Test strip qualification system
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United States of America Patent
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-
Jan 27, 2004
Grant Date -
Sep 18, 2003
app pub date -
Mar 14, 2002
filing date -
Mar 14, 2002
priority date (Note) -
In Force
status (Latency Note)
Importance
Abstract
In connection with a fluidic medical diagnostic device that permits measurement of the coagulation time of blood, software, methods and associated devices for quality control are disclosed. The fluidic device preferably includes a test strip with one end having a sample port for introducing a sample and a bladder at the other end for drawing the sample to a measurement area. A channel carries sample from the sample port to an assay measurement area and first and second control measurement areas. Preferably, a stop junction, between the measurement areas and bladder, halts the sample flow for measurement. If results from measurements taken for each control fall within a predetermined zone or defined limits, the assay measurement is qualified. If not, an error is registered and the test strip is counted as unfit.
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