Seraseq® Sarcoma Plus RNA Fusion Mix
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Table 1. Seraseq Sarcoma Plus RNA Fusion Mix PLEASE NOTE: THESE REAGENTS MUST NOT BE SUBSTITUTED FOR THE MANDATORY POSITIVE AND NEGATIVE CONTROL REAGENTS PROVIDED WITH MANUFACTURED TEST KITS. The Seraseq® Sarcoma Plus Fusion RNA Mix is formulated for use with targeted Next Generation Sequencing (NGS) assays that detect RNA expressed from gene fusions common in cancer. This product is intended as a quality reference material for translational and disease research testing to monitor library preparation, sequencing, and fusion RNA detection under a given set of bioinformatics pipeline parameters. For Research Use Only. Not for use in diagnostic procedures. A well-designed quality control program can provide added confidence in the reliability of results obtained for unknown specimens. The use of independent reference products may provide valuable information concerning assay accuracy and bioinformatics pipeline analysis. Seraseq Sarcoma Plus RNA Fusion Mix is ready to use in NGS assays in steps that follow RNA isolation. No further purification or RNA isolation is needed. Item No. 0710-3809. 1 vial, 20 |jL per vial, 25 ng/|jL. See Technical Product Report for lot specific information. For Research Use Only. Not for use in diagnostic procedures. CAUTION: Handle Seraseq Sarcoma Plus RNA Fusion Mix and all materials derived from human blood products as though it is capable of transmitting infectious agents. Seraseq Sarcoma Plus RNA Fusion Mix is manufactured using genomic RNA extracted from the human cell line GM24385, which is a B-lymphocytic, male cell line from the Personal Genome Project offered by the NIGMS Human Genetic Cell Repository (https://catalog.coriell.org/1/NIGMS). Purified RNA is formulated in a 1 mM Tris / 0.1 mM EDTA pH 8.0 aqueous buffer. Use Centers for Disease Control and Prevention (CDC) recommended universal precautions for handling reference materials and human specimens1. Do not pipette by mouth; do not smoke, eat, or drink in areas where specimens are being handled. Clean any spillage by immediately wiping up with 0.5% sodium hypochlorite solution. Dispose of all specimens and materials used in testing as though they contain infectious agents. Avoid contamination of the product when opening and closing the vials. Store Seraseq Sarcoma Plus RNA Fusion Mix frozen at -70 °C or colder. Once opened, a vial can be thawed and re-frozen up to five (5) times. Sub-aliquoting of the product into low binding tubes may be advisable to limit the number of freeze/thaw cycles to five (5) or less. Seraseq Sarcoma Plus RNA Fusion Mix is a mixture of human total RNA and synthetic RNA transcripts. It should appear as a clear liquid. Alterations in this appearance may indicate instability or deterioration of the product and vials should be discarded. Seraseq Sarcoma Plus RNA Fusion Mix consists of total cellular RNA purified from GM24385 cell line and biosynthetic RNA. The RNA is in 1 mM Tris, pH 8.0, aqueous buffer. 20 jL is provided per vial and the concentration is 25 ng/jL. See Technical Product Report for lot specific information. Refer to instructions supplied by manufacturers of the test kits to be used. Thaw the product vial on ice. Mix by vortexing to ensure a homogenous solution and spin briefly. Seraseq Sarcoma Plus RNA Fusion Mix may be input directly into a reverse transcription assay step in parallel with the test specimens prior to target selection and library preparation. Refer to your usual assay procedures in order to determine the amount of material to use. Seraseq Sarcoma Plus RNA Fusion Mix does not have assigned values for the proportion of fusion transcripts relative to wild-type transcripts for the same genes, or the overall quantity of fusion transcripts. However, the product is tested using fusion-specific digital PCR quantitation to determine approximate transcript level for each fusion RNA listed in Table 2. There are many reasons why fusions contained in the product may not be positively detected, which may or may not be of significance. It is therefore recommended that each laboratory qualify the use of each lot of Seraseq Sarcoma Plus RNA Fusion Mix with each assay system prior to its routine use. Detection of fusion RNA and exon skipping events may differ across different NGS fusion RNA panels and different test reagent lots. While each fusion RNA is present at a similar level as determined by fusion specific digital PCR-based assays, and functional NGS-based assays confirm the presence of all 30 fusion RNA variants, there may be apparent differences in observed fusion levels due to assay characteristics. The fusion RNA species in this product are NOT present at the DNA level. Each laboratory must establish an assay-specific expected value for each fusion and each lot of Seraseq Sarcoma Plus RNA Fusion Mix. When results for the product are outside of the established acceptance range, it may indicate unsatisfactory test performance. Possible sources of error include: deterioration of test kit reagents, operator error, faulty performance of equipment, contamination of reagents, or change in bioinformatics pipeline parameters. Additional support documents are available online at www.seracare.com/oncology. LGC Clinical Diagnostics, Inc. | 37 Birch Street, Milford, MA 01757 USA Phone: +1 508.244.6400 | Toll Free (US Only) 800.676.1818 CDx-info@LGCGroup.com | www.seracare.com

Seraseq® Sarcoma Plus RNA Fusion Mix Table 2 Indicates each of the fusion RNA variants and exon skipping events Adverse shipping and storage conditions or use of outdated product may produce erroneous results. SPECIFIC PERFORMANCE CHARACTERISTICS Seraseq Sarcoma Plus RNA Fusion Mix MUST NOT BE SUBSTITUTED FOR THE CONTROL REAGENTS PROVIDED WITH MANUFACTURED TEST KITS. TEST PROCEDURES and INTERPRETATION OF RESULTS provided by manufacturers must be followed closely. Deviations from procedures recommended by test kit manufacturers may produce unreliable results. This product is offered for...