Patent US2156826A successfully refreshed from Google Patents.
US5203327A
Expired / Lapsed
US
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Method and apparatus for determination of chemical species in body fluid
Assignee: Sudormed Inc
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Filing: 1990-08-15
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Granted: 1993-04-20
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Expires: 2010-08-15
Abstract
Abstract Disclosed is a method and apparatus for the non-invasive determination of one or more preselected analytes in a body fluid expressed through the skin. The fluid is collected in a dermal concentration patch and concentrated by driving off a portion of the substantial water fraction under the influence of body heat. The analyte is optimally complexed with an immobilized specific binding partner and an indicium of the presence of the analyte is visually expressed. The patch may comprise a plurality of test zones for screening for a plurality of analytes. Additional positive and negative control zones are also disclosed. The patch may comprise a feature to detect tampering with the patch to produce false negative results, especially when used in screens for drugs of abuse. In addition to being useful as a drug of abuse screen, the patch is useful for diagnostic purposes.
Inventors
- 👤 Donald W. Schoendorfer
- 👤 William R. Miller
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-24 22:43
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/145; A61B5/14507; A61B5/14517; A61B10/00; A61B10/0035; A61B10/0045; A61B10/0064; A61B5/14521; A61B5/41; A61B5/411; A61B5/414; A61B5/415; A61B5/418; A61B5/42; A61B5/4261; A61B5/4266; A61B5/68; A61B5/6801; A61B5/683; A61B5/6832; A61B5/6833; A61M; A61M35/00; A61M35/003; A61M35/006; B; B01; B01L; B01L3/00; B01L3/50; B01L3/505; A61B10/0051; A61B2010/0009; A61B5/14532; A61F; A61F13/00; A61F2013/00089; A61F2013/00187; A61F2013/00195; A61F2013/00361; A61F2013/00365; A61F2013/00429; A61F2013/00434; A61F2013/00544; A61F2013/00604; A61F2013/00608; A61F2013/00642; A61F2013/00646; A61F2013/00655; A61F2013/00727; A61F2013/00731; A61F2013/00855; A61F2013/00863; A61F2013/00902; A61F13/15; A61F13/84; A61F13/8405; A61F2013/8408; A61F2013/8411; A61F2013/842; A61F2013/8473; A61F2013/8488; A61F2013/8491
Claims Analysis
Total Claims: 45
Claim 1
Independent Claim
119 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, comprising: a water permeable support layer having a first and a second side; at least one first and at least one second reagent immobilized in the support layer; and means for removably securing the first side of the support layer in fluid communication with the subject's skin, wherein said patch is water permeable so that water vapor is permitted to escape through the support layer and outside of the concentration patch, and wherein the first reagent comprises a specific binding partner for the analyte to be determined, and the second reagent comprises a specific binding partner for a reference substituent in the perspiration.
Claim 2
Dependent Claim
119 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, comprising: a water permeable support layer having a first and a second side; at least one first and at least one second reagent immobilized in the support layer; and means for removably securing the first side of the support layer in fluid communication with the subject's skin, wherein said patch is water permeable so that water vapor is permitted to escape through the support layer and outside of the concentration patch, and wherein the first reagent comprises a specific binding partner for the analyte to be determined, and the second reagent comprises a specific binding partner for a reference substituent in the perspiration.
Claim 3
Dependent Claim
22 words
A dermal concentration patch as in claim 1, wherein the first and second reagents are contained in discrete regions on the patch.
Claim 4
Dependent Claim
16 words
A dermal concentration patch as in claim 1, wherein the means for securing comprises adhesive tape.
Claim 5
Independent Claim
153 words
A method of detecting false negative results in an assay of a body fluid from a subject which are the result of noncompliance with the testing procedure by the subject, comprising the steps of: securing a test patch to the subject in communication with a source of body fluid, the test patch comprising first detection chemistry for detecting the presence of an analyte in the body fluid and second detection chemistry for detecting the presence of a reference substituent in the body fluid; removing the test patch from the subject after a sufficient test period of time to enable the first detection chemistry to detect the analyte, if present; determining the amount of reference substituent detected by the second detection chemistry; and comparing the amount of reference substituent detected to a predetermined value to determine whether the test patch remained secured to the subject for substantially all of the test period of time.
Claim 6
Independent Claim
153 words
A method of detecting false negative results in an assay of a body fluid from a subject which are the result of noncompliance with the testing procedure by the subject, comprising the steps of: securing a test patch to the subject in communication with a source of body fluid, the test patch comprising first detection chemistry for detecting the presence of an analyte in the body fluid and second detection chemistry for detecting the presence of a reference substituent in the body fluid; removing the test patch from the subject after a sufficient test period of time to enable the first detection chemistry to detect the analyte, if present; determining the amount of reference substituent detected by the second detection chemistry; and comparing the amount of reference substituent detected to a predetermined value to determine whether the test patch remained secured to the subject for substantially all of the test period of time.
Claim 7
Dependent Claim
27 words
A method of detecting false negative results as in claim 4, further comprising the step of determining whether any analyte was detected by the first detection chemistry.
Claim 8
Dependent Claim
30 words
A method of detecting false negative results as in claim 4, wherein the analyte to be detected by the first detection chemistry comprises a drug of abuse or its metabolite.
Claim 9
Dependent Claim
135 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, in which false negative results produced through elution of the patch with a solvent can be detected, comprising: a water permeable support layer having a first side and a second side, said first side being applicable to the subject's skin; means for removably securing the first side of the support layer in fluid communication with the subject's skin; and a soluble marker within the support layer, the presence of which can be detected after the patch is removed, said patch having sufficient permeability to allow water to escape said patch in the vapor phase, wherein a substantial loss in the quantity of soluble marker present in the patch after the patch is removed is indicative of false negative results.
Claim 10
Dependent Claim
135 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, in which false negative results produced through elution of the patch with a solvent can be detected, comprising: a water permeable support layer having a first side and a second side, said first side being applicable to the subject's skin; means for removably securing the first side of the support layer in fluid communication with the subject's skin; and a soluble marker within the support layer, the presence of which can be detected after the patch is removed, said patch having sufficient permeability to allow water to escape said patch in the vapor phase, wherein a substantial loss in the quantity of soluble marker present in the patch after the patch is removed is indicative of false negative results.
Claim 11
Dependent Claim
15 words
The dermal concentration patch of claim 7, wherein the marker is soluble in non-aqueous solvents.
Claim 12
Dependent Claim
35 words
The dermal concentration patch of claim 7, wherein the marker is a visible marker which will not cause significant trauma to the skin upon prolonged skin contact and is not readily absorbed by the skin.
Claim 13
Independent Claim
162 words
A method of detecting false negative results in an assay for an analyte in a body fluid from a subject which are the result of elution of a test patch with a solvent, comprising the steps of: securing the test patch to the subject in communication with a source of body fluid, the test patch containing a marker soluble in the solvent used for elution; removing the test patch from the subject after a sufficient test period of time to enable the analyte to be detected by an assay for the analyte; determining the amount of marker remaining in the test patch; and comparing the amount of marker remaining in the test patch with a control, the control being the amount of marker empirically determined to be remaining in a test patch worn continuously by a subject for the same length of time, wherein an amount of marker remaining in the test patch lower than the control is indicative of false results.
Claim 14
Independent Claim
162 words
A method of detecting false negative results in an assay for an analyte in a body fluid from a subject which are the result of elution of a test patch with a solvent, comprising the steps of: securing the test patch to the subject in communication with a source of body fluid, the test patch containing a marker soluble in the solvent used for elution; removing the test patch from the subject after a sufficient test period of time to enable the analyte to be detected by an assay for the analyte; determining the amount of marker remaining in the test patch; and comparing the amount of marker remaining in the test patch with a control, the control being the amount of marker empirically determined to be remaining in a test patch worn continuously by a subject for the same length of time, wherein an amount of marker remaining in the test patch lower than the control is indicative of false results.
Claim 15
Dependent Claim
20 words
The method of claim 10, wherein the control is assumed to be substantially all the marker remaining in the patch.
Claim 16
Dependent Claim
38 words
The method of claim 11, wherein the marker comprises a visible dye and the comparing step comprises comparing the color of the test patch after removal of the patch to the color of a test patch before application.
Claim 17
Dependent Claim
149 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, in which false negative results produced through the addition of adulterants to the patch can be detected, comprising: a water permeable support layer having a first side being applicable to the subject's skin; means for removably securing the first side of the support layer in fluid communication with the subject's skin; and a test region on said patch for detecting the presence of an adulterant capable of producing false negative results in an assay for the analyte, wherein the test region comprises color change chemistry responsive to the presence of an adulterant selected from the group consisting of: aluminum, chromate, cobalt, copper, iron, nickel, nitrate, peroxide, sulphite, tin, calcium, high pH, low pH, glucose, protein, and ketones, wherein water is permitted to escape through the support layer and outside of said concentration patch.
Claim 18
Dependent Claim
149 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, in which false negative results produced through the addition of adulterants to the patch can be detected, comprising: a water permeable support layer having a first side being applicable to the subject's skin; means for removably securing the first side of the support layer in fluid communication with the subject's skin; and a test region on said patch for detecting the presence of an adulterant capable of producing false negative results in an assay for the analyte, wherein the test region comprises color change chemistry responsive to the presence of an adulterant selected from the group consisting of: aluminum, chromate, cobalt, copper, iron, nickel, nitrate, peroxide, sulphite, tin, calcium, high pH, low pH, glucose, protein, and ketones, wherein water is permitted to escape through the support layer and outside of said concentration patch.
Claim 19
Independent Claim
119 words
A method of detecting false negative results in an analyte binding assay of a body fluid from a subject which are the result of the addition of an adulterant to a test patch, comprising the steps of: securing said test patch to the subject in communication with the source of said body fluid, said test patch comprising a test strip capable of detecting the adulterant by the development of a detectable change on the strip; removing said test patch from the subject after a sufficient test period of time to enable an analyte to be detected by an assay for said analyte; and determining the presence of adulterant from the presence of the detectable change on the test strip.
Claim 20
Independent Claim
119 words
A method of detecting false negative results in an analyte binding assay of a body fluid from a subject which are the result of the addition of an adulterant to a test patch, comprising the steps of: securing said test patch to the subject in communication with the source of said body fluid, said test patch comprising a test strip capable of detecting the adulterant by the development of a detectable change on the strip; removing said test patch from the subject after a sufficient test period of time to enable an analyte to be detected by an assay for said analyte; and determining the presence of adulterant from the presence of the detectable change on the test strip.
Claim 21
Dependent Claim
13 words
The method of claim 14, wherein the detectable change is a color change.
Claim 22
Dependent Claim
36 words
The method of claim 14, wherein the adulterant is selected from the group consisting of: aluminum, ammonium, chromate, chlorine, cobalt, copper, ion, nickel, nitrate, peroxide, sulphite, tin, calcium, high pH, low pH, glucose, protein, and ketones.
Claim 23
Independent Claim
155 words
A method of detecting false negative results in an assay for an analyte in perspiration from a subject having skin, said negative results being the result of noncompliance with a testing procedure for said assay, comprising the steps of: securing a test patch to the subject in fluid communication with the skin of said subject, said test patch comprising detection chemistry for detecting a reference substituent from perspiration; accumulating perspiration in said test patch; removing the test patch from the skin of said subject after sufficient test period of time to allow a detectable amount of said analyte to accumulate in said test patch if the analyte is present in said perspiration; determining the amount of reference substituent detected by said reference substituent; and comparing the amount of reference substituent detected to a predetermined value to determine whether the test patch was removed at a time after the securing step and before the removing step.
Claim 24
Independent Claim
155 words
A method of detecting false negative results in an assay for an analyte in perspiration from a subject having skin, said negative results being the result of noncompliance with a testing procedure for said assay, comprising the steps of: securing a test patch to the subject in fluid communication with the skin of said subject, said test patch comprising detection chemistry for detecting a reference substituent from perspiration; accumulating perspiration in said test patch; removing the test patch from the skin of said subject after sufficient test period of time to allow a detectable amount of said analyte to accumulate in said test patch if the analyte is present in said perspiration; determining the amount of reference substituent detected by said reference substituent; and comparing the amount of reference substituent detected to a predetermined value to determine whether the test patch was removed at a time after the securing step and before the removing step.
Claim 25
Dependent Claim
23 words
The method of claim 17, further comprising the step of determining whether analyte is present in said test patch after the accumulating step.
Claim 26
Dependent Claim
16 words
The method of claim 17, wherein said analyte comprises a drug of abuse or its metabolite.
Claim 27
Dependent Claim
14 words
The method of claim 17, wherein water is permitted to escape the test patch.
Claim 28
Dependent Claim
24 words
The method of claim 20, wherein water is permitted to escape the test patch in the vapor phase, but not in the liquid phase.
Claim 29
Dependent Claim
125 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, comprising: a water permeable support layer having a first and a second side; a permeable outer protective layer disposed adjacent the second side of said support layer; at least one first and at least one second reagent immobilized in the support layer; and means for removably securing the first side of the support layer in fluid communication with the subject's skin, wherein water is permitted to escape through the support layer and outside of the concentration patch, and wherein the first reagent comprises a specific binding partner for the analyte to be determined, and the second reagent comprises a specific binding partner for a reference substituent in the perspiration.
Claim 30
Dependent Claim
125 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, comprising: a water permeable support layer having a first and a second side; a permeable outer protective layer disposed adjacent the second side of said support layer; at least one first and at least one second reagent immobilized in the support layer; and means for removably securing the first side of the support layer in fluid communication with the subject's skin, wherein water is permitted to escape through the support layer and outside of the concentration patch, and wherein the first reagent comprises a specific binding partner for the analyte to be determined, and the second reagent comprises a specific binding partner for a reference substituent in the perspiration.
Claim 31
Dependent Claim
124 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, comprising: a water permeable support layer having a first and a second side; at least one first and at least one second reagent immobilized in the support layer; wherein the first reagent is a specific binding partner for a drug of abuse or its metabolite; and means for removably securing the first side of the support layer in fluid communication with the subject's skin, wherein water is permitted to escape through the support layer and outside of the concentration patch the first reagent comprises binding partner for the analyte to be determined, and the second reagent comprises a specific binding partner for a reference substituent in the perspiration.
Claim 32
Dependent Claim
124 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, comprising: a water permeable support layer having a first and a second side; at least one first and at least one second reagent immobilized in the support layer; wherein the first reagent is a specific binding partner for a drug of abuse or its metabolite; and means for removably securing the first side of the support layer in fluid communication with the subject's skin, wherein water is permitted to escape through the support layer and outside of the concentration patch the first reagent comprises binding partner for the analyte to be determined, and the second reagent comprises a specific binding partner for a reference substituent in the perspiration.
Claim 33
Dependent Claim
198 words
A dermal patch for the non-invasive determination of at least one preselected low-concentration analyte in a body fluid expressed through the skin as perspiration without the need for conventional instrumentation, comprising: a water-permeable support layer for concentrating components of perspiration, said layer having a single reference zone and at least two analyte detection zones; at least one analyte detection reagent immobilized to each of said analyte detection zones for detecting the presence of the at least one analyte; at least one reference detection reagent immobilized to each of said reference zones for detecting the presence of a reference substituent known to be present in perspiration; the analyte detection reagent in at least one of the analyte detection zones comprising an antibody having an affinity for a drug of abuse or a metabolite thereof cable of passing through the skin; and means for removably securing the support layer in fluid communication with the subject's skin, wherein each analyte detection reagent contained on each analyte detection zone comprises a specific binding partner for an analyte to be determined, and each reference detection reagent contained on each reference zone comprises a specific binding partner for a reference substituent in the perspiration.
Claim 34
Dependent Claim
198 words
A dermal patch for the non-invasive determination of at least one preselected low-concentration analyte in a body fluid expressed through the skin as perspiration without the need for conventional instrumentation, comprising: a water-permeable support layer for concentrating components of perspiration, said layer having a single reference zone and at least two analyte detection zones; at least one analyte detection reagent immobilized to each of said analyte detection zones for detecting the presence of the at least one analyte; at least one reference detection reagent immobilized to each of said reference zones for detecting the presence of a reference substituent known to be present in perspiration; the analyte detection reagent in at least one of the analyte detection zones comprising an antibody having an affinity for a drug of abuse or a metabolite thereof cable of passing through the skin; and means for removably securing the support layer in fluid communication with the subject's skin, wherein each analyte detection reagent contained on each analyte detection zone comprises a specific binding partner for an analyte to be determined, and each reference detection reagent contained on each reference zone comprises a specific binding partner for a reference substituent in the perspiration.
Claim 35
Dependent Claim
155 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, in which false negative results produced through the addition of adulterants to the patch can be detected, comprising: a water permeable support layer having a first side and a second side, said first side being applicable to the subject's skin; means for removably securing the first side of the support layer in fluid communication with the subject's skin; and a test region on said patch for detecting the presence of an adulterant capable of producing false negative results in an assay for the analyte, said test region being on a strip disposed within a region of the patch hidden from the subject's view while the patch is worn by the subject, thereby providing the subject with no visible indication of the test region, wherein water is permitted to escape through the support layer and outside of said concentration patch.
Claim 36
Dependent Claim
155 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, in which false negative results produced through the addition of adulterants to the patch can be detected, comprising: a water permeable support layer having a first side and a second side, said first side being applicable to the subject's skin; means for removably securing the first side of the support layer in fluid communication with the subject's skin; and a test region on said patch for detecting the presence of an adulterant capable of producing false negative results in an assay for the analyte, said test region being on a strip disposed within a region of the patch hidden from the subject's view while the patch is worn by the subject, thereby providing the subject with no visible indication of the test region, wherein water is permitted to escape through the support layer and outside of said concentration patch.
Claim 37
Dependent Claim
103 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, comprising: a water permeable support layer in which said analyte can be concentrated means for removably securing the support layer in fluid communication with the subject's skin; and a reagent which is a specific binding partner for a reference substituent in perspiration immobilized in the support layer, said reference substituent being selected from the group consisting of albumin and IgG, wherein water is permitted to escape through the support layer and outside of the concentration patch, thereby allowing said analyte to be concentrated in said support layer.
Claim 38
Dependent Claim
103 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, comprising: a water permeable support layer in which said analyte can be concentrated means for removably securing the support layer in fluid communication with the subject's skin; and a reagent which is a specific binding partner for a reference substituent in perspiration immobilized in the support layer, said reference substituent being selected from the group consisting of albumin and IgG, wherein water is permitted to escape through the support layer and outside of the concentration patch, thereby allowing said analyte to be concentrated in said support layer.
Claim 39
Dependent Claim
104 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, comprising: a water permeable support layer in which said analyte can be concentrated means for removably securing the support layer in fluid communication with the subject's skin; and a reagent which is a specific binding partner for a reference substituent in perspiration immobilized in the support layer, said reagent being selected from the group consisting of an antibody and an antigen, wherein water is permitted to escape through the support layer and outside of the concentration patch, thereby allowing said analyte to be concentrated in said support layer.
Claim 40
Dependent Claim
104 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, comprising: a water permeable support layer in which said analyte can be concentrated means for removably securing the support layer in fluid communication with the subject's skin; and a reagent which is a specific binding partner for a reference substituent in perspiration immobilized in the support layer, said reagent being selected from the group consisting of an antibody and an antigen, wherein water is permitted to escape through the support layer and outside of the concentration patch, thereby allowing said analyte to be concentrated in said support layer.
Claim 41
Dependent Claim
110 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, comprising: a water permeable support layer in which said analyte can be concentrated means for removably securing the support layer in fluid communication with the subject's skin; and a reagent which is a specific binding partner for a reference substituent in perspiration immobilized in the support layer; and indicator chemistry within the patch for providing an indication of the binding of said reference substituent to said reagent, wherein water is permitted to escape through the support layer and outside of the concentration patch, thereby allowing said analyte to be concentrated in said support layer.
Claim 42
Dependent Claim
110 words
A dermal concentration patch for determining the presence of an analyte in a subject mammal's perspiration, comprising: a water permeable support layer in which said analyte can be concentrated means for removably securing the support layer in fluid communication with the subject's skin; and a reagent which is a specific binding partner for a reference substituent in perspiration immobilized in the support layer; and indicator chemistry within the patch for providing an indication of the binding of said reference substituent to said reagent, wherein water is permitted to escape through the support layer and outside of the concentration patch, thereby allowing said analyte to be concentrated in said support layer.
Claim 43
Dependent Claim
12 words
The patch of claim 28, wherein said indication is a color change.
Claim 44
Independent Claim
132 words
A method of determining the presence of a drug of abuse or metabolite thereof in a subject mammal's perspiration, comprising: removably securing a water permeable support layer in fluid communication with the subject's skin, said support layer being in combination with a concentration patch; accumulating perspiration from said subject in said support layer for a test period of time; permitting water to escape through the support layer, thereby concentrating the drug of abuse or metabolite thereof in the support layer; and detecting false test results if present by including a soluble marker within said patch and detecting the presence of the quantity of said marker after completion of the test period, wherein a substantial loss in the quantity of soluble marker present in the patch is indicative of a false negative result.
Claim 45
Independent Claim
132 words
A method of determining the presence of a drug of abuse or metabolite thereof in a subject mammal's perspiration, comprising: removably securing a water permeable support layer in fluid communication with the subject's skin, said support layer being in combination with a concentration patch; accumulating perspiration from said subject in said support layer for a test period of time; permitting water to escape through the support layer, thereby concentrating the drug of abuse or metabolite thereof in the support layer; and detecting false test results if present by including a soluble marker within said patch and detecting the presence of the quantity of said marker after completion of the test period, wherein a substantial loss in the quantity of soluble marker present in the patch is indicative of a false negative result.
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USPTO Annuity & Maintenance Windows
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