External dried-reagent control for analytical test devices

摘要

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.