The Aria Diagnostics clinical team has successfully validated an oral fluid toxicology panel designed to provide an alternative testing matrix for clinical monitoring and compliance programs. This novel lab developed test (LDT) validation permits in-house oral fluid sample processing rather than through a ‘reference out’ approach, improving sample traceability, result turnaround time, accessioning workflow, and final result reporting format consistency.
Why Did We Do This?
Urine collection introduces practical limitations to clinics, including the need for restroom access, strict observation protocols, and gender-specific collection staff. For certain patient populations such as those with limited mobility, incontinence, minors, or telehealth participants, urine collection may not be practical or appropriate making an alternative to urine specimen collection a requirement for our supported facilities.
Oral fluid collection can be observed and reduces opportunities for specimen substitution or adulteration, making it ‘tamper-resistant’. Because oral fluid generally reflects more recent substance use, it provides useful information for assessing short-term compliance or recent toxicological exposure. OFT can be performed in virtually any clinical environment, including outpatient and telehealth settings, and does not require specialized collection infrastructure. (Rosen, D. et al., 2021; PubMed PMID 32343161).
Processing and Workflow Implications
The validated in-house assay was developed using a ‘dilute and shoot’ preparation protocol without solid-phase extraction (SPE) or other dedicated sample quality cleanup steps allowing for more consistent and accurate sample processing. This approach maintains analytical accuracy while reducing hands-on time, and consumable costs. Specimen validation testing was conducted with a trusted CAP/CLIA certified laboratory to confirm reliable detection and quantitation across the targeted drug classes limits of detection (LODs) commonly monitored in pain management and behavioral health settings. Oral fluid testing will continue to serve as a complementary testing option, as was previously the case, to all Aria supported facilities.