Proof-of-concept study: Remote capillary blood collection for hCG analysis in early pregnancy

Capillary blood collection, a technique traditionally used in diabetes care, shows promise for many applications including pregnancy monitoring. Serial measurement of serum human Chorionic Gonadotrophin (hCG) is frequently necessary for managing early pregnancy, including molar pregnancy, requiring multiple visits to a maternity hospital for blood collection by venepuncture. This proof-of-concept study aimed to assess the clinical performance and user acceptability of capillary blood samples collected remotely, as an alternative to venous blood for hCG measurement.

Women attending the early pregnancy unit who required serum hCG measurement, were invited to participate. Following informed written consent, participants were shown how to collect capillary blood samples using the Mini-Collect® collection device. Matched venous and capillary blood samples were collected in clinic for hCG comparison purposes. Participants were also supplied with a home collection kit in a prepaid return envelope. They were asked to perform a finger-prick blood collection at home using the instructions provided and to return the capillary blood sample by post within 24 h of collection, along with a completed user-satisfaction questionnaire. Statistical analysis was performed using Analyse-it® software.

The study enrolled 71 participants and over a third of these women collected a capillary blood sample at home. The median age of participants was 33 years (range 29-36). Passing-Bablok linear regression (y = -0.037 + 1.04x) and Spearman correlation (r = 0.999, p < 0.0001), demonstrated good agreement and strong correlation between venous and capillary samples, over a broad range of hCG values (1.2 to 224,0000 IU/L). The majority of capillary samples collected remotely (39%, 27/69) had sufficient blood volume for analysis (74%, 20/27). Respondents (77%, 18/25) found the collection device easy to use and expressed willingness to use a future service if available (80%, 20/25) CONCLUSION: The study demonstrated excellent agreement between the hCG results obtained from both collection methods, suggesting that capillary blood can serve as a reliable alternative for venous hCG measurement, particularly in clinical settings requiring frequent hCG monitoring. Feedback from the study questionnaire indicates a preference for this type of follow-up among women, indicating potential improvements in compliance for blood based diagnostic tests.