FAQ

ImmunoScience, Inc.

Frequently Asked Questions – Salivax™

How does Salivax™ work?

Salivax™ works by detecting antibodies to HIV and various other diseases present in saliva by means of a process that highlights these antibodies into visually distinguishable color.

If HIV cannot be transmitted via saliva, how can you detect it from saliva?

Transmission of HIV requires a live virus or virus containing cell. What Salivax™ does is detect antibodies to the virus not the virus itself.

Why is it so difficult to make a diagnosis from saliva?

Saliva is a very difficult medium. It varies from person to person and also in the same person depending upon the state of hydration. It is also contaminated with food particles, tobacco, betelnuts, khat and residues of candy etc. Moreover, the concentration of antibodies in saliva is only about 1/800^th that of blood. So the tests have to overcome a great deal of etchnological difficulties to be accurate.

How accurate is Salivax™?

Salivax™-HIV and Salivax™-Syphilis are as accurate as any rapid blood tests. The sensitivity and specificity are about 99.5%.

How do you make the test so accurate?

ImmunoScience uses proprietary antigens for detection by using a process that is held as a trade secret. In addition, the test uses adequate volumes of saliva to produce the desired accuracy.

Is Salivax™ patented?

The inner workings of Salivax™ are held as trades secret to prevent unauthorized duplication. Once a patent is applied for it is published by the World Intellectual Property Organization (WIPO) thus making all the tricks of the trade public. It is then very easy for a lot of unscrupulous entities to copy. ImmunoScience has chose to hold the technology as a trade secret (similar to the formula for Coca Cola) to prevent such copying. Some parts of the test have patent applications pending.

Is it approved for sale anywhere?

Salivax™-HIV and Salivax™- Syphilis are approved for sale in The Russian Federation, Ghana, Nigeria, South Africa and several other countries. Applications are pending in over 17 different jurisdictions at the moment.

Is it approved by the United States FDA?

As of this writing, the US FDA has not approved any rapid tests for diagnosis of HIV. The concerns of the US FDA are expected to change due to a new way of thinking brought about by the Centers for Disease Control (CDC) and other institutions. The concerns have nothing to do with the technological accuracy of the tests but have more to do with other factors such as adequate counseling and follow-up of those found to be positive. Once the FDA becomes more receptive to the changing climate, ImmunoScience plans to apply for an approval promptly.

How expensive is Salivax™?

Compared to standard blood tests, when one accounts for equipment, labor, blood-drawing materials and risk, Salivax™ is considerably less expensive. It is also non-invasive, making it ideal for use in a variety of environments.

What other Salivax™ tests are you working on?

ImmunoScience is currently involved in developing Salivax™ tests for Hepatitis B & C, Tuberculosis, Drugs of Abuse and Helicobacter pylori. These tests shall be introduced in the market as soon as they are ready.

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Please note that ImmunoScience's products are the subject of many US and International patent applications. This document does not convey any rights to develop, manufacture, use or sell anything described herein.