The SPT Tests Available for Diagnosis article for details) can be used with known latex allergic
patients. SPT is the most sensitive for comparing allergenicity of
different products (especially surgical and exam gloves) but requires
NRL sensitized people who are willing to be retested. This study
requires the permission of the hospital ethics committee and informed
consent of the patient. When only a slight or no reaction occurs in the
group of patients tested, it is probable that the product will not
sensitize and is therefore safe for general use.
The SPT results correlate well with the RAST Inhibition and ELISA
Inhibition methods.
RAST Inhibition (RI)
The advantage of this method in comparison to SPT is that only sera from
NRL sensitized humans is required.
The values used in this test are given in arbitrary units which means
everything is compared to the value set for NRL.
So far this method cannot be used for worldwide standardization because
a standardized NRL allergen as well as a standardized serum pool needs
to be used by all testing laboratories. The same disadvantages prevent
it from being used commercially. It is also a time consuming and
expensive test to do.
In spite of these difficulties, it has been shown that with different
NRL samples and different serum samples a good correlation exists
between various laboratories using this method. For example, the results
obtained by the Mayo Clinic (Yunginger) and the Finnish Latex Research
Group (Soili Makinen-Kiljunen) will rank gloves in the same order of
allergenicity (unpublished).
ELISA Inhibition (EI)
ELISA inhibition is a well known test methodology. The Finnish Latex
Research Group has developed this technique for the analysis of NRL
allergens. The results obtained to date show this method to correlate
very well with SPT and RI (unpublished). This method also uses human
sera from NRL sensitized individuals which means it has the same
limitations as RI.
Total Protein Determination
In NRL there are over 240 different proteins and polypeptides of which
57 have so far been identified as allergens. In addition to genuine NRL
proteins, other proteins such as casein may be added during
manufacturing.
A preferred method for total protein measurement, and recommended by the
FDA, is the modified Lowry. This is a chemical method which has some
drawbacks such as lack of sensitivity, specificity and interferences
from accelerators and other additives used in glove manufacture. It has
been shown that correlation between SPT and the modified Lowry is
relatively good.* Therefore, this method can be used as a primary check
by manufacturers to determine the protein amounts of their products.
Latex ELlSA for Antigenic Proteins (LEAP) Assay
The LEAP Assay (available commercially) relies on the use of antibodies
developed in rabbits against ammoniated latex proteins. Therefore, it is
basically a total protein assay and is not allergen specific.
For the time being, the LEAP assay has not been validated against
specific allergen measuring methods, such as SPT or RAST Inhibition.
*Esah Yip, K Turjanmaa, K.P. Ng and K.L. Mok: Allergic
responses and levels of extractable proteins In NR latex gloves and dry
rubber products. J. nat. Rubb. Res., 9(2), 79-86, 1994.