Simultaneous calibration heterogeneous immunoassay

• US 5,432,057 A
• Filed: 08/28/1992
• Issued: 07/11/1995
• Est. Priority Date: 12/26/1979
• Status: Expired due to Fees

• Current Assignee: Dade Behring Marburg GmbH (Siemens AG)
• Original Assignee: Syva Co. (Siemens AG)
• Inventors: Litman, David J., Ullman, Edwin F.
• Primary Examiner(s): Bidwell, Carol E.
• Application Number:
  US07/937,252
• Time in Patent Office: 1,047 Days
• Field of Search: 435/7.91, 435/7.92, 435/805, 435/810, 435/970, 435/975, 435/967, 422/56, 422/57, 422/61, 436/66
• US Class Current: 435/7.91
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: G01N 33/542 with steric inhibition or signal modification, e.g. fluorescent quenching
• CPC Class Codes: G01N 33/543 with an insoluble carrier for immobilising immunochemicals
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms
• CPC Class Codes: G01N 33/581 with enzyme label (including co-enzymes, co-factors, enzyme inhibitors or substrates)
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/967 Standards, controls, materials, e.g. validation studies, buffer systems
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/975 Kit

Abstract

An assay method and compositions are provided for determining the presence of an analyte in a sample. The analyte is a member of an immunological pair (mip) comprising ligand and receptor. By providing a first measurement surface capable of specifically binding a labelled reagent in an amount depending upon the presence of analyte in the sample and a second calibration surface capable of binding a second labeled reagent in a manner unaffected by the presence of analyte in the sample, calibration of individual tests can be accomplished simultaneously with the performance of the test itself. A signal producing system includes an enzyme, a catalyst usually bonded to a mip which defines the first labeled reagent for binding to the measurement surface and the same catalyst conjugated to a ligand capable of binding to the calibration surface. Preferably, both labeled reagents have the same composition and the calibration surface includes anti-(first catalyst).

Claims

1. An internally calibrated diagnostic apparatus comprising a support, a measurement first surface of a porous material mounted on said support;

a calibration second surface of a porous material mounted on said support in close proximity to said first surface;

a member of a specific binding pair non-diffusively bound to said first surface; and

an enzyme non-diffusively bound to said second surface.

2. An apparatus according to claim 1, wherein said first surface has an enzyme bound thereto, which is the same enzyme as that bound to said second surface.

5. A kit comprising (1) the device of claim 4 and (2) a conjugate of a specific binding pair member and an enzyme.

6. The kit of claim 5 wherein said specific binding pair member is an antibody.

3. A kit for use in a diagnostic assay, said kit comprising (i) an internally calibrated diagnostic apparatus comprising a support, a measurement first surface of a porous material mounted on said support;

a calibration second surface of a porous material mounted on said support in close proximity to said first surface;

a member of a specific binding pair non-diffusively bound to said first surface; and

a member of a specific binding pair non-diffusively bound to said first surface; and

a member of a specific binding pair non-diffusively bound to said second surface; and

(ii) an enzyme-bound-member of a specific binding pair, where the member of a specific binding pair bound to said second surface and the member of said enzyme-bound-member of a specific binding pair are the same, complementary or both bind to different binding sites on the same ligand.

4. A device which comprises:

a support,

at least one measurement first surface of a porous material mounted on said support;

at least one calibration second surface of a porous material mounted on said support in close proximity to said first surface,

a member of a specific binding pair non-diffusively bound to said first surface, and an anti-enzyme non-diffusively bound to said second surface.