Adoption of a biomarker in clinical practice: from bench to bedside

作者:Dehoux Monique*; Chenevier Gobeaux Camille; Ray Patrick; Claessens Yann Erick; Lefevre Guillaume
来源:Annales de Biologie Clinique, 2013, 71(1): 5-11.
DOI:10.1684/abc.2012.0779

摘要

Although numerous diagnostic and/or prognostic biomarkers are proposed in the literature, only a limited number of them are finally used in daily practice. The necessary steps to prove their clinical interest include: 1) an exhaustive clinical and statistical evaluation demonstrating not only the added value of the marker with regard to the existing validated tools but also the modification of the clinical practice induced by the knowledge of the result of the biomarker; 2) an evaluation of the pre-analytical, and analytical performances of its measure necessary to the reliability of the results; 3) an evaluation of its biological variation. These steps are a major prerequisite to an effective, reliable and optimal clinical interpretation of the biomarker, and should be validated for each routine biomarker.

  • 出版日期2013-2