Microsampling and conventional sampling techniques for quantification of tacrolimus in blood samples: A systematic review
DOI:
https://doi.org/10.59188/eduvest.v4i6.1395Keywords:
Tacrolimus, Microsampling, Validation, Therapeutic Drug MonitoringAbstract
Tacrolimus is immunosuppressive drugs that have a narrow therapeutic range, and a large inter-patient variability in their pharmacokinetics. Serial monitoring of tacrolimus after transplantation is important to ensure the concentration in biological fluids is maintained at the therapeutic range. Blood sampling for therapeutic drug monitoring of tacrolimus is mostly by venipuncture, making it inconvenient and invasive due to repeated sampling. Thus, microsampling has been adopted as an alternative for sample collection as it is less invasive and more convenient for patients. This article aims to review validated bioanalysis methods for tacrolimus to compare the methods using venous sample and microsampling methods. Related studies about tacrolimus analysis method in blood samples were screened from several databases and summarized with PRISMA flow diagram. A total of 12 studies were considered eligible and reviewed in this article. This systematic review provides a narrative of sample quantification of tacrolimus that collected by venipuncture and microsampling method, its bioanalytical method employed to perform the analysis, and clinical validation or application to patients with organ transplants. Studies with microsampling methods have been validated and applied to the patients. Some studies that compared both methods concluded there is no significant difference between tacrolimus concentrations by venipuncture or microsampling methods. Therefore, microsampling can be considered an option for future development of sampling method in tacrolimus routine monitoring.
References
Bernardo, M., Mezquida, G., Ferré, P., Cabrera, B., Torra, M., Lizana, A. M., & Brunet, M. (2022). Dried Blood Spot (DBS) as a useful tool to improve clozapine, aripiprazole and paliperidone treatment: From adherence to efficiency. Revista de Psiquiatría y Salud Mental (English Edition), 15(4), 230–237. https://doi.org/10.1016/j.rpsmen.2022.04.002
Capiau, S., Veenhof, H., Koster, R. A., Bergqvist, Y., Boettcher, M., Halmingh, O., Keevil, B. G., Koch, B. C. P., Linden, R., Pistos, C., Stolk, L. M., Touw, D. J., Stove, C. P., & Alffenaar, J.-W. C. (2019). Official international association for therapeutic drug monitoring and clinical toxicology guideline: Development and validation of dried blood spot–based methods for therapeutic drug monitoring. Therapeutic Drug Monitoring, 41(4), 409–430. https://doi.org/10.1097/FTD.0000000000000643
de Loor, H., Vanhove, T., Annaert, P., Lescrinier, E., & Kuypers, D. (2021). Determination of tacrolimus, three mono-demethylated metabolites and a M1 tautomer in human whole blood by liquid chromatography – tandem mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis, 205, 114296. https://doi.org/10.1016/j.jpba.2021.114296
European Medicines Agency. (2010). Guideline on the Investigation Of Bioequivalence. https://doi.org/10.1113/jphysiol.2005.569006
Food and Drug Administration. (2018). Bioanalytical method validation: Guidance for Industry. In Food and Drug Administration. https://doi.org/10.5958/2231-5675.2015.00035.6
Francke, M. I., van Domburg, B., Bouarfa, S., van de Velde, D., Hellemons, M. E., Manintveld, O. C., Last-Koopmans, S., Mulder, M. B., Hesselink, D. A., & de Winter, B. C. M. (2022). The clinical validation of a dried blood spot method for simultaneous measurement of cyclosporine A, tacrolimus, creatinine, and hematocrit. Clinica Chimica Acta, 535, 131–139. https://doi.org/10.1016/j.cca.2022.08.014
Fung, J. J. (2004). Tacrolimus and transplantation: a decade in review. Transplantation, 77(9), S41–S43. https://doi.org/10.1097/01.TP.0000126926.61434.A5
Harahap, Y., Tanujaya, A. T., Nurahman, F., Vianney, A. M., & Purwanto, D. J. (2021). Determination of O6-Methylguanine in dried blood spot of breast cancer patients after cyclophosphamide administration. Heliyon, 7(7), e07558. https://doi.org/10.1016/j.heliyon.2021.e07558
Hashi, S., Masuda, S., Kikuchi, M., Uesugi, M., Yano, I., Omura, T., Yonezawa, A., Fujimoto, Y., Ogawa, K., Kaido, T., Uemoto, S., & Matsubara, K. (2014). Assessment of four methodologies (microparticle enzyme immunoassay, chemiluminescent enzyme immunoassay, affinity column-mediated immunoassay, and flow injection assay-tandem mass spectrometry) for measuring tacrolimus blood concentration in Japanese liver transplant recipients. Transplantation Proceedings, 46(3), 758–760. https://doi.org/10.1016/j.transproceed.2013.11.060
Hinchliffe, E., Adaway, J. E., & Keevil, B. G. (2012). Simultaneous measurement of cyclosporin A and tacrolimus from dried blood spots by ultra high performance liquid chromatography tandem mass spectrometry. Journal of Chromatography B, 883–884, 102–107. https://doi.org/10.1016/j.jchromb.2011.05.016
Hoogtanders, K., van der Heijden, J., Christiaans, M., Edelbroek, P., van Hooff, J. P., & Stolk, L. M. L. (2007). Therapeutic drug monitoring of tacrolimus with the dried blood spot method. Journal of Pharmaceutical and Biomedical Analysis, 44(3), 658–664. https://doi.org/10.1016/j.jpba.2006.11.023
Ialongo, C., & Bernardini, S. (2016). Phlebotomy, a bridge between laboratory and patient. Biochemia Medica, 26(1), 17–33.
Jacobs, C. M., Wagmann, L., & Meyer, M. R. (2021). Development, validation, and application of a quantitative volumetric absorptive microsampling–based method in finger prick blood by means of LC-HRMS/MS applicable for adherence monitoring of antipsychotics. Analytical and Bioanalytical Chemistry, 413(6), 1729–1737. https://doi.org/10.1007/s00216-020-03143-0
Jannetto, P. J., & Fitzgerald, R. L. (2016). Effective use of mass spectrometry in the clinical laboratory. Clinical Chemistry, 62(1), 92–98. https://doi.org/10.1373/clinchem.2015.248146
Kalt, D. A. (2017). Tacrolimus: A Review of Laboratory Detection Methods and Indications for Use. Laboratory Medicine, 48(4), e62–e65. https://doi.org/10.1093/labmed/lmx056
Konermann, L. (2017). Addressing a common misconception: ammonium acetate as neutral pH “buffer” for native electrospray mass spectrometry. Journal of the American Society for Mass Spectrometry, 28(9), 1827–1835. https://doi.org/10.1007/s13361-017-1739-3
Koster, R. A., Alffenaar, J.-W. C., Greijdanus, B., & Uges, D. R. A. (2013). Fast LC-MS/MS analysis of tacrolimus, sirolimus, everolimus and cyclosporin A in dried blood spots and the influence of the hematocrit and immunosuppressant concentration on recovery. Talanta, 115, 47–54. https://doi.org/10.1016/j.talanta.2013.04.027
Lei, B. U. W., & Prow, T. W. (2019). A review of microsampling techniques and their social impact. Biomedical Microdevices, 21(4), 81. https://doi.org/10.1007/s10544-019-0412-y
Li, J., Wang, X., Wang, C., Fu, Q., Liu, L., Huang, M., & Zhou, S. (2008). Rapid and simultaneous determination of tacrolimus (FK506) and diltiazem in human whole blood by liquid chromatography–tandem mass spectrometry: Application to a clinical drug–drug interaction study. Journal of Chromatography B, 867(1), 111–118. https://doi.org/10.1016/j.jchromb.2008.03.024
Lima-Oliveira, G., Lippi, G., Salvagno, G. L., Picheth, G., & Guidi, G. C. (2015). Laboratory Diagnostics and Quality of Blood Collection. Journal of Medical Biochemistry, 34(3), 288–294. https://doi.org/10.2478/jomb-2014-0043
Maggadani, B. P., Harahap, Y., Harmita, Haryono, S. J., & Untu, C. W. P. (2021). Analysis of tamoxifen and its metabolites in dried blood spot and volumetric absorptive microsampling: comparison and clinical application. Heliyon, 7(6), e07275. https://doi.org/10.1016/j.heliyon.2021.e07275
Martial, L. C., Hoogtanders, K. E. J., Schreuder, M. F., Cornelissen, E. A., van der Heijden, J., Joore, M. A., Van Maarseveen, E. M., Burger, D. M., Croes, S., Brüggemann, R. J. M., & Aarnoutse, R. E. (2017). Dried blood spot sampling for tacrolimus and mycophenolic acid in children: analytical and clinical validation. Therapeutic Drug Monitoring, 39(4), 412–421. https://doi.org/10.1097/FTD.0000000000000422
Martin, M. M. (2019). Aspects of Gradient Elution in LC’MS Analysis. In Gradient HPLC for Practitioners (pp. 189–213). Wiley. https://doi.org/10.1002/9783527812745.ch8
Masri, M., Rizk, S., Boujbel, L., Bellahirich, W., Baassoumi, D., Attia, M., & Matha, V. (2013). Prograf five milligrams versus tacrolimus medis in healthy volunteers: a bioequivalence study. Transplantation Proceedings, 45(10), 3453–3457. https://doi.org/10.1016/j.transproceed.2013.08.104
Mathew, B. S., Mathew, S. K., Aruldhas, B. W., Prabha, R., Gangadharan, N., David, V. G., Varughese, S., & John, G. T. (2022). Analytical and clinical validation of dried blood spot and volumetric absorptive microsampling for measurement of tacrolimus and creatinine after renal transplantation. Clinical Biochemistry, 105–106, 25–34. https://doi.org/10.1016/j.clinbiochem.2022.04.014
McShane, A. J., Bunch, D. R., & Wang, S. (2016). Therapeutic drug monitoring of immunosuppressants by liquid chromatography–mass spectrometry. Clinica Chimica Acta, 454, 1–5. https://doi.org/10.1016/j.cca.2015.12.027
Mei, S., Wang, J., Chen, D., Zhu, L., Zhao, M., Tian, X., Hu, X., & Zhao, Z. (2018). Simultaneous determination of cyclosporine and tacrolimus in human whole blood by ultra-high performance liquid chromatography tandem mass spectrometry and comparison with a chemiluminescence microparticle immunoassay. Journal of Chromatography B, 1087–1088, 36–42. https://doi.org/10.1016/j.jchromb.2018.04.028
Moorthy, G. S., Downes, K. J., Vedar, C., & Zuppa, A. F. (2020). A whole blood microsampling assay for vancomycin: development, validation and application for pediatric clinical study. Bioanalysis, 12(18), 1295–1310. https://doi.org/10.4155/bio-2020-0112
Napoli, K. L., Hammett-Stabler, C., Taylor, P. J., Lowe, W., Franklin, M. E., Morris, M. R., & Cooper, D. P. (2010). Multi-center evaluation of a commercial Kit for tacrolimus determination by LC/MS/MS. Clinical Biochemistry, 43(10–11), 910–920. https://doi.org/10.1016/j.clinbiochem.2010.03.016
Page, M. J., McKenzie, J. E., Bossuyt, P. M., Boutron, I., Hoffmann, T. C., Mulrow, C. D., Shamseer, L., Tetzlaff, J. M., Akl, E. A., Brennan, S. E., Chou, R., Glanville, J., Grimshaw, J. M., Hróbjartsson, A., Lalu, M. M., Li, T., Loder, E. W., Mayo-Wilson, E., McDonald, S., … Moher, D. (2021). The PRISMA 2020 statement: An updated guideline for reporting systematic reviews. The BMJ, 372. https://doi.org/10.1136/bmj.n71
Paniagua-González, L., Díaz-Louzao, C., Lendoiro, E., Otero-Antón, E., Cadarso-Suárez, C., López-Rivadulla, M., Cruz, A., & de-Castro-Ríos, A. (2020). Volumetric Absorptive Microsampling (VAMS) for assaying immunosuppressants from venous whole blood by LC–MS/MS using a novel atmospheric pressure ionization probe (UniSprayTM). Journal of Pharmaceutical and Biomedical Analysis, 189, 113422. https://doi.org/10.1016/j.jpba.2020.113422
Protti, M., Mandrioli, R., & Mercolini, L. (2019). Tutorial: Volumetric absorptive microsampling (VAMS). Analytica Chimica Acta, 1046, 32–47. https://doi.org/10.1016/j.aca.2018.09.004
Radovanovic, M., Schneider, J. J., Shafiei, M., Martin, J. H., & Galettis, P. (2022). Measurement of 5- fluorouracil, capecitabine and its metabolite concentrations in blood using volumetric absorptive microsampling technology and LC-MS/MS. Journal of Chromatography B, 1188, 123075. https://doi.org/10.1016/j.jchromb.2021.123075
Romano, P., da Luz Fernandes, M., de Almeida Rezende Ebner, P., Duarte de Oliveira, N., Mitsue Okuda, L., Agena, F., Mendes, M. E., Massakazu Sumita, N., Coelho, V., David-Neto, E., & Zocoler Galante, N. (2018). UPLC–MS/MS assay validation for tacrolimus quantitative determination in peripheral blood T CD4+ and B CD19+ lymphocytes. Journal of Pharmaceutical and Biomedical Analysis, 152, 306–314. https://doi.org/10.1016/j.jpba.2018.01.002
Scott, L. J., McKeage, K., Keam, S. J., & Plosker, G. L. (2003). Tacrolimus: a further update of its use in the management of organ transplantation. Drugs, 63(12), 1247–1297. https://doi.org/10.2165/00003495-200363120-00006
Tron, C., Ferrand-Sorre, M.-J., Querzerho-Raguideau, J., Chemouny, J. M., Houssel-Debry, P., Verdier, M.-C., Bellissant, E., & Lemaitre, F. (2021). Volumetric absorptive microsampling for the quantification of tacrolimus in capillary blood by high performance liquid chromatography-tandem mass spectrometry. Journal of Chromatography B, 1165, 122521. https://doi.org/10.1016/j.jchromb.2020.122521
Vu, D. H., Koster, R. A., Bolhuis, M. S., Greijdanus, B., Altena, R. V., Nguyen, D. H., Brouwers, J. R. B. J., Uges, D. R. A., & Alffenaar, J. W. C. (2014). Simultaneous determination of rifampicin, clarithromycin and their metabolites in dried blood spots using LC–MS/MS. Talanta, 121, 9–17. https://doi.org/10.1016/j.talanta.2013.12.043
Wang, X., Dai, X., Wan, S., Fan, Y., Wu, L., Xu, H., Yan, L., Gong, X., Li, Y., Luo, Y., Bai, Y., & Li, Y. (2022). A volumetric absorptive microsampling UPLC-MS/MS method for simultaneous quantification of tacrolimus, mycophenolic acid and creatinine in whole blood of renal transplant recipients. Pharmaceutics, 14(12), 2547. https://doi.org/10.3390/pharmaceutics14122547
Wilhelm, A. J., den Burger, J. C. G., & Swart, E. L. (2014). Therapeutic drug monitoring by dried blood spot: Progress to date and future directions. Clinical Pharmacokinetics, 53(11), 961–973. https://doi.org/10.1007/s40262-014-0177-7
Yu, K.-W., Li, B.-L., Yuan, Y.-S., Liao, J.-M., Li, W.-K., Dong, H., Ke, P.-F., Jin, X., Chen, L., Zhao, J.-J., Wang, H., Cao, S.-W., Chen, W.-Y., Huang, X.-Z., Zhao, B.-B., & Kang, C.-M. (2022). A modified LC-MS/MS method for the detection of whole blood tacrolimus and its clinical value in Chinese kidney transplant patients. Heliyon, 8(8), e10214. https://doi.org/10.1016/j.heliyon.2022.e10214
Zahir, H., Nand, R. A., Brown, K. F., Tattam, B. N., & McLachlan, A. J. (2001). Validation of methods to study the distribution and protein binding of tacrolimus in human blood. Journal of Pharmacological and Toxicological Methods, 46(1), 27–35. https://doi.org/10.1016/S1056-8719(02)00158-2
Zhang, Y., & Zhang, R. (2018). Recent advances in analytical methods for the therapeutic drug monitoring of immunosuppressive drugs. Drug Testing and Analysis, 10(1), 81–94. https://doi.org/10.1002/dta.2290
Zhao, J., Setchell, K. D. R., Zhao, X., Galandi, S., Garr, B. N., Gao, Z., Chin, C., Stark, S., Steele, P. E., & Ryan, T. D. (2024). Use of volumetric absorptive microsampling and parallel reaction monitoring mass spectrometry for tacrolimus blood trough measurements at home in pediatric heart transplant patients. Journal of Mass Spectrometry and Advances in the Clinical Lab, 31, 1–7. https://doi.org/10.1016/j.jmsacl.2023.11.004
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