Natural rubber latex that has been subjected to the patented Vytex® Natural Rubber Latex (NRL) manufacturing process has been validated over and over through independent laboratory testing and analysis with both chemical and biological immunoassay test standards issued by the American Society of Testing Materials (ASTM).
Over 500 tests of Vytex NRL have been performed by the LEAP Testing Service of the Guthrie Foundation for Medical Research, an independent, highly respected analytical laboratory specializing in immunoassays of NRL for antigenic proteins. Additionally, several manufacturers using Vytex NRL have performed their own versions of these tests with the same results. Products made with Vytex NRL consistently achieve both “below detection” and “not detectable.” These results have been replicated time and time again.
Additionally, tests frequently indicate that Vytex NRL products demonstrate better resistance to aging when compared to products made from Hevea natural rubber latex and have a cleaner, more translucent quality than traditional latex due to the removal of the proteins and other impurities prone to breakdown over time. The benefits of this process can be attributed to the Vytex NRL process which provides manufacturers with a compelling consumer benefit and a unique and powerful point of differentiation.
MODIFIED LOWRY TEST (ASTM D5712-05)
The Modified Lowry test is the recognized national standard for measuring total proteins in natural rubber latex. The Modified Lowery has been standardized as an ASTM test method – D5712-05, for the analysis of protein in NRL and is recognized by the FDA for determination in medical gloves.
Products made with Vytex NRL typically test “below detection” or below 28 micrograms of total protein per gram of natural rubber latex.
ELISA INHIBITION TEST (ASTM D6499-07)
To further validate Vytex NRL, Vystar performed the ELISA Inhibition test (ASTM D6499-07), which is an immunochemical test applied to rabbit and human tissue and measures more precise levels of antigenic protein vs. the total proteins determined through the Modified Lowry test. This test is approximately 150 times more sensitive than the Modified Lowry test methods with a minimum level of detection of 0.2 micrograms per gram. Products made with Vytex NRL report very low levels of antigenic proteins using this highly sensitive test method.