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NEWS & INFORMATION
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Source To Surgery - January 1993, Vol. 1 Issue
Scientific Studies Report
Wide Diversity of Allergenicity in Medical Products
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Yunginger et al (Mayo Clinic) used a 1 :5 w/v extraction for RAST-
inhibition method to detect allergenic activity in 33 lots of different
latex gloves and other latex devices. They found a 400-fold difference
between various gloves. The results by manufacturer and number of
lots tested included Ansell, <10-65 U/ml (n=5); Aladan,13 U/ml
(n=1); Baxter,11-4299 U/ml (n=5); Becton-Dickinson, 15-175 U/ml
(n=4); China,42 U/ml (n=1); Linc,40 U/ml (n=1); Perry,1501-2751
U/ml (n=8); PR, <10 U/ml (n=1); Sterling,2919 U/ml (n=1); Surgikos,
<10 U/ml (n=1); Tagum, 129 U/ml (n=1); T.K.,569-2902 U/ml (n=3),
and Travenol,94 U/ml (n=1). There was no difference in sterile and
non-sterile latex gloves. No activity was detected in synthetic gloves
(Derma PreneTM from Ansell or Sensi-CareTM from Becton-
Dickinson). They also found latex allergen activity in toy balloons, a
disposable anesthesia rebreathing bag, a rubber condom and after 40
punctures also in a rubber stopper. On the other hand, they did not find
latex allergenic activity in rubber nasopharyngeal airways, IV T-
tubing, baby pacifiers and baby bottle nipples. However, Makinen-
Kiljunen (Finland) could demonstrate IgE binding to an extract from a
baby pacifier brand in a RAST test, which means detectable allergenic
activity at least in this particular brand of baby pacifiers.
Alenius et al (Finland) examined eight latex glove brands, seven
surgical and one household glove in immunoblotting and found wide
differences between the gloves. Five glove brands bound IgE
antibodies from one strongly positive latex serum. In two surgical
glove brands, selected IgE was bound to ten protein bands and to five
bands in the household glove brand. The strongest IgE binding was
detected against 14 kD and 30 kD molecular weight protein bands.
Tomazic et al (FDA) also found differences between four glove
extracts in IgE immunoblotting. Usually one to three bands of 25 kD,
45 kD, or 80-90 kD, bound IgE antibodies from one IgE serum.
SUMMARY
- Clinically relevant allergenic activity can be demonstrated with
in vivo tests only. In vitro, allergens or allergenic activity can be
demonstrated only by using human latex IgE - antibodies.
- Total protein can be measured by various methods. However, all
proteins are not necessarily allergens.
- Animal IgE - antibodies do not directly detect allergens, but
protein antigens should be supported with IgE-binding studies.
- Differences were found in allergenic activity and allergen
distribution in different latex glove brands. It is not known
whether this is caused by differences in source material or
different manufacturing processes.
- In addition to latex gloves, Natural Rubber Latex allergens were
demonstrated in many other medical and consumer rubber products.
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