A pivotal step for oral fluid testing

Urine drug testing remains the standard technology for drug detection and is likely to retain its position for years to come. Yet a new set of federal guidelines that are wending their way through the review process could set the stage for significant growth in use of the alternative of oral fluid testing in a variety of settings, including specialty addiction treatment.

Although the proposed guidelines issued in May by the Substance Abuse and Mental Health Services Administration (SAMHSA) will directly apply only to lab-based oral fluid testing for federal workplaces, there are several reasons why final approval of the guidelines is expected to have an impact beyond that realm. From a practical level, many state statutes governing drug testing practices defer to federal guideline language. In addition, testing environments such as addiction treatment centers already are somewhat ahead of the workplace market in exploring alternative drug testing technologies, and the presence of actual federal guidelines for oral fluid testing could fuel interest even more.

“The guidelines will serve to paint lab-based oral fluid testing in a positive light,” says Bill Current, a Florida-based consultant who regularly surveys trends in the drug testing industry and in state laws governing testing procedures.

Recent history

Some veterans of the testing and treatment industries might be surprised that the field is talking of introducing guidelines for lab-based oral fluid testing as late as this. It appeared in the mid-2000s that SAMHSA was preparing to include oral fluid testing and other alternatives to urine testing in federal workplace testing programs (the first federally approved oral fluid test had reached the market by the beginning of that decade). But the Department of Health and Human Services (HHS) concluded at the time that research evidence of the alternatives' effectiveness was too limited.

The research base has expanded since then, and there appears to be wider acceptance of some of the benefits of oral fluid testing, such as the ability to detect traces of drugs in saliva within one hour of drug use.

Current says that once the guidelines that were published last spring are finalized and the federal Department of Transportation (DOT) and Nuclear Regulatory Commission (NRC) formally adopt oral fluid testing procedures, this will serve as a catalyst to use of oral fluid testing elsewhere, such as at the state level in states with drug testing statutes that defer to federal language. Eventually, “You're going to see a wide impact in the non-mandated [testing] arena,” he says.

Current, who has delivered presentations sponsored by leading oral fluid testing company OraSure Technologies, has stated that the future of drug testing cannot look exactly like its past, given the privacy concerns that occupy the minds of many in regard to urine testing. “Now you'll be looking at another testing method embraced by the federal government,” he says. “You will see a lot of markets open.”

Still, that likely will unfold gradually. The federal government's own projections state that in the immediate term, oral fluid testing is likely to capture only about 7% of the regulated drug testing market. Urine testing still dominates the workplace testing arena. However, looking out four to five years from now, Current says that SAMHSA projects the share of under 10% oral fluid testing in the regulated market could grow to 25 to 30%.

Current says he sees evidence of a changing tone about oral fluid testing in the industry surveys he conducts. Whereas comments about oral fluid testing used to go along the lines of, “I thought it would really take off, but it hasn't,” a more common statement today is, “Once the feds approve this, it will take off,” he says.

Guidelines' comment period

The two-month period for submitting comments on the federal guidelines for lab-based oral fluid testing expired in mid-July (the guidelines do not apply to point-of-service testing). Most of the commenters offered general support for the guidelines, although one point of contention centered around cutoff levels for THC to determine positive tests for marijuana. Some commenters want a stricter standard that would function to capture more positives, says Current.

Once SAMHSA routes the guidelines to a number of federal agencies for their review, the expectation is that final guidelines could be published in the Federal Register around April 2016. That would be followed by an implementation period unfolding over one to two years.

Current explains that one of the most significant benefits to the field that has emerged from this process relates to the language used in SAMHSA's issuance of the proposed guidelines. In describing the oral fluid technology's benefits, particularly from the standpoint of the window of detection, “The document really made the case for lab-based oral fluid testing,” he says.