Center for Substance Abuse Prevention, "An evaluation of Non-Instrumented Test Devices"
January 29, 1999:
The Department of Health and Human Services (HHS) published in the Federal Register on April 11, 1988, the Mandatory Guidelines for Federal Workplace Drug Testing Programs. The Mandatory Guidelines detail comprehensive standards for laboratory procedures, specified drugs for which Federal employees can be tested, and established appropriate standards and procedures for periodic review of laboratories and criteria for certification of laboratories engaged in urine drug testing for Federal agencies. The Mandatory Guidelines were revised on June 9, 1994, but the basic requirement for laboratory testing was not changed. In addition to covering the testing of Federal employees in the Executive Branch of the Federal government, the Department of Transportation requires its regulated industries to use HHS certified laboratories.
During the past few years, there has been a rapid expansion in the private sector to test for the presence of illicit drugs in other biological specimens (such as, sweat, oral fluid, and hair) as well as the use of on-site urine drug test devices. Approximately 2 years ago, the Division of Workplace Programs (DWP) began a review of the testing of alternative specimens and the use of on-site test devices. As part of the review, DWP funded Duo Research, Inc., to conduct a study to evaluate the performance of on-site drug testing devices currently being marketed. This study was actually a second study of 15 new or modified on-site test devices that had been originally evaluated for the Administration Office of the U. S. Courts in 1996. As in the first study, this study focused on the testing of specimens clustered above and below the cutoffs, specimens that were clearly negative or positive, and known quality control samples.
This study is not intended to make recommendations for specific products, but to provide a general assessment of the performance of currently available non-instrumented drug test devices.
Rapid Drug Screen:
The device is a cup and a separate card containing the individual test strips. It is packaged in a sealed pouch. Expiration dates are stamped on the pouches. The devices are well labeled, with clear result designations and areas for donor ID and date. The device includes a "control" or validity check. The test requires the insertion of the test card through a slit in the lid and into the specimen. Results can be read within 3 minutes, but should be read within 8 minutes. The endpoint for a positive result is the absence of a line at the test band windows. Manufactured by American Biomedica Corporation.
