b'ReferenceThe 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.Clonality Testing WorkflowPERIPHERAL BLOOD, TISSUE, OR FFPE SAMPLEDNA EXTRACTIONPCR REACTION SETUP (Master Mix + Taq* + DNA sample or control)PCR AMPLIFICATIONCapillary Electrophoresis Next-Generation SequencingGel Electrophoresis with Heteroduplex AnalysisSTEP 1 STEP 1 STEP 1Heat denature Mix with Hi-DiPurify PCRFormamide and amplicons94 C / 5 minutessize standards(see pg. 123)STEP 2STEP 2STEP 2 Snap chill on ice Heat denature Quantify and normalize library1 hour 95 C / 3 minSTEP 3 STEP 3 STEP 3Load and run Snap chill on ice Enrich** and non-denaturingprepare librarypolyacrylamide gel 5 minSTEP 4STEP 4STEP 4 Staining Load and run Load and run capillary instrumentelectrophoresisSTEP 5 STEP 5 STEP 5WARRANTY AND LIABILITY UV illumination Analyze with fragmentProcess with includedanalysis software bioinformaticsInvivoscribe, Inc. (Invivoscribe) is committed to providing the highest quality products. Invivoscribewarrants that the products meet or exceed the performance standards described in thesoftwareInstructions 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 *Or equivalent DNA Polymerase. 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** F or LymphoTrack and LymphoTrack Dx conditions in purchasers laboratory must be established and continually monitored through purchaser defined and controlled processes including but not limited to testing of positive, negative,Assays run on the Ion S5 and PGM only.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 purchaserData Interpretationagreement 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. Invivoscribe 2021|149'