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. 2023 Jun 14;61(12):2159-2166.
doi: 10.1515/cclm-2023-0272. Print 2023 Nov 27.

Self-sampling of blood using a topper and pediatric tubes; a prospective feasibility study for PSA analysis using 120 prostate cancer patients

Nicas van den Brink  1 , Rixt Even  2 , Enver Delic  2 , Sarah van Hellenberg Hubar-Fisher  1 , Huub H van Rossum  1   2
Affiliations
Free article

Self-sampling of blood using a topper and pediatric tubes; a prospective feasibility study for PSA analysis using 120 prostate cancer patients

Nicas van den Brink et al. Clin Chem Lab Med. .
Free article

Abstract

Objectives: Self-collection of blood for diagnostic purposes by blood collection assist devices (BCAD) has gained a lot of momentum. Nonetheless, there are a lack of studies demonstrating the feasibility and reliability of self-collecting capillary blood for routine (immuno)chemistry testing. In this study we describe the topper technology together with pediatric tubes to enable self-collection of blood and investigated its feasibility for PSA testing by prostate cancer patients.

Methods: A total of 120 prostate cancer patients for which a routine follow-up PSA test was requested, were included in this study. Patients received instruction materials and the blood-collection device consisting of a topper, pediatric tube and base-part, and performed the blood collection procedure themselves. Afterwards a questionnaire was filled-in. Finally, PSA was measured on a Roche Cobas Pro.

Results: The overall self-sampling success rate was 86.7 %. Furthermore, when specified per age category, a 94.7 % success rate for patients under 70 years and a 25 % success rate for patients of 80 years and older was observed. Venous and self-collected PSA were highly comparable when analyzed by Passing-Bablok regression with a slope of 0.99 and intercept of 0.00011, Spearmans correlation coefficient (0.998) and average self-collected PSA recovery of 99.8 %.

Conclusions: Evidence is presented that self-collected capillary blood by topper and pediatric tube from the finger is feasible, particularly for patients under 70 years. Furthermore, capillary blood self-sampling did not compromise any of the PSA test results. Future validation in a real-world setting, without supervision and including sample stability and logistics, is required.

Keywords: PSA; capillary blood collection; direct to consumer testing; self-collection.

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