External dried-reagent control for analytical test devices
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United States of America Patent
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Sep 17, 2002
Issued Date -
N/A
app pub date -
Mar 21, 2000
filing date -
May 7, 1998
priority date (Note) -
Expired
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Abstract
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.
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