INTROL HH Panel II is intended for in vitro use as a control product to monitor the analytical performance of extraction, amplification and detection in test systems used for the qualitative measurement of H63D, S65C and C282Y, HFE gene mutations most commonly associated with hereditary hemochromatosis (HH). Hereditary hemochromatosis is an autosomal recessive iron-storage disorder characterized by inappropriately high absorption of iron by the gastrointestinal mucosa, leading to excessive storage of iron (particularly in the liver, skin, pancreas, heart, joints and testes) and ultimately resulting in impaired organ structure and function. This disease is usually treated with periodic therapeutic phlebotomy. ^[1]

Routine use of INTROL HH Panel II with each H63D, S65C and C282Y test run will assist the laboratory in the detection of immediate errors and shifts or trends caused by changes in test system components.  Monitoring of the HH test over time using homogeneous controls like INTROL HH Panel II provides comparable signal levels run to run and lot to lot.  This allows the laboratory to identify changes in the test system and troubleshoot as needed, often before a run fails.

INTROL HH Panel II 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 HH Panel II consists of synthetic HFE DNA suspended in a non-infectious, blood-like matrix.  The Panel consists of three bottles, each containing different genotypes. INTROL HH Panel II DNA has been sequenced to validate the presence of mutant or wild type sequence.

Bottle: G20010-1 G20011-1 G20013-1

Genotype: H63D HET, S65C WT, C282Y HET H63D WT, S65C WT, C282Y MUT H63D WT, S65C MUT, C282Y WT

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

INTROL HH Panel II is provided for Research Use Only.

ORDERING INFORMATION: Catalog No: G201-1

G201-1 contains:         3 bottles, 1 milliliter each

1. King, C.; Barton, D.E.  Best practice guidelines for the molecular genetic diagnosis of Type I (HFE-related) hereditary haemochromatosis.  BMC Medical Genetics 2006, 7:81

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