Method for the rapid diagnosis of targets in human body fluids using undiluted samples

• US 8,647,890 B2
• Filed: 02/08/2010
• Issued: 02/11/2014
• Est. Priority Date: 02/09/2004
• Status: Active Grant

• Current Assignee: Quidel Corporation
• Original Assignee: Rapid Pathogen Screening, Inc
• Inventors: Aberl, Franz, Scheibenzuber, Marcus, Sambursky, Robert P., VanDine, Robert W., Sambursky, Jose S.
• Primary Examiner(s): Haq, Shafiqul
• Assistant Examiner(s): Hollinden, Gary E.
• Application Number:
  US12/701,799
• Publication Number:
  US 20100143891A1
• Time in Patent Office: 1,464 Days
• Field of Search: 436/514, 435/4, 435/7.1, 435/287.1, 435/287.2, 435/287.7
• US Class Current: 436/514
• 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 method for the detection of a target which is selected from pathogens and/or allergy-associated components in a body fluid comprising the steps of:

(a) non-invasively collecting a body fluid sample with a swab member;

(b) directly contacting said swab member with a sample application zone on a lateral flow chromatographic test strip;

wherein the sample is not diluted before contact between the swab member and the sample application zone on the lateral flow chromatographic test strip; and

wherein at least a part of said body fluid sample is released directly into said sample application zone due to said swab member contacting said sample application zone;

wherein the lateral flow chromatographic test strip further comprises a conjugate zone that is located at least partially within the sample application zone and comprises at least one binding partner for the target;

(c) applying an elution medium to an absorbent pad on the lateral flow chromatographic test strip to transfer said sample to a detection zone on the lateral flow chromatographic test strip; and

(d) analyzing the sample.

2. The method of claim 1 wherein the pathogen is selected from viruses, bacterium, microorganisms and parasites.

3. The method of claim 1 wherein the allergy-associated component is selected from allergens and anti-allergens.

4. The method of claim 1 wherein the body fluid is fluid from a body surface selected from mucous membrane fluids, secretions from glands and secretions from lesions or blisters.

5. The method of claim 4 wherein the sample is selected from oral, nasal, ocular, genital, and rectal fluids, and secretions from skin lesions or blisters.

6. The method of claim 5 wherein the sample is an eye fluid.

7. The method of claim 1 wherein the target is a pathogen which is a causative agent of conjunctivitis or a plurality of such causative agents.

8. The method of claim 1 wherein the pathogen is selected from the group consisting of adenoviruses, herpesviruses, chlamydiae, cytomegaloviruses, pseudomonas, streptococci, haemophilus, staphylococci, amoebae and combinations thereof.

9. The method of claim 1 wherein the target is an allergy-associated component which is a causative agent or a mediator of conjunctivitis or a plurality of such causative agents and/or mediators.

10. The method of claim 1, wherein the target comprises at least one pathogen and at least one allergy-associated component.

11. The method of claim 1 wherein the sample is about 0.1 μ

l to about 100 μ

l.

12. The method of claim 11 wherein the sample is about 0.5 μ

l to about 10 μ

l.

13. The method of claim 1 wherein step (a) comprises the substep of wiping or dabbing the swab member over a surface of a body part containing the body fluid to be tested.

14. The method of claim 1 wherein the swab member is sterile.

15. The method of claim 1 wherein the swab member is a part separate from the lateral flow chromatographic test strip.

16. The method of claim 1 further comprising the step of fixing the swab member in a contact position with the lateral flow chromatographic test strip.

17. The method of claim 1 wherein the elution medium is selected from the group consisting of a buffer or water.

18. The method of claim 1 wherein the elution medium is added from an external source or is provided within the lateral flow chromatographic test strip.

19. A method of claim 1 wherein step (d) comprises an immunological or enzymatic detection.

20. The method of claim 1, wherein the binding partner in the conjugate zone comprises at least one labeled binding partner that is able to migrate with the elution medium.

21. A method for the detection of a target which is selected from pathogens and/or allergy-associated components in a body fluid comprising the steps of:

a) non-invasively collecting a body fluid sample with a swab member;

b) directly contacting said swab member and said sample on said swab member with a sample application zone on a lateral flow chromatographic test strip, wherein dilution of the sample does not occur before direct contact between the swab member and the sample and the sample application zone on the lateral flow chromatographic test strip;

c) applying an elution medium to an absorbent pad on said lateral flow chromatographic test strip to transfer said sample to a detection zone on the chromatographic test strip; and

d) analyzing the sample;

wherein the lateral flow chromatographic test strip further comprises a conjugate zone located at least partially within the sample application zone, wherein said conjugate zone comprises at least one labeled binding partner that is able to migrate with the elution medium wherein, when the analyte is present, the labeled binding partner complexes with the analyte and then migrates to the detection zone.

22. The method of claim 21, wherein at least a part of said body fluid sample is released directly into said sample application zone due to said swab member contacting said sample application zone.

23. The method of claim 21, wherein the body fluid sample is an eye fluid sample.

24. The method of claim 21, wherein the target is a pathogen which is a causative agent of conjunctivitis or a plurality of such causative agents.

25. A method for the detection of a target which is selected from pathogens and/or allergy-associated components in a body fluid comprising the steps of:

a) non-invasively collecting a body fluid sample with a swab member;

b) directly contacting said swab member with a sample application zone on a lateral flow chromatographic test strip, wherein at least a part of said body fluid sample is released directly into said sample application zone due to said swab member contacting said sample application zone; and

wherein the lateral flow chromatographic test strip further comprises a conjugate zone that is located at least partially within the sample application zone and comprises at least one labeled binding partner for the target; and

c) applying an elution medium to an absorbent pad on the lateral flow chromatographic test strip to transfer said sample to a detection zone on the lateral flow chromatographic test strip;

wherein the sample is not diluted prior to steps b) and c); and

d) analyzing the sample.

26. A method for the detection of a target which is selected from pathogens and/or allergy-associated components in a body fluid comprising the steps of:

a) non-invasively collecting a body fluid sample with a swab member;

b) directly contacting said swab member and said sample on said swab member with a sample application zone on a lateral flow chromatographic test strip; and

wherein the lateral flow chromatographic test strip further comprises a conjugate zone that is located at least partially within the sample application zone and comprises at least one labeled binding partner for the target;

c) applying an elution medium to an absorbent pad on the lateral flow chromatographic test strip to transfer said sample to a detection zone;

wherein the sample is not diluted prior to steps b) and c); and

d) analyzing the sample.

27. A method for the detection of a target which is selected from pathogens and/or allergy-associated components in a body fluid comprising the steps of:

a) non-invasively collecting a body fluid sample with a swab member;

b) directly contacting said swab member and said sample on said swab member with a sample application zone on a lateral flow chromatographic test strip, wherein dilution of the sample does not occur before direct contact between the swab member and the sample and the sample application zone on the lateral flow chromatographic test strip;

c) applying an elution medium to an absorbent pad on said lateral flow chromatographic test strip to transfer said sample to a detection zone on the chromatographic test strip; and

d) analyzing the sample;

wherein the lateral flow chromatographic test strip further comprises a conjugate zone located within the sample application zone, wherein the conjugate zone comprises at least one labeled binding partner that is able to migrate with the elution medium, and wherein, when the analyte is present, the labeled binding partner complexes with the analyte and then migrates to the detection zone.