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      Therapeutic Drug Monitoring by Dried Blood Spot: Progress to Date and Future Directions

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          Abstract

          This article discusses dried blood spot (DBS) sampling in therapeutic drug monitoring (TDM). The most important advantages of DBS sampling in TDM are the minimally invasive procedure of a finger prick (home sampling), the small volume (children), and the stability of the analyte. Many assays in DBS have been reported in the literature over the previous 5 years. These assays and their analytical techniques are reviewed here. Factors that may influence the accuracy and reproducibility of DBS methods are also discussed. Important issues are the correlation with plasma/serum concentrations and the influence of hematocrit on spot size and recovery. The different substrate materials are considered. DBS sampling can be a valid alternative to conventional venous sampling. However, patient correlation studies are indispensable to prove this. Promising developments are dried plasma spots using membrane and hematocrit correction using the potassium concentration.

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          Tenofovir, emtricitabine, and tenofovir diphosphate in dried blood spots for determining recent and cumulative drug exposure.

          José Castillo-Mancilla, Jia-Hua Zheng, Joseph E Rower … (2013)
          Tenofovir (TFV) disoproxil fumarate (TDF)±emtricitabine (FTC) are widely used for HIV treatment and chemoprophylaxis, but variable adherence may lead to suboptimal responses. Methods that quantify adherence would allow for interventions to improve treatment and prevention outcomes. Our objective was to characterize the pharmacokinetics of TFV-diphosphate (TFV-DP) and FTC-triphosphate (FTC-TP) in red blood cells (RBCs) and peripheral blood mononuclear cells (PBMCs); to extend the RBC analysis to dried blood spots (DBSs); and to model how RBC/DBS monitoring could inform recent and cumulative drug exposure/adherence. Blood samples were collected from 17 HIV-negative adults at 5 visits over a 30-day pharmacokinetics study of daily oral TDF/FTC. Dosing was discontinued on day 30 and blood was collected on days 35, 45, and 60 during the washout period. Plasma/RBCs/PBMCs/DBSs were all quantified by liquid chromatography/tandem mass spectrometry. DBSs were paired with RBCs and plasma for comparisons. The median (interquartile range) RBC TFV-DP half-life was 17.1 (15.7-20.2) versus 4.2 (3.7-5.2) days in PBMCs. At steady state, TFV-DP was 130 fmol/10(6) RBCs versus 98 fmol/10(6) PBMCs. FTC-TP was not quantifiable in most RBC samples. TFV-DP in RBCs versus DBSs yielded an r(2)=0.83. TFV-DP in DBSs was stable at -20°C. Simulations of TFV-DP in RBCs/DBSs, when dosed from one to seven times per week, demonstrated that each dose per week resulted in an average change of approximately 19 fmol/10(6) RBCs and 230 fmol/punch. TFV and FTC in plasma versus DBSs was defined by y=1.4x; r(2)=0.96 and y=0.8x; r(2)=0.99, respectively. We conclude that DBSs offer a convenient measure of recent (TFV/FTC) and cumulative (TFV-DP in RBCs) drug exposure with potential application to adherence monitoring.
          Article 0 comments Cited 117 times – based on 0 reviews     Review now
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            Development, characterization, and application of paper spray ionization.

            N E Manicke, J. Liu, Zheng Ouyang … (2010)
            Paper spray is developed as a direct sampling ionization method for mass spectrometric analysis of complex mixtures. Ions of analyte are generated by applying a high voltage to a paper triangle wetted with a small volume (<10 microL) of solution. Samples can be preloaded onto the paper, added with the wetting solution, or transferred from surfaces using the paper as a wipe. It is demonstrated that paper spray is applicable to the analysis of a wide variety of compounds, including small organic compounds, peptides, and proteins. Procedures are developed for analysis of dried biofluid spots and applied to therapeutic drug monitoring with whole blood samples and to illicit drug detection in raw urine samples. Limits of detection of 50 ng/mL (or 20 pg absolute) are achieved for atenolol in bovine blood. The combination of sample collection from surfaces and paper spray ionization also enables fast chemical screening at high sensitivity, for example 100 pg of heroin distributed on a surface and agrochemicals on fruit peels are detectable. Online derivatization with a preloaded reagent is demonstrated for analysis of cholesterol in human serum. The combination of paper spray with miniature mass spectrometers offers a powerful impetus to wide application of mass spectrometry in nonlaboratory environments.
            Article 0 comments Cited 111 times – based on 0 reviews     Review now
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              Dried blood spot methods in therapeutic drug monitoring: methods, assays, and pitfalls.

              Peter M Edelbroek, Leo Stolk, Rene van der Heijden (2009)
              This article reviews dried blood spot (DBS) sampling in therapeutic drug monitoring. The DBS method involves applying whole blood obtained via a fingerprick to a sampling paper. After drying and transportation, the blood spot is extracted and analyzed in the laboratory. Assays of many medicines in DBS have already been reported in the literature and are reviewed here. The technique involved in and factors that may influence the accuracy and reproducibility of DBS methods are also discussed. DBS sampling ultimately seems to be a useful technique for therapeutic drug monitoring that could have many advantages in comparison with conventional venous sampling. However, its benefits must be weighed against the degree of potential errors introduced via the sampling method; there is evidently a need for more standardization, quality assurance, basic research, and assay development.
              Article 0 comments Cited 78 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Abraham J. Wilhelm: +31 20 4443524 , aj.wilhelm@vumc.nl
                Journal
                Journal ID (nlm-ta): Clin Pharmacokinet
                Journal ID (iso-abbrev): Clin Pharmacokinet
                Title: Clinical Pharmacokinetics
                Publisher: Springer International Publishing (Cham )
                ISSN (Print): 0312-5963
                ISSN (Electronic): 1179-1926
                Publication date (Electronic): 10 September 2014
                Publication date PMC-release: 10 September 2014
                Publication date (Print): 2014
                Volume: 53
                Issue: 11
                Pages: 961-973
                Affiliations
                Department of Clinical Pharmacology and Pharmacy, VU University Medical Center, de Boelelaan 1117, 1081 HV Amsterdam, The Netherlands
                Article
                Publisher ID: 177
                DOI: 10.1007/s40262-014-0177-7
                PMC ID: 4213377
                PubMed ID: 25204403
                SO-VID: 90b90fe9-e3dd-4ef0-a686-e0910c7d8cde
                Copyright © © The Author(s) 2014
                License:

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.

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                Subject: Review Article
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                issue-copyright-statement © Springer International Publishing Switzerland 2014

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