Urine testing for drugs of abuse requires that fresh and unadulterated specimens are obtained, for without this even the most sophisticated assays are of no value. Witnessed collection is impractical and violates personal privacy. Recently issued Federal Guidelines specify procedures to decrease the likelihood of sample tampering, but the methods proposed have significant limitations. As an alternative to direct visualization, Franklin Diagnostics intends to develop a tamper-proof urine collection device that documents sample integrity, yet minimizes the invasion of an individual's privacy. This device will use Franklin's urinary thermometer technology to demonstrate freshness and a variety of solid phase reagents to detect chemical and enzymatic adulteration. Because a collecting device that ensures sample integrity currently does not exist, the proposed collector represents a significant technologic innovation. Its intended use in drug testing, a large and growing market, offers a clear commercial opportunity.
