For in vitro diagnostic use. Others LightMix in-vitro diagnostics kit Multi-SNiP DPYD CE-IVC IVD LightMix® in-vitro diagnostics kit Multi-SNiP DPYD CE-IVC 100 1377683945183 This product is not a Roche product, Roche Global Customer Support is not offering any Support. For any additional information and support please ONLY contact TIB MolBiol directly. Furthermore we can not guarantee that all available information for this product is up to date. PID00000678 Detection of DNA variations in DPYD genefor use with the Roche Diagnostics LightCycler® 480 Instrument family 09 041 915 001 9 041 915 001 09041915001 9041915001 09041915001 LightMix Multi-SNiP DPYD LightMix Multi-SNiP DPYD 04260159332704 Reagents, kits 40-2002-64 64 reactions Not Available false Utilizing genomic human DNA extracted from peripheral blood, this kit enables the simultaneous detection of four single nucleotide polymorphisms (SNP) in the Dihydropyrimidine Dehydrogenase gene (DPYD) encoding the Dihydropyrimidine Dehydrogenase Protein (DPD). The CPIC guidelines recommend testing for four gene variants: SNP Allele HGVS Effect/ protein change rs3918290 rs55886062 rs67376798 rs75017182 or rs56038477 DPYD*2A DPYD*13 Haplotype B3 c.1905+1G>A c.1679T>G c.2846A>T c.1129-5923C>G IVS14 + 1G>A(exon skipping) p.I560S p.D949V IVS10 C>G Lack or a reduced activity of the DPD protein can cause profound toxicity in patients treated with 5-fluorouracil. The patient 's mutation status should be considered in the modulation of 5-fluorouracil dosing; in some cases, a different drug must be selected. Follow the published treatment guidelines. 5-fluorouracil treatment of patients where no mutations were detected with this kit must be closely monitored because other mutations, can also affect DPD activity. en Using PCR methodology, a fragment of the genes of interest is amplified with specific primers. The fragment is detected with a mutation-specific detection probe internally labeled with SimpleProbe® 519 reagent. SimpleProbe® probes are only fluorescent when bound to complementary DNA. The probe binds to a part of the amplified fragment spanning the mutation site. During the melting curve analysis, the temperature is slowly increased. The probe melts off at a specific melting temperature causing the fluorescence to decrease. Any mismatch under the probe binding region, destabilizes the hybrid, producing a left-shift of the melting temperature. In this product the probes that elicit the best possible discrimination have been selected. Whether the selected probes match the wild type or the mutant sequence is described elsewhere in the manual. Interpretation of the genotype results are based on the melting temperatures as compared to the supplied standards. Tm calling results must be reviewed by eye for deviating curves and intermediate melting point temperatures. The genotype must be deduced from the melting tem- peratures following the criteria described in chapter 7. The supplied control DNA standards provide a comparison with clinical samples. en Diagnostic Specificity and Sensitivity More than 20 different genomic DNA samples from individuals of Caucasian origin were analyzed in parallel by sequencing and the present kit. The study compared results obtained utilizing the kit with ABI 3730xl DNA sequencing data obtained by LGC Genomics GmbH, Berlin. en

LightMix^® in-vitro diagnostics kit Multi-SNiP DPYD CE-IVC

Detection of DNA variations in DPYD gene
for use with the Roche Diagnostics LightCycler^® 480 Instrument family

IVD

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LightMix^® in-vitro diagnostics kit Multi-SNiP DPYD CE-IVC

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