Clinical feasibility of dried blood spots: Analytics, validation, and applications

被引:112
作者
Enderle, Yeliz [1 ]
Foerster, Kathrin [1 ]
Burhenne, Juergen [1 ]
机构
[1] Univ Heidelberg Hosp, Dept Clin Pharmacol & Pharmacoepidemiol, Neuenheimer Feld 410, D-69120 Heidelberg, Germany
关键词
Dried blood spots (DBS); Analytical validation; Clinical validation; Clinical applications; PERFORMANCE LIQUID-CHROMATOGRAPHY; QUALITY-OF-LIFE; LC-MS/MS METHOD; CYCLOSPORINE-A; PLASMA SPOTS; REGRESSION PROCEDURES; BIOANALYTICAL METHODS; ANTIRETROVIRAL DRUGS; EBF RECOMMENDATION; INTERNAL STANDARD;
D O I
10.1016/j.jpba.2016.06.026
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
Dried blood spots (DBS) sampling and their specific advantages are becoming common in analytical and clinical routine. Being first established for metabolic disorder screening in neonates, its use emerged to a broad spectrum of clinical applications. Although DBS are easily generated, the conduction of specific analytical and clinical validation procedures should be obligatory when implementing DBS for clinical purposes, e.g. therapeutic drug monitoring or clinical drug trials. A respective recommendation has already been published by the European Bioanalysis Forum. Since no official guidelines are present, investigators are currently free in DBS procedure development and validation. This review summarizes and discusses published clinical validation procedures in relation to their applications to highlight the clinical feasibility of DBS. (C) 2016 Elsevier B.V. All rights reserved.
引用
收藏
页码:231 / 243
页数:13
相关论文
共 118 条
  • [1] Investigation of Different Approaches to Incorporating Internal Standard in DBS Quantitative Bioanalytical Workflows and Their Effect on Nullifying Hematocrit-Based Assay Bias
    Abu-Rabie, Paul
    Denniff, Philip
    Spooner, Neil
    Chowdhry, Babur Z.
    Pullen, Frank S.
    [J]. ANALYTICAL CHEMISTRY, 2015, 87 (09) : 4996 - 5003
  • [2] Method of Applying Internal Standard to Dried Matrix Spot Samples for Use in Quantitative Bioanalysis
    Abu-Rabie, Paul
    Denniff, Philip
    Spooner, Neil
    Brynjolffssen, Jan
    Galluzzo, Paul
    Sanders, Giles
    [J]. ANALYTICAL CHEMISTRY, 2011, 83 (22) : 8779 - 8786
  • [3] Determination of rifampicin in human plasma and blood spots by high performance liquid chromatography with UV detection: A potential method for therapeutic drug monitoring
    Allanson, A. L.
    Cotton, M. M.
    Tettey, J. N. A.
    Boyter, A. C.
    [J]. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2007, 44 (04) : 963 - 969
  • [4] A Validated Method for Quantification of Efavirenz in Dried Blood Spots Using High-Performance Liquid Chromatography-Mass Spectrometry
    Amara, Alieu B.
    Else, Laura J.
    Tjia, John
    Olagunju, Adeniyi
    Puls, Rebekah L.
    Khoo, Saye
    Back, David J.
    [J]. THERAPEUTIC DRUG MONITORING, 2015, 37 (02) : 220 - 228
  • [5] [Anonymous], 2003, Adherence to Long-Term Therapies: Evidence for action
  • [6] [Anonymous], 2016, TRAJAN SCI MED
  • [7] [Anonymous], 2001, Guidance for industry, bioanalytical method validation
  • [8] Endoxifen Levels and Its Association With CYP2D6 Genotype and Phenotype: Evaluation of a Southern Brazilian Population Under Tamoxifen Pharmacotherapy
    Antunes, Marina V.
    Linden, Rafael
    Santos, Tamyris V.
    Wallemacq, Pierre
    Haufroid, Vincent
    Classen, Jean-Francois
    Andreolla, Huander
    Costa, Nathalia
    Fontanive, Tiago O.
    Rosa, Daniela D.
    [J]. THERAPEUTIC DRUG MONITORING, 2012, 34 (04) : 422 - 431
  • [9] Ultra-high performance liquid chromatography tandem mass spectrometric method for the determination of tamoxifen, N-desmethyltamoxifen, 4-hydroxytamoxifen and endoxifen in dried blood spots-Development, validation and clinical application during breast cancer adjuvant therapy
    Antunes, Marina Venzon
    Raymundo, Suziane
    de Oliveira, Vanessa
    Staudt, Dilana Elisabeth
    Goessling, Gustavo
    Peteffi, Giovana Piva
    Biazus, Jorge Villanova
    Cavalheiro, Jose Antonio
    Tre-Hardy, Marie
    Capron, Arnaud
    Haufroid, Vincent
    Wallemacq, Pierre
    Schwartsmann, Gilberto
    Linden, Rafael
    [J]. TALANTA, 2015, 132 : 775 - 784
  • [10] Clinical evaluation of a dried blood spot method for determination of mycophenolic acid in renal transplant patients
    Arpini, Janaine
    Antunes, Marina Venzon
    Pacheco, Larissa Sgaria
    Gnatta, Diego
    Rodrigues, Mariana Ferraz
    Keitel, Elizete
    Linden, Rafael
    [J]. CLINICAL BIOCHEMISTRY, 2013, 46 (18) : 1905 - 1908