Binding assay system and method of making and using same

• US 4,567,149 A
• Filed: 03/17/1983
• Issued: 01/28/1986
• Est. Priority Date: 03/17/1983
• Status: Expired due to Term

• Current Assignee: Hitachi Chemical Diagnostics, Inc. (Resonac Holdings Corp.)
• Original Assignee: MAST Immunosystems, Inc. (Resonac Holdings Corp.)
• Inventors: Sell, William J., Marinkovich, Vincent A., Riege, David H.
• Primary Examiner(s): Warden, Robert J.
• Assistant Examiner(s): Foulke, Cynthia Lee
• Application Number:
  US06/476,367
• Time in Patent Office: 1,048 Days
• Field of Search: 435/4, 435/7, 435/287, 435/291-293, 435/300, 435/301, 436/513, 436/530, 436/804, 436/805, 436/807-809, 424/1.5, 424/12, 424/20, 422/56-58, 422/61, 422/68, 422/71
• US Class Current: 436/513
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: G01N 2035/1062 for testing the liquid while it is in the transfer device
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing

Abstract

Method and apparatus for use in the diagnostic analysis of a liquid specimen through binding assays. The apparatus includes a rigid body having an elongated, shallow well formed in it, with a plurality of elongated strips, preferably in the form of cotton threads, stretched across the well in spaced relationship and generally perpendicular to the well'"'"'s longitudinal axis. Each thread is coated with a separate binding conjugate such as an antigen or allergen. A cover plate that includes a thin plastic layer and an overlaying thin metallic layer covers the well to form an enclosed chamber having a specific volume. The metallic layer includes a separate elongated aperture in alignment with each coated thread. A liquid specimen is introduced into the chamber through one of two ports, for incubation with the coated threads, after which the specimen is removed and the reaction that occurred on each thread is determined.

Claims

1. For use in a system for the diagnostic analysis of a liquid specimen through binding assays, an apparatus comprising:

a rigid body having an elongated well therein for receiving a liquid specimen;

a plurality of elongated strips oriented in spaced relationship to each other across the elongated well and generally transverse to its longitudinal axis and disposed for contacting the liquid specimen, each strip being coated with a binding assay component such that reactive components in the liquid specimen will be bound thereto; and

a cover plate connected to the rigid body and enclosing the elongated well.

2. An apparatus as defined in claim 1, wherein the plurality of elongated strips are cotton threads.

3. An apparatus as defined in claim 1, wherein:

the rigid body includes a substantially flat land surrounding the elongated well; and

the cover plate is substantially flat and is secured to the land of the rigid body, to enclose the elongated well.

4. An apparatus as defined in claim 3, wherein the cover plate includes a thin metallic sheet having a plurality of elongated apertures aligned with each of the plurality of elongated strips.

5. An apparatus as defined in claim 4, wherein the cover plate further includes a thin plastic sheet disposed between the rigid body and the thin metallic sheet.

6. An apparatus as defined in claim 5, wherein:

the rigid body is formed of a plastic material;

the plastic sheet and the metallic sheet are secured to each other by an adhesive; and

the plastic sheet is secured to the land of the rigid body by a sonic weld.

7. An apparatus as defined in claim 5, wherein the thin plastic sheet is transparent.

8. An apparatus as defined in claim 3, wherein each of the elongated strips extends across the well from the land on opposite sides of the well.

9. An apparatus as defined in claim 1, wherein the plurality of elongated strips are held in tension across the elongated well and are each substantially straight and parallel with each other.

10. An apparatus as defined in claim 1, wherein the rigid body further includes a port at each end thereof and communicating with the well, so that the liquid specimen may be inserted into the well through a port.

11. An apparatus as defined in claim 10, wherein the rigid body further includes a pipette projection in alignment with the port located at one end of the elongated well.

12. Apparatus for use in a system for the allergy screening of a liquid specimen through binding assays, the apparatus comprising:

a rigid plastic body having an elongated, shallow well formed therein, and a substantially flat land surrounding the well;

a plurality of cotton threads stretched tautly across the elongated well from the land on its opposite sides, the threads being oriented in spaced parallel relationship substantially perpendicular to the longitudinal axis of the elongated well and disposed for contacting the liquid specimen, each thread coated with a different allergen or group of allergens for binding corresponding antibodies in the liquid specimen;

a substantially flat cover plate secured to the land of the rigid body, to enclose the elongated well, the cover plate including

a thin, transparent plastic sheet overlaying to the land of the rigid body, and

a thin metallic sheet overlaying the plastic sheet and having a plurality of elongated apertures aligned with each of the plurality of cotton threads; and

means defining a port at each end of the elongated elongated well, to facilitate insertion and removal of a liquid specimen in the well, for contact with the plurality of cotton threads.

13. A method for the diagnostic analysis of a liquid specimen through binding assays, comprising the steps of:

coating each of a plurality of elongated strips with a binding assay component such that reactive components in the liquid specimen will be bound thereto;

positioning the plurality of elongated strips in a predetermined spaced relationship to each other in a chamber of prescribed volume formed within a rigid body;

placing a liquid specimen in the chamber and incubating the specimen in contact with the coated strips;

removing the liquid sample from the chamber; and

measuring the reaction occurring between the liquid specimen and each of the coated strips.

14. A method as defined in claim 13 wherein:

the chamber is defined by an elongated, shallow well formed in the rigid body;

the step of positioning includes a step of stretching the elongated strips across the well, generally transverse to its longitudinal axis; and

the method further includes a step of securing a cover plate to the rigid body, to enclose the well and thereby form the chamber.

15. A method as defined in claim 14, wherein the step of securing sonically welds the cover plate to the rigid body.

16. A method as defined in claim 14, wherein said cover plate includes on its outside surface a thin metallic sheet having a plurality of elongated apertures therethrough in alignment with each of the plurality of elongated strips.

17. A method as defined in claim 13, wherein the plurality of elongated strips positioned in the step of positioning are cotton threads.