Stability of maternal serum free β-hCG following whole blood sample transit: First trimester Down’s syndrome screening in Scotland

Abstract

Background Maternal serum free beta human chorionic gonadotrophin (free β-hCG) is used as a biomarker in first trimester screening for fetal Down’s syndrome. Production of free β-hCG can occur in vitro in a time- and temperature-dependent manner; thus, the current Scottish screening protocol states samples must be received by the laboratory within 72 h. To assess the validity of the protocol, an audit was conducted to determine the impact of transit time on maternal serum free β-hCG multiple of median (MoM) values in the Scottish screened population. Methods Corrected MoM values from antenatal screening carried out over one year (April 2017 to March 2018) were stratified according to sample transit time and compared. To investigate possible environmental temperature effects, the data were split according to season and maternal serum free β-hCG concentrations from summer and winter compared. Results Of the 28,368 samples included in the study, 24,368 were received on the day of phlebotomy or after one day in transit. Only 1.5% of samples were received after 3 days in transit. The difference in maternal serum free β-hCG MoM values due to transit time was not significant. No statistical difference was found between maternal serum free β-hCG concentrations from samples collected in summer and winter months. Conclusion The current sample receipt protocol in use by the Scottish Down’s syndrome screening programme is fit for purpose.