Patent ID: 8163510

Claim:
A quantitative ZAP-70 assay for predicting the prognosis of chronic lymphocytic leukemia (CLL), comprising the steps of: (a) staining a patient blood sample with an anti ZAP-70 antibody, an anti-T cell antibody and an anti-B-cell antibody; (b) measuring anti-ZAP-70 antibody staining in the B-cells and T-cells to obtain a mean fluorescent intensity (MFI) in each of the B-cells and the T-cells; (c) converting the median of the MFI to molecules of equivalent fluorochrome (MEFL), wherein an amount of ZAP-70 is reported as an MEFL value, and (d) determining (i) if the amount of ZAP-70 in the B-cells or the T-cells of the patient blood sample is in the top 30% of a preestablished range of patient MEFL values for at least one of the B-cells or T-cells so as to indicate that the patient has progressive CLL, or (ii) if the amount of ZAP-70 in the B-cells of the patient blood sample is in the lower 55% of a pre-established range for the at least one of the B-cells or T-cells so as to indicate that the patient has indolent CLL.