Immunoassays in capillary tubes

• US 5,976,896 A
• Filed: 07/29/1996
• Issued: 11/02/1999
• Est. Priority Date: 06/06/1994
• Status: Expired due to Term

• Current Assignee: IDEXX Laboratories Incorporated
• Original Assignee: IDEXX Laboratories Incorporated
• Inventors: Kumar, Amit, Rocco, Richard Michele, Platshon, Mark Charles, Jang, Larry Sheldon, Leung, Danton Kai-Yu
• Primary Examiner(s): Chin, Christopher L.
• Assistant Examiner(s): GRASER, JENNIFER E
• Application Number:
  US08/688,043
• Time in Patent Office: 1,191 Days
• Field of Search: 436/518, 436/524, 436/20, 436/541, 436/23, 436/172, 436/538, 436/527, 436/56, 436/164, 436/800, 436/825, 436/804, 422/57, 422/55, 422/68.1, 422/82.07, 422/82.08, 422/312, 435/809, 435/810, 435/968, 435/971, 435/972
• US Class Current: 436/527
• CPC Class Codes: G01N 2021/0346 Capillary cells; Microcells
• CPC Class Codes: G01N 2021/6482 Sample cells, cuvettes
• CPC Class Codes: G01N 21/03 Cuvette constructions
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/552 Glass or silica
• CPC Class Codes: G01N 33/94 involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
• CPC Class Codes: G01N 35/00 Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor

Abstract

A fluorescent immunoassay employing the interior surface of a capillary tube is provided. Devices to permit immunoassays using one or more capillary tubes, an apparatus for use with the devices, and a process for screening for analyte in a sample using the devices and apparatus are also provided. Samples suspected of containing analyte are added to a disposable self-contained sample tray containing one or more sample wells, mixed with a reagent, drawn into one or more spaced-apart capillary tubes held within a disposable cartridge connected to an analytical apparatus, reacted with a binding member on the surface of the capillary tube, washed to stop the reaction, and dried by the apparatus. The capillary tube is then exposed to a signal generation device to create a fluorescence signal that is detected using a signal detector. The apparatus determines the presence of the analyte and optionally determines the amount of analyte present in the sample, and presents the results to the operator.

Claims

1. A process for screening for an analyte in a sample, which process comprises

importing a fluid mixture into a capillary tube having a wall and coated on at least a portion of its interior surface with a substrate, wherein the fluid mixture comprises a sample suspected of containing the analyte and a reagent comprising a fluorescently-labeled conjugate that

(a) binds to the analyte or to the analyte and the substrate and

(b) fluoresces when irradiated with an appropriate electromagnetic signal;

maintaining the fluid mixture in the capillary tube for a time sufficient for binding to take place between the substrate and the fluorescently-labeled conjugate;

removing excess fluid mixture from the capillary tube;

externally irradiating the coated portion of the capillary tube with an electromagnetic signal sufficient to cause fluorescence of bound fluorescently labeled conjugate; and

detecting through the capillary tube wall the resulting fluorescence occurring on the capillary tube interior surface to screen for the analyte.

2. The process of claim 1, wherein the capillary tube is dried after the removal of excess fluid from the capillary tube and prior to detecting the resultant fluorescence.

3. The process of claim 2, wherein the capillary tube is dried by spinning the capillary tube on a centrifuge, which is designed to securely hold the capillary tube and spinning it for a sufficient time and at a sufficient speed to dry the capillary tube.

4. The process of claim 3, wherein the capillary tube is held by a cartridge designed to fit and be securely held on said centrifuge.

5. The process of claim 2, wherein the means to dry the capillary tube comprises aspirating the capillary tube with a stream of gas.

6. The process of claim 1, wherein the binding in the capillary tube involves binding a fluorescently-labeled conjugate to the substrate of the interior surface of the capillary tube.

7. The process of claim 6, wherein the electromagnetic signal is generated by a laser or a tungsten lamp.

8. The process of claim 1, wherein the detected fluorescence is used to determine the amount of analyte present.

9. The process of claim 1, wherein data reduction and data analysis of detected fluorescence is used to give a result.

10. The process of claim 9, wherein the result of the process is presented as a digital display, a printout, a computer storable file, an output to an external device, or any combination of the foregoing.

11. The process of claim 8, wherein data reduction and data analysis of detected fluorescence is used to determine the amount of analyte present.