Saliva Collection Device for Lab Based Testing

What is the importance of the patented “volume adequacy” indicator?

A collector with a volume adequacy indicator is the only way to unambiguously  meet SAMHSA guidelines (soon to become law) which spell out drug concentration cut-offs in oral fluids.   SAMHSA mandates similar cut-offs for other specimens.  However, when urine or blood is to be tested, variable volumes of sample can be collected but an exact volume is finally used in a test.  Oral fluid collection devices use a collection pad placed in the subject’s mouth.  The entire pad is then transferred to a tube containing an extraction buffer(solution) and an aliquot(exact volume) is used in the test.  It is obvious that If the amount of oral fluid on the collection pad is unknown, then the amount of diluted oral fluid used in the test is also unknown.  A collection device with a volume adequacy indicator enables the laboratory to use a known volume for the test as is done for urine or blood.  

Would placing the collection pad in the mouth for a fixed amount of time suffice for adequate collection?

No! This is method will not guarantee adequate collection and would violate SAMHSA guidelines.  There is a great variation in salivary flow within the general population.  Consequently, a fixed collection time would result in collection of variable sample volumes, the use of variable sample volumes in a test and an inability to determine whether the test result was truly positive or negative in accordance with SAMHSA.  Only a volume adequacy indicator ensures adequate saliva collection.  It is particularly important when saliva is to be collected from individuals with “dry mouth” syndrome or from individuals who have a vested interest in beating the test.  Individuals in the former group will provide insufficient saliva when fixed short collection times are used while individuals in the latter group attempt to repeatedly swallow their saliva to reduce the amount going into the test and thus the test shows a “false” negative.  Our studies with 322 first time users of the quantisal collector showed that the median time for collection of 1 mL of specimen was 3 minutes with the range being 2 to 10 minutes.

Who collects the specimen?

The specimen donor controls the collection process by placing the collection pad under their tongue. This is done under observation by the person in charge of collecting the specimens.  Hence oral fluids lends itself to gender independent observed collection of a specimen, eliminating the embarrassment and invasion of privacy issues associated with urine.

Does oral fluid have adulteration issues?

Observed collection makes it very difficult to introduce “foreign”  substances or substitute  the specimen. We have investigated the effect of  commonly ingested substances (food, beverages, over the counter medication and mouthwash) and found that they do not affect the end result.

What drugs can you detect in Oral fluids?

Currently, Quantisal collected specimens can be tested for the following drugs: Marijuana, Cocaine, Opiates including oxycodone, Amphetamines class including Ecstasy, PCP, Barbiturates, Benzodiazepines and Methadone.  The list will continually increase

How does oral fluid compare with urine in “window of detection” after drug ingestion?

A large study conducted by LabOne compared oral fluid with urine and concluded that  the positives rates were comparable.  Please read our “window-of-detection” flyer for additional information.

Where are the collected specimens tested?

Specimens collected with the Quantisal collector are sent to a laboratory where they are first screened by Enzyme Immunoassay (ELISA).  Subsequently, all positives can be confirmed by the GC-MS(identical methodology is used for urine confirmation).  Laboratory based screening is done with strict Quality control guidelines and procedures. Most laboratories are certified either by Federal or State regulatory agencies.

Why are the drug levels in oral fluid levels so low?

Oral fluid drug levels tend to correlate with blood levels of the drug (dependent on the Saliva/Plasma ratio for each drug). Urine generally contains excreted drug metabolites.  The body concentrates these metabolites in the urine and therefore urine drug levels are much higher.

Does OSHA classify oral fluid as hazardous?

Currently OSHA considers oral fluid to be non hazardous as long as the fluid is not tinged with blood.

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