Immunoassays for haptens and hapten tracer-antibody complex which can be used therefor, and process for the preparation thereof

• US 5,834,206 A
• Filed: 12/07/1995
• Issued: 11/10/1998
• Est. Priority Date: 12/10/1994
• Status: Expired due to Term

• Current Assignee: Siemens Healthcare Diagnostics Products GmbH (Siemens AG)
• Original Assignee: Behring Diagnostics GmbH
• Inventors: Kasmarker, Reinhard, Neuenhofer, Stephan
• Primary Examiner(s): Huff, Sheela
• Assistant Examiner(s): EYLER, YVONNE L
• Application Number:
  US08/568,821
• Time in Patent Office: 1,069 Days
• Field of Search: 435/7.1, 530/807, 530/300, 530/387.1, 436/63, 436/543
• US Class Current: 435/7.1
• CPC Class Codes: G01N 33/5306 Improving reaction conditions, e.g. reduction of non-specific binding, promotion of specific binding
• CPC Class Codes: G01N 33/531 Production of immunochemical test materials
• CPC Class Codes: G01N 33/533 with fluorescent label
• CPC Class Codes: G01N 33/582 with fluorescent label
• CPC Class Codes: Y10S 530/807 Hapten conjugated with peptide or protein

Abstract

There are disclosed hapten tracer complexes which, on the one hand, contain a hapten which is linked to an indicator component and, on the other hand, an antibody which can bind specifically to the indicator component. These hapten tracer complexes can be employed advantageously in immunoassays.

Claims

1. A hapten tracer complex comprising a hapten linked directly or via a spacer group to an indicator component and an antibody which is bound specifically to said indicator component.

2. A hapten tracer complex as claimed in claim 1, wherein said indicator component is a chemiluminescent group.

3. A hapten tracer complex as claimed in claim 2, wherein said indicator component is acridinium acylsulfonamide, acridinium ester, luminol, isoluminol, dioxetane, oxalic acid ester, oxalamide, or a derivative of one of these compounds wherein said derivative compound contains a reactive group capable of linking said derivative compound to a hapten directly or via a spacer group.

4. A hapten tracer complex as claimed in claim 1, wherein said indicator component is a fluorescent group.

5. A hapten tracer complex as claimed in claim 1, wherein said indicator component is a biolumunescent group.

6. A hapten tracer complex as claimed in claim 1, wherein said indicator component is an electroluminescent group.

7. A hapten tracer complex as claimed in claim 1, wherein said indicator component is a phosphorescent group.

8. A hapten tracer complex as claimed in claim 1, wherein said antibody directed against said indicator component is a monoclonal antibody, a polyclonal antibody, or an antibody fragment.

9. A process for the preparation of a hapten tracer complex as claimed in claim 1, wherein said antibody directed against said indicator component is brought together in an aqueous solution with said hapten which is linked to said indicator component.

10. A test kit for carrying out an immunoassay for the detection of an antigen and/or hapten, comprising a hapten tracer complex as claimed in claim 1.

11. A test kit as claimed in claim 10, wherein said indicator complex of said hapten tracer complex is a luminescent indicator.

12. A test kit as claimed in claim 10, further comprising at least one antibody directed against said hapten, wherein said immunoassay is a competitive immunoassay.

13. A test kit as claimed in claim 10, further comprising magnetizable particles to which said antibodies directed against said hapten are bound.

14. A competitive immunoassay method for detection of an antigen or hapten in a sample, comprising the steps of:

a) contacting the sample with an antibody directed against said antigen or hapten in the presence of a hapten tracer complex as claimed in claim 1;

b) detecting the amount of said indicator component bound to said antibody directed against said antigen or hapten; and

c) determining the amount of said antigen or hapten in the sample by means of appropriate calibration curves.

15. The process as claimed in claim 9, wherein said aqueous solution further comprises organic solvents for improving the solubility of said hapten linked to said indicator component, wherein said organic solvents are acetonitrile, dimethylformamide, dimethyl sulfoxide, or mixtures thereof.

16. A process for increasing the hydrophilicity of haptens linked directly or via a spacer group to an indicator component comprising the step of complexing said haptens with an antibody which binds specifically to the indicator component.