VerOFy® I/II
VerOFy® is a unique platform technology that incorporates rapid and standardized saliva [oral fluid] collection with high quality immunochromatographic test strips providing a system for delivery of immediate results in field or point-of-care locations. The VerOFy® technology was originally developed for roadside drugs of abuse testing, but may be applied to a multitude of diseases, disease states or biomarkers for use in any setting where immediate results are required. The ease of use and simplicity of the test procedure makes the technology suitable for use in remote areas where laboratory facilities are not available, including the Developing World.
Specific applications under development include saliva tests for diabetes, breast cancer [detecting the protein Her-2 / neu], tuberculosis and immune response to anthrax.
How the VerOFy® Device Works
The VerOFy® Rapid, Oral Fluid Test Platform is a unique one step non-invasive point of care testing device. VerOFy® collects saliva from under the tongue by means of a proprietary absorbent material connected to either one or two immunochromatographic test strips located in the device housing and in fluid communication with the test strips. After approximately 1 to 2 minutes of saliva collection time a Sample Volume Adequacy Indicator built into the device changes appearance signifying that sufficient sample has been collected for testing. The device can then be removed from the mouth and allowed to run for an additional time (3-15 minutes depending upon the specific test). As for standard immunochromatographic tests, a line or series of Test lines will appear on the test strips depending on the diseases or analytes being tested. In addition a Control line will appear confirming the validity of the Test and the appropriate function of reagents used in the Tests. If a positive Test result is obtained and a confirmation specimen is required, this can be collected by squeezing the absorbent collection pad through a plastic compression tube provided (see diagram below) and into a standard 2 mL Eppendorf centrifuge (or equivalent) collection tube. Once collected this sample is capped then archived or sent to a laboratory for suitable confirmation testing. The VerOFy® device can be configured to include a single test strip for testing a minimum of one and maximum of four analytes simultaneously [VerOFy® 1] or up to eight analytes simultaneously using the VerOFy® 2 device, where two test strips are incorporated into the platform. The representation above shows the VerOFy® 2 configuration
The unique nature of the VerOFy® platform device enables a series of rapid, multiplex point-of-care tests to be developed at low cost, using saliva samples, with the opportunity for testing in the home or in an over-the-counter (OTC) environment.
Opportunities for Licensing / Partnering
Oasis Diagnostics® is open to licensing its technologies to broaden the applications available for salivary diagnostics to aid mankind. In addition the Company is always open to discussions on collaboration with potential partners with technologies synergistic with its own. Distribution enquiries are also welcomed. For information on any of these opportunities, please contact Oasis Diagnostics® by e-mail at info@4saliva.com or by phone at (360) 546-1563.
POSITIVE TEST RESULTS: A red line will appear in each of the Control regions of each of the test strips. If ANY of the other Test lines fail to appear, the level of that particular drug is above the detectable level of the test. As an example see the diagram above. In this particular case the subject is positive (over the detectable limit) for Cocaine (COC), Methamphetamine (METH), Phencyclidine (PCP) and Opiates(OPI).*NOTE: Many other outcomes are possible depending upon drugs ingested by the subject.
INVALID: If the Control line fails to appear on either strip, the test is considered invalid and the procedure should be repeated using a new test device. The most likely cause of this is insufficient sample volume or incorrect procedural technique. If the problem persists discontinue using the device and run an independent test
Features / Benefits of the VerOFy® Saliva Testing Device
- Non-invasive [saliva or urine] specimen
- Rapid
- Easy to use
- Sample Volume Adequacy Indication
- Confirmation specimen included
- Split-sample capability
- Multiple disease detection possible