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HemosIL FII & FV DNA Control is intended for in vitro diagnostic use as a heterozygous quality control to monitor analytical performance of the extraction, amplification and detection steps of the Xpert™ HemosIL FII & FV genotyping assay on the GeneXpert® Dx System used in the detection of both the Factor II 20210G>A and Factor V 1691G>A (Leiden) mutations.

HemosIL FII & FV DNA Control is synthetic Factor V DNA suspended in a non-infectious blood-like matrix. Each vial includes normal and mutated Factor II and Factor V DNA sequences and is configured as a heterozygous control for both Factor II 20210G>A and Factor V 1691G>A (Leiden) mutations. The quality control material is validated for use with Xpert™ HemosIL® FII & FV genotyping assay on the GeneXpert® Dx System and is processed exactly as whole blood samples during the extraction, amplification and detection steps.

INTROL™ CF Panel I Control is intended for in vitro diagnostic use as a quality control to monitor analytical performance of the extraction, amplification and detection steps of diagnostic assays used in the detection of the Cystic FibrosisTransmembrane Regulator (CFTR) gene mutations and variants. This product is intended to be extracted and analyzed routinely with each CFTR assay run. The INTROL™ CF Panel I Control is designed to monitor the detection of 38 CFTR mutations associated with cystic fibrosis, including the 23 mutations recommended for testing by American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG). The INTROL™ CF Panel I Control also monitors 3 polymorphisms (1506V, I507V, F508C) and the 5/7/9T variants.

Modified INTROL™ CF Panel I Control consists of synthetic (recombinant) CFTR DNA suspended in a matrix of carrier DNA of non-human species, preservatives, dye, and stabilizers. CFTR DNA is stabilized in the matrix and released when processed through common extraction methods as if it were a whole blood specimen. INTROL™ CF Panel I Control was modified to contain additional wild type CFTR DNA required for primer annealing of some CFTR detection assays.

The GentriSure™ Human Genomic DNA Reference Control (HGDRC) is an independent. external run control that is intended for use in assessing the performance of diagnostic assays that detect cytochrome p450 2D6 (CYP2D6) genetic polymorphisms. This control is not intended to be used as a substitute for controls provided with licensed test kits. GentriSure HGDRC can be used for assay validation, staff training and proficiency testing, and as a quality control in routine in vitro diagnostic testing.

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INTROL™ CF Panel I Control is intended for in vitro diagnostic use as a quality control to monitor analytical performance of the extraction, amplification and detection steps of diagnostic assays used in the detection of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene mutations and variants. This product is intended to be extracted and analyzed routinely with each CFTR assay run. The INTROL™ CF Panel I Control is designed to monitor the detection of 38 CFTR mutations associated with cystic fibrosis, including the 23 mutations recommended for testing by American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG). The INTROLTM CF Panel I Control also monitors 3 polymorphisms (1506V, 1507V, F508C) and the 5/7/9T variants.

INTROL™ CF Panel I Control consists of synthetic CFTR DNA suspended in a matrix of synthetic DNA targets, carrier DNA of a non-human species, preservatives, dye, and stabilizers. The synthetic DNA contains all 27 CFTR gene exons plus intronic borders, and contains specific mutations and polymorphisms which are divided among 5 bottles (bottles a, b, c, d, and e). The 5 bottles exist in two versions: Version G106ac includes bottles (a), (b), and (c), while Version G106de includes bottles (a), (b), (d), and (e). The specific mutations present in each bottle are listed below in Table 1; all other CFTR sequence is wild type. CFTR mutations that are not listed cannot be detected in the INTROL™ CF Panel I Control. Control sequences include the mutations, wild type alleles, and polymorphisms recommended for testing by the American College of Medical Genetics (ACMG) and American College of Obstetricians and Gynecologists (ACOG). CFTR mutations that are not listed cannot be detected in the INTROL™ CF Panel I Control. CFTR DNA is stabilized in the matrix and released when processed through common extraction methods as if it were a whole blood specimen. Following extraction, the released DNA can be used in common amplification based molecular assays techniques. Because INTROL™ CF Panel I Control is designed to mimic the whole blood sample, the resulting copy number of the artificial CFTR segment, after extraction, will be similar to that found in a processed human whole blood sample (v/v).