A-319 Capillary Blood Collection for Egg-cellent Reproductive Insights

Abstract

Abstract Background In the United States, an estimated 13% of women between the ages of 15 and 49 years, experience impaired reproductive potential (fecundity). Assessment of fecundity typically requires an in-person physician visit and venous blood collection to evaluate hormone levels and identify potential reproductive health conditions. Exploring less invasive, at-home sampling options could offer couples insights into their personal reproductive abilities, providing peace of mind and aiding in family planning. Methods Capillary blood, obtained using the Tasso®+ capillary blood collection device coupled with a BD Microtainer® serum tube, was utilized for measurements of analytes associated with female fecundity (follicle stimulating hormone, luteinizing hormone, estradiol, progesterone, anti-Müllerian hormone, and prolactin). These are all FDA-approved assays measured on Roche cobas® e801, assay parameters remained unchanged. Professional and self-collected capillary serum samples were acquired in parallel with the standard venous serum samples, to compare clinical equivalency of the capillary sampling option. In addition to isothermal stability studies at room temperature (20-25°C) and refrigerated (2-8°C) conditions, shipping excursion studies based on ISTA 7D recommendations were performed using a novel packaging solution to control sample temperature and thus, specimen integrity. Studies to assess matrix equivalency, linearity, and imprecision of this alternate sample type were also performed to demonstrate analytical performance. Results Method comparison of venous and professional collection of capillary samples demonstrated correlations (R) ≥ 0.9720 with slopes ranging from 0.919 to 0.971 and mean biases within ±8.2% for all analytes (n = 19-79). Self-collected capillary serum samples demonstrated correlations (R) ≥ 0.9827 with slopes that ranged from 0.841 to 0.985 and mean biases within ±10.7% (n = 16-26). Isothermal stability was demonstrated for each analyte up to 7 days at room temperature and refrigerated conditions. Simulated shipping excursion results were found to be acceptable for both winter and summer conditions with mean biases for each analyte within ±10.2% and ±19.2%, respectively. Matrix equivalency, linearity, and imprecision results adhered to current CLIA acceptance limits for each respective measurement. Conclusions The analytical and stability results affirm the feasibility of collecting capillary serum in a patient-centric manner, providing women with relevant information about their reproductive health.