Ortho-clinical Diagnostics, Inc

Quidel Corporation

William J Ferenczy

Michael Hale

Richard Laswell Egan

Rhys De Callier

Rhys L De Callier

Richard L Egan

A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device. The test device and apparatus interact to provide a timer feature for determining a test device specific adjustable cut-off value that is used to ascertain whether signal from a test line in the device corresponds to a positive or negative results, irrespective of the time elapsed since placement of sample on the test device. The adjustable cut-off value renders the system relatively insensitive to incubation time of the test device, where if the incubation time is shorter or longer than needed for accuracy of a test result, the analyzer will report an invalid result, thus preventing the reporting of an incorrect (false negative or false positive) result.

Interactive test system and method for detecting an analyte

Interactive test device and apparatus with timing mechanism

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La Jolla, CA, United States of America

William J Ferenczy