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Validation of (self-collected) capillary blood using a topper collection system as alternative for venous sampling for 15 common clinical chemistry analytes

  • Rümeysa Geujar , Dilana Treffers , Maaike Roelofs , Anna van Dongen , Kalpana Ramkisoensing , Rixt Even and Huub H. van Rossum EMAIL logo
Published/Copyright: June 2, 2025
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 63 Issue 11

Abstract

Objectives

Home blood sampling for clinical purposes has gained much interest. This study validates the recently developed Topper-based capillary blood collection procedure for 15 commonly used chemistry analytes.

Methods

A total of 120 study participants (21 healthy volunteers and 99 patients) were enrolled. A venous sample was obtained and then participants were asked to self-collect blood by the Topper system (SelfSafeSure Blood Collection Devices). Collected sera were analyzed for 15 common clinical chemistry analytes and the serum indices on a Cobas Pro (Roche) system. Spearman correlations, Passing-Bablok regression analysis, and Bland-Altman difference analysis were performed. Comparability was determined using allowable bias criteria based on biological variation (EFLM database).

Results

In 113 out of 120 (94 %) self-collections a sample was obtained that allowed for the analysis of at least one analyte. Bland-Altman difference analysis showed that glucose and uncorrected AST did not meet the minimum bias criterion, creatinine and albumin were within the minimum bias criterion and urea and calcium were within the desirable bias criterion. ALP, corrected AST, ALT, total- HDL- and LDL-cholesterol, CRP, GGT, total protein and triglycerides were all within the optimal bias criterion.

Conclusions

Our study demonstrates that self-collected capillary blood can be used as a reliable alternative to venous sampling for most, if not all, analytes studied. Based on the analyte stability prior to sample processing, home sampling appears to be a reliable sampling option for a selection of these analytes.

Keywords: blood collection; self-collection; capillary blood collection; direct-to-consumer testing
Corresponding author: Huub H. van Rossum, Department of Laboratory Medicine, The Netherlands Cancer Institute, Amsterdam, The Netherlands, E-mail:

Funding source: Health Holland

Award Identifier / Grant number: VV1.99-LSHM20065

Acknowledgments

We would like to thank all study participants for their collaboration.

  1. Research ethics: The study was approved by the local Medical Ethical Committee (Dutch study number NL76225.031.20) and conducted in accordance with the Declaration of Helsinki (as revised in 2013). Date of approval June 21, 2021.

  2. Informed consent: Written informed consent was obtained from each participant.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: H. van Rossum is listed as inventor on patent describing the Topper technology. All other authors state no conflict of interest.

  6. Research funding: This research was supported by a research grant for Health Holland and an institutional grant of the Dutch Cancer Society and of the Dutch Ministry of Health, Welfare and Sport and financial support from NLC Health.

  7. Data availability: Not applicable.

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Received: 2025-02-07
Accepted: 2025-05-24
Published Online: 2025-06-02
Published in Print: 2025-10-27

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2025-0148
Keywords for this article
blood collection; self-collection; capillary blood collection; direct-to-consumer testing

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Advancing diagnostic stewardship through claims-based utilization analysis: toward a system-wide vision of diagnostic excellence
  4. Review
  5. Biomarkers in body fluids and their detection techniques for human intestinal permeability assessment
  6. Mini Review
  7. Challenges of using natriuretic peptides to screen for the risk of developing heart failure in patients with diabetes: a report from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Committee on Clinical Applications of Cardiac Bio-Markers (C-CB)
  8. Opinion Papers
  9. Reference intervals in value-based laboratory medicine: a shift from single-point measurements to metabolic variation-based models
  10. Overview of laboratory diagnostics for immediate management of patients presenting to the emergency department with acute bleeding
  11. What Matters Most: an Age-Friendly approach to pathology and laboratory medicine
  12. No fault or negligence after an adverse analytical finding due to a contaminated supplement: mission impossible. Two examples involving trimetazidine
  13. General Clinical Chemistry and Laboratory Medicine
  14. Utilization analysis of laboratory tests using health insurance claims data: advancing nationwide diagnostic stewardship monitoring systems
  15. Evaluating large language models as clinical laboratory test recommenders in primary and emergency care: a crucial step in clinical decision making
  16. A novel corrective model based on red blood cells indices and haemolysis index enables accurate unhaemolysed potassium determination in haemolysed samples – Hemokalc project
  17. Validation of (self-collected) capillary blood using a topper collection system as alternative for venous sampling for 15 common clinical chemistry analytes
  18. Acoustophoresis-based blood sampling and plasma separation for potentially minimizing sampling-related blood loss
  19. Clinical validation of a liquid chromatography single quadrupole mass spectrometry (LC-MS) method using Waters Kairos™ Amino Acid Kit reagents
  20. Robustness of steroidomics-based machine learning for diagnosis of primary aldosteronism: a laboratory medicine perspective
  21. Investigation of the possible cause of over-estimation of human aldosterone in plasma, using a unique, non-synthetic human aldosterone-free matrix
  22. Performance of afternoon (16:00 h) serum cortisol for the diagnosis of Cushing’s syndrome
  23. MAGLUMI® Tacrolimus (CLIA) assay: analytical performances and comparison with LC-MS/MS and ARCHITECT Tacrolimus (CMIA) assay
  24. Assessment of 2023 ACR/EULAR antiphospholipid syndrome classification criteria in a Spanish cohort
  25. Comprehensive evaluation of antiphospholipid antibody testing methodologies in APS diagnosis: performance comparisons across assay systems and clinical subtypes
  26. Candidate Reference Measurement Procedures and Materials
  27. Exploring commutable materials for serum folate measurement: challenges in cross-method harmonization
  28. Reference Values and Biological Variations
  29. Reference ranges for ionized calcium in plasma in Danish children aged 0 days to 3 years using laboratory registry data
  30. A step forward in pediatric hemophagocytic lymphohistiocytosis and autoimmune disease: pediatric reference interval for serum soluble IL-2 receptor and soluble CD163
  31. Cancer Diagnostics
  32. Cellular expression of PD-1, PD-L1 and CTLA-4 in patients with JAK2V617F mutated myeloproliferative disorders
  33. Diabetes
  34. Serum N-glycans as independent predictors of the incidence of type 2 diabetes: a prospective investigation in the AEGIS cohort
  35. Infectious Diseases
  36. An assessment of molecular diagnosis of tuberculosis and multi-drug resistant tuberculosis testing and quality assessment: findings of an international survey
  37. Letters to the Editor
  38. Targeting low-value laboratory care
  39. Is time a significant factor in the release of potassium from lithium heparin plasma and serum?
  40. External quality assessment in resource-constrained laboratories: a survey of practices and perceptions in Nepal
  41. Is successfulness of platelet clump disaggregation by vortexing influenced by platelet measurement methods?
  42. Oligoclonal banding analysis: assessing plasma use and time interval requirements for paired CSF and blood
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