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.

Click to read more

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 is an in vitro diagnostic product. This product is covered by one or more of the following patents and patent applications owned by or exclusively licensed to Invivoscribe Technologies, Inc.: European Patent Number EP 1549764B1 and other pending patent applications originating from European Patent Application Numbers 03756746.8 and 047326551.9 (16 countries), United States Patent No. 7,785,783, Japanese Patent Number JP04708029B2, United States Patent Application Number 10/531,106, Brazil Patent Application Number PI0410283.5, Canadian Patent Application Number 2525122, Indian Patent Application Number 5792/DELNP/2005, Japanese Patent Application Number 2006-529437, Mexican Patent Application Number PA/a/2005/012102, Chinese Patent Application Number 200480016603.5, and Korean Patent Application Number 10-2005-7021561.

Use of these products may require nucleic acid amplification methods such as Polymerase Chain Reaction (PCR). Use of this product may require nucleic acid amplification methods such as Polymerase Chain Reaction (PCR). Any necessary license to practice amplification methods or to use amplification enzymes or equipment covered by third party patents is the responsibility of the user and no such license is granted by Invivoscribe Technologies, Inc., expressly or by implication.

IdentiClone™ is a trademark of Invivoscribe Technologies, Inc.