Abstract: A secure assay device is disclosed herein that provides: an assay or a test device that provides at least one result, wherein the assay or test device comprises at least one surface which exhibits optical change in response to at least one target particle, at least one marker or a combination thereof; and at least one multi-layer coating that at least partially covers the assay membrane, the assay device or a combination thereof, wherein the multi-layer coating blocks or impairs the user visualization of the optical change, the at least one result or a combination thereof. A secure reader and method of utilizing the secure assay device and secure reader are disclosed herein.

Abstract: A universal and standalone rapid diagnostics test reader is disclosed herein that includes: a set of control electronics, an illumination component, an imaging component, a housing component, a wireless communication component, a rapid diagnostics test component, a universal rapid diagnostics test tray, wherein the tray can hold at least one rapid diagnostics test component having a shape and a size in a fixed position relative to the imaging component and the illumination component, and wherein the reader can accommodate more than one different rapid diagnostics test component, while using the same universal rapid diagnostics test tray.