Apparatus for determination of a component in a sample

• US 5,114,673 A
• Filed: 09/12/1989
• Issued: 05/19/1992
• Est. Priority Date: 01/21/1988
• Status: Expired due to Term

• Current Assignee: Roche Diagnostics Corporation (Roche Holding AG)
• Original Assignee: Boehringer Mannheim Corporation (Roche Holding AG)
• Inventors: Schrenk, Juergen, Berger, Johann, Buck, Harvey, DeLaCroix, Fern
• Primary Examiner(s): Rosen, Sam
• Application Number:
  US07/406,918
• Time in Patent Office: 980 Days
• Field of Search: 422/56, 422/57, 422/60, 436/518, 436/538
• US Class Current: 422/408
• CPC Class Codes: G01N 33/54306 Solid-phase reaction mechanisms
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/6857 Antibody fragments

Abstract

This invention relates to apparatus useful in determining a component or components of a test sample, as well as methods using these apparatus. Of particular interest are apparatus and methods which involve formation and determination of quarternary complexes.

Claims

1. Apparatus for determining an analyte in a fluid sample, comprising:

(a) a first zone containing one component selected from the group consisting of (i) labeled analyte, (ii) labeled analyte analogue, and (iii) labeled receptor which specifically binds to said analyte, wherein said component dissolves in said fluid sample, and wherein if said component is labeled receptor, binds with said analyte to form a complex of analyte and labeled receptor,

(b) a second zone which is in fluid contact with said first zone and which receives fluid sample after passing through said first zone, wherein said second zone contains a solid phase bound receptor which binds to the component previously in said first zone, with the proviso that said solid phase bound receptor does not bind to complexes of analyte and labeled receptor,

(c) a third zone separated from said second zone by a means capable of being rendered fluid permeable, and containing a reactive compound which reacts with the label of said labeled analyte, labeled analyte analogue or labeled receptor when contacted thereto to form a detectable moiety, wherein said means (i) prevents passage of said reactive component into said second zone until completion of binding of said solid phase bound receptor to the component released from said first zone and (ii) permits passage of the component into said second zone thereafter wherein said third zone is positioned relative to said second zone to permit movement of said reactive component into said second zone when said means are rendered fluid permeable, and

(d) a fourth zone in fluid contact with said second zone which removes excess fluid flowing from said second zone.

7. Apparatus of claim 1, 2, 3, or 4, wherein said first and third zones are separate from each other.

8. Apparatus of claim 1, 2, 3, 4, 5, or 6, further comprising a fifth zone, said firth zone being in fluid contact with said first zone.

9. Apparatus of claim 1, 2, 3, or 4, further comprising a fifth zone, said fifth zone being in fluid contact with said first and third zones and adapted for application of sample thereto.

10. Apparatus of claim 1, 2, 3, 4, 5 or 6, further comprising a covering means adapted for viewing a detection reaction therethrough, said covering means containing at least one viewing means positioned in said covering means over said second zone.

11. Apparatus of claim 1, 2, 3, 4, 5 or 6, further comprising a means for separating detectable moiety from uncombined reactive component, said detectable moiety being in fluid contact with said second zone.

12. Apparatus of claim 1, 2, 3 and 4, wherein said first and third zones are in fluid contact with each other.

2. Apparatus for determining an analyte in a fluid sample, comprising:

(a) a first zone containing a plurality of different receptors which dissolved in said fluid sample and which specifically bind to said analyte, wherein one of said receptors carries a label and a second one does not, wherein the labeled receptor and the nonlabeled receptor form a three member complex with said analyte,

(b) a second zone which is in fluid contact with said first zone and which receives fluid sample after passing through said first zone, wherein said second zone contains a solid phase bound receptor which (i) binds to the first zone receptor which does not carry a label and (ii) does not bind to the first zone receptor which does carry a label,

(c) a third zone separated from said second zone by a means capable of being rendered fluid permeable, and containing a reactive component which reacts with the label of said labeled analyte, labeled analyte analogue or labeled receptor when contacted thereto, wherein said means (i) prevents passage of said reactive component into said second zone until completion of binding of said solid phase bound receptor to the component released from said first zone and (ii) permits passage of the component into said second zone thereafter wherein said third zone is positioned relative to said second zone to permit movement of said reactive component into said second zone when said means are rendered fluid permeable, and

(d) a fourth zone in fluid contact with said second zone which removes excess fluid flowing from said second zone.

3. Apparatus for determining an analyte in a fluid sample, comprising:

(a) a first zone containing one component selected from the group consisting of (i) labeled analyte, (ii) labeled analyte analogue, and (ii) labeled receptor which specifically binds to said analyte, wherein said component dissolves in said fluid sample, and wherein said component is labeled receptor, binds with said analyte to form a complex of analyte and labeled receptor,

(b) a second zone which is in fluid contact with said first zone and which receives fluid sample after passing through said first zone, wherein said second zone contains a solid phase bound receptor which binds to the component previously in said first zone, with the proviso that said solid phase bound receptor does not bind to complexes of analyte and labeled receptor,

(c) a third zone which contains a reactive component which reacts with the label of said labeled analyte, labeled analyte analogue or labeled receptor when contacted thereto, wherein said third zone is separated form said second zone by a gap or air space so as to prevent passage of said reactive component from said third zone into said second zone prior to completion of reaction between said solid phase bound receptor and unbound labeled carrying sample, and wherein said third zone moves relative to said second zone so that said second zone and third zones are in fluid contact, wherein said reactive component moves from said third zone into said second zone upon establishment of fluid contact, and

(d) a fourth zone in fluid contact with said second zone which removes excess fluid flowing from said second zone.

4. Apparatus for determining an analyte in a fluid sample, comprising:

(a) a first zone containing a plurality of different receptors which dissolve in said fluid sample and which specifically bind to said analyte, wherein one of said receptors carries a label and a second one does not, wherein the labeled receptor and the nonlabeled receptor form a three member complex with said analyte,

(b) a second zone which is in fluid contact with said first zone and which receives fluid sample after passing through said first zone, wherein said second zone contains a solid phase bound receptor which (i) binds to the first zone receptor which does not carry a label and (ii) does not bind to the first zone receptor which does carry a label,

(c) a third zone which contains a reactive component which reacts with the label of said labeled analyte, labeled analyte analogue or labeled receptor when contacted thereto, wherein said third zone is separated from said second zone by a gap or air space so as to prevent passage of said reactive component from said third zone into said second zone prior to completion of reaction between said solid phase bound receptor and unbound labeled carrying sample, and wherein said third zone moves relative to said second zone so that said second zone and third zones are in fluid contact, wherein said reactive component moves from said third zone into said second zone upon establishment of fluid contact, and

(d) a fourth zone in fluid contact with said second zone which removes excess fluid flowing from said second zone.

5. Apparatus for determining an analyte in a fluid sample, comprising;

(a) a first zone containing one component selected from the group consisting of (i) labeled analyte, (ii) labeled analyte analogue, and (iii) labeled receptor which specifically binds to said analyte, wherein said component dissolves in said fluid sample, and wherein if said component is labeled receptor, binds with said analyte to form a complex of analyte and labeled receptor,

(b) a second zone which is in fluid contact with said first zone and which receives fluid sample after passing through said first zone, wherein said second zone contains all of (1) a solid phase bound receptor which binds to the component previously in said first zone, with the proviso that said solid phase bound receptor does not bind to complexes of analyte and analyte receptor (2) a reactive component which reacts with the label of said labeled analyte, labeled analyte analogue or labeled receptor to form a detectable moiety, and (3) means capable of being rendered fluid permeable which separates said reactive component from labeled analyte, labeled analyte analogue or labeled receptor until reaction with said solid phase is complete and permits contact of said reactive component with immobilized, labeled analyte, labeled analyte analogue or labeled receptor thereafter, and

(c) a third zone in fluid contact with said second zone, which removes excess fluid flowing from said second zone.

6. Apparatus for determining an analyte in a fluid sample, comprising:

(a) a first zone containing a plurality of different receptors which dissolve in said fluid sample and which specifically bind to said analyte one of said receptors carries a label and a second one not, wherein the labeled receptor and the non-labeled receptor form a three member complex with said analyte,

(b) a second zone which is in fluid contact with said first zone and which receives fluid sample after passing through said first zone, wherein said second zone contains all of (1) a solid phase bound receptor which binds to the component previously in said first zone, with the proviso that said solid phase bound receptor does not bind to complexes of analyte and analyte receptor (2) a reactive component which reacts with the label of said labeled analyte, labeled analyte analogue or labeled receptor to form a detectable moiety, and (3) means capable of being rendered fluid permeable which separates said reactive component from labeled analyte, labeled analyte analogue or labeled receptor until reaction with said solid phase is complete and permits contact of said reactive component with immobilized, labeled analyte, labeled analyte analogue or labeled receptor thereafter, and

(c) a third zone in fluid contact with said second zone, which removes excess fluid flowing from said second zone.