An evaluation of the Sebia capillarys Neonat Haemoglobin FAST™ system for routine newborn screening for sickle cell disease.

The West Midlands Newborn Screening Laboratory (NBSL) at Birmingham Children's Hospital (BCH), UK, screens approximately 71 000 babies per annum using the Bio-Rad automated VARIANT™ nbs (Vnbs) high-pressure liquid chromatograph (HPLC). Any abnormal haemoglobins detected, including S, C, D-Punjab, E and O-Arab as directed by the NHS Sickle Cell and Thalassaemia Screening Programme (NHS Sickle Cell and Thalassaemia Screening Programme Website, http://sct.screening.nhs.uk), are then confirmed using Resolve® isoelectric electric focusing (IEF) kits supplied by Perkin-Elmer. The Sebia capillarys Neonat Haemoglobin FAST™ system was evaluated as a possible replacement for the first- or second-line methods used. Both the Sebia and Bio-Rad methods were compared using anonymized blood spots with known haemoglobin patterns. These results were then confirmed when necessary by IEF. The Sebia-recommended sample preparation was also modified to enable testing to be more comparable with our current processes. Percentages of haemoglobins calculated from integration of areas under the peaks were compared between the Bio-Rad Vnbs HPLC and Sebia capillarys Neonat Haemoglobin FAST™ system. Of the 347 blood spots tested by both HPLC and capillary electrophoresis, there were no significant differences. The Sebia capillarys Neonat Haemoglobin FAST™ system can be used to successfully screen newborns for sickle cell disease in blood spots collected for newborn screening with full positive sample identification and traceability.