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IdentiClone™ IGH Gene Rearrangement and Clonality Assays
IdentiClone™ assay kits are in vitro diagnostic products. These standardized PCR-based tests come with a Standard Operating Procedure (SOP), an interpretative guide, master mixes, and controls. Master mixes are composed of a buffered magnesium solution, deoxynucleotides, and multiple primers that target the gene segments of interest. Multiple primers are used to ensure a more comprehensive testing approach necessary to reliably identify clonal rearrangements. These assay kits are complete with the exception of Taq DNA polymerase, which is not provided. A single thermocycler program and similar detection methods are used within each series of kits to improve consistency, reduce human error, and facilitate cross training. Click to read more
Specimen Requirements
This assay tests genomic DNA from the following sources:
  1. 5cc of peripheral blood, bone marrow biopsy, or bone marrow aspirate anti-coagulated with heparin or EDTA (stored at 2C to 8C and shipped at ambient temperature)
  2. Minimum 5mm cube of tissue (stored and shipped frozen; or stored and shipped in RPMI 1640 at ambient temperature or on ice)
  3. 2ug of genomic DNA (stored at 2C to 8C and shipped at ambient temperature)
  4. Formalin-fixed paraffin embedded tissue or slides (stored and shipped at ambient temperature)