CLEVELAND—The Tun Abdul Razak Research Centre is working on a test kit that would determine the allergenicity of natural rubber latex products, but the product still is likely at least a year away from commercialization.
The kit is able to monitor allergens in latex goods such as gloves, according to Alessandra DiCola, a scientist in TARRC's biotechnology unit. The England-based organization—a research and promotion center for the Malaysian Rubber Board—was on hand at the recent ACS Rubber Division's International Elastomer Conference in Cleveland to pass out kit samples. DiCola also presented a paper on the Latex-T Diagnostic kit.
“The kit is dedicated to the detection of two specific allergens,” DiCola said in an interview. “These two, used in combination, have shown that they can be used as a diagnostic for allergenicity. We don't need to monitor all 13 (allergens). If we're able to detect those two, we can have an idea of how allergenic the product is.”
TARRC is hoping to aim the kit at manufacturers in the industry either during or at the end of production, with the testing product utilized as a quality control system.
DiCola said there are two other assays used in many laboratories worldwide, but both have drawbacks. One detects the total protein, but she said this data can be misleading.
“We could have high protein but very little allergens,” she said. “Being high in protein doesn't mean you have high allergens. You might be overestimating the amount of allergens simply because the method is not appropriate.”
The other method is based on immune assay and detects four allergens, but like the other test, it is laborious and needs the support of a lab and equipment.
“Our test is very simple,” DiCola said. “It can run in 10 minutes, and you can have an answer. It's based on the same technology that is used for pregnancy tests—lateral flow technology.”
TARRC has been working on the Latex-T kit for about five years and will need at least another year of testing.
“It's still at the prototype,” she said. “We are fine-tuning it now. At the moment we need some more validation before we can put it on the market.”
Besides the IEC, TARRC and its Rubber Consultants unit exhibited the kit at the International Rubber Conference last summer in Nuremberg, Germany, and at a glove exhibition in Malaysia.
“Overall we can say the feeling is very positive,” DiCola said. “We are talking about it because we want to hear feedback and see if there is a market for it.”
The most common comment TARRC has heard is those wanting to know what are the two allergens being monitored, a question the research center won't disclose. “Then we're approached by many companies that want to buy the kit, but we have to tell them it's still a work in progress,” she said
Apart from producers, there also has been interest from distributors that import items from Asia and want to check to see if the product they are buying is rubber or vinyl. Companies looking to develop deproteinized latex also are showing interest so they can make sure there are no allergens left in their materials.
One thing TARRC still needs to do is simplify the kit, as the quantitative aspect of it is not really of interest to businessmen, DiCola said. “They just want to know if it passes or fails. Is it allergenic or not? So we have to fine tune that and establish what the threshold for allergenicity is. The next prototype will be very simple and have a pass or fail answer, just like a pregnancy test.”