Invivoscribe 2019 | 145 Reference 144 Reference The Invivoscribe European Conformity marked in vitro diagnostics (CE-IVD) and Research Use Only (RUO) clonality assays detect clonal populations in just a few easy steps. These steps include PCR amplification of the immunoglobulin or T-cell receptor genes of interest, followed by detection with non-denaturing polyacrylamide gels, capillary electrophoresis, or next-generation sequencing using an Illumina® MiSeq® , Thermo Fisher Scientific® Ion S5™ or PGM™ instrument. A flowchart illustrating this workflow is shown below. PERIPHERAL BLOOD, TISSUE, OR FFPE SAMPLE Clonality Testing Workflow Data Interpretation Gel Electrophoresis with Heteroduplex Analysis Capillary Electrophoresis Next-Generation Sequencing STEP 1 Heat denature 94 °C / 5 minutes STEP 2 Snap chill on ice 1 hour STEP 4 Staining STEP 5 UV illumination STEP 3 Load and run non-denaturing polyacrylamide gel STEP 1 Mix with Hi-Di Formamide and size standards (see pg. 123) STEP 4 Load and run capillary electrophoresis STEP 5 Analyze with fragment analysis software STEP 3 Snap chill on ice 5 min STEP 2 Heat denature 95 °C / 3 min PCR REACTION SETUP (Master Mix + Taq* + DNA sample or control) PCR AMPLIFICATION DNA EXTRACTION STEP 3 Enrich** and prepare library STEP 2 Quantify and normalize library STEP 4 Load and run instrument STEP 5 Process with included bioinformatics software STEP 1 Purify PCR amplicons *Or equivalent DNA Polymerase. ** For LymphoTrack and LymphoTrack Dx Assays run on the Ion PGM only. 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. CE-marked in vitro diagnostic products are not available for sale or use within North America.