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Scientific information

Indoor Biotechnologies is pleased to introduce FITkit^®, the first specific tests for identifying and quantifying natural rubber latex (NRL) allergens.

These highly sensitive tests use specific monoclonal antibodies developed against the four major latex allergens (Hev b 1, Hev b 3, Hev b 5 & Hev b 6.02) known to be present in NRL products. Consider using FITkit^® to test all of your products that contain NRL including rubber gloves, catheters, supplies for intravenous use, enema cuffs, airway masks, anesthesia bags, etc.

The results of an FDA multi-center study showed that the evaluation of specific allergens with monoclonal antibodies should be considered an alternative testing method. This study compared FITkit^® to ASTM D5712, ASTM 6499 and ELISA/ RAST inhibition (patient serum) in 7 testing laboratories in the US, Asia and Europe to assess the variability and analytical performance of available methods for latex allergen detection. The results have been presented at an ASTM meeting in Miami, FL, USA Dec 9-12, 2002 and a new ASTM standard is being developed using specific allergen measurement or FITkit^®. The following summarizes the advantages of FITkit^® over current testing methods:

• Uses highly purified and characterized allergens
• Enables standardization and quantification of individual NRL allergens
• Measures specific, well defined latex allergens that induce IgE responses
• Shortens assay time (< 2 hours)
• Provides consistent and reliable results. INDOOR Biotechnologies is delighted to distribute the FITkit^® for Quattromed in the US, Canada and South America.