Volumetric Absorptive Microsampling Technique in the LC-MS Determination of Direct Oral Anticoagulants

Zidekova Nela; Prso Kristian; Babalova Lucia; Sivak Stefan; Kurca Egon; Mokry Juraj; Nosal Vladimir; Kertys Martin

doi:10.2478/acm-2023-0004

Abstract

Direct oral anticoagulants represent a significant group of drugs used in the prevention or treatment of venous thromboembolic events and stroke in patients with atrial fibrillation. Although routine therapy monitoring is not required, there is an increasing evidence that plasma levels may vary between individuals, suggesting the benefit of plasma levels measurement in some situations. Therapeutic drug monitoring is becoming more popular and accessible to the broader population. Introducing microsampling techniques for the quantitative collection of blood samples has arisen nowadays. The volumetric absorptive microsampling approach using a commercially available device such as a Mitra stick overcomes the hematocrit effect present in the dry blood spot technique. This review discusses the possible application of the volumetric absorptive microsampling approach in monitoring direct oral anticoagulant therapy efficacy.

References

Samoš M, Bolek T, Stančiaková L, Péč MJ, Brisudová K, Škorňová I, et al. Tailored Direct Oral Anticoagulation in Patients with Atrial Fibrillation: The Future of Oral Anticoagulation? J Clin Med 2022, Vol 11, Page 6369 2022;11:6369. https://doi.org/10.3390/JCM11216369.
Search in Google Scholar Back to article
Roberti R, Iannone LF, Palleria C, Curcio A, Rossi M, Sciacqua A, et al. Direct Oral Anticoagulants: From Randomized Clinical Trials to Real-World Clinical Practice. Front Pharmacol 2021;12:1105. https://doi.org/10.3389/FPHAR.2021.684638/BIBTEX.
Search in Google Scholar Back to article
Dunois C, Singh P, Amedei A. Laboratory Monitoring of Direct Oral Anticoagulants (DOACs). Biomed 2021, Vol 9, Page 445 2021;9:445. https://doi.org/10.3390/BIOMEDICINES9050445.
Search in Google Scholar Back to article
Londhe V, Rajadhyaksha M. Opportunities and obstacles for microsampling techniques in bioanalysis: Special focus on DBS and VAMS. J Pharm Biomed Anal 2020;182:113102. https://doi.org/10.1016/J.JPBA.2020.113102.
Search in Google Scholar Back to article
Kang JS, Lee MH. Overview of Therapeutic Drug Monitoring. Korean J Intern Med 2009;24:1. https://doi.org/10.3904/KJIM.2009.24.1.1.
Search in Google Scholar Back to article
Wieland E, Shipkova M. Pharmacokinetic and pharmacodynamic drug monitoring of direct-acting oral anticoagulants: Where do we stand? Ther Drug Monit 2019;41:180–91. https://doi.org/10.1097/FTD.0000000000000594.
Search in Google Scholar Back to article
Guerra Valero YC, Wallis SC, Lipman J, Stove C, Roberts JA, Parker SL. Clinical application of microsampling versus conventional sampling techniques in the quantitative bioanalysis of antibiotics: a systematic review. Https://DoiOrg/104155/Bio-2017-0269 2018;10:407–23. https://doi.org/10.4155/BIO-2017-0269.
Search in Google Scholar Back to article
Delahaye L, Veenhof H, Koch BCP, Alffenaar JWC, Linden R, Stove C. Alternative Sampling Devices to Collect Dried Blood Microsamples: State-of-the-Art. Ther Drug Monit 2021;43:310–21. https://doi.org/10.1097/FTD.0000000000000864.
Search in Google Scholar Back to article
Moorthy GS, Vedar C, Downes KJ, Fitzgerald JC, Scheetz MH, Zuppa AF. Microsampling Assays for Pharmacokinetic Analysis and Therapeutic Drug Monitoring of Antimicrobial Drugs in Children: A Critical Review. Ther Drug Monit 2021;43:335–45. https://doi.org/10.1097/FTD.0000000000000845.
Search in Google Scholar Back to article
Grüner N, Stambouli O, Ross RS. Dried Blood Spots-Preparing and Processing for Use in Immunoassays and in Molecular Techniques. J Vis Exp 2015:52619. https://doi.org/10.3791/52619.
Search in Google Scholar Back to article
Lakshmy R. Analysis of the Use of Dried Blood Spot Measurements in Disease Screening. J Diabetes Sci Technol 2008;2:242. https://doi.org/10.1177/193229680800200211.
Search in Google Scholar Back to article
Jacobson TA, Kler JS, Bae Y, Chen J, Ladror DT, Iyer R, et al. A state-of-the-science review and guide for measuring environmental exposure biomarkers in dried blood spots. J Expo Sci Environ Epidemiol 2022 2022:1–19. https://doi.org/10.1038/s41370-022-00460-7.
Search in Google Scholar Back to article
Carpentieri D, Colvard A, Petersen J, Marsh W, David-Dirgo V, Huentelman M, et al. Mind the Quality Gap When Banking on Dry Blood Spots. Biopreserv Biobank 2021;19:136–42. https://doi.org/-10.1089/BIO.2020.0131/ASSET/IMAGES/LARGE/BIO.2020.0131_FIGURE1.JPEG.
Search in Google Scholar Back to article
Daousani C, Karalis V, Malenović A, Dotsikas Y. Hematocrit effect on dried blood spots in adults: a computational study and theoretical considerations. Scand J Clin Lab Invest 2019;79:325–33. https://doi.org/10.1080/00365513.2019.1622033.
Search in Google Scholar Back to article
Zakaria R, Allen KJ, Koplin JJ, Roche P, Greaves RF. Advantages and Challenges of Dried Blood Spot Analysis by Mass Spectrometry Across the Total Testing Process. EJIFCC 2016;27:288.
Search in Google Scholar Back to article
Lei BUW, Prow TW. A review of microsampling techniques and their social impact. Biomed Microdevices 2019;21. https://doi.org/10.1007/S10544-019-0412-Y.
Search in Google Scholar Back to article
Delahaye L, Veenhof H, Koch BCP, Alffenaar JWC, Linden R, Stove C. Alternative Sampling Devices to Collect Dried Blood Microsamples: State-of-the-Art. Ther Drug Monit 2021;43:310–21. https://doi.org/10.1097/FTD.0000000000000864.
Search in Google Scholar Back to article
Denniff P, Spooner N. Volumetric absorptive microsampling: A dried sample collection technique for quantitative bioanalysis. Anal Chem 2014;86:8489–95. https://doi.org/10.1021/AC5022562/-SUPPL_FILE/AC5022562_SI_001.PDF.
Search in Google Scholar Back to article
Spooner N, Denniff P, Michielsen L, De Vries R, Ji QC, Arnold ME, et al. A device for dried blood microsampling in quantitative bioanalysis: overcoming the issues associated blood hematocrit. Bioanalysis 2015;7:653–9. https://doi.org/10.4155/BIO.14.310.
Search in Google Scholar Back to article
Mano Y, Kita K, Kusano K. Hematocrit-independent recovery is a key for bioanalysis using volumetric absorptive microsampling devices, MitraTM. Bioanalysis 2015;7:1821–9. https://doi.org/-10.4155/BIO.15.111.
Search in Google Scholar Back to article
Volani C, Caprioli G, Calderisi G, Sigurdsson BB, Rainer J, Gentilini I, et al. Pre-analytic evaluation of volumetric absorptive microsampling and integration in a mass spectrometry-based metabolomics workflow. Anal Bioanal Chem 2017;409:6263. https://doi.org/10.1007/S00216-017-0571-8.
Search in Google Scholar Back to article
Dried Blood Micro Sampling Devices For Quantitative Bioanalysis n.d. https://www.neote-ryx.com/microsampling-devices (accessed March 7, 2023).
Search in Google Scholar Back to article
Aucella F, Lauriola V, Vecchione G, Tiscia GL, Grandone E. Liquid chromatography–tandem mass spectrometry method as the golden standard for therapeutic drug monitoring in renal transplant. J Pharm Biomed Anal 2013;86:123–6. https://doi.org/10.1016/J.JPBA.2013.08.001.
Search in Google Scholar Back to article
Tey HY, See HH. A review of recent advances in microsampling techniques of biological fluids for therapeutic drug monitoring. J Chromatogr A 2021;1635. https://doi.org/10.1016/J.CHRO-MA.2020.461731.
Search in Google Scholar Back to article
Parker SL, Roberts JA, Lipman J, Wallis SC. Quantitative bioanalytical validation of fosfomycin in human whole blood with volumetric absorptive microsampling. Bioanalysis 2015;7:2585–95. https://doi.org/10.4155/BIO.15.173.
Search in Google Scholar Back to article
Kocur A, Pawiński T. Volumetric Absorptive Microsampling in Therapeutic Drug Monitoring of Immunosuppressive Drugs—From Sampling and Analytical Issues to Clinical Application. Int J Mol Sci 2023, Vol 24, Page 681 2022;24:681. https://doi.org/10.3390/IJMS24010681.
Search in Google Scholar Back to article
Qu Y, Brady K, Apilado R, O’Malley T, Reddy S, Chitkara P, et al. Capillary blood collected on volumetric absorptive microsampling (VAMS) device for monitoring hydroxychloroquine in rheumatoid arthritis patients. J Pharm Biomed Anal 2017;140:334–41. https://doi.org/10.1016/-J.JPBA.2017.03.047.
Search in Google Scholar Back to article
Verougstraete N, Lapauw B, Van Aken S, Delanghe J, Stove C, Stove V. Volumetric absorptive microsampling at home as an alternative tool for the monitoring of HbA1c in diabetes patients. Clin Chem Lab Med 2017;55:462–9. https://doi.org/10.1515/CCLM-2016-0411.
Search in Google Scholar Back to article
Gomez-Outes A, Luisa Suarez-Gea M, Calvo-Rojas G, Lecumberri R, Rocha E, Pozo-Hernandez C, et al. Discovery of Anticoagulant Drugs: A Historical Perspective. Curr Drug Discov Technol 2012;9:83–104. https://doi.org/10.2174/1570163811209020083.
Search in Google Scholar Back to article
Tummala R, Kavtaradze A, Gupta A, Ghosh RK. Specific antidotes against direct oral anticoagulants: A comprehensive review of clinical trials data. Int J Cardiol 2016;214:292–8. https://doi.org/10.1016/J.IJCARD.2016.03.056.
Search in Google Scholar Back to article
Steffel J, Collins R, Antz M, Cornu P, Desteghe L, Haeusler KG, et al. 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation. EP Eur 2021;23:1612–76. https://doi.org/10.1093/EUROPACE/EUAB065.
Search in Google Scholar Back to article
Rose DK, Bar B. Direct Oral Anticoagulant Agents: Pharmacologic Profile, Indications, Coagulation Monitoring, and Reversal Agents. J Stroke Cerebrovasc Dis 2018;27:2049–58. https://doi.org/10.1016/J.JSTROKECEREBROVASDIS.2018.04.004.
Search in Google Scholar Back to article
Gouveia F, Bicker J, Gonçalves J, Alves G, Falcão A, Fortuna A. Liquid chromatographic methods for the determination of direct oral anticoagulant drugs in biological samples: A critical review. Anal Chim Acta 2019;1076:18–31. https://doi.org/10.1016/J.ACA.2019.03.061.
Search in Google Scholar Back to article
Douxfils J, Pochet L, Lessire S, Vancraeynest C, Dogné JM, Mullier F. Mass spectrometry in the therapeutic drug monitoring of direct oral anticoagulants. Useful or useless? TrAC Trends Anal Chem 2016;84:41–50. https://doi.org/10.1016/J.TRAC.2016.01.029.
Search in Google Scholar Back to article
Cuker A, Siegal D. Monitoring and reversal of direct oral anticoagulants. Hematol Am Soc Hematol Educ Progr 2015;2015:117–24. https://doi.org/10.1182/ASHEDUCATION-2015.1.117.
Search in Google Scholar Back to article
Gosselin RC, Adcock DM, Bates SM, Douxfils J, Favaloro EJ, Gouin-Thibault I, et al. International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants. Thromb Haemost 2018;118:437–50. https://doi.org/10.1055/s-0038-1627480.
Search in Google Scholar Back to article
Douxfils J, Ageno W, Samama CM, Lessire S, ten Cate H, Verhamme P, et al. Laboratory testing in patients treated with direct oral anticoagulants: a practical guide for clinicians. J Thromb Haemost 2018;16:209–19. https://doi.org/10.1111/JTH.13912.
Search in Google Scholar Back to article
Lagoutte-Renosi J, Le Poupon J, Girard A, Montange D, Davani S. A simple and fast HPLC-MS/MS method for simultaneous determination of direct oral anticoagulants apixaban, dabigatran, rivaroxaban in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci 2018;1100–1101: 43–9. https://doi.org/10.1016/J.JCHROMB.2018.09.026.
Search in Google Scholar Back to article
Foerster KI, Huppertz A, Müller OJ, Rizos T, Tilemann L, Haefeli WE, et al. Simultaneous quantification of direct oral anticoagulants currently used in anticoagulation therapy. J Pharm Biomed Anal 2018;148:238–44. https://doi.org/10.1016/J.JPBA.2017.10.011.
Search in Google Scholar Back to article
Blaich C, Müller C, Michels G, Wiesen MHJ. Multi-analyte analysis of non-vitamin K antagonist oral anticoagulants in human plasma using tandem mass spectrometry. Clin Chem Lab Med 2015;53:1981–90. https://doi.org/10.1515/CCLM-2014-1108.
Search in Google Scholar Back to article
Schmitz EMH, Boonen K, van den Heuvel DJA, van Dongen JLJ, Schellings MWM, Emmen JMA, et al. Determination of dabigatran, rivaroxaban and apixaban by ultra-performance liquid chromatography – tandem mass spectrometry (UPLC-MS/MS) and coagulation assays for therapy monitoring of novel direct oral anticoagulants. J Thromb Haemost 2014;12:1636–46. https://doi.org/10.1111/JTH.12702.
Search in Google Scholar Back to article
Lindahl S, Dyrkorn R, Spigset O, Hegstad S. Quantification of Apixaban, Dabigatran, Edoxaban, and Rivaroxaban in Human Serum by UHPLC-MS/MS-Method Development, Validation, and Application. Ther Drug Monit 2018;40:369–76. https://doi.org/10.1097/FTD.0000000000000509.
Search in Google Scholar Back to article
Slavik L, Lukes J, Friedecky D, Zhanelova M, Nemcova M, Ulehlova J, et al. Multianalyte Determination of NOACs Using LC-MS/MS and Comparison with Functional Coagulation Assays. Clin Lab 2018;64:1611–21. https://doi.org/10.7754/CLIN.LAB.2018.180335.
Search in Google Scholar Back to article
Baldelli S, Cattaneo D, Pignatelli P, Perrone V, Pastori D, Radice S, et al. Validation of an LC–MS/MS method for the simultaneous quantification of dabigatran, rivaroxaban and apixaban in human plasma. Http://DxDoiOrg/104155/Bio15261 2016;8:275–83. https://doi.org/10.4155/BIO.15.261.
Search in Google Scholar Back to article
Foerster KI, Huppertz A, Meid AD, Müller OJ, Rizos T, Tilemann L, et al. Dried-Blood-Spot Technique to Monitor Direct Oral Anticoagulants: Clinical Validation of a UPLC-MS/MS-Based Assay. Anal Chem 2018;90:9395–402. https://doi.org/10.1021/ACS.ANALCHEM.8B02046.
Search in Google Scholar Back to article

Volumetric Absorptive Microsampling Technique in the LC-MS Determination of Direct Oral Anticoagulants

Abstract

Paradigm

My account