Diagnostic patch
The Present invention generally relates to medical diagnostics devices and more specifically to a diagnostic patch attachable to a subject's skin for performing a rapid blood test. A well-known format for performing assays where a sample is applied to a test strip impregnated with assay specific reagents.
1 . A diagnostic device for performing a diagnostic blood test of a subject comprising a flexible patch attachable to the subject's skin, a puncturing unit for producing a blood sample of the subject, and an at least one test element embedded in said patch in a flow communication with said blood sample.
2 . The diagnostic device of claim 1 wherein the device comprises a display window through which test results can be read.
3 . The diagnostic device of claim 2 wherein said test results are visibly read.
4 . The diagnostic device of claim 1 wherein said patch comprises a first flexible sheet comprising an aperture located opposite the puncturing unit and a second flexible sheet overlaying said first flexible sheet and wherein said test element is sandwiched between said first and second flexible sheets in a fluid communication with said aperture.
5 . The diagnostic device of claim 1 wherein the puncturing unit comprises a lancing element mounted within a flexible housing.
6 . The diagnostic device of claim 1 wherein said at least one test element is a diagnostic strip adapted for a lateral flow assay of a whole blood sample.
7 . The diagnostic device of claim 5 wherein said assay is an immunoassay, or an enzymatic assay, or a biochemical assay or a chemical assay.
8 . The diagnostic device of claim 5 wherein said assay is a positive/negative assay.
9 . The diagnostic device of claim 6 wherein said diagnostic strip is configured for detecting the presence and/or concentration of an analyte in a sample applied thereto.
10 . The diagnostic strip of claim 9 wherein said analyte is a blood borne pathogen.
11 . The device of claim 9 wherein said diagnostic strip is impregnated with one or more reagents disposed along the strip, said reagents are selected to provide a visible signal when said analyte is present in said sample.
12 . The diagnostic device of claim 6 wherein said diagnostic strip comprises a whole blood separation zone for entrapping and retaining red blood cells.
13 . The diagnostic device of claim 6 wherein said diagnostic strip comprises a sample receiving zone, a reaction zone and a detection zone.
14 . The device of claim 1 further comprising a reservoir of a releasable reagent solution adapted to release the reagent solution to facilitate running the diagnostic test.
15 . The device according to claim 14 wherein said reservoir of a releasable reagent solution comprises a blister made of liquid impermeable film encapsulating said reagent solution.
16 . The device according to claim 15 wherein said blister is accommodated within the puncturing unit.
17 . The device according to claim 15 wherein said blister is accommodated within a second puncturing unit located upstream the puncturing unit for producing the blood sample of the subject and wherein the patch comprises a channel connecting between said two puncturing units to form a flow communication between the reagent solution released from said blister and the blood sample.
18 . The device of claim 1 further comprising a safety means to prevent premature activation of the puncturing unit.