INTROL TRC Genotype Control 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 Factor II (Prothrombin) and Factor V genes for the mutations Factor II G20210A and Factor V Leiden (G1691A).  These are the most common genetic risk factors for thrombotic events.

Routine use of INTROL TRC Genotype Control with each Factor II and V 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 TRC Genotype Control also provides the laboratory with valuable experience by demonstrating test results of rare genotypes.

INTROL TRC Genotype Control 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.

Each bottle of INTROL TRC Genotype Control contains two synthetic alleles of Factor II DNA and two synthetic alleles of Factor V DNA suspended in a non-infectious, blood-like matrix. Each allele contains a segment of the Factor II gene or a segment of the Factor V gene. Alleles carry either a mutation (Factor II G20210A or Factor V Leiden (G1691A)), or wild type DNA. All alleles have been quality scored sequenced in entirety.

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

INTROL™ TRC Genotype Control is provided for Research Use Only.

Material Safety Data Sheet