Lateral flow medical diagnostic assay device with sample extraction means

• US 5,415,994 A
• Filed: 08/02/1993
• Issued: 05/16/1995
• Est. Priority Date: 08/02/1993
• Status: Expired due to Term

• Current Assignee: Quidel Corporation
• Original Assignee: Quidel Corporation
• Inventors: Miller, Steven P., Zeis, John K., Imrich, Michael R., Pronovost, Allan D.
• Primary Examiner(s): Bidwell, Carol E.
• Application Number:
  US08/100,901
• Time in Patent Office: 652 Days
• Field of Search: 435/7.32, 435/7.34, 435/7.36, 435/7.92, 435/7.94, 435/5, 435/29, 435/287, 435/961, 435/967, 435/970, 435/975, 435/973, 436/514, 436/518, 436/530, 436/531, 436/536, 436/538, 436/540, 436/174, 436/175, 436/808, 436/810, 422/50, 422/55, 422/57, 422/61, 422/101
• US Class Current: 435/5
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: B01L 3/5029 using swabs
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/569 for microorganisms, e.g. protozoa, bacteria, viruses
• CPC Class Codes: Y10S 435/961 including a step of forming, releasing, or exposing the antigen or forming the hapten-immunogenic carrier complex or the antigen per se
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/973 Simultaneous determination of more than one analyte
• CPC Class Codes: Y10S 435/975 Kit

Abstract

The present invention provides devices, methods, and kits for treatment and detection of analytes requiring pretreatment in samples. One-step treatment and detection is possible utilizing the devices and methods of the present invention.

Claims

1. A device for detecting the presence of an analyte in a sample contained on a swab, said device comprising:

an extraction chamber for extracting the analyte from the sample wherein the extraction chamber is disposed over a sample receiving zone on a matrix, and wherein the extraction chamber includes a bowl portion for receiving a liquid extraction solution and a cylindrical portion for receiving the swab; and

a matrix having a sample receiving zone for receiving the extraction liquid containing the analyte, a labelling zone having means for specifically labelling the analyte as it passes therethrough and a capture zone having means for specifically binding the labelled analyte thereon, wherein the sample receiving zone, the labelling zone and the capture zone are arranged on the matrix in a liquid flow path.

2. The device of claim 1, wherein the labelling means is labelled immunoglobulin which specifically binds to the analyte.

3. The device of claim 1, wherein an immunoglobulin which specifically binds to the analyte is immobilized in the capture zone.

4. The device of claim 1 where the labelling means is labelled immunoglobulin that specifically binds to a microbial antigen.

5. The device as claimed in claim 4 wherein the labelled immunoglobulin is specific for the microbial antigen selected from the group consisting of Group A Streptococcus antigen, Group B Streptococcus antigen, Pseudomonas aeruginosa antigen, Chlamydia trachomatis antigen, Neisseria gonorrhoeae antigen, Legionella pneumophila antigen, and herpes simplex virus antigen.

6. The device of claim 1, wherein the matrix is a non-bibulous flow membrane.

7. The device of claim 1, further comprising an absorbent zone located downstream from the capture zone in the matrix.

8. A kit for the detection of an analyte in a sample, comprising:

the device of claim 1; and

a vial containing extraction reagents.

9. The kit of claim 8, wherein the vial is a multichamber allet.

16. A method of detecting an analyte in a sample suspected of containing the analyte, comprising:

inserting a swab containing the sample into the cylindrical portion of the extraction chamber of the device of claim 1;

introducing an extraction solution into the bowl portion of the extraction chamber, wherein the analyte is extracted from the sample into the extraction solution and wherein the extraction solution containing the analyte is washed onto the receiving zone of the matrix and passes through the matrix of the device;

observing accumulation of label in the capture zone of the device; and

determining therefrom the presence of the analyte in the sample by detecting the presence of the label in the capture zone.

17. The method of claim 16, wherein the extraction solution comprises an acid, a detergent or a chelator.

18. The method of claim 16, wherein the analyte is a microbial antigen.

19. A method of claim 18, wherein the microbial antigen is selected from the group consisting of Group A Streptococcus antigen, Group Streptococcus antigen, Pseudomonas aeruginosa antigen, chlamydia trachomatis antigen, Neisseria gonorrhoea antigen, Legionella pneumophila antigen, and herpes simplex virus antigen.

20. The method of claim 19, where the sample is a physiological fluid.

21. The method of claim 16, further comprising rotating the swab in the extraction solution.

10. A device for simultaneously detecting the presence of a plurality of analytes in a sample contained on a swab, said device comprising:

an extraction chamber for extracting the analyte from the sample wherein the extraction chamber is disposed over a sample receiving zone on a matrix, and wherein the extraction chamber includes a bowl portion for receiving a liquid extraction solution and a cylindrical portion for receiving the swab; and

a matrix having a sample receiving zone for receiving the extraction liquid containing the analyte, a labelling zone having means for specifically labelling each of the analytes as they pass therethrough and at least one capture zone having means for specifically binding a first labelled analyte thereon and at least one capture zone for specifically binding a second labelled analyte, wherein the sample receiving zone, the labelling zone and the capture zones are arranged on the matrix in a liquid flow path.

11. The device of claim 10, wherein an immunoglobulin which specifically binds to one analyte is immobilized in each capture zone.

12. The device of claim 10, wherein the matrix is a non-bibulous membrane.

13. The device of claim 10, wherein the immunoglobulin that specially binds to one analyte immobilized in each capture zone is specific for a microbial antigen.

14. The device of claim 13, wherein the immunoglobulin is specific for microbial antigen selected from the group consisting of Chlamydia trachomatis antigen, Neisseria gonorrhoeae antigen, Mycoplasma pneumoniae antigen, Ureaplasma urealyticum antigen and Gardnerella vaginalis antigen.

15. The device of claim 13, the immunoglobulin is specific for microbial antigen selected from the group consisting of Mycoplasma pneumoniae antigen, Legionella pneumophila antigen, Streptococcus pneumoniae antigen, Hemophilus influenzae antigen, and Moraxella catarrhalis antigen.