By Brian P. Feeley, Current Consulting Group
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While oral fluid drug testing currently represents a minority of all workplace drug tests conducted in the United States, interest in oral fluid has been increasing since the release of the Substance Abuse and Mental Health Services Administration’s (SAMHSA’s) Mandatory Guidelines for Oral Fluid Testing (OFMG) in 2019. This was further bolstered by The U.S. Department of Transportation (DOT) announcing its allowance of lab-based oral fluid drug testing for covered agencies in 2023, although we are still waiting for two labs to be Department of Health and Human Services (HHS) certified for testing to officially start.
In the Current Consulting Group’s annual 2023 Drug Testing Industry Survey, over 45% of participating drug test providers indicated that they anticipate oral fluid testing as the specimen offered most in the future, with the same percentage indicating that urine testing would still be used in the future. In years past, these percentages were far more in favor of urine testing, the only method approved by SAMHSA and DOT since the late 1980’s.
The following is a brief list of the perceived pros and cons of oral fluid drug testing.
Advantages
- Accuracy — “Oral fluid provides the same scientific and forensic supportability of drug test results as the Mandatory Guidelines for Federal Workplace Drug Testing Programs using urine.”1
- Collections — May be conducted onsite at the workplace by non-professional collectors or in a laboratory setting. If needed, collector training is available online and collectors can begin collecting immediately after training.
- Offers flexibility — Samples can be collected anytime, anywhere and oral fluid can be implemented in combination with urine testing.
- Shy bladder — Eliminates intentional and unintentional shy bladder issues.
- Recent use detection – The detection of drugs in oral fluid occurs almost immediately after use, and drugs do not remain in the oral fluid for extended periods of time such as with urine testing. This makes oral fluid an ideal specimen for detecting very recent use, such as use immediately prior to or during the workday.
- Drug test cheating — Every oral fluid collection, if conducted properly, is 100% observed, eliminating most, if not all, traditional drug test cheating methods.
- Equal / similar positive rates compared to urine screening — Oral fluid cutoffs used for screening samples have been set at levels that yield very similar positive rates to urine testing.2 Now that SAMHSA has specified specific cutoffs for lab-based oral fluid testing, all certified labs conducting oral fluid testing will be required to use these standardized cutoffs, keeping the playing field level for all those conducting and using oral fluid testing.
- Gender collector issues are eliminated — Because oral fluid collections do not require a donor to use a bathroom stall, the collector and donor gender is not a consideration.
- Legally defensible — Lab-based oral fluid testing technology is reliable and accurate, thus making it legally defensible at the same level as lab-based urine testing. Oral fluid testing today is legal in 47 states. Lab-based oral fluid testing has been tested through the judicial system and has become victorious in most instances.
- Legal marijuana-friendly — With the onset of new legal marijuana laws, employers are increasingly pressed to identify only recent use of marijuana. Some states such as California & Washington even require employers to use drug testing methods that test only for the parent or psychoactive form of marijuana/THC and NOT the metabolite, which is detected using urine screening. Oral fluid tests for the parent or psychoactive form of THC making it an ideal solution for use in those states and others imposing similar laws in the future.
- Time savings — On-site collections significantly reduce time away from work for the donor and supervisor, improving productivity. Additionally, “… specimen volume [with oral fluid] is also much lower, saving time in collection… cost.”1
- Union-friendly — Unions have historically favored oral fluid testing because of the shorter window of detection with oral fluids and the less-invasive nature of the collection process.
Challenges
- Certified labs — Currently there are no labs certified to perform federally-regulated oral fluid tests; however, this is expected to change in 2025 as several laboratories are currently going through the HHS testing and certification process.
- Collectors — Prior to the OFMG, there were no federal standards for the collection of oral fluid samples. Even though oral fluid collections are much less complicated than urine collections, someone certified to collect urine samples is not automatically qualified to collect oral fluid samples. The new regulations require qualified collectors to be trained appropriately in addition to being trained on the proper use of any oral fluid collection device per each manufacturer’s standards. This is also underway in 2025 with one device that appears to be compliant with SAMHSA requirements.
- Inventory — The OFMG only permit the use of FDA-cleared oral fluid collection devices. Providers and end-users must maintain inventory of such devices either at the workplace or at an offsite collection facility, depending on where collections will take place and who will conduct the collections. For employers, this may add a level of complication to the drug test process that offsets some of the clear benefits of oral fluid testing.
- Not widely understood — Many individuals are not familiar with the science behind lab-based oral fluid testing. As such, adoption may start out slowly. However, even given that, SAMHSA projects a transition rate of 7% the first year after the implementation period and 25-30% by year four.1
- Panel options – Oral fluid testing does not have as many or as wide panel variations as urine testing. Companies that require medical professional panels may not be able to mirror the expanded panel with oral fluid testing early on, but it is likely that this will become an option as oral fluid becomes more widely adopted.
- State laws are complicated — Lab-based oral fluid is currently not permitted in three states, while eight states require compliance in whole or in part with federal regulations and still more recommend federal compliance. Additionally, many industry specific laws require federal compliance. With the release of the OFMG, these states’ laws will presumably permit lab-based oral fluid testing, if not already allowed due to federal compliance carve-outs.
- Window of detection — As stated above, oral fluid has a shorter window of detection compared to urine; hours vs. days. Some employers will continue to prefer a wider detection standard.
Conclusion
Clearly, with SAMHSA’s release of the OFMG and the new DOT rules, lab-based oral fluid testing is entering a new era, one in which it is reasonable to predict will result in a significantly larger share of the workplace drug testing market. SAMHSA’s decision to develop the OFMG and permit federal employers (and eventually DOT-covered employers) to use this technology is the biggest development in the drug testing industry since the original release of the government’s mandatory guidelines in 1988.
While it is true that lab-based and rapid/instant oral fluid testing will not replace urine testing, it promises certain advantages that may be ideally suited to coincide with the cultural changes occurring in society—widespread marijuana legalization and the drug testing limitations being legislatively forced upon employers in certain jurisdictions. It is safe to say that oral fluid testing is here to stay.
About the author: Brian Feeley spent 26 years at OraSure Technologies where he was a senior manager involved in the development, launch and implementation of the first FDA-cleared, laboratory-based oral fluid drug testing products (Intercept). Working with laboratory and TPA partners, Brian and his team introduced oral fluid drug testing to some of the largest retailers, manufacturers and other commercial entities in the U.S. in the early 2000’s. In the earlier part of his career Brian also worked in the laboratory, developing drug tests, giving him firsthand experience regarding the technical specifications and importance of assay performance of these tests.