Intercept, a lab-based oral fluid drug test from OraSure Technologies Inc.

Alternative Specimens Not Added to Federal Drug Testing Programs

Proposed revisions that would have allowed drug testing based on hair, oral fluid, and sweat patch specimens and point-of-collection testing of urine specimens in federal workplace drug testing programs aren't ready to go forward, SAMHSA announced in final revisions published in the Federal Register. The agency said "significant issues have been raised by Federal agencies during the review process which require further examination, and may require additional study and analysis."

HHS, the Substance Abuse and Mental Health Services Administration's parent agency, "plans to issue a notice in the Federal Register requesting information and assistance from the general public to provide or identify data and research findings that address specific areas of interest," it said.

The final revisions expand the use of urine testing, however, and establish new procedures for ensure its reliability and accuracy. And they expand the use of urine testing to cover substances including:

  • 3,4-methylenedioxymethamphetamine (MDMA, “Ecstasy,” or “Adam”)
  • 3,4-methylenedioxyamphetamine (MDA or “Love Drug”)
  • 3,4-methylenedioxyethylamphetamine (MDEA or “Eve”)

The agency said the performance of alternative specimens in pilot performance testing has improved over time, but three areas of concern remain. "First, the data from the pilot programs to date show that not all participants have developed the capability to test for all required drug classes, nor to perform such tests with acceptable accuracy. Second, some drug classes are more difficult to detect than others, for any given type of specimen. Third, the specific drug classes that are difficult to detect vary by type of specimen. As a result, it will require additional study to assist agencies in determining how to select the appropriate type of specimen to be collected from a specific donor, when the use of a specific drug is suspected. Nevertheless, HHS believes that the addition of alternative specimens to the Federal Workplace Drug Testing Program would complement urine drug testing and aid in combating the risks posed from available methods of suborning urine drug testing through adulteration, substitution, and dilution. Thus, HHS will continue to pursue testing using alternative specimens. HHS anticipates issuing further revisions to the Mandatory Guidelines addressing the use of oral fluid, sweat patch, and hair, and the use of {point of collection testing) devices for urine and oral fluid. These revisions will be published in the Federal Register, with opportunity for public comment."

It will take at least one year for manufacturers of test kits to modify them to meet the expanded program, and it will take HHS-certified laboratories at least one month to validate and implement the new test kits, according to SAMHSA. Then, it will take two to three months for the National Laboratory Certification Program to challenge the HHS-certified laboratories with performance testing samples to ensure that the kits and test results satisfy the required performance criteria.

The agency's contact for more information is Donna M. Bush, Ph.D., of the Division of Workplace Programs, CSAP, in Rockville, Md. (phone 240-276-2600, e-mail donna.bush@samhsa.hhs.gov.

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