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FAQs about Oratect® III
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Questions concerning Oratect® III Oral Fluid Drug Screen Device
What are the benefits of Oratect® III?
It's objective and easy to run. It can be performed on-site and provides immediate answers.
Oratect® III is a one-step process. There is no sample handling or any instrumentation
required. It is easy to monitor and does not require gender-based observation. If there is a presumptive
positive result, confirmation can be performed on the same sample.
Oral fluid will provide immediate information about the drug status of the subject. Results will show up
in the oral fluid more rapidly than other samples such as urine.
How does the Oratect® III Oral Fluid Drug Screen device work?
The Oratect® III Oral Fluid Drug Screen Device was developed to detect active
drugs-of-abuse present in oral fluid. It is a one-step lateral flow immunoassay device for the qualitative
detection of drugs of abuse. The device will indicate if the sample is negative
or presumptive positive. If the test is presumptive positive, further testing is
indicated.
What is a lateral flow device?
The Oratect® III Oral Fluid Drug Screen Device is based on a competitive immunoassay
procedure in which a membrane with immobilized drug derivatives compete with the drug(s) present in oral
fluid for limited binding sites on the colored colloidal gold antibody conjugates. During the test, saliva is
collected at the collection pad and migrates across the membrane. If no drug is present, the colored colloidal
gold conjugates will bind to the drug derivatives on the membrane to form visible bands at specific test regions.
If a drug is present, it will bind with the colloidal gold antibody conjugate and prevent the latter from
binding with the membrane drug derivative, so no drug band will be formed. The lateral flow is the migration
and competition across the membrane.
What drugs does the device detect?
The test device will detect the most commonly used drugs including amphetamines, cocaine, marijuana,
methamphetamines including MDMA (Ecstasy), opiates, and PCP or benzodiazepines.
How do I ensure the test is working correctly?
The device is easy to use. The test donor should not eat, drink, or smoke for a minimum of 10 minutes
before testing. The test donor should remove the cap from the device and while keeping head level, open
mouth and rub collection pad inside mouth against one cheek in a circular motion several (approximately 15-20)
times. Still keeping head level, rub the collection pad against the opposite cheek in a circular motion several
(approximately 15-20) times. Next rub the collection pad on top of the tongue several (approximately 15-20)
times and then underneath the tongue several (approximately 15-20) times. Make sure the test donor
does not chew, suck, bite or bend the collection pad. Afterwards,
place the collection pad underneath the tongue to collect saliva, making sure the donor holds the device in
place with hand. Once the blue lines begin to flow, remove the device from mouth and re-cap the device. Lay the device on a flat surface and read results within 5 to 30
minutes. The control band must be present for the test to be valid.
How accurate is the test?
Oratect® III has been shown to be greater than 97% accurate when compared to laboratory
based screening and confirmation testing.
How will I know if the oral fluid is presumptive positive for drugs?
The test provides a rapid on-site result. When a subject tests presumptive positive for a particular
drug, there is no band at the drug line. Please note that the control band must be present for the test to be
valid.
Is it possible to adulterate the test?
It is very difficult to adulterate the test. Make sure the subject has not eaten or had anything to
drink for a minimum of 10 minutes before testing.
Can false positive results occur?
Any screening test can give a "false positive" result. Confirmation testing verifies presumptive positive
results and rules out other potentially interfering drugs that might have caused a presumptive positive result.
Can false negative results occur?
There is less chance to find a false negative result with an oral fluid sample than with a urine sample
because of the availability of urine adulterants on the market. In the case of the urine tests, there are
adulterant tests to eliminate false negatives. For oral fluid testing, the chance of false negative results
is very low as long as the test subject does not smoke, eat, or drink for a minimum of 10 minutes prior to
testing.
Can I use the original sample for confirmation?
Yes, the original collection pad can be sent to various laboratories for GC/MS confirmation. It is
achieved by detaching collection pad from the device using the Oratect® III cap. Drop the
collection pad from the cap into the vial of buffer fluid included in the kit. Send to a certified lab for
confirmation.
