For Research Use Only. Not for use in diagnostic procedures. Others UC-TIB-MG Resistance RUO UC-TIB-MG_Resistance 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. PID00001182 10 638 435 001 10638435001 UC-TIB-MG_Resistance UC-TIB-MG_Resistance Reagents, kits 192 reactions Not Available false UC-TIB-MG_Resistance is an automated qualitative in vitro test for the detection of macrolide resistanceassociated mutations (MRAMs) and quinolone resistance-associated mutations (QRAMs) in the genome of Mycoplasma genitalium (MG). The test utilizes amplification of target DNA by RT-PCR and nucleic acid hybridization for the detection of 23S rRNA gene mutations, at nucleotide position A2058 or A2059 (Escherichia coli numbering), parC mutations (S83I/N/R and D87N/Y/G) and gyrA mutations (M95I and D99N/Y). UC-TIB-MG_Resistance is intended as a reflex test and is to be performed exclusively on samples previously identified as positive for Mycoplasma genitalium. en The limit of detection (LoD) for UC-TIB-MG_Resistance was determined by analysis of serial dilutions of plasmid DNA in cobas® PCR media (400 µL sample volume). The study demonstrates that the UC-TIBMG_Resistance detects at least 95 genome equivalent copies or less per mL for Mycoplasma genitalium, determined by LOGIT analysis with a hit rate of 95%. en MRAMs are detected by real-time PCR that amplifies a 103 bp long fragment of the 23S-rRNA gene in channel 02 using a FAM-labelled probe specific for the Wild Type positions A2058 and A2059. The mutations A2058G/C/T and/or A2059G/C/T hinder the efficient binding of the probe, thereby preventing the generation of a signal. QRAMs are detected by real-time PCR that amplifies a 120 bp long fragment of the parC gene in channel 01 using a Cyan500 labelled probe (D87) and in channel 04 using a LC640 labelled probe (S83). These probes are specific for the Wild Type codons and mutations D87N/Y/G and/or S83I/N/R hinder the efficient binding of the probe, thereby preventing the generation of a signal. Additional QRAMs are detected by real-time PCR that amplifies a 118 bp long fragment of the gyrA gene in channel 03 using HEX-labelled probes. These probes are specific to the mutations M95I and D99N/Y and a signal in channel 03 indicates the presence of one of these mutations. The (+) Ctrl comprises plasmids with a 308 bp long synthetic fragment of 23S-rRNA gene, a 171 bp long synthetic fragment of parC gene, and a 297 bp long synthetic fragment of gyrA gene (Accession number: NR_077054 position 1858 - 2112 for 23S-rRNA gene, CP159789 position 242431 - 242601 for parC gene, and CP159789 position 4967 – 5263 for gyrA gene respectively). en

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