Device for the detection of an analyte in a fluid sample

• US 10,001,482 B2
• Filed: 11/20/2013
• Issued: 06/19/2018
• Est. Priority Date: 02/09/2004
• Status: Active Grant

• Current Assignee: Quidel Corporation
• Original Assignee: Quidel Corporation
• Inventors: Aberl, Franz, Scheibenzuber, Marcus, Sambursky, Robert P., VanDine, Robert W., Sambursky, Jose S.
• Primary Examiner(s): Long, Scott
• Assistant Examiner(s): Hollinden, Gary E
• Application Number:
  US14/084,973
• Publication Number:
  US 20140080204A1
• Time in Patent Office: 1,672 Days
• Field of Search: None
• CPC Class Codes: G01N 2333/07 Vaccinia virus; Variola virus
• CPC Class Codes: G01N 33/487 of liquid biological material
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/56983 Viruses
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

More particularly, the present invention relates to a method for the detection of a target, e.g. pathogen in a human body fluid wherein a body fluid sample is collected with a swab member.

Claims

1. A device for the detection of an analyte in an ocular fluid sample comprising:

a lateral flow chromatographic test strip comprising;

a sample application zone;

a detection zone located downstream of the sample application zone;

a conjugate zone located upstream of the detection zone, wherein the conjugate zone comprises at least one labeled binding partner able to migrate with an elution medium;

a housing containing the lateral flow chromatographic test strip and having a sample application window and a read out window; and

a swab member comprising a swab member body having a body opening and a sample collection material extending from the swab member body for collecting the ocular fluid sample;

wherein the lateral flow chromatographic test strip, the housing, and the swab member are formed such that when the lateral flow test strip is contained in the housing and the sample collection material is inserted through the sample application window, the body opening of the swab member body corresponds to the read out window, and the sample collection material is in fluid communication with the sample application zone to transfer the ocular fluid sample from the swab member to the sample application zone;

wherein the at least one labeled binding partner comprises a conjugate of gold particles and an anti-Hexon antibody; and

wherein, when the analyte is present in the ocular fluid sample, the labeled binding partner complexes with the analyte and then migrates to the detection zone.

2. The device of claim 1, wherein the lateral flow chromatographic test strip further comprises an absorbent pad for the application of the elution medium to transfer the ocular fluid sample from the sample application zone to the detection zone, wherein the absorbent pad is located upstream from the sample application zone and the detection zone.

3. The device of claim 1, wherein the lateral flow chromatographic test strip further comprises a waste zone downstream from the detection zone.

4. The device of claim 1, wherein the lateral flow chromatographic test strip further comprises a carrier backing under the sample application zone, the detection zone, and the conjugate zone.

5. The device of claim 1, wherein the detection zone contains an immobilized specific binding partner, wherein the immobilized specific binding partner binds to the analyte.

6. The device of claim 1, wherein the detection zone further comprises a control line containing an immobilized specific binding partner, wherein the immobilized specific binding partner binds the labeled binding partner and indicates the functionality of the device.

7. The device of claim 1, wherein the swab member collects a sample volume of the ocular fluid sample of about 0.1 μ

l to about 100 μ

l.

8. The device of claim 7, wherein the sample volume is about 0.5 μ

l to about 10 μ

l.

9. The device of claim 7, wherein the sample volume is 0.2 μ

l to 20 μ

l.

10. The device of claim 1, wherein the swab member is sterile.

11. The device of claim 1, wherein the sample collection material is selected from the group consisting of highly purified cotton fibers, polyester fibers, rayon fibers, calcium alginate fibers, polyamide fibers, and a fibrous polymeric material.

12. The device of claim 1, wherein the sample collection material and the material of the sample application zone are selected to provide fluid communication between the sample collection material and the sample application zone to transfer the ocular fluid sample from the swab member to the sample application zone without dilution.

16. The device of claim 1, wherein the swab member body is plastic and the sample collection material is fixed to the swab member body by ultrasonic welding.

17. The device of claim 5, wherein the immobilized specific binding partner is a Hexon specific antibody.

13. A device for the detection of an analyte in an ocular fluid sample comprising:

a lateral flow chromatographic test strip comprising;

a sample application zone;

a detection zone located downstream of the sample application zone; and

a conjugate zone located upstream of the detection zone, wherein the conjugate zone comprises at least one labeled binding partner able to migrate with an elution medium;

a housing containing the lateral flow chromatographic test strip; and

a swab member comprising a plastic swab member body having a body opening which corresponds to the read out window and a sample collection material extending from the swab member body for collecting the ocular fluid sample, wherein the sample collection material is fixed to the swab member body by ultrasonic welding;

wherein the sample collection material and the sample application zone are selected to provide fluid communication between the sample collection material and the sample application zone to transfer the ocular fluid sample from the swab member to the sample application zone without dilution;

wherein the at least one labeled binding partner comprises a conjugate of gold particles and an anti-Hexon antibody; and

wherein, when the analyte is present in the ocular fluid sample, the labeled binding partner complexes with the analyte and then migrates to the detection zone.

14. The device of claim 13, wherein the lateral flow chromatographic test strip further comprises an absorbent pad for the application of the elution medium to transfer the ocular fluid sample from the sample application zone to the detection zone, wherein the absorbent pad is located upstream from the sample application zone and the detection zone.

15. The device of claim 13, wherein the swab member collects a sample volume of the ocular fluid sample of about 0.1 μ

l to about 100 μ

l.

18. The device of claim 13, wherein the detection zone contains an immobilized specific binding partner, wherein the immobilized specific binding partner binds to the analyte.

19. The device of claim 18, wherein the immobilized specific binding partner is a Hexon specific antibody.