Screening test and procedure using skin patches

• US 6,585,646 B2
• Filed: 11/26/2001
• Issued: 07/01/2003
• Est. Priority Date: 11/29/2000
• Status: Expired due to Term

• Current Assignee: Hermetic Diagnostics, Inc.
• Original Assignee: Hermetic Diagnostics, Inc.
• Inventors: Berlin, Stuart
• Primary Examiner(s): Nasser, Robert L.
• Assistant Examiner(s): Mallari, Patricia C
• Application Number:
  US09/994,535
• Publication Number:
  US 20020115921A1
• Time in Patent Office: 582 Days
• Field of Search: 600/362-367, 600/306, 600/309, 600/573
• US Class Current: 600/362
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/57434 of prostate

Abstract

Marker compounds indicative of variations in physiological conditions, genetic defects or disease states have been found to be present in apocrine sweat and, in many conditions, these markers are present in apocrine sweat in elevated levels when compared to blood. These markers are collected and/or detected in apocrine sweat and used as an indicator that a disease state or particular physiological condition exists. A skin patch, wipe or electronic detector for vapors released from apocrine sweat are used to indicate the existence of a disease state or changing physiological condition. The patch or wipe can include in monoclonal antibodies or other chemical compounds that can indicate the presence of specific markers. This may include indicators that render visible, the existence of a reaction between the monoclonal antibody or chemical compound and the marker compound to indicate the existence of the condition being tested for. Various different disease states can be detected including, but not limited to heart disease, cancer, autoimmune disease, viral or bacterial disease, renal disease, drug intoxication and other systemic illnesses. Fertility for conception and histocompatibility for organ transplantation of individuals should also be detectable.

Claims

1. A method of diagnosing a disease state or physiological condition in a living mammal comprising collecting liquid or vapor components of apocrine gland secretions and providing means at a point of collection for indicating a presence of a marker compound in those apocrine gland secretions wherein the means of indicating the presence of the marker compound in the apocrine gland secretions comprises electronic sensors which indicate the presence of specific marker compounds.

2. A method of diagnosing an individual for the use of drugs comprising collecting liquid or vapor components of apocrine gland secretions and providing means for indicating a presence of a chemical component or metabolite of the drug in those apocrine gland secretions wherein an absorbent material placed against an underarm, groin or mammary area skin of the mammal collects the apocrine gland secretions, the absorbent material containing a visible indicator responsive to a chemical component or metabolite of the drug and, after a sufficient collection period, observing a color change to detector compounds caused by the presence of the chemical component or metabolite in or on the absorbent material wherein the color change is viewable only after removing the absorbent material from the skin surface.

3. A method of diagnosing an individual for the use of drugs comprising collecting liquid or vapor components of apocrine, gland secretions and providing means for indicating a presence of a chemical component or metabolite of the drug in those apocrine gland secretions comprising collecting the apocrine gland secretions by wiping an underarm, groin or mammary area skin of the mammal with an absorbent patch and observing color changes to detector compounds in or on the absorbent material.

4. The method of claim 3 comprising applying an indicator compound to the absorbent material after collection of the apocrine gland secretions to provide a color change viewable when the indicator compound reacts with a chemical compound or metabolite of the drug in the collected apocrine gland secretions.

5. A method of diagnosing an individual for cardiac disease comprising collecting liquid or vapor components of apocrine gland secretions and providing means for indicating a presence in the apocrine gland secretions of a marker compound indicative of cardiac disease wherein by an absorbent pad placed against an underarm, groin or mammary area skin of the mammal collects the apocrine gland secretions, the absorbent pad containing a visible indicator indicative of the presence of the marker compound and, after a sufficient collection period, observing a color change to detector compounds in or on the pad wherein the color change is viewable only after removing the pad from the skin surface.

6. A method of diagnosing an individual for cardiac disease comprising collecting liquid or vapor components of apocrine gland secretions and providing means for indicating a presence in the apocrine gland secretions of a marker compound indicative of cardiac disease comprising collection the apocrine gland secretions by wiping the skin of an underarm, groin or mammary area of the mammal with an absorbent pad and;

observing color changes to detector compounds in or on the pad.

7. The method of claim 6 comprising applying an indicator compound to the wipe after collection of the apocrine gland secretions to provide a color change viewable when the indicator compound reacts with a marker compound in the collected apocrine gland secretions.

8. A method of diagnosing an individual for cardiac disease comprising collecting liquid or vapor components of apocrine gland secretions and providing means for indicating a presence in the apocrine gland secretions of a marker compound indicative of cardiac disease comprising sensing the cardiac disease marker in the apocrine gland secretions using electronic sensors which indicate the presence of specific marker compounds.

9. A method of diagnosing a disease state or physiological condition in a living mammal comprising collecting liquid or vapor components of apocrine gland secretions and providing means at a point of collection for indicating a presence of a marker compound in those apocrine gland secretions comprising collecting components of the apocrine gland secretions by positioning against the skin of an underarm, groin or mammary area of the mammal an absorbent patch and, after a sufficient collection period, observing a visible appearance change to detector compounds in or on the patch, said appearance change being related to the marker compound wherein the visible appearance change is a color change viewable only after removing the patch from the skin surface.

10. A method of diagnosing a disease state or physiological condition in a living mammal comprising collecting liquid or vapor components of apocrine gland secretions and providing means at a point of collection for indicating a presence of a marker compound in those apocrine gland secretions comprising collecting components of the apocrine gland secretions by wiping an underarm, groin or mammary area skin of the mammal with an absorbent patch and observing a visible appearance change to detector compounds in or on the patch, said appearance change being related to the marker compound.

11. The method of claim 10 wherein an indicator compound is applied to the wipe after collecting components of the apocrine gland secretions to provide a color change viewable when the indicator compound reacts with the marker compound in the collected components of the apocrine gland secretions.

12. A method of diagnosing a mammalian body for an existence of cancer comprising collecting liquid or vapor components of apocrine gland secretions and providing means at a point of collection for indicating a presence of a cancer marker compound in those apocrine gland secretions.

13. The method of claim 12 comprising sensing the cancer marker in the apocrine gland secretions using electronic sensors which indicate the presence of specific cancer marker compounds.

14. The method of claim 12 comprising collecting components of the apocrine gland secretions by positioning against the skin of an underarm, groin or mammary area of the mammal an absorbent patch, said patch containing at least one detector compound reactive with the cancer marker and, further comprising, after a sufficient collection period, observing a color change to the detector compound in or on the patch caused by the presence of the marker compound.

15. The method of claim 14 wherein the color change is viewable without removing the patch.

16. The method of claim 14 wherein the color change is viewable after removing the patch from the skin surface.

17. The method of claim 12 comprising collecting components of the apocrine gland secretions by wiping the skin area of an underarm, groin or mammary region of the mammal with an absorbent patch and, observing color changes to marker reactive detector compounds in or on the patch.

18. The method of claim 17 wherein an indicator compound is applied to the wipe after collecting the apocrine gland secretions to provide a color change viewable when the indicator compound reacts with a marker compound in the collected apocrine gland secretions.