Method and apparatus for determination of chemical species in body fluid

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.