Oral Fluid Q & A
Is ORAL• screen™ legally defensible?
ORAL• screen™ is a screening test. All screening tests (oral fluid, hair, and urine) are recommended to have positives confirmed using GC/MS. Confirmation using GC/MS has been challenged in court and is legally defensible.GC/MS is the only certain measure of illegal drug use.
Do you need to confirm a positive? How?
It is recommended. A positive on a screening method like ORAL• screen™ only confirms that the class of drug has been used. It does not identify whether that specific drug was illegal or prescribed. We offer GC/MS confirmation using either oral fluid or urine.
How does ORAL• screen™ correlate to urine?
ORAL• screen™ correlates well to urine tests. However, there will be some samples that differ, since ORAL• screen™ can detect drugs immediately after ingestion, it is possible to get positives before the drug metabolizes and shows up in urine. For this reason, ORAL• screen™ is a better indicator of influence (i.e. the drug effects are still being felt by the user). Urine typically indicates past use.
What are the cutoff values and how do they compare to urine?
Drug concentrations and the related cut-off levels, are different in urine and oral fluid. The ORAL.Screen (TM) test is more sensitive to accommodate the lower cut-offs necessary for accurate saliva testing.
What are the windows of detection for ORAL• screen™ ?
Opiates: From time of ingestion for 48 to 72 hours
Cocaine: From time of ingestion for 48 to 72 hours
THC: One hour after ingestion, for up to 14 hours
Methamphetamine and Ecstasy (MDMA)*: From time of ingestion for 48 to 72 hours
*Ecstasy comes up under the Methamphetamine screen.
Is ORAL• screen™ approved for DOT?
The DOT has not yet approved any on-site screens for drug testing. Saliva alcohol screens are DOT approved. However, SAMHSA guidelines are being reviewed to include oral fluid and on-site tests as acceptable to DOT. At that time, we anticipate ORAL• screen™ will be approved for use by the DOT.
How long does ORAL• screen™ take to run?
The sample is collected in 2 minutes. The test is completed in 15 minutes after sample completion
What does a positive and negative result look like?
A negative result is indicated by the appearance of a red/pink line. A positive result is indicated if no line develops.
ORAL• screen™ costs more than my current test. How can I justify the higher cost?
True, the unit price is more expensive than urine. However, more often the total cost for running urine is much higher than ORAL• screen™. When calculating the total cost you need to include the following:
Collection site fee: ORAL• screen™: = None - Urine: varies, but often $10 - $30
Cost of time to collect sample: ORAL• screen™: = Minutes - Urine: minutes to hours, especially when donor is unable to immediately void.
Bio-Hazard Related Costs: ORAL• screen™: = None - Urine: Can be a significant cost due to spills, etc.
Time to wait for result: ORAL• screen™: = 15 minutes - Urine: Immediate with instant kits; hours to days with labs
Gender specific personnel costs: ORAL• screen™ = None - Urine: Can be major cost, especially when "observed urines" are required. Even "supervised urines" can be a problem.
Cost related to adulteration/substitution: ORAL• screen™ = None - Urine: Often a problem, resulting in higher costs, particularly if the urine test is defeated by a sophisticated drug abuser.
What about FDA clearance?
Approximately 75-80% of the drug testing market does not require FDA clearance. This market requires a product approved for forensic use and ORAL• screen™ is approved for forensic use. Only clinical users(hospital and doctors offices) require an FDA cleared product. ORAL• screen™ will be submitted to the FDA and clearance is expected in late 2000 or early 2001.
