Method and apparatus for determining an analyte from a sample fluid

• US 5,945,281 A
• Filed: 02/02/1996
• Issued: 08/31/1999
• Est. Priority Date: 02/02/1996
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Prabhu, Ajoy K.
• Primary Examiner(s): Houtteman, Scott W.
• Application Number:
  US08/594,610
• Time in Patent Office: 1,306 Days
• Field of Search: 435/6, 435/526, 435/525
• US Class Current: 435/6.11
• CPC Class Codes: B01L 2200/0647 Handling flowable solids, e.g. microscopic beads, cells, particles
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2400/043 magnetic forces
• CPC Class Codes: B01L 3/502761 specially adapted for handling suspended solids or molecules independently from the bulk fluid flow, e.g. for trapping or sorting beads, for physically stretching molecules investigating characteristics of particles G01N15/00
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: C12Q 1/6834 Enzymatic or biochemical coupling of nucleic acids to a solid phase
• CPC Class Codes: G01N 33/54326 Magnetic particles
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 35/0098 involving analyte bound to insoluble magnetic carrier, e.g. using magnetic separation magnetic particles used in immunoassays G01N33/54326; magnetic separation in general B03C

Abstract

A device and system for assaying a target analyte from a sample fluid. According to the device, the target analyte is separated from the sample fluid through interaction with magnetic capture agents and application of an electromagnetic field. In this manner, fluid reagents used in the assay need not be transported or removed from the device when the assay is being conducted.

Claims

1. A device for assaying a target analyte, comprising:

a housing comprising means for receiving a tray,

the tray comprising at least one well and an interconnected detection region wherein the well and detection region contain a fluid,

said well containing said target analyte, a magnetic capture agent and a label;

input means for inputting to said device data selected from the group consisting of information identifying said target analyte, information identifying a volume of said fluid, information identifying said magnetic capture agent and information identifying said label;

microprocessor means for applying a wave-like electrical potential for transporting a complex of said target analyte, said magnetic capture agent and said label to said detection region of said tray; and

identification means for identifying the presence of said target analyte in said labeled complex at said detection region.

2. The device according to claim 1, wherein said tray provides said magnetic capture agent and said label in separate wells.

3. The device according to claim 1, wherein said electrical potential transports said complex through a wash buffer before reaching said detection region.

4. The device according to claims 1, wherein said microprocessor means also applies an electrical potential to displace magnetized material in a direction substantially normal to a line through said at least one well and said detection region.

5. A tray, comprising a body provided with a well and an interconnected detection region, wherein the well and detection region contain a fluid said well containing a magnetic capture agent and a label for binding to a target analyte.

6. A tray, comprising a body provided with two interconnected wells and a detection region connected to one of said wells oriented along an axis, wherein the wells and detection region contain a fluid, wherein one said wells contains a magnetic capture agent for binding to a target analyte and the other of said wells contains a label for binding to said target analyte.

7. A process for assaying a target analyte, said process comprising the steps of:

selecting an assay tray provided with a well and an interconnected detection region wherein the well and the detection region contain a fluid, said well further containing a magnetic capture agent and a label;

adding to said well a target analyte sample;

causing any target analyte in said sample to form a complex with said magnetic capture agent and said label;

applying electrical potential to said complex and transporting said complex to detection region; and

determining the presence of said complex in said detection region.

8. The process according to claim 7, further comprising the step of determining the concentration of said complex in said detection region.

9. The process according to claim 7, wherein said magnetic capture agent and said label are provided in separate wells in said assay tray.

10. The process according to claim 9, wherein said assay tray further provides a wash well and said process further comprises washing said complex in said wash well before determining the presence of said label.