Processes and apparatus for carrying out specific binding assays

• US 5,610,077 A
• Filed: 07/19/1994
• Issued: 03/11/1997
• Est. Priority Date: 06/20/1980
• Status: Expired due to Term

• Current Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Unilever Patent Holdings BV (Unilever PLC)
• Inventors: Davis, Paul J., Porter, Philip
• Primary Examiner(s): Scheiner, Toni R.
• Application Number:
  US08/275,755
• Time in Patent Office: 966 Days
• Field of Search: 435/7.92, 435/7.94, 436/518, 436/524, 436/528, 436/807, 436/810
• US Class Current: 436/518
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54393 Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
• CPC Class Codes: G01N 33/577 involving monoclonal antibodies binding reaction mechanisms characterised by the use of monoclonal antibodies; monoclonal antibodies per se are classified with their corresponding antigens; G01N33/53 - G01N33/576 take precedence
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/962 Prevention or removal of interfering materials or reactants or other treatment to enhance results, e.g. determining or preventing nonspecific binding
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A process for carrying out a specific binding assay by reacting (a) a sample under assay for the possible presence of a substance being tested for, (b) a specific binding partner for the substance being tested for, immobilised on a solid support, and (c) a specific binding partner for the substance being tested for which is conjugated to a detectable marker, to thereby form a complex by reacting between whatever quantities are present of the substance being tested for in (a) with reagents (b) and (c). The marker is immobilised to the support via the substance being tested for, and is detected or assayed as an index of the quantity present in the sample (a) of any of the substance. The reaction ingredients (a), (b) and (c) are all mixed in a single step for reaction in a single reaction liquid. Competitive interference between the binding reactions of the substance being tested for and reagents (b) and (c) is avoided by use of monoclonal antibodies of narrow and different, non-interfering specificity, reaction reagent (b) is immobilized on the surface of a displacer body.

Claims

1. In the process for carrying out a specific binding assay comprising the steps of reacting (a) a sample under assay, possibly containing a substance being tested for, with (b) a specific binding partner for the substance being tested for, immobilised on a solid support, and (c) a specific binding partner for the substance being tested for which is conjugated to a detectable marker, thereby to form a sandwich complex by reaction between whatever quantities are present of the substance being tested for with reagents (b) and (c) and immobilising the marker to the support via the substance being tested for, the marker being detected or assayed as an index of the quantity of the substance being tested for present in the sample (a), the improvement which comprises using reagents (b) and (c) together for reaction with sample (a) and avoiding competitive interference between the binding reactions of the substance being tested for and reagents (b) and (c) by using as reagents (b) and (c), monoclonal antibodies each of narrow and different, non-interfering specificity, the binding reagent (b) being immobilised on the surface of a displacer body which occupies a majority of the volume of a well or cup containing aqueous liquid in which the specific binding reaction takes place.

2. A process according to claim 1, in which the displacer body (2) has a shape substantially complementary to and slightly smaller than that of the well or cup (1), reducing the volume available in the well or cup (1) for occupation by the aqueous reaction liquid by a factor of 2-10.