US 12,474,333 B2
Interactive test system and method for detecting an analyte
Rhys L. de Callier, San Marcos, CA (US); Richard L. Egan, Oceanside, CA (US); William J. Ferenczy, La Jolla, CA (US); and Michael Jon Hale, San Diego, CA (US)
Assigned to Ortho-Clinical Diagnostics, Inc., Raritan, NJ (US)
Filed by Quidel Corporation, San Diego, CA (US)
Filed on Jun. 9, 2021, as Appl. No. 17/343,490.
Application 17/343,490 is a continuation of application No. 13/783,065, filed on Mar. 1, 2013, granted, now 11,061,020.
Claims priority of provisional application 61/757,023, filed on Jan. 25, 2013.
Claims priority of provisional application 61/666,689, filed on Jun. 29, 2012.
Claims priority of provisional application 61/636,105, filed on Apr. 20, 2012.
Claims priority of provisional application 61/605,694, filed on Mar. 1, 2012.
Prior Publication US 2021/0293793 A1, Sep. 23, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/543 (2006.01); G01N 33/53 (2006.01); G01N 33/58 (2006.01)
CPC G01N 33/54388 (2021.08) [G01N 33/5302 (2013.01); G01N 33/585 (2013.01)] 17 Claims
 
1. A system, comprising:
a test device comprising:
(a) a label zone comprising
(i) a first population of mobilizable, detectable particles for specific binding to a test analyte in a sample; and
(ii) a second population of mobilizable, detectable particles for specific binding to a non-test analyte but not to the test analyte;
(b) a first detection site at a first position comprising a first binding member having specific binding affinity for detectable particles in the first population bound to the test analyte; and
(c) a second detection site at a second position that is separate from the first position, the second detection site comprising a second binding member having specific binding affinity for detectable particles in the second population bound to the non-test analyte; and
an analyzer comprising:
(1) an opening dimensioned to receive the test device,
(2) an optical system for detection of a signal generated from the first population of mobilizable, detectable particles at the first position and the second population of mobilizable, detectable particles at the second position when each population reaches a specific and separate position on the test device,
(3) a processor communicatively coupled with the optical system to receive the signal and to evaluate a ratio of a signal detected from all or a portion of the first population of mobilizable, detectable particles to a cut-off value to determine a presence or an absence of analyte in the sample based on the ratio, and
(4) a memory storing the cut-off value, wherein the cut-off value is an exponentially transformed signal from all or a portion of the second population of mobilizable, detectable particles, adjusted by an empirically determined constant value for a manufacturing lot comprising the test device.