Validation of (self-collected) capillary blood using a topper collection system as alternative for venous sampling for 15 common clinical chemistry analytes
-
Rümeysa Geujar
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.
Funding source: Health Holland
Award Identifier / Grant number: VV1.99-LSHM20065
Acknowledgments
We would like to thank all study participants for their collaboration.
-
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.
-
Informed consent: Written informed consent was obtained from each participant.
-
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
-
Use of Large Language Models, AI and Machine Learning Tools: None declared.
-
Conflict of interest: H. van Rossum is listed as inventor on patent describing the Topper technology. All other authors state no conflict of interest.
-
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.
-
Data availability: Not applicable.
References
1. Lingervelder, D, Kip, MMA, Wiese, ED, Koffijberg, H, Ijzerman, MJ, Kusters, R. The societal impact of implementing an at-home blood sampling device for chronic care patients: patient preferences and cost impact. BMC Health Serv Res 2022;22:1529. https://doi.org/10.1186/s12913-022-08782-w.Suche in Google Scholar PubMed PubMed Central
2. Poland, DCW, Cobbaert, CM. Blood self-sampling devices: innovation, interpretation and implementation in total lab automation. Clin Chem Lab Med 2025;63:3–13. https://doi.org/10.1515/cclm-2024-0508.Suche in Google Scholar PubMed
3. Ansari, S, Abdel-Malek, M, Kenkre, J, Choudhury, SM, Barnes, S, Misra, S, et al.. The use of whole blood capillary samples to measure 15 analytes for a home-collect biochemistry service during the SARS-CoV-2 pandemic: a proposed model from North West London Pathology. Ann Clin Biochem 2021;58:411–21. https://doi.org/10.1177/00045632211004995.Suche in Google Scholar PubMed PubMed Central
4. Li, M, Diamandis, EP, Grenache, D, Joyner, MJ, Holmes, DT, Seccombe, R. Direct-to-consumer testing. Clin Chem 2017;63:635–41. https://doi.org/10.1373/clinchem.2016.260349.Suche in Google Scholar PubMed
5. Paniagua-González, L, Lendoiro, E, Otero-Antón, E, López-Rivadulla, M, de-Castro-Ríos, A, Cruz, A. Comparison of conventional dried blood spots and volumetric absorptive microsampling for tacrolimus and mycophenolic acid determination. J Pharm Biomed Anal 2022;208:114443. https://doi.org/10.1016/j.jpba.2021.114443.Suche in Google Scholar PubMed
6. Müller, IR, Linden, G, Charão, MF, Antunes, MV, Linden, R. Dried blood spot sampling for therapeutic drug monitoring: challenges and opportunities. Expert Rev Clin Pharmacol 2023;16:691–701. https://doi.org/10.1080/17512433.2023.2224562.Suche in Google Scholar PubMed
7. van den Brink, N, Even, R, Delic, E, van Hellenberg Hubar-Fisher, S, van Rossum, HH. Self-sampling of blood using a topper and pediatric tubes; a prospective feasibility study for PSA analysis using 120 prostate cancer patients. Clin Chem Lab Med 2023;61:2159–66. https://doi.org/10.1515/cclm-2023-0272.Suche in Google Scholar PubMed
8. The EFLM biological variation database. Available from: https://biologicalvariation.eu.Suche in Google Scholar
9. Colak, S, Tasdemir, O, van der Schaaf, M, Opdam, F, van den Noort, V, van den Broek, D, et al.. Design, validation and performance of aspartate aminotransferase- and lactate dehydrogenase-reporting algorithms for haemolysed specimens including correction within quality specifications. Ann Clin Biochem 2024;61:239–47. https://doi.org/10.1177/0004563219878475.Suche in Google Scholar PubMed
10. Kuwa, K, Nakayama, T, Hoshino, T, Tominaga, M. Relationships of glucose concentrations in capillary whole blood, venous whole blood and venous plasma. Clin Chim Acta 2001;307:187–92. https://doi.org/10.1016/s0009-8981(01)00426-0.Suche in Google Scholar PubMed
11. Noble, LD, Dixon, C, Moran, A, Trottet, C, Majam, M, Ismail, S, et al.. Painless capillary blood collection: a rapid evaluation of the onflow device. Diagnostics (Basel) 2023;13. https://doi.org/10.3390/diagnostics13101754.Suche in Google Scholar PubMed PubMed Central
12. Wickremsinhe, E, Fantana, A, Berthier, E, Quist, BA, Lopez de Castilla, D, Fix, C, et al.. Standard venipuncture vs a capillary blood collection device for the prospective determination of abnormal liver chemistry. J Appl Lab Med 2022;8:535–50. https://doi.org/10.1093/jalm/jfac127.Suche in Google Scholar PubMed
13. Maroto-García, J, Deza, S, Fuentes-Bullejos, P, Fernández-Tomás, P, Martínez-Espartosa, D, Marcos-Jubilar, M, et al.. Analysis of common biomarkers in capillary blood in routine clinical laboratory. Preanalytical and analytical comparison with venous blood. Diagnosis (Berl) 2023;10:281–97. https://doi.org/10.1515/dx-2022-0126.Suche in Google Scholar PubMed
14. Doeleman, MJH, Koster, AF, Esseveld, A, Kemperman, H, Swart, JF, de Roock, S, et al.. Comparison of capillary finger stick and venous blood sampling for 34 routine chemistry analytes: potential for in hospital and remote blood sampling. Clin Chem Lab Med 2025;63:747–52. https://doi.org/10.1515/cclm-2024-0812.Suche in Google Scholar PubMed
15. Roelofs, M, Ramkisoensing, K, Even, R, van Rossum, HH. Pre-processing stability of routine clinical chemistry analytes in a clotting tube; investigating the (un)suitability for at-home sample collection. Clin Chim Acta 2025;567:120035. https://doi.org/10.1016/j.cca.2024.120035.Suche in Google Scholar PubMed
16. Tanner, M, Kent, N, Smith, B, Fletcher, S, Lewer, M. Stability of common biochemical analytes in serum gel tubes subjected to various storage temperatures and times pre-centrifugation. Ann Clin Biochem 2008;45:375–9. https://doi.org/10.1258/acb.2007.007183.Suche in Google Scholar PubMed
17. Dupuy, AM, Cristol, JP, Vincent, B, Bargnoux, AS, Mendes, M, Philibert, P, et al.. Stability of routine biochemical analytes in whole blood and plasma/serum: focus on potassium stability from lithium heparin. Clin Chem Lab Med 2018;56:413–21. https://doi.org/10.1515/cclm-2017-0292.Suche in Google Scholar PubMed
18. Oddoze, C, Lombard, E, Portugal, H. Stability study of 81 analytes in human whole blood, in serum and in plasma. Clin Biochem 2012;45:464–9. https://doi.org/10.1016/j.clinbiochem.2012.01.012.Suche in Google Scholar PubMed
19. Zhou, J, Fabros, A, Lam, SJ, Coro, A, Selvaratnam, R, Brinc, D, et al.. The stability of 65 biochemistry analytes in plasma, serum, and whole blood. Clin Chem Lab Med 2024. https://doi.org/10.1515/cclm-2023-1192.Suche in Google Scholar PubMed
20. van Balveren, JA, Huijskens, MJ, Gemen, EF, Péquériaux, NC, Kusters, R. Effects of time and temperature on 48 routine chemistry, haematology and coagulation analytes in whole blood samples. Ann Clin Biochem 2017;54:448–62. https://doi.org/10.1177/0004563216665868.Suche in Google Scholar PubMed
© 2025 Walter de Gruyter GmbH, Berlin/Boston
