The specification of a glove treated with the MPXX™ technology meets the international requirements of ASTM International, formerly known as the American Society for Testing and Materials; the European Standard EN 455, part 1, 2 and 3 and other equivalent standards. The quality of the glove is of an extremely high level. Besides fulfilling all requirements under above mentioned standards, gloves treated with MPXX™ also have been tested under FITkit®, RAST-inhibition and HPLC.
MPXX™ is proven by the FITkit® method. FITkit® is the first ever test for the measurement of clinically relevant NRL allergens and enables standardization and quantification of individual allergens. It overcomes the significant limitations of other tests by using highly purified and characterized allergens, and specific monoclonal antibodies, against the major latex allergens known to be present in NRL products.
All products washed with the MPXX™ technology show unquantifiable levels of allergens. For the four major allergens these levels are as follow:
- Hev b1 < 0.05 µg/g
- Hev b3 < 0.05 µg/g
- Hev b5 < 0.025 µg/g
- Hev b6.02 < 0.025 µg/g
The FITkit® technology is compliant with the ASTM International standard D7427-08 (please click here).
For more information please see also www.icosagen.com/fitkit/about-fitkit-1 (please click here).
Gloves treated with the MPXX™ method have been subjected to a RAST-inhibition test at the Clinic of the University in Erlangen, Germany. This RAST-inhibition test was based on the determination of latex specific IgE anti-bodies in a pool serum of 10 patients with latex allergy. All submitted gloves treated with the MPXX™ method showed the following result: undetectable allergen specific IgE.