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ARS Home » Midwest Area » Ames, Iowa » National Animal Disease Center » Food Safety and Enteric Pathogens Research » Research » Publications at this Location » Publication #254703
Title: Are Proteomic Technologies Ready for IVDs?

Author
item TABATABAI, LOUISA
item ZIMMERLI, MANDY - IOWA STATE UNIVERSITY

Submitted to: In Vitro Diagnostic Technology
Publication Type: Review Article
Publication Acceptance Date: 6/12/2010
Publication Date: 8/27/2010
Citation: Tabatabai, L.B., Zimmerli, M.K. 2010. Are proteomic technologies ready for IVDs? In Vitro Diagnostic Technology. Fall 2010:10-15.

Interpretive Summary: During the last decade as a result of the unparalleled advancements in mass spectrometry-based methods in protein analysis, biomarker research has escalated to new heights in the academic, government and industrial research laboratories. Translation of biomarker research to IVDs, however, presents new challenges to both research laboratory and the Food and Drug Administration to move biomarker research forward to critically-needed devices for the clinical hospital laboratory and the medical community for screening purposes, pre-treatment decisions, identification of specific diseases and post-treatment monitoring.

Technical Abstract: Over the last decade major progress has been achieved in proteomic technologies. This came about because of the advances made in atmospheric ionization developments prior to mass spectrometry which allowed soft ionization and measurements of singly ionized relatively large molecules to be measured by time of flight instruments. Following this development, publications on the measurement of biological samples have increased exponentially. In fact most major research institutions and pharmacology industries now employ proteomic techniques for their research projects. Along with the development and advancement of proteomic technologies, new applications were immediately applied to clinical applications for biomarker research in disease and health. However, standardization, accuracy and precision in addition to costly instrumentation are currently the major hurdle to overcome before these technologies can be applied in a clinical setting. Strict rules guide the use and application of IVDs for use in the clinical laboratory. The majority of applications that are currently being developed in the research laboratory include complex biological samples such as serum, plasma and urine from diseased and normal states. Developments in multiplexing and high-throughput platforms look promising as well. Numerous biomarkers have been identified through rigorous research in a laboratory setting and are being tested in parallel with accepted IVD platforms. The next few years should see an increase in targeted biomarkers for IVDs in the clinical diagnostic laboratory.