Abstract: The invention relates to means and methods for assessing clonal immunoglobulin (IG)/T cell receptor (TR) gene rearrangements in a clinical, diagnostic and/or research setting. Provided is a quality control composition comprising a mixture of genomic DNA isolated from a set of nine cultured cell lines, said set comprising the B cell lines ALL/MIK (ALL), Raji (Burkitt lymphoma), REH (B cell precursor ALL), TMM (CML-BC/EBV+B-LCL), TOM-1 (B cell precursor ALL), WSU-NHL (B cell lymphoma) and the T cell lines JB6 (ALCL), Karpas299 (ALCL) and MOLT-13 (ALL), or wherein one or more cell lines of said set is replaced with one or more other cell line(s) comprising the same IG/TR gene rearrangements. Also provided is a quality control composition consisting of essentially equimolar amounts of genomic DNA isolated from healthy human thymus, healthy human tonsil and healthy human peripheral blood mononuclear cells.

Abstract: The invention relates to PCR-based clonality studies for among others early diagnosis of lymphoproliferative disorders. Provided is a set of nucleic acid amplification primers comprising a forward primer, or a variant thereof, and a reverse primer, or a variant thereof, capable of amplifying a rearrangement selected from the group consisting of a VH-JH IGH rearrangement, a DH-JH IGH rearrangement, a VK-JK IGK rearrangement, a VK/intron-Kde IGK rearrangement, a V?-J? IGL rearrangement, a V?-J? TCRB rearrangement, a D?-J? TCRB rearrangement, a V?-J? TCRG rearrangement, a V?-J? TCRD rearrangement, a D?-D? TCRD rearrangement, a D?-J? TCRD rearrangement, a V?-D? TCRD rearrangement, or a translocation selected from t(11;14)(BCL1-IGH) and t(14;18)(BCL2-IGH). The primers can be used in PCR-based clonality studies for early diagnosis of lymphoproliferative disorders and detection of minimal residual disease (MRD). Also provided is a kit comprising at least one set of primers of the invention.

Abstract: The invention relates to PCR-based clonality studies for among others early diagnosis of lymphoproliferative disorders. Provided is a set of nucleic acid amplification primers comprising a forward primer, or a variant thereof, and a reverse primer, or a variant thereof, capable of amplifying a rearrangement selected from the group consisting of a VH-JH IGH rearrangement, a DH-JH IGH rearrangement, a VK-J? IGK rearrangement, a VK/intron-Kde IGK rearrangement, a V?-J? IGL rearrangement, a V?-J? TCRB rearrangement, a D?-J? TCRB rearrangement, a V?-J? TCRG rearrangement, a V?-J? TCRD rearrangement, a D?-D? TCRD rearrangement, a D?-J? TCRD rearrangement, a V?-D? TCRD rearrangement, or a translocation selected from t(11;14)(BCL1-IGH) and t(14;18)(BCL2-IGH). The primers can be used in PCR-based clonality studies for early diagnosis of lymphoproliferative disorders and detection of minimal residual disease (MRD). Also provided is a kit comprising at least one set of primers of the invention.