31
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	07/26/2007		2007-07-31
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	10/02/2009		2007-07-31
Csl Behring Ag	PRIVIGEN	immune globulin intravenous (human), 10% liquid	Injection	125201	02/07/2013		2007-07-31
Bio Products Laboratory	GAMMAPLEX	immune globulin intravenous (human)	Injection	125329	09/17/2009		2007-07-31
Bio Products Laboratory	GAMMAPLEX	immune globulin intravenous (human)	Injection	125329	02/06/2017		2007-07-31
Csl Behring Ag	HIZENTRA	immune globulin subcutaneous (human), 20% liquid	Injection	125350	03/04/2010		2007-07-31