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 5UV illumination Analyze with fragmentProcess with includedanalysis software bioinformaticssoftware *Or equivalent DNA Polymerase. ** F or LymphoTrack and LymphoTrack Dx Assays run on the Ion S5 and PGM only. Data InterpretationCE-marked in vitro diagnostic products are not available for sale or use within North America. Invivoscribe 2020|153'