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Easy Virtual Drug Test Helps People Get Back to Work
We are excited to offer a quick and easy-to-use candidate or back-to-work drug test option for customers eager to expedite their return to business as usual following the COVID-19 global health crisis. Our virtual drug test offering* is performed by a simple mouth swab collection and reading that can be conducted over video chat with your candidates or the employees your organization is ready to bring back to work.
Just ship the device to your candidate or employee, schedule a video chat (Skype, Zoom, etc.) with your wellness or HR team member and have him or her observe the individual taking the non-invasive oral test to determine if the candidate or employee’s test is negative.
A few instructions are included with the test and made available online for a seamless user experience. The test takes about two minutes to complete and the results can be reviewed live via video conference. The results will indicate use of the following drugs:
If the screening test results read negative, no further action is needed, and the individual can be considered ready for work. If the test results read presumptive positive or inconclusive, the employee or candidate will need to visit a drug testing facility in person to provide a urine sample.
This innovative solution not only addresses the need to get people hired or back to work quickly, it also eliminates the significant time delays that can come with lab scheduling and travel time.
Easily ensure your employees and candidates are ready to work while limiting the risk to your business and your brand with our virtual drug test offering.
*OralTox® Rapid Oral Fluid Drug Screen
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OralTox® Rapid Oral Fluid Drug Screen Frequently Asked Questions
Drug abuse in the workplace puts employers at risk of increased accidents, more absenteeism, lower productivity, and higher insurance costs. Oral fluid testing, like all drug testing methodologies, helps to mitigate these risks by filtering out drug users from an employer’s workforce as well as deterring drug use within it.
Oral fluid drug testing offers a minimally-invasive, observed collection to detect recent drug use. Using oral fluid, an employer can oversee a donor as he or she collects their own oral fluid specimens, reducing the likelihood of tampering or cheating as well as a donor challenge later in the drug testing process.
OralTox is a lateral flow immunoassay, rapid oral fluid drug test manufactured by Premier Biotech. The OralTox test provides results in less than seven minutes, identifying the absence or presence of illicit drugs.
Some of the advantages of OralTox oral fluid drug testing include:
- Fast test results returned within minutes
- Patented design with one drug per strip • Easy-to-administer procedure with clear results
- FDA 510(k) cleared device
- Saturation indicator on device changes color when a sufficient sample of oral fluid has been collected
- Proven accuracy and sensitivity with an overall accuracy of greater than 99% agreement with LC-MS/MS results for each drug being tested
- Observed collection reduces the likelihood of donor cheating
- No secured restroom requirements
- Eliminates problems with shy bladder
- Less invasive means of collection that can be done anywhere, anytime, and by anyone
- Unique QR code ties each OralTox device to the donor who completed the test
- Ability to utilize O-Scan, Premier Biotech’s mobile reader IOS app.
Rapid oral fluid drug testing can be used for on-site collections at places of employment, hiring events, and job fairs, as well as at collection sites. The flexibility of OralTox provides options that suit most drug testing situations.
OralTox augments existing drug testing programs when a fast, on-site result is needed, an observed collection
is desired, or when there is a lack of available secured restrooms for urine drug test collection. Additionally, recruiting events and on-site testing scenarios present excellent situations for using OralTox.
OralTox offers near immediate detection of drugs in as little as two hours after ingestion.
Yes. Premier Biotech was granted 510(k) clearance for OralTox, its flagship, patented rapid oral fluid drug screen device, on February 2, 2018 for amphetamines, cocaine, marijuana, methamphetamine, opiates, and PCP. On September 20th, 2018, Premier Biotech Inc. was granted a 510(k) clearance from the Food and Drug Administration (FDA) for two additional oral fluid assays, Oxycodone and Methadone. In total, OralTox® has 510(k) clearance for in vitro diagnostic use including point-of-care sites for the following 8 drugs: Amphetamine, Cocaine, Marijuana, Methadone, Methamphetamine, Opiates, Oxycodone and Phencyclidine. The drug cutoffs are listed below.
A 510(k) is a premarket submission made to the U.S. Food and Drug Administration (FDA) to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval. All manufacturers who seek to market medical devices in the U.S. must first pass a very thorough process with the FDA and meet regulatory requirements. The FDA does not endorse any medical product.
OralTox is an effective rapid oral device for screening THC. However, OralTox is not as sensitive as lab-based oral fluid tests for the detection of THC. Since THC is a fat-soluble, rather than a water-soluble drug, it does not cross directly into oral fluid. Therefore, THC is detected as residual smoke or parent compound in saliva, not as a metabolite. As a result, THC has a shorter window of detection than traditional urine based testing.
OralTox has a built-in saturation indicator that changes color when a sufficient sample has been collected. This mechanism eliminates completion time guesswork from the collection process and helps to reduce recollections stemming from an insufficient oral fluid sample.
A collector gives the swab to a donor and instructs him or her to sweep the inside of their mouth (cheek, gums, and tongue) several times. The donor will hold the swab in their closed mouth until the color on the saturation indicator strip appears in the indicator window of the swab. The donor must not suck or chew on the collection sponge. Additionally, the donor should not remove the sponge from his or her mouth during the collection. The collection is complete when the saturation indicator strip appears in the indicator window of the swab. Last, the donor removes collection swab from his or her mouth and hands it to the drug test collector.
When the saturation indicator strip appears in the indicator window of the swab, the collection is complete. Most donors will saturate the collection sponge within two to four minutes, however, a collection for individuals who experience dry mouth may exceed four minutes. If after seven minutes the saturation indicator has not changed color, discard the OralTox device and repeat the test.
The OralTox test should be placed on a flat surface and remain there for the duration of the test, enabling gravity to pull the oral fluid directly onto the strips. Moving the device, lifting it up, holding it, or tilting it back to read results may interfere with the reading and move the specimen away from the strips. It can also increase the likelihood of an invalid drug test result. Once the handle locks into place, OralTox is airtight and tamper evident.
A mechanism inside the OralTox device will now extract the maximum oral fluid sample volume amount for testing. After three minutes, the collector will check the OralTox device to ensure that lines are forming on all of the drug test strips. Oral fluid has a tendency to form air bubbles, which can adhere to the bottom of the strip, and prevent the test from running. If any of the test strips do not have lines beginning to form, gently tap the OralTox drug test device on the table or counter surface. This action will pop any air bubbles that may have formed around the base of the strips and allow capillary action to begin, thereby initiating the test.
Negative drug test results using OralTox can be read as soon as the test and control line appear on any strip, typically within two minutes after the interpretation process begins. At ten minutes, the collector can interpret the OralTox drug test as negative, presumptive positive, or invalid. Any indication of a line in the test region should be considered a line and therefore a negative result. Results cannot be read after 20 minutes.
Consult your organizations drug testing protocol when confirmation testing is required. In the event a subsequent oral fluid testing device for laboratory confirmation is to be used, follow your current protocol. A presumptive positive result can be confirmed by sending the OralTox directly to the laboratory. OralTox is now the only FDA 510(k) cleared device with the ability to secure a laboratory confirmation result without the need for a second sample to be collected.
An OralTox drug test is considered invalid when the top control line fails to appear next to any drug screen result. Discard the device and repeat the drug test with a new OralTox test kit.
The criteria used for evaluating a rapid and laboratory-based oral fluid drug test include speed of a test result, window of drug detection, marijuana sensitivity, drug cutoff levels, legal considerations, convenience, and cost.
The decision to share a drug test result with a donor is determined by the employer’s organization. In most cases, the donor is released from the collection area after the oral fluid specimen is collected and prior to reading the drug test result. This allows the process to continue and reduces unnecessary confrontation with a donor, especially if there is a non-negative result. Alternatively, organizations that prefer to complete the testing process with the donor present can release the donor if the OralTox screen indicates a negative result.
Because the OralTox drug test collections are observed and collected in the presence of the employer’s representative, cheating, tampering, and adulteration is difficult.
Yes. Collectors can take a comprehensive online training program that details device information and OralTox collection procedures. If the collector scores 100% on the quiz, he or she will receive a personalized certificate of training for their records. Training is available via the following URL: https://premierbiotech.com/innovation/oraltox-training/
Rapid oral fluid drug testing laws vary by state in the United States. Check with an attorney to ensure that your state permits both oral fluid and rapid drug testing.
OralTox test devices should be stored at 36-86°F (2-30°C) in their sealed foil package. If storage temperatures exceed 86°F (30°C), test performance may degrade. If the product is refrigerated, an OralTox test device must be brought to room temperature prior to opening the pouch. Do not use an OralTox device after its expiration date.
Yes, you can view the OralTox procedure video below: