Ansell Newsletter

On page 3 you could read how powder-free Natural Rubber Latex (NRL) gloves remain a good choice for barrier protection. For years now, Ansell has been on a quest to minimize the onset of type I allergic reactions to these gloves. Its state-of-the-art manufacturing processes guarantee particularly low levels of allergens. How it is so sure about that? Ansell relies on the most accurate NRL allergen testing method available on today’s market: FITkit®. Such tests have recently reconfirmed that our efforts to minimize latex allergies are bearing fruit.

To truly understand the allergenicity of NRL gloves, we have to return to their natural source: the rubber tree. The liquid latex extruded from the rubber tree contains over 200 proteins. 13 of them have been identified as allergens, i.e. components that can cause allergic reactions. Many proteins degrade, denature or lose their activity during the rubber manufacturing process but some manage to survive the extensive washing and leaching procedures. According to current literature, it is mainly proteins known as heveins (Hev b1, Hev b3, Hev b5 and Hev b6.02) that retain their allergenic properties and are often found in extracts of latex gloves. Ansell decided to control the levels of these four allergens, as an essential step towards minimizing the allergenicity of its NRL gloves. The methodology used for these measurements is the innovative FITkit® tests.

A worldwide research standard
FITkit® is the first-ever immunological test methodology to identify and quantify clinically relevant levels of Hev b1, Hev b3, Hev b5 and Hev b6.02 in NRL products, including barrier protective gloves. The tests use specific monoclonal antibodies specially developed against the four major latex allergens known to be present in NRL products. By using highly purified and characterized allergens and monoclonal antibodies, FITkit® guarantees sensitive, accurate and reliable results without interference or cross reactions with other substances. It is this sensitivity, accuracy and reliability that set this method apart from all the other tests on the market. FITkit® makes it possible to directly measure all the relevant allergens individually, as a separate test is available for measuring each of them.

Best-in-class manufacturing approach
The FITkit® test is the result of many years’ research and studies by a couple of leading Finnish scientists working in the area of NRL allergies. They developed the methodology in close partnership with major glove manufacturers, including Ansell. At Ansell, the innovative method is the standard procedure to measure the allergen levels of powder-free NRL gloves. That Ansell’s constant quest for low allergen content works, has recently been proven again by FITkit® tests on its Gammex® range of surgical gloves. Thanks to the intensive post-washing and leaching procedures during their manufacturing process, the Gammex® PF, Gammex® PF Underglove®, Gammex® PF MicroThin®, Gammex® PF HydraSoft® and the new Gammex® PF XP® all showed undetectable levels of allergens.