Alternative Sampling Devices to Collect Dried Blood Microsamples: State-of-the-Art

ABSTRACT Dried blood spots (DBS) have been utilized in newborn screening programs for several years. More recently, there has been growing interest in using DBS as a home sampling tool for the quantitative determination of analytes. However, this presents challenges, mainly due to the well-known hematocrit effect and other DBS-specific parameters, including spotted volume and punch site, which could add to the method uncertainty. Therefore, new microsampling devices that quantitatively collect capillary dried blood are continuously being developed.In this review, we provided an overview of devices that are commercially available or under development that allow the quantitative (volumetric) collection of dried blood(-based) microsamples, and are meant to be used for home or remote sampling. Considering the field of therapeutic drug monitoring (TDM), we examined different aspects that are important for a device to be implemented in clinical practice, including ease of patient use, technical performance, and ease of integration in the workflow of a clinical laboratory. Costs related to microsampling devices are briefly discussed, as this additionally plays an important role in the decision-making process.Although the added-value of home sampling for TDM and the willingness of patients to perform home sampling has been demonstrated in some studies, real clinical implementation is progressing at a slower pace. More extensive evaluation of these newly developed devices, not only analytically but also clinically, is needed to demonstrate their real-life applicability, which is a prerequisite for their use in the field of TDM.

[1]  Christophe Stove,et al.  Official International Association for Therapeutic Drug Monitoring and Toxicology guideline: Development and Validation of Dried Blood Spot-based Methods for Therapeutic Drug Monitoring. , 2019, Therapeutic drug monitoring.

[2]  N. Spooner,et al.  Investigation of the effect of blood hematocrit and lipid content on the blood volume deposited by a disposable dried blood spot collection device , 2018, Journal of pharmaceutical and biomedical analysis.

[3]  C. Stove,et al.  Clinical application of microsampling versus conventional sampling techniques in the quantitative bioanalysis of antibiotics: a systematic review. , 2018, Bioanalysis.

[4]  V. Stove,et al.  Wet absorptive microsampling at home for HbA1c monitoring in diabetic children , 2018, Clinical chemistry and laboratory medicine.

[5]  K. Bateman,et al.  Extractability‐mediated stability bias and hematocrit impact: High extraction recovery is critical to feasibility of volumetric adsorptive microsampling (VAMS) in regulated bioanalysis , 2018, Journal of pharmaceutical and biomedical analysis.

[6]  S. MacRury,et al.  HbA1c determination from HemaSpot™ blood collection devices: comparison of home prepared dried blood spots with standard venous blood analysis , 2019, Diabetic medicine : a journal of the British Diabetic Association.

[7]  Hua Lin,et al.  Therapeutic drug monitoring of valproic acid using a dried plasma spot sampling device. , 2020, Journal of mass spectrometry : JMS.

[8]  G. Plazzi,et al.  Development and validation of volumetric absorptive microsampling coupled with UHPLC-MS/MS for the analysis of gamma-hydroxybutyric acid in human blood. , 2019, Biomedical chromatography : BMC.

[9]  Chester L. Bowen,et al.  Drug monitoring by volumetric absorptive microsampling: method development considerations to mitigate hematocrit effects. , 2018, Bioanalysis.

[10]  K. Bateman,et al.  Clinical application of volumetric absorptive microsampling to the gefapixant development program. , 2020, Bioanalysis.

[11]  S. Peel,et al.  Stability of Human Immunodeficiency Virus Serological Markers in Samples Collected as HemaSpot and Whatman 903 Dried Blood Spots , 2018, Journal of Clinical Microbiology.

[12]  V. Stove,et al.  Volumetric absorptive microsampling at home as an alternative tool for the monitoring of HbA1c in diabetes patients , 2017, Clinical chemistry and laboratory medicine.

[13]  G. Gerra,et al.  Determination of oxycodone and its major metabolites in haematic and urinary matrices: Comparison of traditional and miniaturised sampling approaches , 2018, Journal of pharmaceutical and biomedical analysis.

[14]  L. Diero,et al.  HemaSpot, a Novel Blood Storage Device for HIV-1 Drug Resistance Testing , 2015, Journal of Clinical Microbiology.

[15]  H. Tinto,et al.  The changing epidemiology of hepatitis B and C infections in Nanoro, rural Burkina Faso: a random sampling survey , 2020, BMC Infectious Diseases.

[16]  R. Boshuizen,et al.  Capillary blood microsampling to determine serum biopharmaceutical concentration: Mitra® microsampler vs dried blood spot. , 2018, Bioanalysis.

[17]  A. Helander,et al.  Study of measurement of the alcohol biomarker phosphatidylethanol (PEth) in dried blood spot (DBS) samples and application of a volumetric DBS device. , 2018, Clinica chimica acta; international journal of clinical chemistry.

[18]  B. Williamson,et al.  LC-ESI-MS/MS analysis of testosterone at sub-picogram levels using a novel derivatization reagent. , 2012, Analytical chemistry.

[19]  C. Stove,et al.  Role of therapeutic drug monitoring in pulmonary infections: use and potential for expanded use of dried blood spot samples. , 2015, Bioanalysis.

[20]  N. Roxhed,et al.  Evaluation of a Volumetric Dried Blood Spot Card Using a Gravimetric Method and a Bioanalytical Method with Capillary Blood from 44 Volunteers. , 2019, Analytical chemistry.

[21]  J. Kosterink,et al.  What is the right blood hematocrit preparation procedure for standards and quality control samples for dried blood spot analysis? , 2015, Bioanalysis.

[22]  N. Roxhed,et al.  High-Yield Passive Plasma Filtration from Human Finger Prick Blood. , 2018, Analytical chemistry.

[23]  K. Johnson-Davis,et al.  Feasibility of Immunosuppressant Drug Monitoring by a Microsampling Device. , 2019, The journal of applied laboratory medicine.

[24]  W. Lambert,et al.  Potassium-based algorithm allows correction for the hematocrit bias in quantitative analysis of caffeine and its major metabolite in dried blood spots , 2014, Analytical and Bioanalytical Chemistry.

[25]  M. V. Antunes,et al.  Simultaneous determination of vancomycin and creatinine in plasma applied to volumetric absorptive microsampling devices using liquid chromatography‐tandem mass spectrometry , 2019, Journal of pharmaceutical and biomedical analysis.

[26]  P. V. D. van der Boog,et al.  Therapeutic drug monitoring of tacrolimus and mycophenolic acid in outpatient renal transplant recipients using a volumetric dried blood spot sampling device , 2018, British journal of clinical pharmacology.

[27]  C. Stove,et al.  Is the hematocrit still an issue in quantitative dried blood spot analysis? , 2019, Journal of pharmaceutical and biomedical analysis.

[28]  Stefan Gaugler,et al.  The Application of Fully Automated Dried Blood Spot Analysis for Liquid Chromatography-Tandem Mass Spectrometry using the CAMAG DBS-MS 500 Autosampler. , 2020, Clinical biochemistry.

[29]  C. Stove,et al.  Hematocrit prediction in volumetric absorptive microsamples. , 2020, Journal of pharmaceutical and biomedical analysis.

[30]  E. Swart,et al.  Therapeutic Drug Monitoring by Dried Blood Spot: Progress to Date and Future Directions , 2014, Clinical Pharmacokinetics.

[31]  J. Schellens,et al.  Volumetric absorptive microsampling (VAMS) as an alternative to conventional dried blood spots in the quantification of miltefosine in dried blood samples , 2017, Journal of pharmaceutical and biomedical analysis.

[32]  Sara Capiau,et al.  Opening the toolbox of alternative sampling strategies in clinical routine: A key-role for (LC-)MS/MS , 2016 .

[33]  W. Lambert,et al.  Does volumetric absorptive microsampling eliminate the hematocrit bias for caffeine and paraxanthine in dried blood samples? A comparative study. , 2015, Analytica chimica acta.

[34]  N. Roxhed,et al.  An Autonomous Microfluidic Device for Generating Volume-Defined Dried Plasma Spots. , 2019, Analytical chemistry.

[35]  M. Chiasson,et al.  Quantification of HIV-1 RNA Among Men Who Have Sex With Men Using an At-Home Self-Collected Dried Blood Spot Specimen: Feasibility Study , 2018, JMIR public health and surveillance.

[36]  A. Zuppa,et al.  Development and validation of a volumetric absorptive microsampling- liquid chromatography mass spectrometry method for the analysis of cefepime in human whole blood: Application to pediatric pharmacokinetic study. , 2019, Journal of Pharmaceutical and Biomedical Analysis.

[37]  P. Patsalos,et al.  Volumetric absorptive microsampling: A new sampling tool for therapeutic drug monitoring of anti-epileptic drugs. , 2019, Therapeutic drug monitoring.

[38]  R. Rouhl,et al.  Therapeutic drug monitoring of anti-epileptic drugs – a clinical verification of volumetric absorptive micro sampling , 2020, Clinical chemistry and laboratory medicine.

[39]  C. Stove,et al.  Self-sampling at home using volumetric absorptive microsampling: coupling analytical evaluation to volunteers’ perception in the context of a large scale study , 2020, Clinical chemistry and laboratory medicine.

[40]  L. Mercolini,et al.  Tutorial: Volumetric absorptive microsampling (VAMS). , 2019, Analytica chimica acta.

[41]  P. Monks,et al.  Quantitation of salbutamol using micro-volume blood sampling – applications to exacerbations of pediatric asthma , 2018, The Journal of asthma : official journal of the Association for the Care of Asthma.

[42]  D. Lindsay,et al.  Evaluation of a novel dried blood spot collection device (HemaSpot™) to test blood samples collected from dogs for antibodies to Leishmania infantum. , 2014, Veterinary parasitology.

[43]  M. Fassnacht,et al.  A method for the minimally invasive drug monitoring of mitotane by means of volumetric absorptive microsampling for a home-based therapeutic drug monitoring , 2019, Analytical and Bioanalytical Chemistry.

[44]  R. Aebersold,et al.  Separation of blood microsamples by exploiting sedimentation at the microscale , 2018, Scientific Reports.

[45]  Gabriel Lenk,et al.  A disposable sampling device to collect volume-measured DBS directly from a fingerprick onto DBS paper. , 2015, Bioanalysis.

[46]  M. Siegert,et al.  Procedures for Analysis of Dried Plasma Using Microsampling Devices to Detect Sulfur Mustard-Albumin Adducts for Verification of Poisoning. , 2016, Analytical chemistry.

[47]  K. Setchell,et al.  Stable-Isotope Dilution HPLC-Electrospray Ionization Tandem Mass Spectrometry Method for Quantifying Hydroxyurea in Dried Blood Samples. , 2016, Clinical chemistry.

[48]  J. Henion,et al.  A Book-Type Dried Plasma Spot Card for Automated Flow-Through Elution Coupled with Online SPE-LC-MS/MS Bioanalysis of Opioids and Stimulants in blood. , 2016, Analytical chemistry.

[49]  E. Woolf,et al.  A device for dried blood microsampling in quantitative bioanalysis: overcoming the issues associated blood hematocrit. , 2015, Bioanalysis.

[50]  K. V. Hateren,et al.  A volumetric absorptive microsampling LC-MS/MS method for five immunosuppressants and their hematocrit effects. , 2019, Bioanalysis.

[51]  Howard Bernstein,et al.  Microneedle-based device for the one-step painless collection of capillary blood samples , 2018, Nature Biomedical Engineering.

[52]  D. Mikhailov,et al.  Evaluation of a novel blood microsampling device for clinical trial sample collection and protein biomarker analysis. , 2020, Bioanalysis.

[53]  T. Dervieux,et al.  Capillary blood collected on volumetric absorptive microsampling (VAMS) device for monitoring hydroxychloroquine in rheumatoid arthritis patients , 2017, Journal of pharmaceutical and biomedical analysis.

[54]  L. Mercolini,et al.  Enantioseparation and determination of asenapine in biological fluid micromatrices by HPLC with diode array detection. , 2018, Journal of separation science.

[55]  C. Stove,et al.  Volumetric absorptive microsampling as an alternative sampling strategy for the determination of paracetamol in blood and cerebrospinal fluid , 2018, Analytical and Bioanalytical Chemistry.

[56]  Y. Kudva,et al.  Volumetric Microsampling of Capillary Blood Spot vs Whole Blood Sampling for Therapeutic Drug Monitoring of Tacrolimus and Cyclosporin A: Accuracy and Patient Satisfaction. , 2020, The journal of applied laboratory medicine.

[57]  F. Regnier,et al.  Simple, miniaturized blood plasma extraction method. , 2013, Analytical chemistry.

[58]  M. Fillet,et al.  Volumetric absorptive microsampling: Current advances and applications. , 2018, Journal of pharmaceutical and biomedical analysis.

[59]  S. Parker,et al.  Quantitative bioanalytical validation of fosfomycin in human whole blood with volumetric absorptive microsampling. , 2015, Bioanalysis.

[60]  M. Breadmore,et al.  Precise, accurate and user-independent blood collection system for dried blood spot sample preparation , 2018, Analytical and Bioanalytical Chemistry.

[61]  J. Henion,et al.  Dried blood spots: the future , 2013 .

[62]  J. Alffenaar,et al.  Dried blood spots: a new tool for tuberculosis treatment optimization. , 2011, Current pharmaceutical design.

[63]  G. Tripodi,et al.  Volumetric adsorptive microsampling‐liquid chromatography tandem mass spectrometry assay for the simultaneous quantification of four antibiotics in human blood: Method development, validation and comparison with dried blood spot , 2017, Journal of pharmaceutical and biomedical analysis.

[64]  N. Spooner,et al.  Volumetric absorptive microsampling: a dried sample collection technique for quantitative bioanalysis. , 2014, Analytical chemistry.

[65]  Zhengqi Ye,et al.  Evaluation of sample extraction methods for minimizing hematocrit effect on whole blood analysis with volumetric absorptive microsampling. , 2017, Bioanalysis.

[66]  Pieter MM De Kesel,et al.  Hemato-critical issues in quantitative analysis of dried blood spots: challenges and solutions. , 2013, Bioanalysis.

[67]  C. Stove,et al.  Volumetric absorptive microsampling as an alternative tool for therapeutic drug monitoring of first-generation anti-epileptic drugs , 2018, Analytical and Bioanalytical Chemistry.

[68]  Aurélien Thomas,et al.  New microfluidic-based sampling procedure for overcoming the hematocrit problem associated with dried blood spot analysis. , 2015, Analytical chemistry.

[69]  M. Charão,et al.  Dried blood spots analysis with mass spectrometry: Potentials and pitfalls in therapeutic drug monitoring. , 2016, Clinical biochemistry.

[70]  M. Rauh,et al.  Adhesive blood microsampling systems for steroid measurement via LC–MS/MS in the rat , 2017, Steroids.

[71]  S. Bakker,et al.  Volumetric absorptive microsampling and dried blood spot microsampling vs. conventional venous sampling for tacrolimus trough concentration monitoring , 2020, Clinical chemistry and laboratory medicine.

[72]  M. Aalders,et al.  A Novel, Nondestructive, Dried Blood Spot-Based Hematocrit Prediction Method Using Noncontact Diffuse Reflectance Spectroscopy. , 2016, Analytical chemistry.

[73]  J. Adamec,et al.  Validity of plasma collection cards for ferritin assessment—A proof‐of‐concept study , 2020, European journal of haematology.

[74]  J. Schellens,et al.  Validation and clinical application of an LC-MS/MS method for the quantification of everolimus using volumetric absorptive microsampling. , 2019, Journal of chromatography. B, Analytical technologies in the biomedical and life sciences.

[75]  C. Stove,et al.  Evaluation of the Performance and Hematocrit Independence of the HemaPEN as a Volumetric Dried Blood Spot Collection Device. , 2019, Analytical chemistry.

[76]  C. Stove,et al.  Evaluation of the Capitainer-B Microfluidic Device as a New Hematocrit-Independent Alternative for Dried Blood Spot Collection. , 2018, Analytical chemistry.

[77]  L. Mercolini,et al.  Assessment of capillary volumetric blood microsampling for the analysis of central nervous system drugs and metabolites. , 2020, The Analyst.

[78]  M. Joore,et al.  Cost Evaluation of Dried Blood Spot Home Sampling as Compared to Conventional Sampling for Therapeutic Drug Monitoring in Children , 2016, PloS one.

[79]  A. Servais,et al.  Determination of iohexol by capillary blood microsampling and UHPLC-MS/MS , 2019, Journal of pharmaceutical analysis.

[80]  J. Henion,et al.  Novel membrane devices and their potential utility in blood sample collection prior to analysis of dried plasma spots. , 2015, Bioanalysis.

[81]  T. Akita,et al.  Evaluation of the efficiency of dried blood spot-based measurement of hepatitis B and hepatitis C virus seromarkers , 2020, Scientific Reports.

[82]  Y. Daali,et al.  Evaluation of Mutual Drug–Drug Interaction within Geneva Cocktail for Cytochrome P450 Phenotyping using Innovative Dried Blood Sampling Method , 2016, Basic & clinical pharmacology & toxicology.

[83]  F. V. Nakadi,et al.  A simple and direct atomic absorption spectrometry method for the direct determination of Hg in dried blood spots and dried urine spots prepared using various microsampling devices , 2020 .

[84]  J. Henion,et al.  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. , 2016, Analytical chemistry.

[85]  C. Stove,et al.  Dried blood microsampling-based therapeutic drug monitoring of anti-epileptic drugs in children with nodding syndrome and epilepsy in Uganda and the Democratic Republic of the Congo. , 2019, Therapeutic drug monitoring.

[86]  Y. Mano,et al.  Application of volumetric absorptive microsampling device for quantification of tacrolimus in human blood as a model drug of high blood cell partition , 2017, Journal of pharmaceutical and biomedical analysis.

[87]  M. Aalders,et al.  Correction for the Hematocrit Bias in Dried Blood Spot Analysis Using a Nondestructive, Single-Wavelength Reflectance-Based Hematocrit Prediction Method. , 2017, Analytical chemistry.

[88]  Y. Mano,et al.  Hematocrit-independent recovery is a key for bioanalysis using volumetric absorptive microsampling devices, Mitra™. , 2015, Bioanalysis.

[89]  A. Åsberg,et al.  Tacrolimus Can Be Reliably Measured With Volumetric Absorptive Capillary Microsampling Throughout the Dose Interval in Renal Transplant Recipients. , 2019, Therapeutic drug monitoring.