title: Signal amplification systems in immunoassays: implications for clinical diagnostics.
abstract: Biomarkers in physiological specimens serve as useful sensors for clinical diagnosis. Accurate detection of specific markers is crucial for the diagnosis of disease, monitoring drug therapy and patient screening. In vitro immunoassays are probably the most common, simple and relatively inexpensive serological tools used in clinical laboratories for the diagnosis and management of disease. Despite continued efforts to improve the performance of immunoassays in the past three decades, there is a need for highly sensitive assays that can detect the lowest levels of disease markers with greater accuracy. This review summarizes recent advances made towards increasing the sensitivity of immunoassays by amplifying detection signals, with implications for the development of highly sensitive diagnostic systems; it also discusses the principles of related methodologies.
authors.affiliation: Center for Biologics Evaluation and Research, Immunopathogenesis Section, Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, 1401 Rockville Pike, Rockville, MD 20852-1448, USA. subhash.dhawan@fda.hhs.gov
authors.forename: Subhash
authors.initials: S
authors.lastname: Dhawan
mesh_terms: D003933:Diagnosis; D004194:Disease; D005470:Fluorometry; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation* / Q000379:methods*