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.

Standard Protocol:

1. Using gloved hands, remove the master mixes from the freezer. Allow the tubes to thaw; then gently vortex to mix.
2. In a containment hood or dead air box remove an appropriate aliquot to clean, sterile microfuge tube (one tube for each of the master mixes). Aliquot volumes should be 45ul for each sample + 135ul for the positive, negative and no template controls. We recommend adding an additional 20ul to correct for pipetting errors.
3. Add the appropriate amount of either AmpliTaq Gold or AmpliTaq DNA polymerase (0.25ul of either AmpliTaq Gold or AmpliTaq @ 5U/ul per 50ul total PCR reaction volume) to each of the master mixes and gently mix by inverting several times or gently vortexing.
4. Aliquot 45ul of master mix to individual wells of a PCR plate.
5. Add 5ul of DNA from the unknown and control samples to individual tubes or wells containing the respective master mix reactions, and pipette up and down several times to mix. Amplify target DNA using the universal thermocycler program.

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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)

This product is covered by European Patent EP 1549764B1, European patent application 03756746.8 and divisional applications thereof, Japanese Patent Number P04708029B2, and United States Patent Application Number 10/531,106. All of these patents and patent applications are licensed exclusively to Invivoscribe Technologies, Inc.

This product requires nucleic acid amplification methods such as Polymerase Chain Reaction (PCR). No license under these patents to use amplification processes or enzymes.