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1. SPECIMEN
Q: How is the sample collected?
A: The donor actively swabs the inside of the mouth and the top of the
tongue. As soon as the sponge softens slightly, gently press the sponge between
the tongue and teeth to ensure complete saturation (about 3 minutes).
2. TEST DETECTION
Q: Is this a FDA approved test?
A:
Forensic Use Only devices are not intended by the
manufacturer to be used for any in vitro diagnostic applications and are clearly
labeled and marked "For Forensic Use Only" or equivalent. Such devices are to
be sold to court systems, police departments,
probation/parole offices, juvenile detention centers, prisons, jails, correction
centers and other similar law enforcement entities, or to laboratories
performing forensic testing fore these entities. This saliva test is for
Forensic or Investigational Use Only.
Devices or products listed on the
TestSymptomsathome.com website as "Forensic Use Only" are not FDA 510(k) cleared
and should not be distributed or used for in-vitro medical diagnosis, cure,
mitigation, treatment purposes, prevention of disease or illness. These
products should not be distributed for “at home” or “over-the-counter” sales in
the U.S. or its territories nor are they intended to be marketed or sold to end
users via the Internet.
Q: What drugs does the device detect and at what cutoffs?
A: Amphetamine, Cocaine, Methamphetamine, Opiates, Marijuana, and
Phencyclidine.
Q: What is the detection window compared to other drug testing methods?
A: Saliva and blood have similar detection windows. Testing saliva/blood
will detect drug use faster than testing urine. Saliva/blood may detect drug
ingestion immediately while drug detection in urine may take 6-8 hours post
ingestion.
Q: What is a lateral flow device?
A: The oral fluids test is based on competitive binding. Drugs that may be
present in the oral fluid specimen compete against their respective drug
conjugate for binding sites on their specific antibody. During testing, a
portion of the oral fluid sample migrates across the membrane. If no drug is
present above the cutoff, the sample will not saturate the binding sites of its
specific antibody. The antibody will then react with the drug-protein conjugate
and a visible colored line will show up in the test line region. The presence of
a drug above the cut-off concentration will saturate all the binding sites of
the antibody and a line will not form in the test region. The lateral flow is
the migration and competition across the membrane.
Q: Does the test quantify the concentration of drugs present in the oral
fluids sample?
A: A positive test result does not indicate the concentration of drug in the
sample. All positive results are presumptive and should be confirmed by an
alternate method (e.g. GC/MS or GC/MS/MS). Negative results may not necessarily
indicate a drug-free sample. Drug may be present in the sample below the cutoff
level of the assay.
3. TEST PROCEDURE
Q: If the donor has a dry mouth, can they have a drink of water?
A: Yes. A drink of water may be given to the donor. It is best to wait for
about 10 minutes after the drink before attempting another collection.
Q: What type of drug testing is this test best for?
A: Everyone can benefit from using our oral fluids test device particularly
workplace and criminal justice segments.
4. INTERPRETATION
Q: How do I know the test device is working properly?
A: A control line will be present if the test is working properly.
If a control line does not appear, repeat the test. Insufficient specimen volume
or incorrect procedural techniques are most likely the reasons for control line
failure. Review the procedure and repeat the test using a new device.
Q: Can the test be adulterated?
A: The test is virtually impossible to adulterate. Make sure the donor has
not eaten or had anything to drink for a minimum of 10 minutes prior testing.
Q: How do I know if the test is negative?
A: Red lines appear in the control region (C) and next to each particular
drug name in the test region. The negative result indicates that the drug
concentration is below the detectable level. The shade of red in the test region
will vary, but it should be considered negative wherever there is even a faint
pink line.
Q: How do I know if the test is positive?
A: Red lines appear in the control region (C). No line appears in the test
region next to a particular drug name. This positive result indicates that the
drug concentration is above the detectable level. All positive results are
presumptive and should be confirmed by an alternate method (e.g. GC/MS or
GC/MS/MS).
Q: What if the test line is very faint?
A: The shade of red in the test region will vary, but it should be
considered negative wherever there is even a faint pink line.
Q: What should I do if the test results indicate a positive?
A: Refer to your Drug Free Policy for guidance on this subject.
5. STORAGE
Q: What is the shelf life?
A: The test has a shelf life of 18 months.
Q: What is the storage temperature?
A: Store as packaged in the sealed pouch at 2-30°C (36-86°F)
Click here for Drug Testing Supplies such as test cups, transport vials, adulteration tests, and latex gloves and masks.
Click here for a book on how to treat teens with drug use problems.
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