Sickle SCAN™ (BioMedomics) fulfills analytical conditions for neonatal screening of sickle cell disease

Sickle SCAN (TM) is a rapid, qualitative, point-of-care lateral flow immunoassay for the identification of AS, AC, SS/S beta(0)thal, SC and CC/C beta(0) thal phenotype. We evaluated this test under the conditions encountered in the French newborn screening (NBS) program for sickle cell disease: a total of 104 dried blood spots (DBSs) were tested with an HPLC reference method and then with the Sickle SCAN (TM) device. Sickle SCAN (TM) identified the hemoglobin (Hb) phenotype correctly on 96% of cases. In the four non-concordant cases, the antibody anti-HbS cross-reacted with HbE (n=2), HbD (n=1) or HbX (n=1). There were no false negative. In order to test Sickle SCAN (TM)'s sensitivity to low levels of IlbA and IlbS in the presence of high HbF levels, we selected another 21 DBS cards with low percentages of HbA (0.6-4.2%) and HbS (2.0-6.9%). HbA and HbS were always detected when present at levels of more than 1% and 2%, respectively. Sickle SCAN (TM) appears to be an accurate point-of-care method for the identification of newborns with SCD trait. The device meets the criteria for sickle cell disease NBS programs in endemic countries with poor access to laboratory equipment.