XALIVA^® THC

A: Our XALIVA^® THC test detects the presence of THC in saliva using a 10 ng/mL cut-off. Ricovr Healthcare’s underlying platform technology’s accuracy in detecting THC’s presence was validated to be 100% compared to the gold standard, mass spectrometry. This study was performed in collaboration with Rutgers University. Link

The sensitivity, specificity, and accuracy levels of the final version of the XALIVA^® THC test will all be clearly labeled and documented in the product materials enclosed with the XALIVA^® THC Device and the disposable Test Kit.

A: The XALIVA^® THC product is an immunoassay designed on Ricovr Healthcare’s novel optical detection technology platform. The platform utilizes microfluidic technology and requires only a small amount of saliva with a user-friendly workflow to detect the presence of THC in about 15 minutes.

A: Traditionally, screening for cannabis use in the workplace would test hair or urine samples. These sample types will detect past cannabis use; in the case of urine, this could be up to 30 days, and for hair, up to 90 days. The detection window of urine and hair is too long, which could cause employers difficulty retaining employees in the context of safe recreational or medical use outside of the workplace. Although not yet available, devices using breath collection can only detect use within about 2 hours; this detection window is too short to capture the window of cannabis impairment fully.

Saliva has emerged as the best sample for determining recent cannabis use. By using a 10 ng/mL cut-off for THC, the window of detection in saliva is about 10 hours. This aligns with the window of impairment, which lasts up to 8 to 10 hours or over the typical work day, helping to promote a safe workplace environment.

Sources:

J A Hubbard, et al. Biomarkers of Recent Cannabis Use in Blood, Oral Fluid and Breath, Journal of Analytical Toxicology, Volume 45, Issue 8, October 2021, Pages 820–828, Link

Danielle McCartney et al. Determining the magnitude and duration of acute Δ9-tetrahydrocannabinol (Δ9-THC)-induced driving and cognitive impairment: A systematic and meta-analytic review, Neuroscience & Biobehavioral Reviews, Volume 126, 2021:175-193. Link

A: XALIVA^® THC tests have a detection window that starts immediately after consumption and lasts for the entire impairment window, which can last up to 10 hours.

The illustration below is modeled on several peer-reviewed publications showing THC concentration in saliva over time. While concentrations of THC in saliva can vary from person to person, these studies show that oral fluid THC concentration follows this general trend over time.

The United States Substance Abuse and Mental Health Services Administration (SAMHSA) has set a 4 ng/mL saliva THC cut-off for the Department of Transportation (DOT) and federally regulated employees. Using a 4 ng/mL cut-off has a window of detection of about 20-24 hours; this longer window of detection may be suitable for DOT and federally regulated employees.

For non-federally regulated employees (non-DOT), a 4 ng/mL cut-off may be too strict in balancing safety and fairness. A 10 ng/mL cut-off is aligned with a window of detection of about 10 hours; this covers a typical working day and the window of impairment from consuming cannabis.

Thus, XALIVA^® THC rapid saliva-based testing enables an easy, cost-effective method for deterring cannabis use in the workplace.

Sources

McCartney, D, et al. Determining the magnitude and duration of acute Δ9-tetrahydrocannabinol (Δ9-THC) induced driving and cognitive impairment: A systematic and meta-analytic review, Neuroscience & Biobehavioral Reviews, Volume 126, 2021:175-193. Link

Lee, D. et al., Cannabinoid disposition in oral fluid after controlled smoked cannabis. Clin. Chem. 58, 748–56 (2012). Link

Lee, D. et al. Oral Fluid Cannabinoids in Chronic, Daily Cannabis Smokers during Sustained, Monitored Abstinence: Chem. 57, 1127–1136 (2011). Link

Milman, G., Schwope, D. M., Gorelick, D. A. & Huestis, M. A. Cannabinoids and metabolites in expectorated oral fluid following controlled smoked cannabis. Chim. Acta413, 765–770 (2012). Link

Vandrey, R. et al., Pharmacokinetic Profile of Oral Cannabis in Humans: Blood and Oral Fluid Disposition and Relation to Pharmacodynamic Outcomes. Anal. Toxicol. 41, 83–99 (2017). Link

Anizan, S. et al., Oral fluid cannabinoid concentrations following controlled smoked cannabis in chronic frequent and occasional smokers. Bioanal. Chem.405, 8451–8461 (2013). Link

Hoffman, M. A. et al., Blood and Oral Fluid Cannabinoid Profiles of Frequent and Occasional Cannabis Smokers. Anal. Toxicol.45, 851–862 (2021). Link

Swortwood, M. J. et al., Cannabinoid disposition in oral fluid after controlled smoked, vaporized, and oral cannabis administration. Drug Test. Anal. 9, 905–915 (2017). Link

A: Marijuana legalization has increased access, which has led to an increase in consumption during work hours. Similar to alcohol, marijuana impairment poses an inherent safety risk and increases the likelihood of workplace accidents and injuries.

XALIVA^® THC detects recent marijuana use on-site and provides employers with objective testing results to make more informed decisions on whether an employee is a safety risk.

A: It is crucial for employers and TPAs to stay current on the science and latest drug testing technology.  Urine tests detect past use, and if your team wants to detect historic marijuana use, then be sure that your team knows this. There are two main issues with the urine-based marijuana drug tests:

1. Adulteration refers to an individual cheating on a urine test. Most urine tests require privacy where the donor is unsupervised in the bathroom, while providing a urine sample allows for potential cheating. Fake urine is available for purchase or taken from someone else to pass the test. According to the Quest 2023 DTI report, the increase in substituted urine specimens in the general U.S. workforce, a population of over 5.5 million, increased by 633% (0.015% in 2022 versus 0.11% in 2023) or more than six times over one year from 2022 to 2023. Invalid urine specimens in the general U.S. workforce increased by 45.2% (0.31% in 2022 versus 0.45% in 2023).
2. The length of detection time for urine is well past the cannabis impairment window. This refers to the amount of time that marijuana is detected in urine and can range from a few days up to 30 days for cannabis. The window of impairment, on the other hand, refers to the length of time the psychoactive properties of cannabis affect the user and create a “high.” A comprehensive review of all impairment studies from Neuroscience Behavioral Reviews suggests that cannabis impairment can last 3 to 10 hours, making the urine test detect past use, not recent use (2).

Sources:

1. Workforce Drug Test Cheating Surged in 2023, Finds Quest Diagnostics Drug Testing Index Analysis of Nearly 10 Million Drug Tests. Quest Diagnostics, May 15^th Link.

2. Danielle McCartney, Thomas R. Arkell, Christopher Irwin, Iain S. McGregor, Determining the magnitude and duration of acute Δ9-tetrahydrocannabinol (Δ9-THC)-induced driving and cognitive impairment: A systematic and meta-analytic review, Neuroscience & Biobehavioral Reviews, Volume 126, 2021:175 193. Link