| US 7,553,675 B2 | ||
| Diagnostic assay device having an apparent non-signal line | ||
| Jeremy Jerome, Carlsbad, Calif. (US); Mark Daquipa, San Diego, Calif. (US); Bruce Jacono, Ramona, Calif. (US); Hans Boehringer, San Diego, Calif. (US); Paul Lambotte, San Diego, Calif. (US); and Paul J. Lawrence, Pacific Grove, Calif. (US) | ||
| Assigned to Quidel Corporation, San Diego, Calif. (US) | ||
| Filed on Jan. 11, 2007, as Appl. No. 11/622,201. | ||
| Application 11/622201 is a continuation of application No. 10/241822, filed on Sep. 10, 2002, granted, now 7,179,657. | ||
| Application 10/241822 is a continuation in part of application No. 09/950366, filed on Sep. 10, 2001, granted, now 6,855,561. | ||
| Prior Publication US 2007/0111323 A1, May 17, 2007 | ||
| This patent is subject to a terminal disclaimer. | ||
| Int. Cl. G01N 33/53 (2006.01) | ||
| U.S. Cl. 436—518 [436/514; 436/169; 436/172; 436/175; 436/530; 436/533; 436/807; 436/170; 436/823; 435/823; 435/287.8; 435/287.9; 435/805; 422/57; 422/58; 422/59; 422/60; 422/61] | 17 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.
|