Oral Specimen Collection Device Developed for High-Throughput Laboratories

An oral fluid-sample device is used to collect high-quality oral fluid specimens for high-throughput laboratory testing.

The Aware Messenger oral fluid-sample collection device uses an untreated, soft, tasteless swab and takes only 15-20 seconds to collect a sample rich in oral mucosal transudate. The device yields a large quantity of sample that is ready for testing without additional processing by the testing laboratory, either immediately upon receipt, or later at a remote testing laboratory. Unlike other oral fluid collection devices, the swab contains no salts, animal proteins, or other additives that can interfere with assays or cause an adverse taste. Additionally, the sample buffer used in the system is formulated with immunoassay friendly components at appropriate levels facilitating assay optimization and improving performance.

Collecting a sample with the Aware Messenger device involves a simple back and forth wipe of the upper and lower gum line with a swab, which is then placed into a buffer tube. The swab is expressed into the tube and discarded immediately after use. The tube containing the sample can then be delivered to the laboratory where the sample can be immediately and directly used in a suitably validated assay without processing, or stored for batch testing later.

The Aware Messenger oral fluid collection system is derived from the collection system developed for Calypte Biochemical Corp.'s (Portland, OR, USA) Aware human immunodeficiency virus (HIV)-1/2 rapid test where it has been extensively field tested and demonstrated its capability to consistently collect a quality, IgG-rich oral fluid sample.

"We developed the Aware Messenger device in response to inquiries from several of our U.S. and international customers who requested a safe, simple, and cost-effective alternative to currently marketed sampling devices. In addition, the device will meet the sample collection needs of potential customers who are seeking an alternative to blood testing but still prefer the advantages of high volume batch testing provided by traditional diagnostic methods such as [enzyme immunoassay] EIA,” stated Roger I. Gale, Calypte's president and CEO.

The current device is generic, and it will require user validation for each individual application for diagnostic use by the laboratory. A constantly growing body of literature supports the use of oral fluid specimens as an accurate alternative to blood for the testing for antibodies, antigens, drugs, and genetic testing.

Calypte Biomedical is a healthcare company focused on the development and commercialization of rapid testing products for sexually transmitted diseases that are suitable for use at the point-of-care and at home. The company believes there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in developing countries lacking the medical infrastructure to support laboratory-based testing.


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