For in vitro diagnostic use. Others LightMix in-vitro diagnostics kit FGB -455G-A IVD LightMix® in-vitro diagnostics kit FGB -455G/A 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. TIBMOLBIOL-0215 Detection of the G-455A DNA variation in the FGB gene for use with the Roche Diagnostics LightCycler® Instruments. 07 163 142 001 7 163 142 001 07163142001 7163142001 07163142001 LightMix FGB [G-455A] LightMix FGB [G-455A] 04260159332629 Reagents, kits 40-0645-64 64 reactions Not Available false This kit allows to determine the Fibrinogen beta (FGB) promoter polymorphism G/A in position -455 (FGB:c.4577G>A; rs1800790). The FGB -455 genotype alone does not allow predictions on a disease risk. The kit is not intended to be the only basis for therapy decision. The patient´s mutation status should be considered alongside other disease factors. Note: The performance of the assay can be guaranteed only when used with LightCycler® Instruments. en Using PCR methodology, a 198 bp fragment of the FGB promoter is amplified with specific primers. The PCR fragment is analyzed using an internally labeled SimpleProbe® oligomer binding to the region spanning the mutation site. During the melting curve analysis, the temperature is slowly increased. The probe leaves at a specific temperature (Tm) causing a fluorescence decrease. Any mismatch covered by the probe destabilizes the hybrid and lowers the Tm. In this product, the probe matches the sequence of the mutant genotype and the presence of the wild type genotype will yield a reduced Tm. Reading of the genotype results is based on the melting temperatures compared to the supplied standards. If permitted by the instrument software reading of the genotype results can be achieved by the automated genotyping module (instrument-dependent: software module 'Melt Curve Genotyping'). Automated genotyping results must be reviewed by eye for deviating curves and intermediate melting point temperatures. In case that automated typing fails to report consistent genotype results, the genotype must be deduced from the melting temperatures following the criteria described in the method sheet, chapter 7. en Analytical SpecificityThe specificity to the target gene and the suitability of the PCR amplification employed in the present test was demonstrated by sequencing of the amplicon.Analytical SensitivityDetection of serial dilutions of several heterozygous human genomic DNAs has revealed that the limit of detection of the present kit is 250 copies (1.5 ng).Diagnostic Specificity and SensitivityA total number of 94 different genomic DNA samples from Caucasian origin individuals were analyzed in parallel with a previously established kit. Study results: results for both analytical methods were in 100% concordance. In particular, 58 samples were homozygous wild type (62%), 32 samples were heterozygous (34%), and 3 samples were homozygous mutant (3%). Reported allele frequencies in the Caucasian population are 73%, 22% and 5%, respectively.In one sample, identified as homozygous wild type, an additional melting peak at a Tm of approximately 47°C was visible. Sanger sequencing confirmed the presence of the SNP -450 C/T which is registered as rs2227392; the published frequency is 2-4% in African-origin Americans and less than 1% in Causasians.For SNP rs2227392 there is no association with a known disease risk (see 7.8.2 Rare Variants). en

LightMix^® in-vitro diagnostics kit FGB -455G/A

Detection of the G-455A DNA variation in the FGB gene for use with the Roche Diagnostics LightCycler^® Instruments.

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LightMix^® in-vitro diagnostics kit FGB -455G/A

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