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

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: 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 70years and a 25% success rate for patients of 80years 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 70years. 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.