Quidel Corporation

Jeremy Jerome

Hans R Boehringer

Bruce L Jacono

Mark Daquipa

Paul J Lawrence

Paul Lambotte

A test device and method for determining the presence or absence of an analyte in a fluid sample, the test device including a support bearing a mark thereon, and a matrix defining an axial flow path. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (&#x2212;) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (&#x2212;) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Method for adding an apparent non-signal line to a lateral flow assay

A test device and method for determining the presence or absence of one or more analytes in a fluid sample, the test device including a support or member bearing a mark thereon, and a matrix or member containing a capture zone. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (&#x2212;) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (&#x2212;) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Method for adding an apparent non-signal line to a rapid diagnostic assay

Diagnostic assay device having an apparent non-signal line

Lateral flow assay device

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Carlsbad, CA, United States of America

Jeremy Jerome