Prevalence of IgE to natural rubber latex in unselected blood donors and performance characteristics of AlaSTAT testing

Background: The prevalence of IgE to natural rubber latex (NRL) proteins in the general population remains unsettled, both because of the difficulty of obtaining an unbiased population representative of the general population of the United States and because of concerns about the reproducibility of tests for anti-latex IgE antibodies. Establishing the prevalence in the population is important toward defining the potential risks of persons entering areas where latex exposure may occur. Objective: The purposes of this study were to determine the prevalence of IgE to latex in a general population and to assess the performance characteristics of the AlaSTAT microtiter plate test for anti-latex IgE when performed independently by different laboratories. Methods: One thousand nine hundred and ninety-seven consecutive blood samples obtained from the Oklahoma Blood Institute were assayed independently in three laboratories for IgE to NRL using the FDA-approved AlaSTAT ELISA for IgE to NRL. The group consisted of 56% men and 44% women. Ninety percent were Caucasian, 4% African American, and 6% were "other." Results: The prevalence IgE to NRL between the 3 laboratories varied from 5.4% to 7.6% at the designated cut off of 0.35 kU/L. Examination of results for specific individuals demonstrated >90% agreement between the three sites with the most reproducible results at the Class II cutoff of greater than or equal to 0.7 kU/L. There was no difference in the percent of positive values at the three laboratories, Conclusions: There is good agreement between laboratories as to NRL IgE reactive and non-reactive sera using the AlaSTAT test. This report of the largest sample of blood donors confirms earlier reports as to the prevalence of IgE NRL in blood donors.