Patent ID: 7544513
Filing Date: 2009-06-09
Classification: C07K,G01N,Y10S,Y10T

Abstract:
1. A method for neonatal screening of hemoglobinopathies, comprising the following steps: i) obtaining a blood sample taken from a newborn; ii) adding at least one pair of labelled hemoglobin specific reagents, wherein the first and second members of said pair are differently labelled and specifically recognize a different hemoglobin variant, and a third reagent, wherein the third reagent is a monoclonal antibody recognizing the hemoglobin α-chain; iii) allowing the reagents to bind to hemoglobin present in the sample, thereby forming differentially labeled hemoglobin/reagent complexes; iv) optionally, immobilizing the formed complexes; v) detecting the signals generated by the labels in the formed differentially labelled hemoglobin/reagent complexes; vi) calculating the ratio between the signals generated by the labels from each one of the differentially labelled hemoglobin/reagent complexes; and vii) determining whether the sample is derived from a non-afflicted subject or from an afflicted subject or carrier by correlating said ratio with at least one pre-selected cut-off value; wherein said first member of said reagent pair is hemoglobin A (HbA) specific; said second member of said reagent pair is selected from the group consisting of hemoglobin S (HbS), hemoglobin C (HbC), hemoglobin D (HbD), hemoglobin E (HbE) and hemoglobin F (HbF) specific reagents; and said third reagent is coupled to a solid support or comprises a binding moiety for attachment to a solid support.