Regulatory Approval for the OLFACT Test Battery
DESCRIPTION (provided by applicant): The major objective of this application is to develop clinical tests for the assessment of olfactory function which are not only sensitive and economical, but can also be administered via the World Wide Web (WWW). The tests will incorporate state-of-the-art Micro-Electro-Mechanical Systems (MEMS) microvalves, which are small, inexpensive, discrete devices produced using techniques analogous to those used in manufacturing integrated circuits. The microvalves will form the basis of the MEMS olfactometer, a small, relatively inexpensive device capable of producing up to 64 discrete odor stimuli. Moreover, the MEMS olfactometer will have the capacity for generating the stimuli for a large number of trials (>100), and will be able to replenish this capability by replacing inexpensive odor cartridges. The tests selected for development are: 1) an odor identification test; and 2) a detection threshold test. The tests will be called the OLFACT (Olfactory Function Assessment by Computerized Testing) and OLFACT-RL, respectively. A single MEMS olfactometer can generate the stimuli for both tests. Additional tests, e.g., discrimination and odor memory tests, will be developed in the future, employing the same olfactometer. The presentation of the test items, along with scoring of the test and recording of all pertinent data, will be totally computerized. To facilitate the design and programming of the tests, stand-alone versions, i.e., controlled by a local computer, will be constructed first. Once this has been accomplished, standardized norms for the tests will be developed and compared with norms already available for other commercial tests. Finally, the tests will be enhanced to run on the WWW as Web applications. Once a MEMS olfactometer has been purchased and connected to a computer, all transactions, including the purchase (authorization) of tests as well as payment, can then be conducted over the WWW. The development of the OLFACT tests will provide the clinician/researcher with tests that are more economical than current tests, while offering far greater utility.
* information listed above is at the time of submission.