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

被引：2

作者：

Dehoux, Monique ^{[1
]}

Chenevier-Gobeaux, Camille ^{[2
]}

Ray, Patrick ^{[3
]}

Claessens, Yann-Erick ^{[4
]}

Lefevre, Guillaume ^{[5
]}

机构：

[1] Hop Bichat Claude Bernard, AP HP, Biochim Lab, F-75877 Paris 18, France

[2] AP HP, GH Cochin Broca Hotel Dieu, Biochim Lab, Paris, France

[3] Univ Paris 06, Hop Tenon, AP HP, Serv Accueil Urgences, Paris 6, France

[4] Ctr Hosp Princesse Grace, Dept Med Urgence, Monaco, Monaco

[5] Hop Tenon, AP HP, Lab Biochim & Hormonol, F-75970 Paris, France

来源：

ANNALES DE BIOLOGIE CLINIQUE | 2013年 / 71卷 / 01期

关键词：

biomarkers; evaluation; quality; BIOLOGICAL VARIATION; NATRIURETIC PEPTIDE; TROPONIN; STANDARDIZATION; PERFORMANCE; VALIDATION; COPEPTIN; QUALITY; MARKERS; ASSAYS;

D O I：

10.1684/abc.2012.0779

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

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.

引用

页码：5 / 11

页数：7

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