b"11.What are the differences between the TCRG Gene 15.What are the recommended settings for my ABI instrument? Clonality Assay and the T-Cell Receptor Gamma GeneInstruments should be calibrated with the DS-30 matrix Rearrangement Assay 2.0? standards (Dye set D) for the ABI 310, 3100, or 3130 instrument The TCRG Gene Clonality Assay was designed by theseries. For the ABI 3500 sequencer series, we advise that you EuroClonality/ BIOMED-2 Group and consists of two mastercalibrate the instrument with DS-33 matrix standards. We also mixes. For polyclonal populations, four Gaussian distributions arerecommend using either POP-4 or POP-7 depending on which generated. The T-Cell Receptor Gamma Gene RearrangementABI instrument you are using. If your equipment supports POP-7, Assay 2.0 was designed by Invivoscribe and it's performancewe recommend using this polymer as it can be utilized for both was subsequently reviewed and validated by the EuroClonality/ fragment analysis and sequencing; whereas, POP-4 can only be BIOMED-2 Group. It targets all functional V H- J Hrearrangementsutilized for fragment analysis.in a single master mix and produces smaller amplicons grouped under a single Gaussian distribution. This allows for16.How should peaks outside the valid size range be interpretedeasier interpretation and makes the assay more suitable forwhen using assay kits?DNA extracted from FFPE tissue, which may consist of partiallyYou should not interpret peaks outside of the valid size range; degraded DNA that would not amplify well with the larger validalthough, in theory, it is possible to have a true rearrangement size range of the TCRG Gene Clonality Assay. fall outside this region. If you are concerned about a suspect 12.What are the differences between the IGH-BCL2 Translocationpeak, you may sequence your product for confirmation. Please note that samples should always be interpreted within the Assay and the IGH-BCL2 t(14;18) Translocation Assay? context of all available clinical information.The IGH-BCL2 Translocation Assay was designed by the EuroClonality/BIOMED-2 Group and is available as either a17.Is cell-free DNA (cfDNA) a suitable sample type for InvivoscribeCE-IVD or research use only assay whereas; the IGH-BCL2LymphoTrack or LymphoTrack Dx Assays? t(14;18) Translocation Assay was designed by InvivoscribeThe average size of cfDNA (~170 bps) makes it a suitable sample and is only available for research use only. Both of thesetype to run with IGH FR3 master mixes. The use of cfDNA with assays target MBR and Mcr translocations, but the IGH-BCL2TRG master mixes might be possible, but expected amplicon Translocation Assay also targets the translocations at the 3sizes generated with this assay are near the upper limits of the Mbr. The IGH-BCL2 t(14;18) Translocation Assay was fragment lengths typically found with this sample type.designed as a nested PCR allowing greater sensitivities(1 clonal cell per 10,000 normal cells) to be achieved. The limit18.Is DNA extracted from FFPE tissue suitable to use withof detection of the IGH-BCL2 Translocation Assay is 1 clonalInvivoscribe LymphoTrack or LymphoTrack Dx Assays? cell per 100 normal cells. Lastly, the IGH-BCL2 TranslocationTo ensure DNA from challenging specimens is of sufficient Assay includes 33 reactions, whereas the IGH-BCL2 t(14;18)quality and quantity to generate a valid result, samples may be Translocation Assay includes 30 reactions. tested with the Specimen Control Size Ladder master mix. 13. Do you offer quantitative chromosome translocation 19.and (e.g., BCR-ABL1) controls? On which instruments can I use the LymphoTrackLymphoTrack Dx Assays?Our controls are validated for qualitative use, although ourWe have different versions of our assays for the S5/PGM and customers do successfully use them with quantitative assays.MiSeq instruments (LymphoTrack TRB is currently available only Unfortunately, we cannot guarantee their performance with anyon MiSeq). No other DNA sequencers (e.g. 454) are currently assay that was not designed by Invivoscribe. supported. Assays for the Ion S5/PGM and MiSeq platforms 14.Which capillary electrophoresis instruments are currentlydiffer slightly in terms of the total number of indices, etc., butvalidated for use with our assay kits? both have similar benefits such as a one-step PCR reaction and Currently the capillary electrophoresis instruments Invivoscribeincluded bioinformatics software.has validated include: ABI 3100 and 3130 series for all capillary20.How much DNA is needed for the LymphoTrack andelectrophoresis detection assays. The ABI 310 and 3500LymphoTrack Dx Assays?instrument series have also been validated for the majority50 ng of high-quality genomic DNA is required for the Ion S5/of our capillary electrophoresis detection assays. We are notPGM and MiSeq LymphoTrack and LymphoTrack Dx Assays for able to support using instruments not listed as validated in theclonality and somatic hypermutation applications.instructions for use of our CE-IVD assays.Invivoscribe 2021|157"