Test strip qualification system

Details Test strip qualification system Test strip qualification system

2005-02-01

2005-02-01

Wallenhorst, Maureen M. (Department: 1743)

Chemistry: analytical and immunological testing

Composition for standardization, calibration, simulation,...

C436S069000, C435S013000, C600S369000, C073S064410, C702S019000, C702S032000

Reexamination Certificate

active

06849456

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 provided. 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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