METHOD, REAGENTS, AND KITS FOR DETECTING MINIMAL RESIDUAL DISEASE

摘要

The invention relates to the field of minimal residual disease (MRD) diagnostics, which is progressively more applied for the evaluation of treatment effectiveness in patients with a hematological malignancy, such as B-cell precursor acute lymphoblastic leukemia (BCP-ALL), B-cell chronic lymphocytic leukemia (B-CLL), and multiple myeloma (MM). Provided are unique reagent compositions with carefully selected and thoroughly tested combinations of antibodies, for ≧8-color flow cytometric stainings as well as for 10-color and 12-color flow cytometric stainings, which can reach sensitivities of at least 10−4, even down to 10−5. Also provided are diagnostic kits and methods for detecting MRD.

主权项

1. A reagent composition for flow cytometric detection of B-cell precursor ALL (BCP-ALL) in a human subject, comprising a panel of at least eight distinct fluorochrome-conjugated antibodies, the panel comprising at least antibodies against the core markers CD10, CD19, CD20, CD34 and CD45, and wherein the panel further comprises one or more antibodies selected from the group of antibodies against CD38 CD81, CyIgμ, and deoxynucleotidyl transferase (NuTdT).