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CYSTIC FIBROSIS
INTROL™ Cystic Fibrosis Panel I
Control
* * Now FDA cleared ! * *
Catalog # G106ac* 3 bottles x 2 mL
Catalog # G106de* 4 bottles x 2 mL
* Please consult with MMQCI for correct version
for your CF test system.
MTHFR
Thrombotic
Risk
Cystic Fibrosis Panel I
Control is intended
for in vitro use as a control product to monitor the
analytical performance of the extraction, amplification and
detection of test systems used in the qualitative measurement of
the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)
gene. This product is an external quality control to be
extracted and analyzed routinely with each cystic fibrosis (CF)
test run.
The Cystic Fibrosis Panel I
Control is designed to monitor the presence of 38 CFTR
mutations, genetic risk factors associated with
cystic fibrosis (CF). The CF Panel I mutations include the
25 mutations recommended for testing by the American College of
Medical Genetics (ACMG) and the American College of Obstetricians
and Gynecologists (ACOG). CF is a fatal recessive hereditary
disease characterized by thickened secretions that clog bronchi
and pancreatic ducts. CF Panel I also monitors the presence
of 3 polymorphisms that may confound interpretation of some CF
test results, and the status of the 5/7/9T alleles. 5T is a
genetic risk factor associated with congenital bilateral absence
of the vas deferens (CBVD) and CF.
Each bottle of Cystic
Fibrosis Panel I contains two synthetic alleles of CFTR DNA
suspended in a patented, non-infectious, blood-like matrix. The
DNA should be extracted before analysis. Each allele contains all
24 CFTR exons and their intronic borders linked together. The
alleles carry varying configurations of mutant and wild type
(normal) sequences. All CFTR alleles have been quality scored
sequenced in entirety.
Cystic Fibrosis Panel I
consists of three or four bottles, depending on the CF assay used. Each bottle contains a different combination of CFTR
mutations, polymorphisms and wild type sequence.
Please contact MMQCI to determine the best version for your
laboratory.
Since the controls are designed
as a two allele system, analysis of the controls will provide the
laboratory with experience in interpretation of patient results
when certain neighboring mutations cause assay interferences, thus
preventing potential reporting errors.
INTROL™ CF Panel I is
provided for in vitro diagnostic use.
MSDS
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