<b>Peripheral Blood:</b> 5 mL in EDTA tube.<br>
<b>H&E slide (required) plus paraffin block.</b><br>
<b>Cut Slides:</b> H&E slide (required) plus 5-10 unstained slides cut at 5+ microns.<br>
<b>Note on FFPE:</b> Paraffin block is preferred. Do not use zinc fixatives. If submitting slides, please use positively-charged slides and 10% NBF fixative. Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.<br>
<b>Note:</b> Test is DNA-based. Please select Extract & Hold - DNA if specimen hold service is desired.</p>
The IgH Clonality by NGS test is designed to detect clonal populations of B-lymphocytes in a given patient sample through the analysis of the VDJ segment of the immunoglobulin heavy chain (IgH) gene. Detecting the presence of clonal B-lymphocyte populations is important for the diagnosis of B-cell lymphoma or leukemia. Additionally, this test provides important information on somatic hypermutations in the neoplastic clone as well as tumor heterogeneity.
The presence of more than one clone or subclones within the B-cell lymphoma/leukemia cells can also be determined by this assay. The IgH Clonality by NGS test is also useful for monitoring patients with B-cell lymphoma/leukemia due to its high sensitivity and its quantitative nature. Using this technology has been reported to be reliable in monitoring patients with diffuse large B-cell lymphoma (DLBCL) and acute lymphoblastic lymphoma (ALL).