Screening test and procedure using skin patches

Details Screening test and procedure using skin patches Screening test and procedure using skin patches

2001-11-26

2003-07-01

Nasser, Robert L. (Department: 3736)

Surgery

Diagnostic testing

Measuring or detecting nonradioactive constituent of body...

C600S306000, C600S309000, C600S573000

Reexamination Certificate

active

06585646

ABSTRACT:

The present invention relates primarily to a test for diagnosing the existence of certain disease states or physiological conditions in mammals based on the collection and analysis of apocrine sweat.
BACKGROUND OF THE INVENTION
It is known that certain disease states or variations from normal physiological conditions can be detected or monitored by analyzing body fluids for variations in constituents of those body fluids. Blood is a highly complex suspension with many elements, which can be measured and analyzed to measure normal homeostasis and variations from normality. Blood is frequently analyzed for variations of various constituents (cholesterol, glucose, etc.), as well as its cellular constituents, as indicators of possible abnormal health conditions. In a like manner, a urine analysis may be used to detect various chemical imbalances, pregnancy or the presence of various legal or illegal drugs by testing for metabolites of the target drug. In addition, there are numerous examples of calorimetric test strips, typically used on urine, for indicating various concentrations of normal fluid constituents or environmental contaminants such as various metals, glucose, protein and ketones. The strips provide a visible indication of a threshold level of normally present reference analyte such as IgG, albumin or the like.
Diagnostic studies of chemical imbalances in other body fluids, such as sweat, can also be indicative of different disease states. For example, an increase in the level of chloride ion in sweat is indicative of cystic fibrosis. U.S. Pat. No. 3,552,929 describes a band-aid type test patch for collecting perspiration. The test patch is applied to an accessible skin surface for collecting eccrine, not apocrine sweat. It is then removed and subjected to a series of analytical tests to determine the concentration of chloride ions as an indicator of cystic fibrosis. U.S. Pat. No. 4,329,999 to Phillips is a further example of a sweat collection device for the detection of drug or alcohol use. The patch was applied to shaved skin surfaces (ankle or calf) which do not have apocrine sweat glands and remained in place for ten days. U.S. Pat. No. 4,706,676 discloses a third example of a dermal patch for detecting exposure to various different environmental chemicals. No attempt was made to collect apocrine sweat.
U.S. Pat. No. 5,676,144 to Schoendorfer and related patents (U.S. Pat. Nos. 5,638,815; 5,465,713; 5,438,984; 5,441,048; 5,203,327 and 4,957,108) describe skin patches which contain various immobilized specific binding agents for certain reference analytes as well as compounds to be detected. Schoendorfer recognizes that there are both eccrine and apocrine sweat glands, that perspiration can be either sensible or insensible and that various locations on the body sweat at different rates. However, he fails to recognize the unique diagnostic function of apocrine sweat glands and proceeds to collect eccrine sweat from the chest because large quantities of sweat can be collected. After a sufficient volume of sweat is collected the patches are then removed and subjected to various different laboratory procedures to detect the presence or increased levels of various substances such as creatine kinase MB (CK—MB). CK—MB is released from cardiac muscle during myocardial infarction and other cardiac stress and therefore is an indicator of cardiac injury. As indicated in U.S. Pat. No. 5,203,327, many chemical species detectable in blood or urine, such as sodium, calcium, chloride and potassium, are also detectable in lower concentrations in sweat. Table 1 of the '327 patent also lists numerous other normally occurring components detectable in various concentrations in sweat. Affinity chemistry can be developed and incorporated in skin patches for monitoring the concentration of these various chemicals. In addition, various metabolites of drugs of abuse such as THC, morphine, cocaine or methadone can be detected in sweat. However, with the exception of colorimetric indication of a normally present reference compound, such as IgG or albumin, which is used to provide an indication that a minimum volume of sweat has entered the patch, the compounds of interest are merely collected by the patch (U.S. Pat. No. 5,203,327, col. 16, lines 4-30). Detection and analysis of the target component is then performed in a laboratory setting.
The FDA has approved sweat collection patches for use in drug abuse screening programs to test for amphetamines, cocaine, marijuana, PCP, heroin meth-amphetamines, their metabolites and other opiates. Manufacturers of these products include the Sudormed Sweat Specimen Container, made by Sudorned, of Santa Anna, Calif., the EIA Micro-Plate Assay, made by SolarCare Technologies Corporation, Bethlehem, Pa. and the PharmaChek™ Sweat Patch from Pharmachem Laboratories Inc. of Menlo Park, Calif. These patches are waterproof, adhesive pads about the size of a playing card which is worn on the back, upper arm or lower chest. As such, it collects eccrine sweat. The patch has a tamper-proof feature so it can be applied only once and not removed and reapplied later. It is not designed for use by individuals; instead it is intended for use by trained drug abuse testing professionals in clinical and rehabilitation centers. After removal, the test patch is sent to a test laboratory where the presence and quantity of the target compound is detected by a special laboratory assay. It must be worn for 5 to 14 days to collect an adequate quantity of chemicals indicative of drugs of abuse used during that period. Sweat testing for drugs of abuse provides a convenient and considerably less invasive method for monitoring drug exposure than blood or urine. Typically, ELISA immunoassay is used to detect opiates collected on the patch from eccrine sweat and GC/MS is used to determine specific opiates. For comparison urine specimens are subjected to qualitative analysis by EMIT. However, the percentage of false negative results with the patches indicates that weekly sweat testing may be less sensitive than thrice weekly urine testing in detecting opiate use. (Huestis M. A., Cone, E. J., Wong, C. J., Umbricht, A., and Preston, K. L.
Journal of Analytical Toxicology,
24, pp. 509-521, 2000). This is most likely because those skilled in the art selected an inappropriate source of sweat (eccrine sweat), not recognizing the unique diagnostic capacity of apocrine sweat, Further, because of the extended wear requirement (up to 14 days), the ability to rapidly test for the presence of drugs using presently available sweat collection patches and procedures is not possible.
Besides the use of skin patches to collect sweat, there are also several skin patch designs for use to deliver chemicals to the skin surface, such as anti-infectives or allergens, for treating various maladies or for analyzing sensitivity to various allergens.
It is also known to collect an analyte on a test strip and then perform various tests on the analyte in a laboratory environment. U.S. Pat. No. 5,459,080 sets forth numerous prior techniques for analysis, both quantitatively and qualitatively, of the presence of various compounds found in body fluids. In particular, the use of specific binding reagents is discussed. Such analytes include, but are not limited to, antibodies, antigens, drugs and hormones. One technique for analyzing these materials, referred to as immunoassay procedures, uses antibodies and antigens, i.e. immunoreactants, which are capable of binding with each other, creating a highly specific reaction product indicative of the presence of the antigen. To use these techniques the analyte must first be collected and then transported to a laboratory where the analytical procedure can be performed. Typically, the analyte on the test strip is then contacted with an indicator reagent which is then subjected to a detection means. The requirement for such a procedure results in a major deficiency for diagnostic test strips as it is often desirable to be able to read the test strip on the patient or im

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