Integrated patch and assay device with visual detection means

A method for detecting a target analyte obtained from a sample surface comprising:

• 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.

A method for producing an analyte detection patch for collecting a sample from a sample surface comprising:

• 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.