Abstract: A lateral flow assay device includes a housing, and a test strip disposed within the housing having a membrane with a detection region and a collection region. A sample meter includes a first end for absorption of a test sample, and a storage section that receives and stores at least a component of the test sample. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed adjacent the collection region of the membrane. The test sample component is transferable from the storage section to the collection region for subsequent migration to the detection region. An activatable isolation mechanism is provided within the housing and is disposed so as to isolate portions of the sample meter storage section upon activation thereof such that a defined length of the storage section is presented to the collection region of the membrane.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. The kit includes a housing, and a membrane disposed within the housing having a detection region and a collection region. A blood sample meter is provided having a first end for absorption of a blood sample, a filtering section adjacent to the first end that filters red blood cell components from the blood sample, and a storage section adjacent to the filtering section that receives plasma or serum from the filtering section. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed in fluid communication with the collection region of the membrane. The plasma or serum is transferred from the storage section of the sample meter to the collection region of the membrane for subsequent migration to the detection region.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. The kit includes a housing, and a membrane disposed within the housing having a detection region and a collection region. A blood sample meter is provided having a first end for absorption of a blood sample, a filtering section adjacent to the first end that filters red blood cell components from the blood sample, and a storage section adjacent to the filtering section that receives plasma or serum from the filtering section. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed in fluid communication with the collection region of the membrane. The plasma or serum is transferred from the storage section of the sample meter to the collection region of the membrane for subsequent migration to the detection region.

Abstract: A diagnostic method and associated test kit for detecting an analyte residing in a test sample is provided. The kit includes a housing, and a membrane disposed within the housing having a detection region and a collection region. A blood sample meter is provided having a first end for absorption of a blood sample, a filtering section adjacent to the first end that filters red blood cell components from the blood sample, and a storage section adjacent to the filtering section that receives plasma or serum from the filtering section. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed in fluid communication with the collection region of the membrane. The plasma or serum is transferred from the storage section of the sample meter to the collection region of the membrane for subsequent migration to the detection region.

Abstract: A lateral flow assay device includes a housing, and a test strip disposed within the housing having a membrane with a detection region and a collection region. A sample meter includes a first end for absorption of a test sample, and a storage section that receives and stores at least a component of the test sample. An opening in the housing is sized for insertion of the sample meter into the housing such that the storage section of the sample meter is disposed adjacent the collection region of the membrane. The test sample component is transferable from the storagesection to the collection region for subsequent migration to the detection region. An activatable isolation mechanism is provided within the housing and is disposed so as to isolate portions of the sample meter storage section upon activation thereof such that a defined length of the storage section is presented to the collection region of the membrane.

Abstract: Diagnostic devices, systems and methods for detecting the presence of an analyte in a sample are provided. In one embodiment, the device comprises a substrate, a binder printed in a pattern onto a surface of the substrate, and a means for directing a sample towards the surface of the substrate that is printed with the binder. Systems of the present invention further include a light source that can be directed through the aforementioned means or another opening to the binder-printed surface to test for diffraction.

Abstract: The present invention provides a simple, reliable, and inexpensive process for the manufacture of diagnostic biosensor films such as diffraction-based diagnostic films. The present invention includes a method for preparing a diffraction-based diagnostic biosensor film that includes the steps of: a) providing a receptor solution that includes a receptor and a carrier fluid, b) applying the receptor solution to a printing cylinder having a longitudinal axis and an engraved pattern of cells, each cell having a width, height, and depth for acceptance of the receptor solution, the printing cylinder being rotated about the longitudinal axis, c) transferring the receptor solution from the rotating printing cylinder to a substrate, and, d) drying the printed substrate, wherein the dried receptor forms a pattern that includes individual printed areas having a center-to-center spacing ranging from about 0.1 microns to about 100 microns.

Abstract: Diagnostic devices, systems and methods for detecting the presence of an analyte in a sample are provided. In one embodiment, the device comprises a substrate, a binder printed in a pattern onto a surface of the substrate, and a means for directing a sample towards the surface of the substrate that is printed with the binder. Systems of the present invention further include a light source that can be directed through the aforementioned means or another opening to the binder-printed surface to test for diffraction.

Abstract: Diagnostic methods and devices are provided to aid health-care professionals and non-professionals to determine whether a person's upper respiratory ailments are caused by a viral infection, bacterial infection, fungal infection, and/or allergy. In one embodiment, the method comprises contacting a sample to a surface that is printed with a binder that will bind, react or otherwise associate with a particular biomarker for these causes (e.g., bacterial infection) and diffract light that is reflected off of or that is transmitted through the printed surface. In another embodiment, the method comprises contacting a sample to a surface that is printed with a binder that will bind, react or otherwise associate with IgE antibodies to diffract light that is reflected off of or that is transmitted through the printed surface.