CAT #: 11010061
IGH Gene Clonality Assay for ABI Fluorescence Detection
This Research Use Only assay identifies immunoglobulin heavy chain clonality and is useful for the study of identifying clonal B-cell populations and evaluation of new research and methods in malignancy studies.
Summary and Explanation of the Test
Rearrangements of the antigen receptor genes occur during ontogeny in B and T lymphocytes. These gene rearrangements generate products that are unique in length and sequence for each cell. Therefore, polymerase chain reaction (PCR) assays can be used to identify lymphocyte populations derived from a single cell by detecting the unique V-J gene rearrangements present within these antigen receptor loci.1 This PCR assay employs multiple consensus DNA primers that target conserved genetic regions within the immunoglobulin heavy chain gene. This test is used to detect the vast majority of clonal B-cell malignancies from DNA. Test products can be analyzed using a variety of detection formats, including gel and capillary electrophoresis.
Invivoscribe’s Gene Rearrangement and Translocation Assays represent a simple approach to PCR-based clonality testing. These standardized assays were carefully optimized testing positive and negative control samples using multiplex master mixes.
This test kit includes six (6) master mixes. Tubes A, B, and C target the framework 1, 2, and 3 regions (respectively) within the variable (VH) region and the joining region of the Ig heavy chain locus. Tubes D and E target the diversity (DH) and joining (JH) regions. The last master mix, the Specimen Control Size Ladder, targets multiple genes and generates a series of amplicons of 100, 200, 300, 400, and 600 base pairs (bp) to ensure that the quality and quantity of input DNA is adequate to yield a valid result.
This assay tests extracted and purified genomic DNA (gDNA). Common sources of gDNA include:
- 5 cc of peripheral blood, bone marrow biopsy or bone marrow aspirate anti-coagulated with heparin or EDTA. Ship at ambient temperature; OR
- Formalin-fixed paraffin embedded tissue or slides.
1. Miller, JE et al. (1999). Molecular Diagnostics. 4:101-117.
2. Van Dongen, JJM et al. (2003). Leukemia. 17:2257-2317.
This assay is based on the EuroClonality/BIOMED-2 Concerted Action BMH4-CT98-3936.
Warranty and Liability
Invivoscribe, Inc. (Invivoscribe®) is committed to providing the highest quality products. Invivoscribe® warrants that the products meet or exceed the performance standards described in the Instructions For Use, as to products with such an insert. If a product is covered by product specifications and does not perform as specified, our policy is to replace the product or credit the full purchase price. No other warranties of any kind, expressed or implied, are provided by Invivoscribe®. Invivoscribe® liability shall not exceed the purchase price of the product. Invivoscribe® shall have no liability for direct, indirect, consequential or incidental damages arising from the use, results of use, or inability to use its products; product efficacy under purchaser controlled conditions in purchaser’s laboratory must be established and continually monitored through purchaser defined and controlled processes including but not limited to testing of positive, negative, and blank controls every time a sample is tested. Ordering, acceptance, and use of product constitutes purchaser acceptance of sole responsibility for assuring product efficacy and purchaser agreement to the limitation of liability set forth in this paragraph.
This product is for Research Use Only; not for use in diagnostic procedures.
This product is covered by one or more of the following: European Patent Number 1549764, European Patent Number 2418287, European Patent Number 2460889, Japanese Patent Number 4708029, United States Patent 8859748, United States Patent 10280462, and related pending and future applications. All of these patents and applications are licensed exclusively to Invivoscribe®. Additional patents licensed to Invivoscribe® covering some of these products apply elsewhere. Many of these products require nucleic acid amplification methods such as Polymerase Chain Reaction (PCR). No license under these patents to use amplification processes or enzymes is conveyed expressly or by implication to the purchaser by the purchase of this product.
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