Latex allergen testing with FITkit®
FITkit® is an ELISA test for measuring natural rubber latex (NRL) allergens from a variety of rubber products, such as gloves, condoms, teats, etc. FITkit® technology has been developed by the leading scientists working in the field of NRL allergy, in cooperation with major glove manufacturers. It shows a good correlation to the allergen content of gloves, measured by currently available patient IgE methods.
This novel method is the first ever test for the measurement of clinically relevant NRL allergens, and enables quantification of individual allergens. It overcomes the significant limitations of other tests by using highly purified and characterized allergens, and specific monoclonal antibodies, against four major latex allergens (Hev b 1, Hev b 3, Hev b 5 and Hev b 6.02) known to be present in NRL products. A separate FITkit® is available for measuring each of the major allergens. FITkit® technology is compliant with ASTM International standard D7427-16.
The advantages of FITkit® are:
- Direct measurement of the relevant allergens individually;
- Unique sensitivity;
- Consistent and reliable results;
- Convenient procedure and short assay time (< 2 hours);
- No interference from other substances.
Possible applications for the FITkit test vary, based on the R&D or quality control needs of producers to measure latex allergens in finished products or in different phases along the production line, to assessing production development as a type of quality control criteria in the different distribution organizations of purchasing departments. A newer approach has found the FITkit applicable for use in synthetic product contamination control. If the absence of major NRL allergens in synthetic protective gloves or in other synthetic rubber products with a medical use requires verification, use of the FITkit offers a useful solution.
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the American Society for Testing and Materials (ASTM).