OralTox® Certified Training


This certified training program is intended to provide drug test administrators information to better understand the OralTox product and testing procedure. Please read through all of the information within this training program. After completing the training portion, you may test your knowledge with our online certification quiz. Once you have successfully passed the quiz with 100% accuracy, you will receive a personalized certificate of training which you can print for your records.

Procedure Video


Product Overview


OralTox is a lateral flow immunoassay, rapid oral fluid test for simultaneous detection of up to 12 drugs. OralTox is FDA 510(k) cleared for the following 8 drugs: Amphetamine, Cocaine, Marijuana, Methadone, Methamphetamine, Opiates, Oxycodone and Phencyclidine.

Product Features And Benefits


  • 510(k) cleared for AMP/COC/MET/MTD/OPI/OXY/PCP/THC
  • Ability to detect up to 12 drugs simultaneously
  • Oral fluid held in airtight chamber for confirmation
  • Customizable panel configurations to test for multiple combinations of drugs
  • Prevents adulteration with all collections observed
  • Less invasive means of drug testing
  • No shy bladder issues, collection takes only minutes
  • Saturation Indicator changes color when sufficient oral fluid is collected
  • Easily performed procedure involving NO MESS
  • Crystal-clear container with magnification of the results window
  • Unique QR code tied to device

Drug Concentrations


The “Cutoff Level” is the concentration level established as a break-point or threshold for labeling a result positive or negative (e.g. 40ng/mL THC or 20ng/mL COC). The concentration of a drug is expressed in nanograms (ng) per milliliters (mL) or ng/mL. One nanogram is equal to one billionth of a gram and 1mL is equal to about 1/30 of a fluid ounce.

AMP-Amphetamines50ng/mL
BAR-Barbiturates*50ng/mL
BUP-Buprenorphine*5ng/mL
BZO-Benzodiazepine*10ng/mL
COC-Cocaine20ng/mL
COT-Cotinine*
30ng/mL
FYL-Fentanyl*10ng/mL
K2–K2/Spice*30ng/mL
KET-Ketamine*30ng/mL
MET-Methamphetamine50ng/mL
MTD-Methadone30ng/mL
OPI-Opiates40ng/mL
OXY-Oxycodone20ng/mL
PCP-Phencyclidine10ng/mL
THC-Marijuana40ng/mL (Parent Drug)
TML–Tramadol*30ng/mL

*Forensic Use Only

Storing And Packaging


  • Carefully inspect the OralTox pouch to ensure there are no tears, cuts, or damage to the packaging.
  • Check the lot number and expiration date. The expiry date is typically 1 year from time of delivery.
  • Do not use the device after the expiration date printed on the pouch, example: 2018-04 = April 30, 2018
  • OralTox test is to be stored at 36-86°F (2-30°C) in its sealed foil package. If storage temperatures exceed 86° F (30°C), the test performance may degrade.

Components And Test Preparation


  • The donor must avoid placing anything in their mouth for at least 10 minutes prior to the collection. This includes, food, drink, gum and tobacco products.
  • To aid in collecting enough oral fluid, the donor should be instructed to pool oral fluid prior to collection.
  • Open OralTox device pouch in front of the donor
  • Request the donor remove the collection swab from the OralTox device.

Specimen Collection


Instruct the donor to sweep the inside of mouth (cheek, gums, tongue) several times, then hold swab in closed mouth until color on the saturation indicator strip appears in the indicator window of the collection swab.

Most donors will saturate the collection sponge within 2-4 minutes. Please note that some individuals will experience dry mouth and collection may exceed 4 minutes.

It is very important that the donor does NOT SUCK OR CHEW on the collection sponge or remove the collection sponge from his/her mouth during the collection time, until the indicator changes color.

The collection is completed when color appears on the indication strip inside the collection swab which indicates there is sufficient amount of oral fluid for testing. If after 7 minutes the saturation indicator has not changed color, discard the device and repeat the test.

Test Activation


Donor removes collection swab from the mouth and hands to the administrator. Next, insert the collection swab sponge first into the device, pushing and turning until the threaded handle locks into place.

Observe that there is sufficient oral fluid coming in contact with each strip.

The OralTox device should remain on a FLAT SURFACE at all times to ensure the test performs as intended.

The control line is the uppermost line appearing in each test area. Before reading the test result lines, verify that all control lines have formed. Results from any test without a top control line is invalid and the test must be discarded.

Interpreting Test Results


NEGATIVE results can be read as soon as the test and control lines appear on any test strip (often within 2 minutes). 

A negative result is indicated by two colored bands appearing on the membrane. One band appears in the control region (C), and another band appears in the test region (T). The intensity of the test lines may vary. Any line, without regard to intensity, color or size, is a line and indicates a negative result.

PRESUMPTIVE POSITIVE results are to be read at 10 minutes. Interpret test as negative, presumptive positive, or invalid. Do not read test results after 20 minutes. Follow your organizations established protocol for presumptive positive results. After the results have been interpreted, the OralTox device may be thrown in a regular trash receptacle.

You have now completed the OralTox training. You may go back over any or all of the material above anytime. Once you feel confident with the material presented, you may proceed to the certification quiz by clicking the button below. After you complete the quiz with 100% accuracy, a certificate will be generated on your screen that you may print for your records.

Test Your Knowledge By Taking The Certification Quiz

Premier Biotech, Inc.
Product: 888-686-9909

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Minneapolis, MN 55414

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Laboratory: 855-718-6917

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