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Journal of Long-Term Effects of Medical Implants

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v15.i2.10
pages 115-124

Allergen Profiles of Natural Rubber Latex (NRL) Proteins on Gloves and Glove Powders

Vesna J. Tomazic-Jezic
Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Biology, Rockville, MD, USA
B. A. Sanchez
FDA, Center for Devices and Radiological Health, Rockville, Maryland, USA

ABSTRACT

The contributing role of glove powder in sensitization to natural rubber latex (NRL) proteins has been well documented in laboratory studies and through clinical evaluations. However, the quantitative relationship of the respiratory and topical exposures in the sensitization process remains unknown because the relative levels of protein on the glove powders in relation to the total levels of protein on NRL gloves have not been determined. In this study we evaluated the proportion of four individual NRL allergens—Hev b 1, Hev b 3, Hev b 5, and Hev b 6.02—on randomly selected surgical and examination NRL gloves. We also examined the binding pattern of the four allergens to several glove powders that showed a different affinity to NRL proteins. The level of powder-bound protein was determined by the ELISA Inhibition Assay (ASTM D6499 standard method). Two cross-linked corn starch powders, one sample of cooking corn starch and one oat starch sample, were exposed to ammoniated (AL) or nonammoniated (NAL) raw NRL protein extracts. The levels of individual allergens were determined using the NRL allergen kit. In the NRL glove extracts we observed a wide range in the total allergen levels and a great diversity in the proportion of the four allergens. On the other hand, the evaluated starches had similar ratios of four individual allergens, regardless of the differences in their total allergen levels. The exposure of starches to NRL proteins with different allergen profiles did not affect the allergen ratio. All samples demonstrated a selective affinity for binding Hev b 1 and Hev b 5 allergens and a lesser affinity for the Hev b 6.02 allergen. Allergen Hev b 6.02 made up about 60% of the total allergen in the NAL extract, but only 12−30% of Hev b 6.02 was bound to starches. In contrast, there was only 3−7% of Hev b 1 allergen in the NAL extract, but powders had 35−45% of Hev b 1. These findings indicate that allergenic properties of NRL gloves and respective glove powders may be different.