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

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.