Dry chemistry cascade immunoassay and affinity assay

• US 5,677,133 A
• Filed: 09/11/1996
• Issued: 10/14/1997
• Est. Priority Date: 02/17/1993
• Status: Expired due to Fees

• Current Assignee: Cardiovascular Diagnostics, Inc. (PharmaNetics, Inc.)
• Original Assignee: Cardiovascular Diagnostics, Inc. (PharmaNetics, Inc.)
• Inventors: Oberhardt, Bruce J.
• Primary Examiner(s): Housel, James C.
• Assistant Examiner(s): Wolski, Susan C.
• Application Number:
  US08/712,370
• Time in Patent Office: 398 Days
• Field of Search: 435/7.1, 435/5, 435/6, 435/7.2, 435/7.4, 435/7.7, 435/7.92, 435/7.93, 435/7.94, 435/13, 435/287.1, 435/287.2, 435/288.3, 435/288.4, 435/288.5, 435/288.7 , 435/808, 435/810, 435/970, 436/526, 436/527, 436/46, 436/805, 436/806, 436/808, 436/809, 422/57, 422/58, 422/61, 422/73, 209/212, 209/213, 209/214, 209/215, 210/695, 210/222
• US Class Current: 435/7.1
• CPC Class Codes: G01N 33/54333 Modification of conditions of immunological binding reaction, e.g. use of more than one type of particle, use of chemical agents to improve binding, choice of incubation time or application of magnetic field during binding reaction
• CPC Class Codes: Y10S 435/808 Optical sensing apparatus
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/806 Electrical property or magnetic property
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/808 Automated or kit
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10T 436/112499 with sample on test slide

Abstract

A method is described for performing an affinity assay comprising contacting a sample to be assayed for the presence of an analyte with a dry reagent containing the analyte (hapten, antigen, antibody, receptor, or complementary polynucleotide) bound to a reaction cascade initiator, an antibody or other binding pair partner reactive with said analyte, and magnetic particles, to form an assay mixture in a reaction chamber, incubating the assay mixture, applying an oscillating or moving static magnetic field to the assay mixture, activating the reaction cascade initiator to initiate a reaction cascade, monitoring the response of the magnetic particles to the oscillating or moving static magnetic field to provide a time varying signal, and determining the analyte concentration of the sample by analysis of the time varying signal, as well as a kit for performing the assay and a diagnostic system for performing the assay.

Claims

1. A system for performing an assay, comprising:

a) a reaction slide comprising

1) a sample well having a sample inlet through which a sample to be analyzed can be added to the sample well;

2) one or more reaction chambers connected to and in fluid communication with the sample well, wherein each of said one of more reaction chambers has a vent;

3) a dry chemistry reagent in at least one of said one or more reaction chambers,

b) one or more means of generating a rotating or oscillating magnetic field

c) means for providing a motive force to move a sample from said sample well to at least one of said one of more reaction chambers, wherein said means for providing a motive force is a vacuum source or a pressure source,

wherein when said means for providing a motive force is a vacuum source, said vacuum source is applied at at least one of said vents in said one of more reaction chambers into which it is desired to transport the sample, and wherein when said means for providing a motive force is a pressure source, said pressure source is applied at said inlet to force transport of said sample from said sample well to said one of more reaction chambers.

d) one of more optical detection systems comprising an illumination means and a detection means; and

e) one or more means for amplifying and processing of a signal from each of said optical detection systems to determine a concentration of one or more analytes in the sample.

2. The system of claim 1, wherein said vacuum source or said pressure source operate within 5-10 mm of atmospheric pressure.

3. The system of claim 1, wherein said vent is covered by a hydrophilic membrane wherein said hydrophilic membrane is gas permeable and liquid impermeable.

4. The system of claim 3, wherein said hydrophilic membrane has a thickness of from 0.5 to 3 mil, a porosity of from 35 to 55% with a pore size of from 0.02 to 0.06 micron.