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As an alternative to urine drug testing, saliva-drug test or oral fluid drug testing is also used for testing drug use habits. Oral fluid (saliva) is one of the fastest growing matrices used in drug of abuse testing, and part of the Thermo Scientific™ extensive menu for drugs of abuse testing. Oral fluid is the liquid found in the oral (mouth) cavity, consisting of saliva from the salivary glands, cells and tissues of the gum and cheek, cellular debris, microorganisms and food residues.
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Oral fluid consists primarily of water, but also contains electrolytes and enzymes. Due to passive diffusion from the blood into the saliva, drugs may be detected in oral fluid shortly after administration and absorption into the blood. That is why oral fluids detect recent drug usage. Oral fluids can be used as an alternative or complement to urine drug testing.1,2
One of the biggest concerns with urine testing can be sample adulteration, leading to a false negative result. For urine testing, patients must report to a collection station for a supervised specimen collection. Alternately, oral fluids are collected in an open environment, anytime, anywhere. Specimen collection is easy and only takes 10 minutes from start to finish.
A collection device containing an absorbent pad is placed in the participant's mouth and some devices, such as the Oral-Eze™ Oral Fluid Collection System, have a colored indicator to signal when there is enough oral fluid on the pad. The pad is then placed in a buffer and sent to the laboratory for analysis. The complete collection process generally takes less than 10 minutes.3,4 Since privacy is not an issue, collection can be performed on-site (anywhere, anytime) making sample collection more convenient.
Laboratories receive numerous samples for both urine and oral fluids.5 Depending on the number of samples, automated analysis may be easier and more economical compared to point of care (POC) testing. Today POC oral fluid testing is primarily used in the field to detect driving under the influence. These tests use lateral flow and are read visually. Though they are improving, POC assays are generally considered less accurate and less precise than automated testing.6 Below is a comparison between automation and POC.
Automation | POC | Benefit | |
---|---|---|---|
Runs Multiple Patient Samples in a Single Run | ✔ | X | Saves time and money |
Test Multiple Drugs Single Run | ✔ | ✔ | Saves time |
Test 1 to Over 1000 tests/hour* | ✔ | X | Saves time |
Improved Accuracy at Drug Cutoff Level | ✔ | X | Reduced false positive and false negative results saving time and money |
Barcode Providing Positive Sample ID | ✔ | X | Reduces errors |
Daily Quality Control | ✔ | X | Confidence in results - ensures the highest levels of accuracy and precision |
Automated Reporting | ✔ | X | Streamlines documentation and reduces errors |
*Please refer to the manufacturer's product specification for chemistry analyzer of interest.
For available applications for running the assays using Thermo Scientific Oral Fluid Tests Kits, please contact your local Thermo Scientific Sales Representative, Authorized Distributor, or Thermo Scientific Technical Service Representative for available applications.
Negative Screening Result
Non-Negative Screening Result
For available applications for running the assays using Thermo Scientific Oral Fluid Tests Kits, please contact your local Thermo Scientific Sales Representative, Authorized Distributor, or Thermo Scientific Technical Service Representative for available applications.
Negative Screening Result
Non-Negative Screening Result
Yes. When using the Oral-Eze™ Collection Device available from Thermo Fisher Scientific™, we instruct the donor to empty the mouth of gum, food, tobacco, etc. prior to oral-fluid collection. If the donor’s mouth is not empty immediately prior to collection, have the subject rinse his/her mouth with water (up to 4 oz.) and wait a minimum of 10 minutes before collecting a specimen.3,4
No. The test kit, calibrators and device make up a system and have been validated and proven together. Different collection devices use different buffers and buffer volumes which can cause erroneous results.4
Thermo Fisher Scientific used the proposed Substance Abuse and Mental Health Services Administration (SAMHSA) guidelines along with partnering with leading experts in the industry to set its cut-offs.1
Although this is not common, it may occur in some individuals and should not adversely affect the Oral-Eze specimen.
Analyte Tested | Oral-Eze Cutoff-Diluted/Neat(ng/mL) | Tested Concentration (ng/mL) | Neat Oral Fluid by LC-MS/MS (ng/mL) | Diluted Oral Fluid by LC-MS/MS (ng/mL) | # Neg/#Pos Agreement | Percent Agreement |
---|---|---|---|---|---|---|
Amphetamines | 50 Diluted/150 Neat | 75 | 88.18 | 26.84 | 0 Neg/50 Pos | 100% |
Barbiturates | 20 Diluted/60 Neat | 30 | 29.4 | 9.7 | 80 Neg/0 Pos | 100% |
Benzodiazepines | 1 Diluted/3 Neat | 1.5 | 1.56 | 0.48 | 80 Neg/0 Pos | 100% |
Buprenorphine | 1 Diluted/3 Neat | 1.5 | 1.53 | 0.54 | 80 Neg/0 Pos | 100% |
Cocaine | 5 Diluted/15 Neat | 7.5 | 7.46 | 2.34 | 50 Neg/0 Pos | 100% |
Methadone | 5 Diluted/15 Neat | 7.5 | 7.35 | 2.49 | 80 Neg/0 Pos | 100% |
Methamphetamines | 40 Diluted/120 Neat | 60 | 60.47 | 17.34 | 50 Neg/0Pos | 100% |
Opiates | 10 Diluted/30 Neat | 15 | 17.99 | 5.07 | 50 Neg/0 Pos | 100% |
Oxycodone | 10 Diluted/30 Neat | 15 | 14.7 | 5.06 | 80 Neg/0 Pos | 100% |
PCP | 1 Diluted/3 Neat | 1.5 | 1.62 | 0.46 | 50 Neg/0 Pos | 100% |
THC | 1 Diluted/3 Neat | 1.5 | 1.28 | 0.39 | 50 Neg/0 Pos | 100% |
1 Diluted/3 Neat |
Please see each assay package insert for full listing of concentrations tested.
Both the Oral-Eze Collection System and 6 major screening assays, Amphetamines, Cocaine, Methamphetamines, Opiates, PCP and Cannabinoids (THC) have FDA 510(k) market clearance.
Though urine is still the predominate matrix used for drug screening, oral fluids is the fastest growing matrix, primarily due to its rapid, easy and non-invasive sample collection. Oral fluid testing is ideal for workplace screening (pre-employment, random, reasonable suspicion, periodic, post-accident, return to duty and return of duty follow-up) and is especially well suited for unscheduled testing such random testing or testing for cause).6 It can also be used for testing within the criminal justice system, and forensic laboratory testing.