Device for collection and assay of oral fluids

• US 7,541,194 B2
• Filed: 01/17/2007
• Issued: 06/02/2009
• Est. Priority Date: 03/30/1998
• Status: Expired due to Term

• Current Assignee: Orasure Technologies Incorporated
• Original Assignee: Orasure Technologies Incorporated
• Inventors: Bohannon, Robert C., Goldstein, Andrew S., Mink, Ronald W.
• Primary Examiner(s): NGUYEN, BAO THUY L
• Application Number:
  US11/653,916
• Publication Number:
  US 20070116597A1
• Time in Patent Office: 867 Days
• Field of Search: 435/7.1, 435/7.94, 435/7.8, 435/7.9, 435/287.1, 435/287.2, 435/287.7, 435/974, 436/514, 436/518, 436/162, 436/170, 436/810
• US Class Current: 436/514
• CPC Class Codes: A61B 10/0051 for taking saliva or sputum samples devices for receiving spittle A61J9/00
• CPC Class Codes: A61B 2010/0006 involving a colour change
• CPC Class Codes: G01N 30/90 Plate chromatography, e.g. thin layer or paper chromatography
• CPC Class Codes: Y10S 435/974 Aids related test
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

A device for collecting and transporting aqueous fluid from the oral cavity to a lateral chromatographic strip for test is disclosed. The lateral chromatographic strip is placed within and extend along a cavity defined in a housing. At least one inspection site to the lateral chromatographic strip is provided to enable inspection of selected sites on the lateral chromatographic strip for test results. A porous wick material protrudes from the housing to a collection site exterior of the housing at one end and communicates to the lateral chromatographic strip at the other end. The porous wick material has particulate construction, the particles adsorbing aqueous oral fluid to transport the fluid from the mouth to the lateral chromatographic strip without substantial absorption. The particles of the porous wick material are bound together to define a continuous interstitial volume for the flow of oral fluid to be transported and are treated to be hydrophilic to the adsorbed oral fluids. The porous wick material readily releases oral fluid to the lateral chromatographic strip. Prevention of reverse flow to the oral cavity from the lateral chromatographic strip naturally occurs due to the circuitous flow path of the porous wick material. A bite plate is coupled to the housing and insertable between the teeth of the patient to position the porous wick in the oral cavity for collecting the oral fluid. The bite plate is typically held in place by the occlusal force of the teeth, preferably the molars and/or the bicuspids, to position the porous wick in the buccal space. By observing the lateral chromatographic strip while the test device is in the mouth immediate test results are obtained.

Claims

1. A method for rapid collection and assay of oral fluids, comprising the steps of:

(a) placing an assay device into an oral cavity, said assay device comprising;

(i) an assay portion housing a lateral flow assay strip, said lateral flow assay strip containing at least one reagent that is used to detect one of the presence or absence of at least one analyte in a fluid;

(ii) a neck portion extending from said assay portion, said neck portion forming a channel for delivery of fluid to said assay strip and said channel being defined by a first, narrow part proximal to the assay portion and a second part including an opening for receiving the oral fluid, wherein said second part includes a channel width that is substantially wider than the channel width at the narrow end;

(iii) a collection strip in fluid communication with said lateral flow assay strip, said collection strip having a first portion disposed within the channel and a second portion protruding outwardly from the neck portion opening; and

(iv) a blocking strip coupled between and in flow communication with said lateral flow assay strip and said collection strip;

(b) removing said assay device from said oral cavity; and

(c) determining the presence or absence of at least one analyte.

2. The method of claim 1, wherein said fluid source is an oral cavity.

3. The method of claim 1, wherein said collection strip comprises a capillary matrix adapted for rapid wicking of fluid from a fluid source to the assay strip.

4. The method of claim 1, wherein said second portion of the collection strip is one of a paddle-shape and a substantially bulbous shape.

5. The method of claim 1, wherein said second portion of said collection strip is paddle-shaped.

6. The method of claim 1, wherein the width of said neck portion tapers from the opening width to the narrow end width.

7. The method of claim 1, wherein said lateral flow assay strip is an immunochromatography strip.

8. The method of claim 1, wherein said reagent is a binding partner which bears a detectable label.

9. The method of claim 8, wherein said reagent is a label comprised of a colloidal gold particle.

10. The method of claim 9, wherein said colloidal gold particle is gold sol.

11. The method of claim 8, wherein said reagent is an enzyme labeled binding partner.

12. The method of claim 1, wherein said reagent comprises one of an antigen and an antibody.

13. The method of claim 1, wherein said blocking strip contains at least one blocking agent or a buffer.

14. The method of claim 1, wherein said collection strip is adsorbent.

15. The method of claim 1, wherein said blocking strip contains a blocking agent or a buffer.

16. The method of claim 15, wherein said buffer is to adjust the pH of the oral fluid sample.

17. The method of claim 15, wherein said lateral flow assay strip further comprising a conjugate strip coupled between and in flow communication with the blocking strip and the lateral flow assay strip, wherein said conjugate strip contains a labeled binding partner for at least one type of antibody in the oral fluid.

18. The method of claim 1, wherein said lateral flow assay strip further comprising a conjugate strip coupled between and in flow communication with the collection strip and the lateral flow assay strip, wherein the conjugate strip contains a labeled binding partner for at least one type of antibody in the oral fluid.

19. The method of claim 1, wherein said analyte is at least one of an atom, a molecule, or a group of molecules.

20. The method of claim 1, wherein said analyte is at least one of an antibody, an antigen, a growth factor, an enzyme, a therapeutic drug, a drug of abuse, or a ligand.

21. The method of claim 1, wherein said analyte is selected from the group consisting of antibodies to HIV, antibodies to HTLV, antibodies to Helicobacter pylori, antibodies to hepatitis, antibodies to measles, antibodies to mumps, antibodies to rubella, cotinine, cocaine, benzoylecgonine, benzodiazepine, tetrahydrocannabinol, nicotine, ethanol theophylline, phenyloin, acetaminophen, lithium, diazepam, nortryptyline, secobarbital, phenobarbitol, theophylline, testosterone, estradiol, 17-hydroxyprogesterone, progesterone, thyroxine, thyroid stimulating hormone, follicle stimulating hormone, luteinizing hormone, transforming growth factor alpha, epidermal growth factor, insulin-like growth factors I and II, growth hormone release inhibiting factor, IGA, sex hormone binding globulin, glucose, caffeine, cholesterol, corticosteroid binding globulin, PSA, DHEA binding glycoprotein and combinations thereof.

22. The method of claim 1, wherein said oral fluid contains at least one of salivary fluids or mucosal transudate.

23. The method of claim 1, wherein said assay device is placed against or wires around the oral mucosa in said oral cavity at the gingival crest or gingival base.

24. An assay method for HIV using oral fluids, comprising the steps of:

(a) placing an assay device into an oral cavity, said assay device comprising;

(i) an assay portion housing a lateral flow assay strip, said lateral flow assay strip containing at least one reagent that is used to detect one of the presence or absence of at least one HIV antibody in the fluid;

(ii) a neck portion extending from said assay portion, said neck portion forming a channel for delivery of fluid to said assay strip and said channel being defined by a first, narrow part proximal to the assay portion and a second part including an opening for receiving the oral fluid, wherein said second part includes a channel width that is substantially wider than the channel width at the narrow end;

(iii) a collection strip in fluid communication with said lateral flow assay strip, said collection strip having a first portion disposed within the channel and a second portion protruding outwardly from the neck portion opening; and

(iv) a blocking strip coupled between and in flow communication with said lateral flow assay strip and said collection strip;

(b) removing the assay device from the oral cavity; and

(c) determining the presence or absence of HIV antibodies.

25. The method of claim 24, wherein said oral fluid contains at least one of saliva or mucosal transudate.

26. The method of claim 24, wherein said assay device is placed against the oral mucosa in an oral cavity at the gingival crest or gingival base.