Claims for Patent: 7,553,675

Summary for Patent: 7,553,675

Title:	Diagnostic assay device having an apparent non-signal line
Abstract:	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 (-) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (-) 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.
Inventor(s):	Jerome; Jeremy (Carlsbad, CA), Daquipa; Mark (San Diego, CA), Jacono; Bruce (Ramona, CA), Boehringer; Hans (San Diego, CA), Lambotte; Paul (San Diego, CA), Lawrence; Paul J. (Pacific Grove, CA)
Assignee:	Quidel Corporation (San Diego, CA)
Application Number:	11/622,201
Patent Claims:	1. A test device for determining the presence or absence of an analyte in a fluid sample, the test device comprising a test strip comprising: a) a support bearing a mark thereon; b) one or more matrices in fluid flow contact with one another and positioned over the support, the one or more matrices comprising: i) a sample receiving zone for applying a fluid sample suspected of comprising an analyte, ii) a label zone comprising a detectable mobile labeled reagent selected to bind to the analyte, and iii) an observation area comprising a capture zone comprising an immobilized capture reagent, wherein the labeled reagent produces a detectable signal in the capture zone that is related to the presence of analyte in the sample, and wherein the observation area comprises a material that is opaque in a dry state and transparent in a moist state; and wherein the mark is detectable within the observation area when the observation area is in a moist state. 2. The test device of claim 1, wherein the label zone and observation area comprise separate matrices in fluid-flow contact. 3. The test device of claim 1, wherein the sample receiving zone, label zone and observation area comprise separate matrices in fluid-flow contact. 4. The test device of claim 1, wherein: c) the mark has a shape such that a first symbol is detectable within the observation area when the observation area is in a moist state, and d) the capture zone has a shape such that, in the presence of the analyte in the sample, a second symbol is detectable, and detection of the first symbol taken together with detection of the second symbol indicates a positive result. 5. The test device of claim 4, wherein in the absence of analyte in the sample, the detectable first symbol indicates a negative result. 6. The test device of claim 1, wherein the observation area further comprises a control area spatially distinct from the capture zone. 7. The test device of claim 1, wherein the matrix further comprises a control area having a control line that is spatially distinct from the observation area. 8. The test device of claim 7, wherein the control area is a negative control area, a positive control area, an end of assay control area, or a combination thereof. 9. The test device of claim 1, wherein the observation area comprises nitrocellulose. 10. The test device of claim 1, wherein the observation area is laminated on a plastic backing material. 11. The test device of claim 1, wherein the label zone comprises a labeled reagent that binds an analyte selected from the group consisting of a toxin, an organic compound, a protein, a peptide, a microorganism, a bacteria, a virus, an amino acid, a nucleic acid, a carbohydrate, a hormone, a steroid, a vitamin, a drug, an antibody, a hapten, and an aggregation or combination thereof. 12. The test device of claim 1, wherein the label zone comprises a labeled reagent that binds an analyte selected from the group consisting of a heartworm antigen, human chorionic gonadotropin, influenza antigen, and streptococcus A. 13. A method of determining the presence or absence of an analyte in a fluid sample, comprising the steps of: a) contacting the sample receiving zone of the device of claim 1 with a fluid sample; and b) inspecting the observation area for analyte restrained in the capture zone, wherein the mark is detectable within the observation area when the observation area is in a moist state, and wherein the mark and the restrained labeled analyte are separately detectable. 14. The method of claim 1 wherein the analyte is human chorionic gonadotropin. 15. The method of claim 14, wherein: a) the mark has a shape such that a first symbol is detectable within the observation area when the observation area is in a moist state, and b) the capture zone has a shape such that, in the presence of the analyte in the sample, a second symbol is detectable to indicate a positive result. 16. The method of claim 14, wherein the observation area further comprises a defined control area spatially distinct from the capture zone. 17. The method of claim 14, wherein the matrix further comprises a control area that is spatially distinct from the capture zone.

Details for Patent 7,553,675

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	January 15, 1974	7,553,675	2027-01-11
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	December 27, 1984	7,553,675	2027-01-11
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 15, 1985	7,553,675	2027-01-11
Ferring Pharmaceuticals Inc.	NOVAREL	chorionic gonadotropin	For Injection	017016	February 16, 1990	7,553,675	2027-01-11