Abstract:
The present invention relates to analytical devices for determining the presence or amount of an analyte in a test sample. The analytical devices comprise an inlet port, a vent, a channel, and an array of structures. The structures have immobilized reagent covalently or non-covalently attached to the surface of the structures. The immobilized reagent captures analyte in the test sample where it is detected by a detection system. The present invention also provides methods and reagents for performing assays utilizing the analytical devices of the present invention. The present invention also provides methods of manufacturing the analytical devices of the present invention.
Abstract:
The present invention is directed to improving the performance of assays using a disposable assay device which includes a porous material (20) in liquid communication with a capillary track (18). In particular, the capillary track (18) is used in conjunction with the solid support to direct test sample and assay reagents directly to a defined reaction site (22) on or in the porous material (20). Signal development at the reaction site (22) indicates the assay result. The present invention is also directed to the construction of a disposable assay device (10) which includes a capillary track (18). In particular, the capillary track is formed by printing a fluid insoluble material (25a), in the reverse image of the desired capillary track (18), on a film layer (23) and then capping the printed material. Alternatively, the capillary track (18) is formed by printing a fluid insoluble material, in the reverse image (30) of the desired capillary track (18), on a porous material (25b) which is then sandwiched between two film layers (23, 26). The present invention is also directed to a drop-forming means (50) which may incorporate one or more assay reagents to allow for improved sample processing and reagent addition, mixing and incubation.
Abstract:
The present invention is directed to improving the performance of assays using a disposable assay device which includes a porous material in liquid communication with a capillary track. In particular, the capillary track is used in conjunction with the solid support to direct test sample and assay reagents directly to a defined reaction site on or in the porous material. Signal development at the reaction site indicates the assay result. The present invention is also directed to the construction of a disposable assay device which includes a capillary track. In particular, the cappillary track is formed by printing a fluid insoluble material, in the reverse image of the desired capillary track, on a film layer and then capping the printed material. Alternatively, the capillary track is formed by printing a fluid insoluble material, in the reverse image of the desired capillary track, on a porous material which is then sandwiched between two film layers.
Abstract:
The present invention is directed to improving the performance of assays using a disposable assay device which includes a porous material in liquid communication with a capillary track. In particular, the capillary track is used in conjunction with the solid support to direct test sample and assay reagents directly to a defined reaction site on or in the porous material. Signal development at the reaction site indicates the assay result. The present invention is also directed to the construction of a disposable assay device which includes a capillary track. In particular, the cappillary track is formed by printing a fluid insoluble material, in the reverse image of the desired capillary track, on a film layer and then capping the printed material. Alternatively, the capillary track is formed by printing a fluid insoluble material, in the reverse image of the desired capillary track, on a porous material which is then sandwiched between two film layers.
Abstract:
The present invention relates to analytical devices for determining the presence or amount of an analyte in a test sample. The analytical devices comprise an inlet port, a vent, a channel, and an array of structures. The structures have immobilized reagent covalently or non-covalently attached to the surface of the structures. The immobilized reagent captures analyte in the test sample where it is detected by a detection system. The present invention also provides methods and reagents for performing assays utilizing the analytical devices of the present invention. The present invention also provides methods of manufacturing the analytical devices of the present invention.
Abstract:
A method for increasing the permeability of the stratum corneum by means of a source of light, preferably a laser, more preferably a pulsed laser. By increasing the permeability of the stratum corneum, access to the interstitial fluid is achieved, thereby enabling measurement of analytes in the interstitial fluid. In one aspect, the method comprises the steps of (a) providing a source of light having a wavelength of from about 930 nm to about 1040 nm; and (b) exposing a region of the stratum corneum of the patient to said source of light for a period of time sufficient to form an opening in the stratum corneum. Preferably, exposure of the region of the stratum corneum to the source of light is ceased when an amount of interstitial fluid fills the opening in the stratum corneum, which amount is sufficient to cause the scatter intensity of the light reflected from the surface of the interstitial fluid occupying the opening in the stratum corneum to differ from the scatter intensity of the light reflected from a region of the stratum corneum that is substantially free of interstitial fluid. The invention also involves an apparatus for carrying out the foregoing method.
Abstract:
An article (10) capable of both collecting interstitial fluid and detecting an analyte in that fluid and a method for use of that article (10). Preferably, the article (10) is also capable of measuring the amount of analyte in the interstitial fluid. The article (10) can be used in conjunction with a meter that contains an appropriate detection element for determining the amount of analyte in the interstitial fluid. In one preferred embodiment, the article (10) is a multiple-layer element comprising: (1) a layer (15) that is capable of being placed in contact with the skin of a patient; (2) a layer (16) that is coated over the skin-contacting layer (15); (3) a layer (18), substantially coplanar with the overcoat layer (16), that is capable of transporting interstitial fluid by means of chemically aided wicking; (4) a layer (20), overlying the interstitial fluid transporting layer (18), that is capable of being placed in contact with a meter (28), said layer having an opening (24) therein through which light can be transmitted; (5) a layer (28), disposed on the surface of the meter-contacting layer (20) that faces the skin-contacting layer (15), that is capable of detecting the presence of analyte or measuring the amount of analyte in the fluid. In order to use the multiple-layer (18) element (10), light from a source of light is transmitted through the opening (24) in the multiple-layer material to be absorbed at a light-absorbing target (22) on the skin-contacting layer (15). This light transfers energy to the target (22), and this transferred energy causes an opening to form in the skin-contacting layer (15) and an opening to form in the stratum corneum. Interstitial fluid exudes from the opening in the stratum corneum and contacts the interstitial fluid transporting layer (18). The interstitial fluid then moves along or through the interstitial fluid transporting layer (18) to the detecting layer (28).
Abstract:
A method for increasing the permeability of the stratum corneum by means of a source of light, preferably a laser, more preferably a pulsed laser. By increasing the permeability of the stratum corneum, access to the interstitial fluid is achieved, thereby enabling measurement of analytes in the interstitial fluid. In one aspect, the method comprises the steps of (a) providing a source of light having a wavelength of from about 930 nm to about 1040 nm; and (b) exposing a region of the stratum corneum of the patient to said source of light for a period of time sufficient to form an opening in the stratum corneum. Preferably, exposure of the region of the stratum corneum to the source of light is ceased when an amount of interstitial fluid fills the opening in the stratum corneum, which amount is sufficient to cause the scatter intensity of the light reflected from the surface of the interstitial fluid occupying the opening in the stratum corneum to differ from the scatter intensity of the light reflected from a region of the stratum corneum that is substantially free of interstitial fluid. The invention also involves an apparatus for carrying out the foregoing method.
Abstract:
An article (10) capable of both collecting interstitial fluid and detecting an analyte in that fluid and a method for use of that article (10). Preferably, the article (10) is also capable of measuring the amount of analyte in the interstitial fluid. The article (10) can be used in conjunction with a meter that contains an appropriate detection element for determining the amount of analyte in the interstitial fluid. In one preferred embodiment, the article (10) is a multiple-layer element comprising: (1) a layer (15) that is capable of being placed in contact with the skin of a patient; (2) a layer (16) that is coated over the skin-contacting layer (15); (3) a layer (18), substantially coplanar with the overcoat layer (16), that is capable of transporting interstitial fluid by means of chemically aided wicking; (4) a layer (20), overlying the interstitial fluid transporting layer (18), that is capable of being placed in contact with a meter (28), said layer having an opening (24) therein through which light can be transmitted; (5) a layer (28), disposed on the surface of the meter-contacting layer (20) that faces the skin-contacting layer (15), that is capable of detecting the presence of analyte or measuring the amount of analyte in the fluid. In order to use the multiple-layer (18) element (10), light from a source of light is transmitted through the opening (24) in the multiple-layer material to be absorbed at a light-absorbing target (22) on the skin-contacting layer (15). This light transfers energy to the target (22), and this transferred energy causes an opening to form in the skin-contacting layer (15) and an opening to form in the stratum corneum. Interstitial fluid exudes from the opening in the stratum corneum and contacts the interstitial fluid transporting layer (18). The interstitial fluid then moves along or through the interstitial fluid transporting layer (18) to the detecting layer (28).