What
are the benefits of Oratect III®
It objective and easy to run. It can be performed on-site and provides
immediate answers. Oratect® II 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.
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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. In the future, benzodiazepines will also be
available.
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 cover from the device and while keeping head level, open
mouth and rub collection pad inside mouth against one cheek in a
circular motion twenty times. Still keeping head level, rub the
collection pad against the opposite cheek in a circular motion twenty
times. Next rub the collection pad on top of the tongue twenty times and
then underneath the tongue twenty 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. If a pink-purple
flow appears after 30 seconds, remove from mouth and cap the
device with the blue cap. Lay the device on a flat surface and read
results within 5 to 7 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.
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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.
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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.
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