Introduction

The Substance Abuse & Mental Health Services Administration’s (SAMHSA’s) released mandatory guidelines for oral fluid testing (OFMG) in 2019.¹ Recently the U.S. Department of Transportation (DOT) proposed an amendment to the transportation industry drug testing program regulations to include oral fluid testing.² This movement to oral fluid as an option for regulated drug testing  has many providers and buyers of drug testing interested in learning more about lab-based oral fluid drug testing and how oral fluid testing compares to urine testing.

Is Oral Fluid Testing Legal?

“Lab-based oral fluid testing has been used and accepted in the judicial system for a long time. The reason for acceptance is sound scientific technology behind lab-based oral fluid testing."

• The federal government — After 30 years of only permitting lab-based urine testing, SAMHSA published the final OFMG on October 25, 2019 in the Federal Register.³ These new guidelines establish a standard for conducting lab-based oral fluid drug testing in the Federally mandated testing programs. Acceptance of oral fluid as a test matrix in the regulated testing also has impact on non-regulated testing as the industry looks to Federal guidelines in establishing test program requirements. Oral fluid as an alternative to urine testing in regulated testing means that the employers in non-regulated space can adopt it as well. 
• Legal defensibility — Lab-based oral fluid testing has been used and accepted in the judicial system for a long time. The reason for acceptance is sound scientific technology behind lab-based oral fluid testing.⁴
• The Food & Drug Administration (FDA) — There are several FDA-cleared oral fluid collection devices and testing systems currently available. It is noteworthy that the new OFMG only permit the use of certain FDA-cleared collection devices with specific features. These features include but are not limited to a specimen volume adequacy indicator demonstrating sufficient volume is collected, ability to collect split specimen and components that ensure pre-analytical drug and drug metabolite stability.⁵
• Legal marijuana-friendly — Oral fluid testing detects the parent drug. For this reason, the window of detection for oral fluid begins within minutes of a person’s ingestion of a drug but only lasts for several hours (vs. days or longer for other specimens). This makes it possible for an employer to, at the very least, claim that a non-negative test result means the person may have used the drug recently. This aligns in a positive way with the current emphasis on “recent use” detection by a growing number of state laws and legislative proposals.

Is Oral Fluid Testing Accurate?

“Oral fluid drug testing is based on the same scientific principles and conducted using the same technology as urine. It is scientifically accurate."

• Science — In the OFMG, SAMHSA articulated several reasons why the agency chose to move forward with the development of lab-based oral fluid testing guidelines. Among these reasons was the science of lab-based oral fluid testing. According to the OMFG “The scientific basis for the use of oral fluid as an alternative specimen for drug testing has now been broadly established and the advances in the use of oral fluid in detecting drugs have made it possible for this alternative specimen to be used… with the same level of confidence that has been applied to the use of urine.”⁶
• Accuracy — Oral fluid drug testing is based on the same scientific principles and conducted using the same technology as urine. It is scientifically accurate. SAMHSA also stated that the OFMG provide the same accuracy and supportability of drug test results that follow the urine mandatory guidelines.⁷
• Cut-off levels — Under the OFMG, certified laboratories must use SAMHSA-approved cut-off levels designed to show the presence of drugs in a manner similar to the cut-off levels used for urine testing. The presence of a drug in oral fluid is measured in nanogram per milliliter (ng/mL) just as with urine. 
• Positivity performance — Oral fluid testing mostly detects the parent drug versus a metabolite of a drug. The parent drug is detectable in oral fluid almost immediately after a drug has been ingested, whereas drug metabolites take longer to become detectable. For this reason, oral fluid testing is considered ideal for detection of recent use. Conversely, because oral fluid testing has a shorter window of detection compared to urine, urine tests will capture positives for a longer period of time. The overall positivity rates for the two testing matrices are very similar.
• Split specimens — Split specimen collections are required under the new OFMG.
• Certified labs — Currently there are a number of labs certified by the federal government to perform oral fluid tests, though that number is constantly changing as more labs meet the relatively new requirements.⁸ Similar certification standards as those that apply to urine testing certification are required by the National Laboratory Certification Program (NLCP). These standards help to protect the integrity of the drug test process.
• Collectors — Prior to the OFMG, there was no federal standard for the collection of oral fluid samples. The new OFMG include specific training requirements in order to become an oral fluid collector for federal testing. Generally, oral fluid collections are much less complicated than other specimen collections. The new regs require qualified collectors to be trained in the details of the OFMG and in the proper use of each oral fluid collection device per manufacturers’ standards.
• Drug panel — Oral fluid testing can have limitations for the number of drugs as compared to urine testing. Companies that require medical professional panels, for example, may not be able to mirror such an expanded panel with oral fluid testing using immunoassay screens. The OFMG require testing for marijuana (THC) and cocaine, and permit testing for opioids, amphetamines, and PCP.

Is Oral Fluid Testing Practical?

• Flexibility — Oral fluid collections may be conducted on-site at the workplace by non-professional or professional collectors, or at off-site collection facilities. The OFMG permit flexibility in who conducts the collection and where the collection takes place.⁹
• Easy to administer — Oral fluid collections eliminate the need For special facilities.
• Drug test cheating — The OFMG state that every oral fluid collection is completely observed. The donor and the collector are always in sight of one another while the donor provides the sample, reducing the opportunity for drug test cheating.
• Gender collector issues —Because oral fluid collections do not require a donor to use a bathroom stall, the collector and donor gender is not a consideration, regardless of the reason for testing.
• Time savings — On-site collections significantly reduce time away from work for the donor and supervisor.
• Improved productivity — Oral fluid collections require less time and usually do not require individuals to be off the job for very long or away from the workplace. More time on the job means more productivity.
• Shy bladder — Oral fluid collections eliminate shy bladder issues.
• Custody and control form (CCF) — The OFMG require the use of the same federal Custody and Control Form (CCF) used for urine collections.