Patent ID: 7759076

Claim:
A quantitative ZAP-70 assay for predicting the prognosis of chronic lymphocytic leukemia (CLL), comprising the steps of: a. staining a first control cell population with an anti-ZAP-70 antibody, an anti-T-cell antibody and an anti-B-cell antibody, wherein said first control cell population comprises equal mixture of ZAP-70 + T-cells and ZAP-70 − B-cells; b. separating the B-cells and the T-cells and measuring anti-ZAP-70 antibody staining in the B-cells and T-cells to obtain a mean fluorescent intensity (MFI) in each; c. converting the median of the MFI to molecules of equivalent fluorochrome (MEFL), wherein MEFL indicates an amount of ZAP-70; d. repeating steps a)-c) on a patient blood sample if the amount of ZAP-70 in the first control cell population is within a pre-established range of ZAP-70 for normal and indolent CLL B-cells and T-cells; e. wherein an amount of ZAP-70 in B-cells of the patient blood sample in the top 30% of said pre-established range for B-cells indicates that the patient has progressive CLL, and an amount of ZAP-70 in B-cells of the patient blood sample in the lower 55% of said pre-established range for B-cells indicates that the patient has indolent CLL.