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OpenSampling

The Library

1530 papers on microsampling and monitoring, each with a finding paraphrased to our standard and labelled in one vocabulary. Every entry links to a legitimate copy; nothing is copied from an abstract.

62 papers labelled “immunosuppressants”, newest first.

  1. 2026

    In lung and renal transplant recipients, VAMS sampling with LC-MS/MS quantification of mycophenolic acid and tacrolimus showed good linearity and accuracy, and with a haematocrit-adjusted conversion formula achieved clinical agreement in most samples; tacrolimus did not require haematocrit correction. The approach is virtually painless and enables richer sampling for more accurate drug exposure estimates, supporting decentralised therapeutic drug monitoring.

    Evaluation of hematocrit-adjusted conversion strategies for mycophenolic acid and tacrolimus monitoring using volumetric absorptive microsampling in lung and renal transplant recipientsJuan et al., Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques

    • blood
    • dried
    • vams
    • neoteryx-mitra
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
    • haematocrit
  2. 2026

    This study validated a dried blood spot method for tacrolimus monitoring and demonstrated agreement with venous whole blood measurements in kidney transplant recipients. It also found that dried blood spot analysis of the biomarker CXCL-10 was elevated in patients experiencing rejection or infection, supporting its use for decentralised monitoring.

    Dried Blood Spot for CXCL-10 and Tacrolimus: Integrated Non-Invasive Monitoring to Guide Personalized Treatment in Adult Kidney Transplant RecipientsMillán et al., Pharmaceuticals

    • venous-agreement
    • blood
    • dbs
    • tdm
    • dried
    • immunosuppressants
    • validation
    • biomarkers
  3. 2026

    The study found that quantitative dried blood spot sampling provided high clinical agreement for tacrolimus and creatinine monitoring, with patients rating the self-collection devices as user-friendly. These results support the feasibility of decentralised therapeutic drug monitoring for immunosuppressants.

    Patient-centric capillary dried blood spot sampling for tacrolimus and creatinine monitoring in clinical practiceDe Baets et al., Clinical chemistry and laboratory medicine (paywalled)

    • blood
    • dried
    • capillary
    • dbs
    • qdbs
    • self-collection
    • venous-agreement
    • acceptability
    • tdm
    • immunosuppressants
  4. 2026

    This study validated a method for monitoring mycophenolic acid in paediatric patients, demonstrating that quantitative dried plasma spots achieved close agreement with venous plasma. Quantitative dried blood spots showed significant haematocrit-related bias, making the plasma-based format more suitable for decentralised monitoring.

    Matrix fidelity in microsampling: Plasma-first LC-MS/MS quantification of mycophenolic acid and MPAGKocur et al., Journal of chromatography. B, Analytical technologies in the biomedical and life sciences (paywalled)

    • venous-agreement
    • blood
    • qdbs
    • tdm
    • haematocrit
    • dried
    • pediatric
    • immunosuppressants
    • validation
  5. 2026

    Fingerstick capillary sampling showed strong agreement with venous sampling for mycophenolic acid, tacrolimus and cyclosporine A, with acceptable bias and improved agreement for mycophenolic acid after haematocrit correction. This minimally invasive approach may reduce procedural burden and support outpatient or home based therapeutic drug monitoring in children.

    Minimally Invasive Therapeutic Drug Monitoring of Immunosuppressants in Children with Kidney Diseases: Validation of Fingerstick Sampling Using LC-MS/MSIshii et al., Pharmaceuticals

    • venous-agreement
    • blood
    • tdm
    • haematocrit
    • capillary
    • pediatric
    • immunosuppressants
    • validation
  6. 2026

    A liquid-phase microsampling method using 2.8 µL of whole blood demonstrated strong correlation with conventional venous sampling for immunosuppressant monitoring in renal transplant recipients. This approach enables patient-centric therapeutic drug monitoring, reducing burden and supporting implementation in home-based, paediatric, and telemedicine settings.

    Clinical Application of Microvolume LC-MS/MS for Therapeutic Drug Monitoring of Immunosuppressants in Solid-Organ Transplant RecipientsIwami et al., Journal of clinical medicine

    • blood
    • liquid
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
    • haematocrit
  7. 2026

    In matched clinical samples from rheumatoid arthritis, VAMS and DBS showed strong agreement for methotrexate polyglutamates (slopes 0.95-1.07; bias within -4.21% to 0.36%; SRCC ≥ 0.969), with up to 100% of total MTXPG results within ±20% limits; capillary microsampling agreed closely with whole blood but differed from red blood cells, indicating matrix-specific differences that must be accounted for when interpreting against RBC-based reference values.

    Multi-Matrix LC-MS/MS Validation of Methotrexate Polyglutamates: Comparison of VAMS, DBS, and Conventional Blood Sampling in Rheumatoid ArthritisKocur et al., International journal of molecular sciences

    • blood
    • dried
    • capillary
    • vams
    • neoteryx-mitra
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  8. 2025

    A systematic review found mixed economic evidence for microsampling in therapeutic drug monitoring; one study reported no cost reduction with DBS home-sampling, €688 versus €676, whilst another predicted savings up to 61%. The authors caution that more work is required to assess costs alongside clinical outcomes and optimise logistics for decentralised implementation.

    The economic evidence for microsampling to support therapeutic drug monitoring: A systematic reviewCarland et al., British Journal of Clinical Pharmacology (paywalled)

    • vams
    • blood
    • economics
    • dbs
    • tdm
    • self-collection
    • dried
    • antimicrobials
    • pediatric
    • immunosuppressants
    • validation
  9. 2025

    Dried saliva collected with the Mitra device correlated strongly with wet saliva but poorly with plasma unbound and total concentrations, indicating it is not a reliable substitute for plasma in routine therapeutic drug monitoring of mycophenolic acid and its glucuronide metabolite. Capillary blood collected via VAMS remains a promising alternative for long term monitoring in paediatric patients.

    Volumetric Absorptive Microsampling of Saliva for Pharmacokinetic Evaluation of Mycophenolic Acid and Its Glucuronide Metabolite in Pediatric Renal Transplant Recipients: Bioanalytical Method Validation and Clinical Feasibility EvaluationKocur et al., Pharmaceuticals

    • blood
    • saliva
    • dried
    • capillary
    • vams
    • neoteryx-mitra
    • validation
    • pediatric
    • tdm
    • immunosuppressants
  10. 2025

    The paper summarises that volumetric finger-prick self-sampling is suitable for monitoring immunosuppressants and biomarkers after kidney transplantation, but successful implementation requires careful design of the entire workflow, including patient training and method validation. This matters because it provides a real-world framework for moving critical monitoring from the clinic to the patient's home.

    Implementation of Volumetric Finger-Prick Self-Sampling for Therapeutic Drug Monitoring of Immunosuppressants After Kidney Transplantation: Lessons Learned From the PracticeVethe et al., Therapeutic drug monitoring (paywalled)

    • vams
    • volumetric
    • neoteryx-mitra
    • blood
    • tdm
    • self-collection
    • immunosuppressants
    • validation
    • biomarkers
  11. 2025

    A study of 12 kidney transplant recipients providing 69 paired samples found that a VAMS-based assay for mycophenolic acid and its metabolite had 90% to 106% accuracy. Converting microsampling results to plasma concentrations met agreement criteria, supporting decentralised monitoring, though the study was small and limited to a single centre.

    Development and Clinical Validation of a Volumetric Absorptive Capillary Microsampling Method for Quantification of Mycophenolic Acid and Mycophenolic Acid Glucuronide in Kidney Transplant RecipientsDrevland et al., Therapeutic drug monitoring (paywalled)

    • vams
    • venous-agreement
    • blood
    • tdm
    • dried
    • capillary
    • immunosuppressants
    • validation
  12. 2025

    A validated LC-MS/MS method for everolimus using Mitra and Capitainer devices found excellent agreement between capillary microsamples and venous whole blood in 33 adult transplant recipients. The results showed high accuracy and negligible haematocrit effects, supporting the use of microsampling for decentralised therapeutic drug monitoring.

    Therapeutic Drug Monitoring of Everolimus Using Volumetric Absorptive Microsampling and Quantitative Dried Blood Spot Methods with LC-MS/MS in Adult Solid Organ Transplant Recipients: An Analytical and Clinical Comparative StudyKocur et al., Molecules

    • vams
    • venous-agreement
    • neoteryx-mitra
    • blood
    • qdbs
    • tdm
    • haematocrit
    • dried
    • capillary
    • immunosuppressants
    • validation
  13. 2025

    In children with SLE, VAMS finger-prick capillary blood gave haematocrit-adjusted MPA and MPAG concentrations indistinguishable from plasma, and the AUC from VAMS derived plasma-equivalent concentrations matched plasma AUC with R2 0.97. This supports accurate pharmacokinetically guided dosing of MMF using only three timed capillary microsamples.

    Volumetric Absorptive Microsampling Combined with Mass Spectrometry to Support Pharmacokinetically-Guided Precision Dosing of Mycophenolate Mofetil in Pediatric Lupus Nephritis PatientsZhao et al., The journal of applied laboratory medicine (paywalled)

    • vams
    • venous-agreement
    • blood
    • tdm
    • haematocrit
    • dried
    • capillary
    • pediatric
    • immunosuppressants
    • validation
  14. 2025

    A validated offline SPE-LC-MS/MS method using the Mitra microsampling device successfully quantified tacrolimus, cyclosporine A, tryptophan, kynurenine, and creatinine simultaneously. The method met EMA and FDA criteria, showing agreement between capillary and venous sampling, which could facilitate decentralised therapeutic drug monitoring and transplant follow-up through patient self-collection.

    An Offline SPE-LC-MS/MS Method for Simultaneous Quantification of Tacrolimus, Cyclosporine A, Kynurenine, Tryptophan, and Creatinine Using Volumetric Absorptive Microsampling Device MitraNierychlewski et al., Therapeutic drug monitoring

    • blood
    • dried
    • capillary
    • vams
    • neoteryx-mitra
    • validation
    • tdm
    • immunosuppressants
    • biomarkers
  15. 2025

    Microsampling, particularly VAMS and quantitative DBS, can enable patient-centric therapeutic drug monitoring of immunosuppressants after transplantation, allowing home self-sampling and long-term monitoring when patients live far from transplant centres. These volumetric dried formats have largely overcome the haematocrit effect and sample heterogeneity that limit conventional dried blood spots.

    Microsampling techniques and patient-centric therapeutic drug monitoring of immunosuppressantsKocur & Pawiński, Bioanalysis (paywalled)

    • vams
    • venous-agreement
    • blood
    • qdbs
    • tdm
    • self-collection
    • haematocrit
    • dried
    • capillary
    • immunosuppressants
  16. 2025

    A dried blood spot LC-MS/MS method for voclosporin was analytically validated using volumetric sampling devices, demonstrating strong agreement with whole blood analysis across a 10-600 µg/L range. The method meets ICH M10 guidelines and allows remote therapeutic drug monitoring in kidney transplant recipients.

    Dried blood spot LC-MS/MS quantification of voclosporin in renal transplant recipients using volumetric dried blood spot samplingMetscher et al., Journal of pharmaceutical and biomedical analysis (paywalled)

    • blood
    • dried
    • dbs
    • volumetric
    • validation
    • tdm
    • immunosuppressants
  17. 2024

    Head-to-head clinical validation of two VAMS devices for tacrolimus and mycophenolic acid, with roughly 86–88% of samples within ±20% of venous.

    Clinical validation of two volumetric absorptive microsampling devices to support home-based therapeutic drug monitoring of immunosuppressionLeino et al., British Journal of Clinical Pharmacology (paywalled)

    • vams
    • venous-agreement
    • acceptability
    • neoteryx-mitra
    • blood
    • tdm
    • self-collection
    • dried
    • immunosuppressants
    • validation
  18. 2024

    The study validated a VAMS-based LC-MS/MS method for measuring sirolimus levels, showing it was clinically equivalent to the standard whole blood method and suitable for therapeutic drug monitoring in paediatric transplant patients, supporting the use of decentralised microsampling for this purpose.

    Personalization of pharmacotherapy with sirolimus based on volumetric absorptive microsampling (VAMS) in pediatric renal transplant recipients-from LC-MS/MS method validation to clinical applicationKocur et al., Pharmacological reports : PR

    • vams
    • venous-agreement
    • neoteryx-mitra
    • blood
    • tdm
    • haematocrit
    • dried
    • capillary
    • pediatric
    • immunosuppressants
    • validation
  19. 2024

    The study developed and validated LC-MS/MS methods for ciclosporin in whole blood and volumetric absorptive microsampling across 1-2000 ng/mL, meeting international bioanalytical criteria, and confirmed interchangeability with clinical samples and external proficiency testing, supporting decentralised microsampling for therapeutic drug monitoring in children.

    A novel approach to therapeutic drug monitoring of Ciclosporin in pediatric renal transplant recipients using volumetric absorptive microsampling (VAMS) - Teaching old dog new tricksKocur et al., Clinica chimica acta; international journal of clinical chemistry (paywalled)

    • vams
    • blood
    • tdm
    • pediatric
    • immunosuppressants
    • validation
  20. 2024

    This systematic review of 67 studies involving 34,739 kidney disease patients found dried blood microsampling was mainly used for immunosuppressant therapeutic drug monitoring and kidney function assessment. The approach offered cost savings, was preferred by patients for home self-collection, and provides a patient-centric opportunity to upscale longitudinal sampling and reduce participation bias in decentralised kidney disease research.

    A Systematic Literature Review on the Use of Dried Biofluid Microsampling in Patients With Kidney DiseaseLamond et al., Journal of clinical laboratory analysis

    • blood
    • dried
    • capillary
    • self-collection
    • validation
    • acceptability
    • tdm
    • immunosuppressants
    • economics
  21. 2024

    When patiromer is taken three hours after tacrolimus, it does not alter tacrolimus exposure in kidney transplant recipients. The study also shows that self-collected capillary blood samples using volumetric absorptive microsampling (VAMS) can reliably measure tacrolimus concentrations, which simplifies pharmacokinetic studies and enables decentralised therapeutic drug monitoring.

    Patiromer Does Not Alter Tacrolimus Pharmacokinetics in Kidney Transplant Recipients When Administered Three Hours Post-TacrolimusDrevland et al., Transplantation direct

    • blood
    • dried
    • capillary
    • vams
    • neoteryx-mitra
    • self-collection
    • tdm
    • immunosuppressants
    • dct
  22. 2023

    A study of 50 paediatric renal transplant recipients found that a validated VAMS LC-MS/MS method for tacrolimus showed high correlation with the reference method over 0.5–60 ng/mL, with minimal haematocrit effect.

    Therapeutic Drug Monitoring of Tacrolimus Based on VAMS in Renal Transplant Pediatric Recipients — LC-MS/MS Method, Hematocrit Effect, and Clinical ApplicationKocur et al., Pharmaceutics

    • vams
    • neoteryx-mitra
    • blood
    • tdm
    • haematocrit
    • dried
    • capillary
    • pediatric
    • immunosuppressants
    • validation
  23. 2023

    VAMS microsampling found no significant difference from venous blood for tacrolimus in paediatric patients; samples were stable for 14 days, with average difference between paired at-home samples of 0.12 ± 0.94 ng/mL.

    VAMS and parallel-reaction-monitoring mass spectrometry for tacrolimus trough measurements at home in paediatric heart-transplant patientsZhao et al., J. Mass Spectrometry and Advances in the Clinical Lab

    • vams
    • venous-agreement
    • acceptability
    • blood
    • dbs
    • tdm
    • self-collection
    • dried
    • capillary
    • pediatric
    • immunosuppressants
    • validation
  24. 2023

    A structured review: many VAMS assays are analytically validated and can substitute for venous sampling for well-characterised analytes, though clinical-validation depth varies.

    Analytical and Clinical Validation of Assays for VAMS of Drugs in Different Blood Matrices: A Literature ReviewNugraha et al., Molecules

    • vams
    • venous-agreement
    • blood
    • tdm
    • dried
    • immunosuppressants
    • validation
  25. 2023

    A study of 50 paediatric renal transplant recipients found that a UHPLC-MS/MS method successfully quantified mycophenolic acid in VAMS microsampling samples over a 0.10-15 µg/mL range. However, converting microsampling results to plasma equivalents using haematocrit-based regression is required for clinical interpretation, supporting patient-centric decentralised monitoring.

    Therapeutic drug monitoring of mycophenolic acid (MPA) using volumetric absorptive microsampling (VAMS) in pediatric renal transplant recipients: ultra-high-performance liquid chromatography-tandem mass spectrometry analytical method development, cross-validation, and clinical applicationKocur et al., Pharmacological reports : PR

    • vams
    • venous-agreement
    • blood
    • tdm
    • haematocrit
    • dried
    • capillary
    • pediatric
    • immunosuppressants
    • validation
  26. 2023

    A study of 37 kidney transplant recipients found Capitainer and Mitra microsampling feasible for decentralised monitoring. Capitainer showed consistent sampling success, 92%-96%, and higher analytical accuracy than Mitra, 52%-88% success. Proportions within ±15% of venous reference for creatinine and haemoglobin were 92%-100% and 93%-100% for Capitainer, versus 79%-96% and 67%-92% for Mitra, despite small cohorts.

    Clinical performance of volumetric finger-prick sampling for the monitoring of tacrolimus, creatinine and haemoglobin in kidney transplant recipientsVethe et al., British journal of clinical pharmacology (paywalled)

    • blood
    • capillary
    • qdbs
    • volumetric
    • neoteryx-mitra
    • self-collection
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  27. 2023

    Automated dried blood spot analysis achieved clinical and analytical acceptance criteria for tacrolimus, sirolimus, everolimus and cyclosporin A after haematocrit correction. This validates a method that could enable decentralised, patient-centric therapeutic drug monitoring for transplant recipients.

    Application of a Fully Automated Dried Blood Spot Method for Therapeutic Drug Monitoring of Immunosuppressants: Another Step Toward Implementation of Dried Blood Spot AnalysisDeprez & Stove, Archives of pathology & laboratory medicine (paywalled)

    • blood
    • dried
    • dbs
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
    • haematocrit
  28. 2023

    VAMS finger-prick microsampling showed reliable agreement with venous blood sampling for measuring tacrolimus and creatinine after correction for systematic differences, supporting its use in therapeutic drug monitoring. This offers a patient-centric, decentralised alternative to frequent venipunctures in kidney transplant recipients.

    Serum Creatinine and Tacrolimus Assessment With VAMS Finger-Prick Microsampling: A Diagnostic Test StudyScuderi et al., Kidney medicine

    • blood
    • dried
    • capillary
    • vams
    • neoteryx-mitra
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  29. 2023

    VAMS capillary samples from 32 liver transplant recipients showed strong agreement with venous blood for everolimus measurement, with a correlation of r squared 0.92 and no proportional or constant bias on Bland Altman analysis. No effect of haematocrit or sampling time was observed, supporting VAMS as a virtually painless decentralised alternative to venous draws for immunosuppressant monitoring in transplant patients.

    Volumetric Absorptive Microsampling for the Therapeutic Drug Monitoring of Everolimus in Patients Who Have Undergone Liver TransplantYoo et al., Therapeutic drug monitoring (paywalled)

    • blood
    • dried
    • vams
    • neoteryx-mitra
    • venous-agreement
    • tdm
    • immunosuppressants
    • haematocrit
  30. 2023

    This review surveys published LC-MS/MS methods that use dried blood microsampling for therapeutic drug monitoring of immunosuppressants in transplantation, chemotherapy and autoimmune disease, finding that volumetric dried blood samples can replace conventional venous draws for home sampling and improve patient quality of life. The authors discuss pre-analytical considerations, clinical applicability, cost-effectiveness, harmonisation gaps and patient perception, concluding that obstacles to routine clinical implementation remain despite growing methodological maturity.

    Dried blood microsampling-assisted therapeutic drug monitoring of immunosuppressants: An overviewDeprez & Stove, Journal of chromatography. A (paywalled)

    • blood
    • dried
    • dbs
    • volumetric
    • validation
    • acceptability
    • tdm
    • immunosuppressants
    • economics
  31. 2023

    In adult kidney transplant patients, fingerprick VAMS and dried blood spot microsampling achieved accurate simultaneous measurement of tacrolimus, mycophenolic acid, and prednisolone compared with venepuncture. The authors noted an overall preference for VAMS over conventional dried blood spots.

    Fingerprick Microsampling Methods Can Replace Venepuncture for Simultaneous Therapeutic Drug Monitoring of Tacrolimus, Mycophenolic Acid, and Prednisolone Concentrations in Adult Kidney Transplant PatientsScuderi et al., Therapeutic drug monitoring (paywalled)

    • blood
    • dried
    • capillary
    • vams
    • dbs
    • neoteryx-mitra
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  32. 2023

    Microsampling assays for immunosuppressant monitoring showed three- to fourfold higher imprecision across 14 laboratories than conventional whole-blood analysis, with coefficients of variation of 11.7 to 18.6 percent versus 3.9 to 4.9 percent. In a patient specimen, this analytical scatter produced a different clinical decision, proving that current microsampling practice lacks the standardisation required for safe home-based therapeutic drug monitoring.

    Results From a Proficiency Testing Pilot for Immunosuppressant Microsampling AssaysVeenhof et al., Therapeutic drug monitoring

    • blood
    • dried
    • capillary
    • vams
    • neoteryx-mitra
    • validation
    • tdm
    • immunosuppressants
  33. 2023

    A method for tacrolimus quantification from volumetric dried blood spots collected with a hemaPEN device was validated using automated LC-MS/MS extraction. The assay was linear from 1 to 100 µg/L and met all analytical and clinical validation criteria, enabling decentralised therapeutic drug monitoring of immunosuppressants through home-based capillary blood sampling.

    New perspectives for the therapeutic drug monitoring of tacrolimus: Quantification in volumetric DBS based on an automated extraction and LC-MS/MS analysisRosé et al., Journal of chromatography. B, Analytical technologies in the biomedical and life sciences (paywalled)

    • blood
    • dried
    • capillary
    • dbs
    • volumetric
    • validation
    • tdm
    • immunosuppressants
  34. 2023

    The review found that volumetric absorptive microsampling can reliably assay tacrolimus and mycophenolic acid for therapeutic drug monitoring, though correction factors are often required to meet regulatory agreement standards. This supports the use of microsampling for decentralised trials and dose optimisation in transplant recipients.

    Volumetric Absorptive Microsampling to Enhance the Therapeutic Drug Monitoring of Tacrolimus and Mycophenolic Acid: A Systematic Review and Critical AssessmentLeino et al., Therapeutic drug monitoring (paywalled)

    • blood
    • dried
    • vams
    • neoteryx-mitra
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  35. 2023

    Deprez et al. validated LC‑MS/MS methods for four immunosuppressants and creatinine from a single 10 μL quantitative dried blood spot. With biases under 10 % and CVs below 8 %, the approach enables accurate patient‑centric therapeutic drug monitoring from capillary blood at home, mitigating the haematocrit effect through volumetric collection.

    Liquid chromatography-tandem mass spectrometry for therapeutic drug monitoring of immunosuppressants and creatinine from a single dried blood spot using the Capitainer® qDBS deviceDeprez et al., Analytica chimica acta (paywalled)

    • blood
    • dried
    • capillary
    • qdbs
    • volumetric
    • validation
    • tdm
    • immunosuppressants
    • haematocrit
  36. 2022

    A single VAMS run quantified two immunosuppressants plus creatinine with minimal haematocrit effect: combined drug-and-organ-function monitoring from one dried tip.

    A VAMS UPLC-MS/MS Method for Simultaneous Quantification of Tacrolimus, Mycophenolic Acid and Creatinine in Whole Blood of Renal Transplant RecipientsWang et al., Pharmaceutics

    • vams
    • venous-agreement
    • acceptability
    • blood
    • tdm
    • haematocrit
    • dried
    • immunosuppressants
    • validation
  37. 2022

    This review shows that patient-centric Mitra microsampling devices accurately collect fixed blood volumes for immunosuppressant monitoring, reducing haematocrit bias compared to classic dried blood spots. While ideal for paediatric adherence, wider decentralised adoption requires further multicentre validation and cross-laboratory harmonisation to address current analytical and cost limitations.

    Volumetric Absorptive Microsampling in Therapeutic Drug Monitoring of Immunosuppressive Drugs — From Sampling and Analytical Issues to Clinical ApplicationKocur & Pawiński, Int. J. Molecular Sciences

    • vams
    • neoteryx-mitra
    • blood
    • tdm
    • haematocrit
    • dried
    • pediatric
    • immunosuppressants
    • validation
  38. 2022

    Clinical validation for tacrolimus and mycophenolic acid monitoring showed that while volumetric absorptive microsampling met analytical criteria after concentration correction, conventional dried blood spots achieved superior adherence to strict clinical criteria, sample quality, and cost efficiency without significant haematocrit bias.

    Comparison of conventional dried blood spots and volumetric absorptive microsampling for tacrolimus and mycophenolic acid determinationPaniagua-González et al., Journal of pharmaceutical and biomedical analysis (paywalled)

    • blood
    • dried
    • capillary
    • vams
    • dbs
    • neoteryx-mitra
    • self-collection
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
    • economics
    • haematocrit
  39. 2022

    Validated a dried blood spot assay for tacrolimus and mycophenolic acid therapeutic drug monitoring and creatinine-based kidney function in kidney transplant recipients. DBS showed excellent agreement with venous sampling for tacrolimus trough and AUC, adequate agreement for creatinine-based GFR trend monitoring, but suboptimal agreement for mycophenolic acid AUC and inadequate performance for iohexol-based GFR. VAMS was generally inferior. This enables remote, simultaneous immunosuppressant and kidney function monitoring in outpatients, reducing clinic visits.

    Volumetric microsampling for simultaneous remote immunosuppressant and kidney function monitoring in outpatient kidney transplant recipientsZwart et al., British journal of clinical pharmacology

    • blood
    • dried
    • vams
    • dbs
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  40. 2022

    The study found that automating sample preparation for tacrolimus testing on VAMS devices reduced operator time and improved workflow consistency without compromising agreement with manual methods. This supports the scalability of decentralised therapeutic drug monitoring using patient-centric microsampling.

    Automation of tacrolimus measurement on volumetric absorptive microsampling devices by tandem mass spectrometryCarling et al., Bioanalysis (paywalled)

    • blood
    • dried
    • vams
    • neoteryx-mitra
    • validation
    • tdm
    • immunosuppressants
  41. 2022

    The study developed and validated a laboratory technique to accurately quantify tacrolimus and mycophenolic acid from the Neoteryx Mitra device in human whole blood, supporting its use for home-based therapeutic drug monitoring in transplant patients.

    Application of a new volumetric microsampling device for quantitative bioanalysis of immunosuppressionLeino et al., Bioanalysis (paywalled)

    • blood
    • dried
    • vams
    • tdm
    • immunosuppressants
  42. 2022

    The authors validated a quadratic calibration model for automated UV-Vis-based haematocrit prediction from dried blood spots, achieving bias below 0.025 L L-1 and total precision of 2.7%. In therapeutic drug monitoring of tacrolimus, predicted haematocrit values showed good concordance with reference Sysmex measurements, supporting the use of this patient-centric microsampling approach for decentralised immunosuppressant monitoring.

    In-depth evaluation of automated non-contact reflectance-based hematocrit prediction of dried blood spotsBoffel et al., The Analyst (paywalled)

    • blood
    • dried
    • dbs
    • validation
    • tdm
    • immunosuppressants
    • haematocrit
  43. 2022

    A new LC-MS/MS method quantifies four immunosuppressants from one 3.2 mm dried blood spot using cold-induced phase separation, achieving accurate results and favourable interchangeability with a certified whole blood method in 120 paired clinical samples, supporting decentralised therapeutic drug monitoring.

    Quantification of immunosuppressants from one 3.2 mm dried blood spot by a novel cold-induced phase separation based LC-MS/MS methodLe et al., Analytica chimica acta (paywalled)

    • blood
    • dried
    • dbs
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  44. 2022

    LC-MS/MS assay validation for monitoring tacrolimus and creatinine in renal transplant patients demonstrated that volumetric absorptive microsampling is the preferred single-sampling approach compared to traditional dried blood spots and venous sampling.

    Analytical and clinical validation of dried blood spot and volumetric absorptive microsampling for measurement of tacrolimus and creatinine after renal transplantationMathew et al., Clinical biochemistry (paywalled)

    • blood
    • dried
    • vams
    • dbs
    • neoteryx-mitra
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  45. 2021

    A study of 39 paediatric transplant recipients found capillary VAMS microsampling agreed closely with venous sampling for tacrolimus, with 92% of predose and 88% of postdose pairs within ±20% difference. Although sampling was performed in-clinic rather than at home, VAMS shows feasibility for patient-centric, decentralised monitoring.

    Tacrolimus Measured in Capillary Volumetric Microsamples in Pediatric Patients-A Cross-Validation StudyKindem et al., Therapeutic drug monitoring

    • blood
    • vams
    • validation
    • venous-agreement
    • pediatric
    • tdm
    • immunosuppressants
  46. 2021

    Capillary blood collected with the Neoteryx Mitra device showed a high correlation with venous samples for tacrolimus monitoring in transplant recipients, but yielded concentrations that were on average 22.5% higher. This minimally invasive method offers a convenient alternative to venepuncture for therapeutic drug monitoring, provided the consistent positive bias is accounted for in clinical interpretation.

    Validation of a Capillary Dry Blood Sample MITRA-Based Assay for the Quantitative Determination of Systemic Tacrolimus Concentrations in Transplant RecipientsUndre et al., Therapeutic drug monitoring

    • blood
    • dried
    • capillary
    • vams
    • neoteryx-mitra
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  47. 2021

    A bioanalytical method for tacrolimus quantitation from MITRA capillary blood samples met all FDA and EMA validation criteria, showing accuracy and precision across 1–50 ng/mL. Haematocrit and hyperlipidaemia did not affect quantitation, and samples remained stable for up to 96 days, supporting minimally invasive therapeutic drug monitoring from a fingerprick.

    Quantitation of Tacrolimus in Human Whole Blood Samples Using the MITRA Microsampling DeviceUndre et al., Therapeutic drug monitoring

    • blood
    • dried
    • vams
    • neoteryx-mitra
    • validation
    • tdm
    • immunosuppressants
  48. 2021

    The HPLC-MS/MS assay on dried capillary blood collected with VAMS was linear, precise and stable, and showed strong agreement with liquid venous tacrolimus measurements, supporting its use for therapeutic drug monitoring in transplant recipients.

    Volumetric absorptive microsampling for the quantification of tacrolimus in capillary blood by high performance liquid chromatography-tandem mass spectrometryTron et al., Journal of chromatography. B, Analytical technologies in the biomedical and life sciences (paywalled)

    • blood
    • dried
    • capillary
    • vams
    • neoteryx-mitra
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  49. 2020

    Fingerprick blood collected with Neoteryx Mitra devices showed minimal bias compared to venous sampling for tacrolimus (-5.6%) and creatinine (-6.5%) in renal transplant patients. This validated method could enable home-based therapeutic drug monitoring and kidney function testing, reducing the need for hospital visits.

    Assessment of tacrolimus and creatinine concentration collected using Mitra microsampling devicesMarshall et al., Annals of clinical biochemistry (paywalled)

    • blood
    • capillary
    • vams
    • neoteryx-mitra
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  50. 2020

    The authors developed and validated a VAMS method for quantifying immunosuppressants from venous whole blood using LC-MS/MS with a novel UniSpray ionisation probe. This supports patient-centric microsampling for transplant recipients requiring therapeutic drug monitoring.

    Volumetric Absorptive Microsampling (VAMS) for assaying immunosuppressants from venous whole blood by LC-MS/MS using a novel atmospheric pressure ionization probe (UniSpray™)Paniagua-González et al., Journal of pharmaceutical and biomedical analysis (paywalled)

    • blood
    • vams
    • validation
    • tdm
    • immunosuppressants
  51. 2020

    The Mitra microsampling device showed high clinical concordance with venous blood for tacrolimus (89%) and cyclosporin A (98%) monitoring, with inter- and intra-precision within 11.5% CV and samples stable for up to 7 days at room temperature. Transplant patients preferred collecting capillary samples at home for their immunosuppressant monitoring, supporting decentralised TDM.

    Volumetric Microsampling of Capillary Blood Spot vs Whole Blood Sampling for Therapeutic Drug Monitoring of Tacrolimus and Cyclosporin A: Accuracy and Patient SatisfactionMbughuni et al., The journal of applied laboratory medicine (paywalled)

    • blood
    • capillary
    • vams
    • volumetric
    • neoteryx-mitra
    • validation
    • venous-agreement
    • acceptability
    • tdm
    • immunosuppressants
  52. 2020

    Capillary microsampling using the Neoteryx Mitra device predicted tacrolimus AUC with high accuracy and precision compared with venous sampling in renal transplant recipients, with 85% of estimates within ±11.9% error. Patients could self-sample accurately at home, enabling patient-centred therapeutic drug monitoring without extended hospital stays.

    Tacrolimus Area Under the Concentration Versus Time Curve Monitoring, Using Home-Based Volumetric Absorptive Capillary MicrosamplingGustavsen et al., Therapeutic drug monitoring (paywalled)

    • blood
    • capillary
    • vams
    • neoteryx-mitra
    • self-collection
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  53. 2020

    In adult kidney transplant patients, adding DBS home sampling to usual care did not reduce outpatient visits or per-visit costs versus usual care alone, though most patients were willing to use DBS if it cut hospital attendances; logistical optimisation of mailing and timely analysis is required to realise travel and cost benefits.

    Effects, costs and implementation of monitoring kidney transplant patients' tacrolimus levels with dried blood spot sampling: A randomized controlled hybrid implementation trialVeenhof et al., British journal of clinical pharmacology

    • blood
    • dried
    • dbs
    • self-collection
    • acceptability
    • tdm
    • immunosuppressants
    • dct
    • economics
  54. 2019

    Volumetric absorptive capillary microsampling gave reliable tacrolimus measurements throughout the dose interval in renal transplant recipients, with mean biases of -3.1% for mailed samples and -4.2% for direct delivery versus venous blood. Dried microsamples remained stable for one month at ambient temperature, enabling home-based therapeutic drug monitoring with postal shipment.

    Tacrolimus Can Be Reliably Measured With Volumetric Absorptive Capillary Microsampling Throughout the Dose Interval in Renal Transplant RecipientsVethe et al., Therapeutic drug monitoring (paywalled)

    • blood
    • dried
    • capillary
    • vams
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  55. 2019

    A systematic review of dried blood spot sampling for tacrolimus monitoring across adult and paediatric organ transplant recipients demonstrated that reported analytical bias compared with venous sampling fell within acceptable limits across the majority of studies. This supports dried blood microsampling as an accurate approach for decentralised therapeutic drug monitoring.

    Predictability of Capillary Blood Spot Toward Venous Whole Blood Sampling for Therapeutic Drug Monitoring of Tacrolimus in Solid Organ Transplant RecipientsGallant et al., European journal of drug metabolism and pharmacokinetics (paywalled)

    • blood
    • dried
    • capillary
    • dbs
    • validation
    • venous-agreement
    • pediatric
    • tdm
    • immunosuppressants
  56. 2019

    Microsampling with the Neoteryx Mitra device showed acceptable linearity and precision for cyclosporine A, everolimus, sirolimus and tacrolimus, and agreed closely with conventional venous extraction by Deming regression, supporting its use for decentralised immunosuppressant therapeutic drug monitoring.

    Feasibility of Immunosuppressant Drug Monitoring by a Microsampling DeviceGruzdys et al., The journal of applied laboratory medicine (paywalled)

    • blood
    • vams
    • neoteryx-mitra
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  57. 2019

    Fingerprick dried blood spots showed analytical agreement with whole blood for sirolimus and everolimus in transplant patients, but only 77.3% and 61.5% of samples fell within the pre-defined 15% clinical relevance limit, missing the 80% target for both drugs. This suggests the method cannot yet replace conventional sampling for immunosuppressant monitoring without accepting less stringent clinical criteria, which constrains its use in decentralised diagnostics.

    Clinical application of a dried blood spot assay for sirolimus and everolimus in transplant patientsVeenhof et al., Clinical chemistry and laboratory medicine (paywalled)

    • blood
    • dried
    • dbs
    • self-collection
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  58. 2018

    Volumetric dried blood spot sampling showed good agreement with conventional venous sampling for tacrolimus and mycophenolic acid concentrations in renal transplant recipients, with most concentrations and abbreviated AUCs falling within ±20% of conventional measures. Dosing recommendations differed on some occasions but the clinical impact was modest, suggesting home-based microsampling could support decentralised therapeutic drug monitoring with appropriate patient training.

    Therapeutic drug monitoring of tacrolimus and mycophenolic acid in outpatient renal transplant recipients using a volumetric dried blood spot sampling deviceZwart et al., British journal of clinical pharmacology (paywalled)

    • blood
    • dried
    • dbs
    • volumetric
    • self-collection
    • validation
    • venous-agreement
    • tdm
    • immunosuppressants
  59. 2017

    Clinical validation in twenty-eight children showed that dried blood spot sampling predicted venous tacrolimus concentrations adequately, with ninety-five percent of predicted-to-observed ratios between 0.74 and 1.28 and median prediction error below fifteen percent, whereas mycophenolic acid predictions were more variable, indicating semiquantitative utility. The authors concluded that home-based dried blood spot collection is suitable for tacrolimus therapeutic drug monitoring in paediatric transplant recipients.

    Dried Blood Spot Sampling for Tacrolimus and Mycophenolic Acid in Children: Analytical and Clinical ValidationMartial et al., Therapeutic drug monitoring (paywalled)

    • blood
    • dried
    • dbs
    • validation
    • venous-agreement
    • pediatric
    • tdm
    • immunosuppressants
  60. 2015

    Capillary dried blood spots collected at home by pediatric transplant patients and mailed to the laboratory gave tacrolimus and sirolimus results that were clinically comparable to venous whole blood, with small negative biases within acceptable limits, enabling remote therapeutic drug monitoring.

    Tacrolimus and sirolimus in capillary dried blood spots allows for remote monitoringDickerson et al., Pediatric transplantation (paywalled)

    • blood
    • dried
    • capillary
    • dbs
    • self-collection
    • venous-agreement
    • pediatric
    • tdm
    • immunosuppressants
  61. 2015

    Dried blood spots from finger-pricks, collected either in clinic or by families at home, showed wide fluctuations in methotrexate levels in 17 of 48 children with juvenile arthritis or dermatomyositis, indicating nonadherence. Younger age and oral administration predicted poorer adherence, while subcutaneous dosing gave higher drug concentrations, proving that decentralised therapeutic drug monitoring is feasible in paediatric patients.

    Methotrexate polyglutamates as a potential marker of adherence to long-term therapy in children with juvenile idiopathic arthritis and juvenile dermatomyositis: an observational, cross-sectional studyHawwa et al., Arthritis research & therapy

    • blood
    • dried
    • dbs
    • self-collection
    • pediatric
    • tdm
    • immunosuppressants
  62. 2014

    The authors developed and validated a sensitive LCMS assay for methotrexate polyglutamates in dried blood spots from finger-prick samples, demonstrating agreement with conventional HPLC-UV analysis of matched red-cell samples in 47 paediatric patients. This enables minimally invasive, parent-collected sampling at home for therapeutic drug monitoring, supporting decentralised clinical studies and care in paediatric rheumatology.

    A novel dried blood spot-LCMS method for the quantification of methotrexate polyglutamates as a potential marker for methotrexate use in childrenHawwa et al., PloS one

    • blood
    • dried
    • dbs
    • validation
    • pediatric
    • tdm
    • immunosuppressants

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