For in vitro diagnostic use. Others LightMix in-vitro diagnostics kit Lactose Intolerance CE-IVD IVD LightMix® in-vitro diagnostics kit Lactose Intolerance 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-0121 Detection of the C-13910T DNA variation and detection of futher variations, in particular C-13907G, T-13913C, and T-13915G, in the MCM6 genefor use with the Roche Diagnostics LightCycler® Instruments 06 896 391 001 6 896 391 001 06896391001 6896391001 06896391001 LightMix Lactose Intolerance LightMix Lactose Intolerance 04260159330915 Reagents, kits 40-0307-64 64 reactions Not Available false This in-vitro diagnostic PCR kit is intended to be used to identify carriers of the mutated allele of the MCM6 gene which is associated with lactase persistence (no lactose intolerance), using human genomic DNA from a nucleic acid extract obtained from peripheral blood. This device detects the mutation -13910T (dbSNP: rs4988235) located in intron 13 of the helicase encoding minichromosome maintenance 6 (MCM6) gene providing Caucasian (or Scandinavian) type lactose tolerance and allows to identify carriers of the homozygous wild type allele -13910C who are potentially lactose-intolerant. Three other mutations, C-13907G (rs41525747), T-13913C (rs41456145) and T-13915G (rs41380347), located close by, are detected by the present kit. Also these mutations are assumed to confer lactose tolerance. Due to the fact that there may be other variations causing similar temperature melting peaks this device does not make definite predictions on the lactose tolerance status for other genotypes than wild type -13910C and -13910T. 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 156 bp fragment of the MCM6 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 Scandinavian mutant genotype -13910 T; the presence of the wild type allele genotype -13910C will result in a peak with a lowered melting temperature, while the variants -13907 G, -13913 C and -13915 G will produce an even lower Tm, because there are two mismatches between target and probe.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. 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 100 different genomic DNA samples from Caucasian origin individuals were analyzed with the present kit and compared with ABI 3730xl DNA sequencing performed by LGC Genomics GmbH, Berlin.Study results: results for both analytical methods were in 100% concordance.In particular, from 100 samples analyzed 74 were found to be homozygous wild type, 23 samples heterozygous and 2 samples homozygous mutant. One sample failed as the type could not be called by the LightCycler® software but could be manually identified by its melting temperature as type African Type tolerant. The sample was confirmed by sequencing to be -13915G / -13910C. en

LightMix^® in-vitro diagnostics kit Lactose Intolerance CE-IVD

Detection of the C-13910T DNA variation and detection of futher variations, in particular C-13907G, T-13913C, and T-13915G, in the MCM6 gene
for use with the Roche Diagnostics LightCycler^® Instruments

IVD

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LightMix^® in-vitro diagnostics kit Lactose Intolerance CE-IVD

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