US 12,411,139 B2
Highly sensitive system and method for analysis of troponin
Philippe J. Goix, Piedmont, CA (US); Robert Puskas, Manchester, MO (US); John Todd, Lafayette, CA (US); Richard Livingston, Webster Groves, MO (US); Douglas Held, Ballwin, MO (US); and Allan H. B. Wu, Palo Alto, CA (US)
Assigned to Novilux, LLC, Racine, WI (US)
Filed by Novilux LLC, Bainbridge, WA (US); and The Regents of the University of California, Oakland, CA (US)
Filed on Sep. 6, 2023, as Appl. No. 18/242,804.
Application 18/242,804 is a continuation of application No. 16/842,727, filed on Apr. 7, 2020, abandoned.
Application 16/842,727 is a continuation of application No. 15/660,783, filed on Jul. 26, 2017, abandoned.
Application 15/660,783 is a continuation of application No. 14/921,553, filed on Oct. 23, 2015, granted, now 9,719,999, issued on Aug. 1, 2017.
Application 14/921,553 is a continuation of application No. 13/798,547, filed on Mar. 13, 2013, granted, now 9,182,405, issued on Nov. 10, 2015.
Application 13/798,547 is a continuation of application No. 13/667,372, filed on Nov. 2, 2012, granted, now 8,535,895, issued on Sep. 17, 2013.
Application 13/667,372 is a continuation of application No. 12/902,182, filed on Oct. 12, 2010, granted, now 8,343,728, issued on Jan. 1, 2013.
Application 12/902,182 is a continuation of application No. 12/062,412, filed on Apr. 3, 2008, granted, now 7,838,250, issued on Nov. 23, 2010.
Application 12/062,412 is a continuation of application No. 11/784,213, filed on Apr. 4, 2007, abandoned.
Claims priority of provisional application 60/914,995, filed on Apr. 30, 2007.
Claims priority of provisional application 60/925,402, filed on Apr. 19, 2007.
Claims priority of provisional application 60/872,986, filed on Dec. 4, 2006.
Claims priority of provisional application 60/861,498, filed on Nov. 28, 2006.
Claims priority of provisional application 60/808,662, filed on May 26, 2006.
Claims priority of provisional application 60/793,664, filed on Apr. 19, 2006.
Claims priority of provisional application 60/789,304, filed on Apr. 4, 2006.
Prior Publication US 2024/0085430 A1, Mar. 14, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/68 (2006.01); G01N 21/64 (2006.01); G01N 33/58 (2006.01)
CPC G01N 33/68 (2013.01) [G01N 21/6428 (2013.01); G01N 21/6486 (2013.01); G01N 33/582 (2013.01); G01N 33/6887 (2013.01); G01N 33/6893 (2013.01); G01N 2333/47 (2013.01); G01N 2800/32 (2013.01); G01N 2800/324 (2013.01); G01N 2800/325 (2013.01); G01N 2800/50 (2013.01)] 22 Claims
 
1. A method for determining cardiac damage in a human subject, comprising:
(a) determining concentration of cardiac troponin I (cTnI) in a blood, serum or plasma sample from the subject in an assay having a limit of detection for cTnI of less than 3 pg/mL by comparing a measured concentration of cTnI in the sample to a standard curve generated by running cTnI standards of known concentration in the assay;
(b) comparing the determined concentration of cTnI in the sample to a threshold concentration of cTnI in blood, serum or plasma in a healthy population, wherein the threshold concentration represents the 99th percentile of cTnI in the healthy population and is within the range of 1 pg/ml to 10 pg/ml, and wherein the threshold concentration determined by a method having a limit of detection for cTnI of less than 3 pg/mL;
(c) determining cardiac damage in the subject when the concentration of cTnI in the sample is greater than the threshold concentration.