External dried-reagent control for analytical test devices

A variety of diagnostic tests for diseases and other biological conditions which utilize test products featuring built-in, specimen-activated control elements have been described in the patent literature. The purpose, utility and function of these control elements are described in U.S. Pat. Nos. 5,268,146, 5,416,003, 5,585,273, 5,571,684, and 5,660,790. All patents cited in this specification are incorporated herein by reference. A control device serving as a source of control reagent for a solid-phase analytical test device is disclosed. The analytical test device analyzes a biological sample for the presence of an analyte such as an enzyme or other chemical species or a particular pH range, and registers the presence or absence of the analyte as a detectable change in an indicator. The control device contains a control reagent that produces the same indicator change and that can be transferred to the analytical test device by a sample implement such as a wet swab. The control reagent is present on the control device as a dry lamina or combination of laminae. A positive control reagent on a control device in accordance with this invention mimics the action of the analyte once it is transferred to the analytical test device, while a negative control reagent on the control device mimics the action of a sample that lacks the analyte.