For in vitro diagnostic use. Others LightMix in-vitro diagnostics kit Factor V Leiden CE-IVD IVD LightMix® in-vitro diagnostics kit Factor V (Leiden) CE-IVD 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-0124 Detection of the G1691A DNA variation in the Factor V genefor use with the Roche Diagnostics LightCycler® Instruments 06 896 529 001 6 896 529 001 06896529001 6896529001 06896529001 LightMix Factor V Leiden LightMix Factor V Leiden 04260159332179 Reagents, kits 40-0594-64 Reagents for 64 reactions Not Available false This diagnostic PCR kit allows the detection of the 'Factor V Leiden' mutation, the 1691G-A transition (NCBI dbSNP: rs6025) in exon 10 of the Coagulation Factor V gene (OMIM: 612309), resulting in amino acid substitution Arginin position 506 to Glutamin (R506Q or HGVS: NP_000121.2:p.Arg534Gln), to be used with human genomic DNA from a nucleic acid extract obtained from peripheral blood. The coagulation Factor V encodes a 330-kD plasma glycoprotein with little or no activity. This precursor is activated by cleavage by thrombin (Factor II). The activated Factor Va is an essential protein in the coagulation pathway and acts as a cofactor for factor X in the conversion of prothrombin to thrombin. Activated Factor Va itself is inactivated by Activated Protein C. The Factor V G1691A gene mutation encodes a dysfunctional enzyme variant, that is resistant to the Activated Protein C; it is inactivated approximately ten times slower than normal Factor V and persists longer in the circulation. Homozygous carriers of the gene 1691 A/A variant, and to less extend also compound heterozygous individuals with the allele combination G1691A exhibit prolonged activity of activated Factor V, resulting in a higher risk to develop deep venous thrombosis (Bertina et al., 1994)1 . As the risks for thrombosis increases for those individuals bearing Factor V Leiden and Factor II mutations, patients with a propensity for thrombosis should be analyzed also for the Factor II G20210A mutation, for example using the LightMix® Kit 40-0593-64. 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 (see 1.3.2 for details). 1 Bertina, R. M., Koeleman, B. P. C., Koster, T., Rosendaal, F. R., Dirven, R. J., de Ronde, H., van der Velden, P. A., Reitsma, P. H. Mutation in blood coagulation factor V associated with resistance to activated protein C. Nature 369: 64-67, 1994. en Using PCR methodology, a 110 bp fragment of the Factor V gene 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 wild type genotype and the presence of a mutation 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 deducted from the melting temperatures following the criteria described in the method sheet, chapter 7.Change in effect from lot 2655xxxx (February 2014)The SNP rs72561750 was situated in the former reverse primer binding region 7 bases from the 3’-end. This SNP appears in 2% of the African and African-American population. Although no malfunction has been reported the reverse primer has been modified to exclude any potential risk (more information described in the method sheet, see Version History).Due to the change of both primers the amplicon is shortened to 110 bp and the signal levels have been about doubled. en

LightMix^® in-vitro diagnostics kit Factor V (Leiden) CE-IVD

Detection of the G1691A DNA variation in the Factor V gene
for use with the Roche Diagnostics LightCycler^® Instruments

IVD

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LightMix^® in-vitro diagnostics kit Factor V (Leiden) CE-IVD

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