Integrated patch and assay device with visual detection means
First Claim
1. An integral fluid collection device for collecting a fluid sample from a sample surface comprising:
- at least three internal layers of which a first layer includes a hydrophilic nanofiltration material adhered to a second layer;
the second layer includes absorbent material adhered to a third layer;
the third layer includes an assay detection zone having integrated direct chemical calorimetric or enzymatic-based calorimetric detection suitable for detecting an analyte, the third layer adhered to a fourth layer; and
a fourth layer including a visually-clear occlusive material, and being external to the first, second and third layers, the fourth layer also having an area greater than the at least three internal layers so as to overlap the three internal layers at an area of contact with the sample surface.
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Abstract
Methods and apparatus for collecting a fluid sample using an integrated collection device are disclosed. The integrated collection device includes an analyte detector and a gradient means to actively and rapidly drive the transport of a sample fluid from the point of contact to the point of detection and reading. The analyte detector can include a visually-read colorimetric detector using a chemical or enzymatic detection process. The gradient means can include physical and/or chemical processes as described in more detail herein. In some embodiments, the device is provided as an occlusive patch. Preferably, the test device provides a reading immediately upon fluid contact with the analyte detector. Consequently, the time-to-result is sample volume and transport time dependent. By providing immediate or nearly immediate reading of results, the device is particularly useful in those applications in which immediate results are advantageous.
48 Citations
20 Claims
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1. An integral fluid collection device for collecting a fluid sample from a sample surface comprising:
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at least three internal layers of which a first layer includes a hydrophilic nanofiltration material adhered to a second layer;
the second layer includes absorbent material adhered to a third layer;
the third layer includes an assay detection zone having integrated direct chemical calorimetric or enzymatic-based calorimetric detection suitable for detecting an analyte, the third layer adhered to a fourth layer; and
a fourth layer including a visually-clear occlusive material, and being external to the first, second and third layers, the fourth layer also having an area greater than the at least three internal layers so as to overlap the three internal layers at an area of contact with the sample surface. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method for detecting a target analyte obtained from a sample surface comprising:
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obtaining a patch comprising;
at least three internal layers, the first layer having hydrophilic nanofiltration material adhered to a second layer;
the second layer having absorbent material adhered to a third layer;
the third layer comprising an assay detection zone having integrated direct chemical colorimetric or enzymatic-based colorimetric detection suitable for detecting an analyte, the third layer adhered to a fourth layer;
the fourth layer having a visually-clear occlusive region and being external to the first, second, and third layers and having an area greater than the three internal layers so as to overlap the three internal layers;
applying the patch to the sample surface; and
viewing through the visually-clear occlusive region a calorimetric change in the patch, wherein the colorimetric change indicates the presence of the target analyte. - View Dependent Claims (9, 10, 11, 12, 13, 14)
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15. A method for producing an analyte detection patch for collecting a sample from a sample surface comprising:
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providing a first layer having hydrophilic nanofiltration material;
providing a second layer having absorbent material;
providing a third layer comprising an assay detection capability including integrated direct chemical calorimetric or enzymatic-based colorimetric detection chemistry suitable for detecting an analyte; and
providing a fourth layer comprising a visually-clear occlusive material, the fourth layer being external to the first, second and third layers and having an area greater than these three internal layers, the fourth layer also having a release liner and an adhesive zone peripheral to the three internal layers. - View Dependent Claims (16, 17, 18, 19, 20)
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Specification