Sovereign Silver Shows Superior Comparative Performance in New 3rd Party Assay.
Date: May 21, 2005
Antimicrobic Efficacy of Sovereign Silver and Six Competitive Products (performed by STS Duotek, an independent, FDA licensed, 3rd party laboratory)
A scientifically controlled adaptation of the internationally acknowledged, standard test method, the U.S.P. <51> protocol, was performed to evaluate comparative antimicrobial potency of several silver products. The study was conducted by an independent, FDA-licensed, pre-clinical testing laboratory and was supervised by that laboratory’s Quality Assurance Department.
In this study, Natural-Immunogenics Corp.'s Sovereign Silver demonstrated superior bactericidal performance vs. U.S.P. <51> challenge bacteria (S. aureus, E.coli, and P. Aerugenosa), compared with the performance of 6 competitive products included in this study..
This study was performed to determine the comparative antimicrobic efficacy of Sovereign Silver vs. six competitive products. The products tested were Source Natural Wellness ™, Source Natural Ultra ™, Silver Biotics ™, Future Biotics ™, Innovative Natural Products ™, and Mesosilver ™. The concentrations of silver in their products, as claimed by each manufacturer, are given below:
Materials and Methods
The study was performed, in its entirety, by STS Duotek Laboratories, Rush, N.Y. STS Duotek Laboratories is a pre-clinical testing laboratory registered by the FDA (F.D.A. Registration # 1316257) for performing Good Laboratory Practice (G.L.P.) Pre-Clinical Studies, overseen by the STS Microbiology Study Director.
The U.S.P. Antimicrobic Susceptibility Test (U.S.P. <51>) was selected as the base protocol because it is an acknowledged, standard procedure, recognized by the FDA for assessing the ability/efficacy of a substance to provide protection (i.e. kill and/or inhibit growth) against microbiological agents. The standard U.S.P. <51> test protocol defines representative micro-organisms as challenges to product antimicrobial performance. The defined bacterial representatives used in this study are listed below:
Natural-Immunogenics Corp. selected a total incubation period of only 90 seconds in order to provide a parameter which would permit product performance differentiation WITHOUT changing the proportions and/or concentrations of the reactants (i.e. microorganisms and product) of the U.S.P. protocol. All products were treated identically relative to microbial exposure, proportions, and microbial concentrations, plate counting, etc.
The results of the Negative Control preparation demonstrate that microbial growth/biochemical vigor of each of the microbial strains was not compromised. It is also apparent that different microorganisms are differently susceptible to silver products antimicrobial activity.
The table below shows the average number of each type of bacteria killed (of the original microbial challenge) after a treatment with each product for 90 seconds ±5 seconds. The higher the number, the more potent the antimicrobial activity of the product listed.
Reproducibility is ± 20%
The following charts illustrate the antimicrobial potency of the seven products in this study vs. each U.S.P. <51> challenge microorganisms (S. aureus, P.aerugenosa, and E. coli):
The entire test was approved and performed by an independent FDA-licensed pre-clinical testing laboratory and its Study Director, using a modification of the worldwide standard test method for evaluating antimicrobial effectiveness: the U.S.P. <51> test method. As explained previously, the protocol was modified slightly (with the approval of the independent laboratory’s study director) to differentially assess the ability of substances to serve as antimicrobial agents.
This uses only a 90 second exposure of individual products vs. standard microorganisms? It is a biochemical pharmacological truism that a product which is able to bring about its demonstrated effect more quickly is more potent/reactive. The principals in the field of pharmacokinetics and the massive supporting data in this field support this concept.
Perhaps the exposure time is atypical, but who REALLY knows how long reactive silver entities must be in direct contact for silver to be effective? This study points to the answer. For Sovereign Silver, it is only 90 seconds. For the competitive products… well… it must be longer.
The following conclusions may be drawn: