Hematocrit effect on dried blood spots in adults: a computational study and theoretical considerations

References

• Guthrie R, Susi A. A simple phenylalanine method for detecting phenylketonuria in large populations of newborn infants. Pediatrics. 1963;32:338–343.
   PubMed Web of Science ®Google Scholar
• Kostić N, Dotsikas Y, Jović N, et al. Quantitation of pregabalin in dried blood spots and dried plasma spots by validated LC-MS/MS methods. J Pharm Biomed Anal. 2015;10:79–84.
   Web of Science ®Google Scholar
• Sharma A, Jaiswal S, Shukla M, et al. Dried blood spots: concepts, present status, and future perspectives in bioanalysis. Drug Test Anal. 2014;6:399–414.
   PubMed Web of Science ®Google Scholar
• Chace DH. Mass spectrometry in newborn and metabolic screening: historical perspective and future directions. J Mass Spectrom. 2009;44:163–170.
   PubMed Web of Science ®Google Scholar
• Edelbroek PM, van der Heijden J, Stolk LM. Dried blood spot methods in therapeutic drug monitoring: methods, assays, and pitfalls. Ther Drug Monit. 2009;31:327–336.
   PubMed Web of Science ®Google Scholar
• Wilhelm AJ, den Burger JCG, Swart EL. Therapeutic drug monitoring by dried blood spot: progress to date and future directions. Clin Pharmacokinet. 2014;53:961–973.
   PubMed Web of Science ®Google Scholar
• Stove CP, Ingels AS, De Kesel PM, et al. Dried blood spots in toxicology: from the cradle to the grave? Crit Rev Toxicol. 2012;42:230–243.
   PubMed Web of Science ®Google Scholar
• Mercolini L, Protti M. Biosampling strategies for emerging drugs of abuse: towards thefuture of toxicological and forensic analysis. J Pharm Biomed Anal. 2016;130:202–219.
   PubMed Web of Science ®Google Scholar
• Spooner N, Lad R, Barfield M. Dried blood spots as a sample collection technique for the determination of pharmacokinetics in clinical studies: considerations for the validation of a quantitative bioanalytical method. Anal Chem. 2009;81:1557–1563.
   PubMed Web of Science ®Google Scholar
• Denniff P, Spooner N. The effect of hematocrit on assay bias when using DBS samples for the quantitative bioanalysis of drugs. Bioanalysis. 2010;2:1385–1395.
   PubMed Web of Science ®Google Scholar
• de Kesel PMM, Sadones N, Capiau S, et al. Hematocritical issues in quantitative analysis of dried blood spots: challenges and solutions. Bioanalysis. 2013;5:2023–2041.
   PubMed Web of Science ®Google Scholar
• Beutler E, Waalen J. The definition of anemia: what is the lower limit of normal of the blood hemoglobin concentration? Blood. 2006;107:1747–1750.
   PubMed Web of Science ®Google Scholar
• Jager NG, Rosing H, Schellens JH, et al. Procedures and practices for the validation of bioanalytical methods using dried blood spots: a review. Bioanalysis. 2014;6:2481–2514.
   PubMed Web of Science ®Google Scholar
• Abu-Rabie P, Denniff P, Spooner N, et al. Investigation of different approaches to incorporating internal standard in DBS quantitative bioanalytical workflows and their effect on nullifying hematocrit-based assay bias. Anal Chem. 2015;87:4996–5003.
   PubMed Web of Science ®Google Scholar
• Adam BW, Alexander RJ, Smith SJ, et al. Recoveries of phenylalanine from two sets of dried-blood spot reference materials: prediction from hematocrit, spot volume, and paper matrix. Clin Chem. 2000;46:126–128.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Guideline on bioanalytical method validation. EMEA/CHMP/EWP/192217/2009; Committee for Medicinal Products for Human Use (CHMP), [cited 2011 July 21]. Available from www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/08/WC500109686.pdf
   Google Scholar
• Timmerman P, White S, Cobb Z, et al. Update of the EBF recommendation for the use of DBS in regulated bioanalysis integrating the conclusions from the EBF DBS-microsampling consortium. Bioanalysis. 2013;5:2129–2136.
   PubMed Web of Science ®Google Scholar
• de Kesel PMM, Capiau S, Lambert WE, et al. Current strategies for coping with the hematocrit problem in dried blood spot analysis. Bioanalysis. 2014;6:1871–1874.
   PubMed Web of Science ®Google Scholar
• Velghe S, Delahaye L, Stove CP. Is the hematocrit still an issue in quantitative dried blood spot analysis? J Pharm Biomed Anal. 2019;163:188–196.
   PubMed Web of Science ®Google Scholar
• de Kesel PMM, Lambert WE, Stove CP. Does volumetric absorptive microsampling eliminate the hematocrit bias for caffeine and paraxanthine in dried blood samples? A comparative study. Anal Chim Acta. 2015;881:65–73.
   PubMed Web of Science ®Google Scholar
• Li F, Zulkoski J, Fast D, et al. Perforated dried blood spots: a novel format for accurate microsampling. Bioanalysis. 2011;3:2321–2333.
   PubMed Web of Science ®Google Scholar
• Verplaetse R, Henion J. Hematocrit-independent quantitation of stimulants in Dried Blood Spots: pipet versus microfluidic-based volumetric sampling coupled with automated Flow-Through Desorption and Online Solid Phase Extraction-LC-MS/MS Bioanalysis. Anal Chem. 2016;88:6789–6796.
   PubMed Web of Science ®Google Scholar
• Kolocouri F, Dotsikas Y, Loukas YL. Dried plasma spots as an alternative sample collection technique for the quantitative LC-MS/MS determination of gabapentin. Anal Bioanal Chem. 2010;398:1339–1347.
   PubMed Web of Science ®Google Scholar
• Nakahara T, Otani N, Ueno T, et al. Development of a hematocrit-insensitive device to collect accurate volumes of dried blood spots without specialized skills for measuring clozapine and its metabolites as model analytes. J Chromatogr B. 2018;1087–1088:70–79.
   PubMed Web of Science ®Google Scholar
• Spooner N, Olatunji A, Webbley K. Investigation of the effect of blood hematocrit and lipid content onthe blood volume deposited by a disposable dried blood spot collection device. J Pharm Biomed Anal. 2018;149:419–424.
   PubMed Web of Science ®Google Scholar
• Capiau S, Stove VV, Lambert WE, et al. Prediction of the hematocrit of dried blood spots via potassium measurement on a routine clinical chemistry analyser. Anal Chem. 2013;85:404–410.
   PubMed Web of Science ®Google Scholar
• Liao H-W, Lin S-W, Lin Y-T, et al. Identification of potential sphingomyelin markers for the estimation of hematocrit in dried blood spots via a lipidomic strategy. Anal Chim Acta. 2018;1003:34–41.
   PubMed Web of Science ®Google Scholar
• Oostendorp M, El Amrani M, Diemel EC, et al. Measurement of hematocrit in dried blood spots using near-infrared spectroscopy: robust, fast, and non-destructive. Clin Chem. 2016;62:1534–1536.
   PubMed Web of Science ®Google Scholar
• Capiau S, Wilk LS, de Kesel PMM, et al. Correction for the Hematocrit bias in Dried Blood Spot analysis using a nondestructive, single-wavelength reflectance-based Hematocrit prediction method. Anal Chem. 2018;90:1795–1804.
   PubMed Web of Science ®Google Scholar
• Foivas A, Malenović A, Kostić N, et al. Quantitation of brinzolamide in dried blood spots by a novel LC-QTOF-MS/MS method. J Pharm Biomed Anal. 2016;119:84–90.
   PubMed Web of Science ®Google Scholar
• Skopp G. Institute of Legal Medicine and Traffic Medicine. [cited 2010 April 5] Available from http://www.frfoundation.comcastbiz.net/print/128bloodspotanalysis.pdf.
   Google Scholar
• Miller IJ, Poston PA, Rutan SC, et al. An On-card approach for assessment of Hematocrit on Dried Blood Spots which allows for correction of sample volume. J Anal Bioanal Tech. 2013;4:162.
   Google Scholar
• R Core Team. R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. 2018. [cited 2019 May 25]. Available from http://www.R-project.org/.
   Google Scholar
• Mayo Clinic: Hematocrit test. [cited 2019 May 25]. Available from http://www.mayoclinic.org/tests-procedures/hematocrit/details/results/rsc-20205482.
   Google Scholar
• Karalis V. The role of the upper sample size limit in two-stage bioequivalence designs. Int J Pharm. 2013;456:87–94.
   PubMed Web of Science ®Google Scholar
• OnlineStatBook Version 2.0. Normal distribution calculator. [cited 2019 May 25]. Available from http://onlinestatbook.com/2/calculators/normal_dist.html.
   Google Scholar
• Hinderling PH. Red blood cells: a neglected compartment in pharmacokinetics and pharmacodynamics. Pharmacol Rev. 1997;49:279–295.
   PubMed Web of Science ®Google Scholar
• Wickremsinhe ER, Abdul BG, Huang NH, et al. Dried blood spot sampling: coupling bioanalytical feasibility, blood–plasma partitioning and transferability to in vivo preclinical studies. Bioanalysis. 2011;3:1635–1646.
   PubMed Web of Science ®Google Scholar
• Rowland M, Emmons GT. Use of dried blood spots in drug development: pharmacokinetic considerations. Aaps J. 2010;12:290.
   PubMed Web of Science ®Google Scholar
• Emmons GT, Rowland M. Pharmacokinetic considerations as to when to use dried blood spot sampling. Bioanalysis. 2010;2:1791–1796.
   PubMed Web of Science ®Google Scholar
• Kong ST, Lim SH, Lee WB, et al. Clinical validation and implications of dried blood spot sampling of carbamazepine, valproic acid and phenytoin in patients with epilepsy. PLoS One. 2014;9:e108190.
   PubMed Web of Science ®Google Scholar
• Kothare PA, Bateman KP, Dockendorf M, et al. An integrated strategy for implementation of dried blood spots in clinical development programs. Aaps J. 2016;18:519–527.
   PubMed Web of Science ®Google Scholar
• O’Mara M, Hudson-Curtis B, Olson K, et al. The effect of hematocrit and punch location on assay bias during quantitative bioanalysis of dried blood spot samples. Bioanalysis. 2011;3:2335–2347.
   PubMed Web of Science ®Google Scholar
• Enderle Y, Foerster K, Burhenne J. Clinical feasibility of dried blood spots: analytics, validation, and applications. J Pharm Biomed Anal. 2016;130:231–243.
   PubMed Web of Science ®Google Scholar
• Rmandić M, Dotsikas Y, Malenović A. Identification of the factors affecting the consistency of DBS formation via experimental design and image processing methodology. Microchem J. 2019;145:1003–1010.
   Web of Science ®Google Scholar
• Koster RA, Alffenaar J-W, Botma R, et al. What is the right blood haematocrit preparation procedure for standards and quality control samples for dried blood spot analysis? Bioanalysis. 2015;7:345–351.
   PubMed Web of Science ®Google Scholar
• Zukunft S, Sorgenfrei M, Prehn C, et al. Targeted metabolomics of dried blood spot extracts. Chromatographia. 2013;76:1295–1305.
   Web of Science ®Google Scholar
• Petrick L, Edmands W, Schiffman C, et al. An untargeted metabolomics method for archived newborn dried blood spots in epidemiologic studies. Metabolomics. 2017;13:27.
   PubMed Web of Science ®Google Scholar