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    INTROL™ PGx 1 Control:
 
Product Name

Genotype Table

INTROL PGx 1 Control is intended for in vitro use as a quality control to monitor analytical performance of the extraction, amplification and detection steps performed according to the eSensor® Warfarin Sensitivity Plus Test on the eSensor® XT-8 (Osmetech). This product is intended to be extracted and analyzed routinely with each run of the eSensor® Warfarin Sensitivity Plus Test. Please contact MMQCI for compatibility of INTROL PGx 1 Control with other test systems.

Warfarin (Coumadin®) is the most commonly prescribed anti-coagulant and is among the top 20 most prescribed drugs in the US. However, it is often difficult to determine optimal dose for each patient and the consequences of incorrect dosing can be severe, including thrombosis, hemorrhage, and even death. While variation in drug response is caused by many factors such as diet, age, and medications, a patient’s genotype accounts for one-third (32%) of the variation.1 Warfarin genotyping assists the physician with determination of the optimal warfarin dose.

Routine use of INTROL PGx 1 Control with eSensor® Warfarin Sensitivity Plus Test will assist the laboratory in detection of immediate errors and shifts or trends caused by changes in test system components. Analysis of INTROL PGx 1 Control also provides the laboratory with valuable experience by demonstrating test results of rare genotypes.

INTROL PGx 1 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 PGx 1 Control contains two synthetic alleles of Cytochrome P450 2C9 (CYP2C9), Cytochrome P450 4F2 (CYP4F2), and Vitamin K Epoxide Reductase Complex, Subunit 1 (VKORC1) DNA suspended in a non-infectious, blood-like matrix. Specific nucleotide polymorphisms associated with warfarin sensitivity found in INTROL™ PGx 1 Control are listed in the genotype table. 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™ PGx 1 Control is provided for Research Use Only.

Ordering Information: Catalog No: P102-1
P102-1 contains:      3 bottles (b, c, d), 1 milliliter each

1  Gage, et al. (2008) Clin Pharmacol Ther. Feb 27

Safety Data Sheet

 


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