Potential of the Sebia Capillarys neonat fast automated system for neonatal screening of sickle cell disease.

BACKGROUND Most screening programs for sickle cell disease (SCD) utilize isoelectric focusing (IEF) or high performance liquid chromatography (HPLC) to detect haemoglobin (Hb) variants. The first method is not automated and becomes too tedious when many samples have to be investigated. The aim of this work is to explore the capacity of an automated capillary electrophoresis (CE) system, with full traceability, as a tool for newborn screening of SCD. METHODS The Capillarys neonat fast automated system has been developed by Sebia for newborn screening. We performed separate studies using different types of samples to evaluate the utility of the Capillarys for (i) separating Hb S and other variants, and (ii) for performing the routine activity of our laboratory for 20 working days. RESULTS A throughput of 48 samples per hour with a loading capacity of 192 samples was achieved. Migration times of the major Hb variants were distinct. There were few variants showing similar migration times to Hb S and Hb C and thalassaemia could be detected. In addition, late screening, screening of premature or transfused babies and screening performed using poor quality Guthrie's cards did not interfere with reporting of accurate phenotypes. CONCLUSIONS Sebia Capillarys neonat fast automated system is a reliable tool for haemoglobinopathy neonatal screening.