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CAT #: 12070051
T-Cell Receptor Gamma Gene Rearrangement Assay for ABI Fluorescence Detection
Assay Use
This Research Use Only assay identifies T-Cell Receptor Gamma gene rearrangements and is useful for the study of clonal T-cell populations and evaluation of new research and methods in malignancy studies.
Product Details
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Summary and Explanation of the Test
BACKGROUND
Rearrangement of the variable (Vγ) and joining (Jγ) gene segments of the TRG locus results in Vγ-Jγ products of unique length and sequence. Clonal TRG rearrangements can be most rapidly identified by analyzing the size distribution of DNA products amplified from conserved sequences that flank this Vγ-Jγ region.1 DNA isolated from a normal heterogeneous population of polyclonal T-cells produces a Gaussian distribution (bell-shaped size curve) of amplified products. DNA amplified from a clonal T-cell population generates one or two product(s) of unique size that reflects proliferation of a single rearranged clone.1,2The T-cell receptor gamma (TRG, formerly known as TCRG) chain locus spans 160 kilobases on chromosome 7 (7p14). The locus consists of 14 Vγ gene segments in six (6) subgroups, and five (5) Jγ gene segments interspersed between two (2) constant (Cγ) gene segments. However, the repertoire of functional TRG molecules is limited to 4-6 functional Vγ gene segments that belong to two (2) subgroups.2
SUMMARY
Invivoscribe’s gene rearrangement and translocation assays represent a simple approach to PCR-based testing and utilize a series of standardized master mixes that have been carefully optimized. Several master mixes are used to test for rearrangements at each receptor locus and each master mix targets a different conserved region within the receptor gene. This comprehensive testing approach maximizes identification of clonal rearrangements. A single universal thermal cycler program and similar detection methodologies are used with all of our tests; this improves consistency and facilitates cross-training.This test kit includes three (3) master mixes. TCRG Mix 1 and TCRG Mix 2 target framework regions within the variable (V) region and the joining (J) region of the TCR gamma chain locus. The Amplification Control master mix targets the HLA-DQα locus and generates an amplicon of 235 base pairs (bp) to ensure the quality and quantity of input DNA is adequate to yield a valid result.
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Specimen Requirements
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.
References
1. Miller, JE et al. (1999) Molecular Diagnostics. 4(2):101-117.
2. van Dongen, JJM et al. (2003) Leukemia. 17(12):2257-2317.
Legal Notice
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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