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A homogeneous chemiluminescent immunoassay method.

Akhavan-Tafti, Hashem; Binger, Dean G; Blackwood, John J; Chen, Ying; Creager, Richard S; de Silva, Renuka; Eickholt, Robert A; Gaibor, Jose E; Handley, Richard S; Kapsner, Kenneth P; Lopac, Senja K; Mazelis, Michael E; McLernon, Terri L; Mendoza, James D; Odegaard, Bruce H; Reddy, Sarada G; Salvati, Michael; Schoenfelner, Barry A; Shapir, Nir; Shelly, Katherine R; Todtleben, Jeff C; Wang, Guoping; Xie, Wenhua.

J Am Chem Soc ; 135(11): 4191-4, 2013 Mar 20.

Article in English | MEDLINE | ID: mdl-23477541

ABSTRACT

A new homogeneous chemiluminescent immunoassay method featuring the use of specific binding members separately labeled with an acridan-based chemiluminescent compound and a peroxidase is reported. Formation of an immunocomplex brings the chemiluminescent compound and the peroxidase into close proximity. Without any separation steps, a chemiluminescent signal is generated upon addition of a trigger solution, and the intensity is directly correlated to the quantity of the analyte.

Subject(s)

Acridines/chemistry , Immunoassay/methods , Luminescent Agents/chemistry , Luminescent Measurements/methods , Animals , Antibodies, Immobilized/chemistry , Cyclic AMP/analysis , Horseradish Peroxidase/analysis , Humans , Interleukin-8/analysis , Mice , Prostate-Specific Antigen/analysis , Rats , Sheep

The challenges and concerns companies face pertaining to the US Food and Drug Administration 510(k) process for cardiac biomarkers.

Apple, Fred S; Morrow, David; Zaugg, Christian; Hickey, David; Zaharik, Michelle; Blackwood, John J; Jakobsen, Kirsten.

Clin Chem ; 58(1): 31-8, 2012 Jan.

Article in English | MEDLINE | ID: mdl-22096032

Subject(s)

Drug Industry/legislation & jurisprudence , Government Regulation , Heart Diseases/diagnosis , Troponin I/blood , Troponin T/blood , Acute Coronary Syndrome/diagnosis , Biomarkers/blood , Clinical Trials as Topic/legislation & jurisprudence , Humans , Myocardial Infarction/diagnosis , Reagent Kits, Diagnostic , Reference Values , Sensitivity and Specificity , United States , United States Food and Drug Administration

ABSTRACT

Subject(s)

Subject(s)

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