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    INTROL™ Thrombosis Genotype Panel:
 
Product Name

INTROL Thrombosis Genotype Panel is intended for in vitro use as a control product to monitor the analytical performance of extraction, amplification and detection of test systems used in qualitative measurement of the Factor II (Prothrombin), Factor V Leiden and methylenetetrahydrofolate reductase (MTHFR) genes for mutations Factor II G20210A, Factor V G1691A Leiden, MTHFR C677T and A1298C.  Factor II G20210A and Factor V Leiden (G1691A) are the most common genetic risk factors for thrombotic events. MTHFR mutations C677T and A1298C are associated with thrombosis, cancers, leukemias, neural tube defects, high homocystine levels, cardiovascular disease, schizophrenia, Alzheimer’s and toxicity of anti-folate drugs like methotrexate.

Routine use of INTROL Thrombosis Genotype Panel with each Factor II G20210A, Factor V G1691A Leiden, MTHFR C677T and A1298C test run will assist the laboratory in the detection of immediate errors, and shifts or trends caused by changes in test system components. Analysis of INTROL Thrombosis Genotype Panel also provides the laboratory with valuable experience by demonstrating test results of rare genotypes.

INTROL Thrombosis Genotype Panel is to be extracted before analysis just as patient whole blood samples are, which allows the control to fit efficiently into normal laboratory work flow. The unique extractability characteristic provides monitoring of the extraction step as required by CLIA regulations and best laboratory practice.

INTROL Thrombosis Genotype Panel consists of synthetic Factor II, Factor V and MTHFR DNA suspended in a non-infectious, blood-like matrix.  There are three bottles, each containing a different genotype.  Bottle a contains wild type (normal) Factor II, Factor V, MTHFR C677T & A1298C.  Bottle b contains heterozygous Factor II, Factor V, MTHFR C677T & A1298C. Bottle c contains mutant Factor II, Factor V, MTHFR C677T & A1298C. INTROL Thrombosis Genotype Panel has been sequenced to validate the presence of mutant or wild type sequence.

Analyte Bottle a Bottle b Bottle c
FII G2021A WT HET MUT
FV Leiden G1691A WT HET MUT
MTHFR C677T WT HET MUT
MTHFR A1298C WT HET MUT

Please contact MMQCI at 207-885-1072 or e-mail us with any questions you may have.

INTROL™ Thrombosis Genotype Panel is provided for Research Use Only.

ORDERING INFORMATION: Catalog No: G123
G123-1 contains: 3 bottles (a, b, c), 1 milliliter each
G123-2 contains: 3 bottles (a, b, c), 2 milliliters each

Safety Data Sheet

 


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