Commercial Immunoassays in Biomarkers Studies: Researchers Beware!

[摘要] In the last few years, there has been a marked increase in the number of scientific publications on biomarker research. According to the NIH RePORT database, of the >14 000 grants for biomarker research funded between 2009 and 2011, >4000 dealt with biomarker discovery and validation (1). A search with “biomarker” in PubMed identified approximately 140 000 publications from the same period. The great interest in biomarkers reflects their clinical utility. Biomarkers are routinely used in the diagnosis, staging, screening, and prediction of risk of disease, for prediction and monitoring of treatment response, and for treatment compliance. Additionally, the search for a biomarker to be used as a surrogate for a clinical end point in clinical trials is of considerable interest, because it has the potential to shorten the trial, thus reducing both cost and the time to get novel therapies to patients.The biomarker pipeline is a long and uncertain road. It involves multiple complex steps and requires the talents of a diverse group of scientists, including analytical and protein chemists, mass spectrometrists, clinical chemists, and clinical investigators. The paradigm starts with a discovery stage and progresses to qualification, verification, and, finally, validation of the candidate biomarker for an intended clinical use (2). The 4 stages differ with respect to types of samples used, the technologies employed, and the patient populations examined, with the emphasis changing from sensitivity to specificity as one proceeds downstream. Typically, various types of mass spectrometers are used in …

[学科分类] 过敏症与临床免疫学