Patent ID: 8426210

Claim:
A method of determining the risk of post-transfusion hemolysis in a blood transfusion recipient by determining a relative hemolytic index for said recipient, the method comprising the steps of: obtaining a sample of plasma or serum from a patient in need of a blood transfusion; optionally preparing an absorbed eluate of the sample; measuring the total immunoglobulin concentration in the sample or absorbed eluate of the sample, wherein the total immunoglobulin concentration is scored based on detection of a low immunoglobulin concentration, a medium immunoglobulin concentration, or a high immunoglobulin concentration, and the low immunoglobulin concentration is defined as a concentration less than 1:16 titer and is assigned zero points on the relative hemolytic index, the medium immunoglobulin concentration is defined as a concentration range greater than 1:16 titer and less than 1:64 titer and is assigned 2 points on the relative hemolytic index, and the high immunoglobulin concentration is defined as a concentration greater than 1:64 titer and is assigned 10 points on the relative hemolytic index; measuring the antibody isotype of the immunoglobulins in the sample or absorbed eluate of the sample, wherein the immunoglobulin isotype is scored based on a presence of IgM, IgG1, IgG2, IgG3, or IgG4, and the presence of IgM is assigned 10 points on the relative hemolytic index, the presence of IgG1 is assigned 10 points on the relative hemolytic index, the presence of IgG2 is assigned 5 points on the relative hemolytic index, the presence of IgG3 is assigned 10 points on the relative hemolytic index, and the presence of IgG4 is assigned zero points on the relative hemolytic index; measuring the Fc gamma receptor affinity of the immunoglobulins in the sample or absorbed eluate of the sample, wherein the Fc gamma receptor affinity is scored based on detection of a Fcy RI binding, a Fcy RII binding, and/or a Fcy RIII binding and detection of the Fcy RI binding is assigned 10 points on the relative hemolytic index, detection of the Fcv RII binding is assigned 2 points on the relative hemolytic index, and detection of the Fcv RIII binding is assigned 5 points on the relative hemolytic index; measuring the C1q binding capacity of the immunoglobulins in the sample or absorbed eluate of the sample, wherein C1q binding capacity is scored based on detection of a low C1q binding (less than 0.49) or a high C1q binding (0.5 or higher), and the low C1q binding is assigned 2 points on the relative hemolytic index and the high C1q binding is assigned 10 points on the relative hemolytic index; and calculating the relative hemolytic index based on said measurements of total immunoglobulin concentration, antibody isotype of the immunoglobulins, Fc gamma receptor affinity of the immunoglobulins, and C1q binding capacity of the immunoglobulins and thereby determining the risk of post-transfusion wherein the relative hemolytic index is the sum of total points accrued hemolysis for said patient.