Allergenic
Protein Levels Virtually “Undetectable”
Vystar has treated natural rubber latex using the patented Vytex™ Natural Rubber Latex (NRL) manufacturing process, and then analyzed the resulting material with both chemical and biological immunoassay tests. Over 500 tests were performed by the LEAP Testing Service of the Guthrie Foundation for Medical Research, an independent, highly respected analytical laboratory specializing in immunoassays of natural rubber latex for antigenic proteins. Vytex NRL has produced results on samples that are both "below detection" and "not detectable", and these results have been reproduced in subsequent tests.
Modified Lowry Test (ASTM D5712-05)
The Modified Lowry test has become the recognized national standard for measuring allergens in NRL. One early sample of natural rubber latex provided to the laboratory had a non-Vytex NRL manufacturing process measurement in the area of 750 micrograms of total protein per gram of natural rubber latex. The results of testing the Vytex NRL product produced readings that were "below detection" or below 28 micrograms of total protein per gram of NRL.
ELISA INHIBITION TEST (ASTM D6499-07)
A more specific assay to further define Vytex NRL is 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. This test is approximately 150 times more sensitive than the Modified Lowry test methods, and has a minimum level of detection of 0.2 micrograms per gram. Repeated tests reported an antigenic protein level less than 0.2 micrograms per gram for products made with Vytex NRL.
Test Results for Potential Medical Devices made with Vytex NRL
| Sample ID |
ASTM D6499-03 ELISA (ug/ml) |
ASTM D6499-03 ELISA (ug/g) |
ASTM D5712-05 Modified Lowry (ug/ml) |
ASTM D5712-05 Modified Lowry (ug/g) |
| Condoms |
b.d. |
< 0.2 |
b.d. |
< 47 |
| Surgical Gloves |
0.7 |
3.4 |
< 8.3 |
< 42 |
| Exam Gloves |
0.2 |
0.8 |
b.d. |
< 28 |
| Breather Bags |
b.d. |
< 0.2 |
b.d. |
< 42 |
| Probe Covers |
0.1 |
0.4 |
b.d. |
< 42 |
| Tubing |
b.d. |
< 0.2 |
b.d. |
< 42 |
b.d. - Below Detection
