For in vitro diagnostic use. Others LightMix in-vitro diagnostics kit ApoB R3500Q CE-IVD IVD LightMix® in-vitro diagnostics kit ApoB R3500Q 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-0139 Detection of the G10708A DNA variation in the Apolipoprotein B-100 genefor use with the Roche Diagnostics LightCycler® Instruments 05 997 682 001 5 997 682 001 05997682001 5997682001 05997682001 LightMix ApoB-100 R3500Q LightMix ApoB-100 R3500Q 04260159331653 Reagents, kits 40-0519-64 Not Available Not Available false Increased plasma cholesterol can cause atherosclerosis. Results from classical clinical chemistry testing with total cholesterol >8 and LDL- cholesterol >5 and a quotient total/HDL- cholesterol > 6.5 may suspect - if not a case of secondary hypercholesterolaemia - a genetic defect (familial hypercholesterolaemia). Secondary hypercholesterolaemia can be a result of diabetes mellitus type 2, obesity, alcohol, monoclonal gammopathy, dialysis, nephrotic syndrome, obstructive jaundice, hypothyroidism, Cushing’s syndrome, or anorexia nervosa but can be also due to medication with diuretics, cyclosporin, glucocorticoids, beta blockers or retinoic acid. This molecular test is intended to be used to analyze individuals with a known ApoB mutations familiarity and the genetic background of individuals with increased cholesterol plasma levels which, in most cases, are not due to secondary hypercholesterolaemia: Assessment of the cause of a primary hypercholesterolaemia Assessment in case of an early (< age of 55) atherosclerosis Family background of high prevalent hypercholesterolaemia Diagnosis of a familial hypercholesterolaemia Study of individuals directly related to an index patient 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). en Using PCR methodology, a 77 bp fragment of the ApoB 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 mutated genotype and the presence of a wild type will result 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

LightMix^® in-vitro diagnostics kit ApoB R3500Q CE-IVD

Detection of the G10708A DNA variation in the Apolipoprotein B-100 gene
for use with the Roche Diagnostics LightCycler^® Instruments

IVD

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LightMix^® in-vitro diagnostics kit ApoB R3500Q CE-IVD

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