Bronchial challenge tests are used in routine diagnostics, in asthma
research, clinical trials and in allergen identification. Typically,
concentrated stock solutions of provocation agents or specific allergens
are diluted on site immediately prior to introduction to a nebuliser.
This is often an expensive and inefficient process which can introduce
variability to the test protocol between individual tests and between
trial sites.
The MDE range of Bronchial Challenge Test kits offers a new level
of convenience, reliability and reproducibility. MDE manufactures
and packs Histamine, Methacholine and Adenosine Monophosphate kits
in standard or custom concentration ranges with a 6 to 12 month shelf
life depending on the product. All MDE Bronchial Challenge Test kits
are manufactured in the EU in GMP accredited aseptic filling units
and each delivery is accompanied by a Certificate of Analysis confirming
(as a minimum) sterility, product concentration and pyrogenicity.
Stability studies on potentially labile products support batch shelf
life data.
Kits supplied for clinical trial purpose can be labelled according
to trial requirements, QP released and transported to trial sites
in monitored refrigerated vans.
Adenosine Monophosphate Kit:
Standard concentration range 0.4, 0.8, 1.5, 3, 6, 12, 25, 50, 100,
200 and 400 mg/ml in standard saline solution. Limited range kits
covering part of this range are available as are custom range kits
to meet specific requirements.
Histamine Kit:
Standard concentration range 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 4,
8, 16, 32 mg/ml in phosphate buffered saline. Limited range kits covering
part of this range are available as are custom range kits to meet
specific requirements.
Methacholine Kit:
Standard concentration range 0.03, 0.06, 0.12, 0.25, 0.5, 1, 2, 4,
8, 16, 32 mg/ml in standard saline. Limited range kits covering part
of this range are available as are custom range kits to meet specific
requirements.
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