What is Oral Fluids Drug testing?

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

Easy, Gender-Neutral, Observed Sample Collection

Detects Recent
Drug Use

Excellent agreement with
LC-MS/MS >97%

Oral fluid collection reduces the risk of sample adulteration

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.

drugs-of-abuse-oral-fluid-testing-oft-training

Automation vs. Point of Care Testing

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. 

Oral Fluid Testing Fits into the Current Workflow

Integrated-Workflow-774pix_1
  • Use existing collection sites and shipping methods with the Oral-Eze Collection System
  • Provides option to collect on-site for unscheduled testing such as random workplace screening
  • Greatly reduces sample adulteration because collection is observed from start to finish
  • Drugs are stable in the Oral-Eze Collection Device for up to 21 days at 2-30o C
Integrated-Workflow-774pix_2
  • Eleven different OFT assays in different size configurations to meet laboratory needs
  • Detects recent drug use and complements urine testing for drugs that stay in the urine longer, i.e. THC and benzodiazepines
  • Proven CEDIA Technology


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.

Integrated-Workflow-774pix_3

Negative Screening Result

  • Report results to employer
  • Excellent agreement between Thermo Scientific oral fluid screening assays and LC-MS/MS;  100% agreement near the cut-off calibrators

Non-Negative Screening Result

  • Confirmation testing and MRO review
  • Positivity rates in oral fluid are similar or slightly higher than urine
Integrated-Workflow-774pix_1
  • Use existing collection sites and shipping methods with the Oral-Eze Collection System
  • Provides option to collect on-site for unscheduled testing such as random workplace screening
  • Greatly reduces sample adulteration because collection is observed from start to finish
  • Drugs are stable in the Oral-Eze Collection Device for up to 21 days at 2-30o C
Integrated-Workflow-774pix_2
  • Eleven different OFT assays in different size configurations to meet laboratory needs
  • Detects recent drug use and complements urine testing for drugs that stay in the urine longer, i.e. THC and benzodiazepines
  • Proven CEDIA Technology


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.

Integrated-Workflow-774pix_3

Negative Screening Result

  • Report results to employer
  • Excellent agreement between Thermo Scientific oral fluid screening assays and LC-MS/MS;  100% agreement near the cut-off calibrators

Non-Negative Screening Result

  • Confirmation testing and MRO review
  • Positivity rates in oral fluid are similar or slightly higher than urine
FAQ
  • Convenient, Easy and Secure Sample Collection 1
    • Sample collections are supervised from start to finish so sample adulteration is highly unlikely2,3
    • Samples can be collected on site in just 10 minutes or less without the need for a “supervised” restroom visit1,2,3,4
  • Oral fluids detect recent drug use generally within 48 hours and as early as 30 minutes post marijuana use. This is important for drugs like marijuana which can stay in the urine for weeks after use.2
  • Oral fluids generally detect parent compounds with concentrations similar to circulating blood levels. This means oral fluids can often distinguish between different classes of drugs, reducing false negatives due to non-cross-reacting metabolites.2

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

 

  • Oral-Eze Collection Device has a built-in sample window to ensure adequacy of sample collection. A non-toxic indicator dye travels with the sample as it is absorbed into the portion of the pad contained in the handle, and a blue color appears in the window when the collected volume reaches adequate levels. The dye is wholly contained within the handle and never comes into contact with the donor.4
  • The Oral-Eze Collection Device uses pure cotton fibers on its pad which reduce the chance for allergic reactions in donors, and does not leave a salty or citric after-taste in the mouth.

 

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

 

  • Each manufacturer’s collection device is different.  Some use neat or undiluted oral fluid, which can be viscous and difficult to test.3 Other devices, like Oral-Eze Collection System, collect sample on an absorbent pad and then put the pad in buffer which dilutes the sample. The buffer provides a consistent test medium and is used as a preservative to prevent bacterial growth and stabilize the analytes. This allows the sample to be transported to the laboratory at room temperature and stored for up to 21 days at 2 - 30°C.4
  • The dilution factor used with the Oral-Eze collection device is 1:3 (one part sample to 2 parts buffer). The assay result is reported as a positive or negative result relative to the cutoff calibrator. For the Thermo Scientific CEDIA THC Assay, the cutoff calibrator is equal to 1 ng/mL. This is the diluted value. The equivalent neat value, is 3 ng/mL (1 ng/mL x dilution factor of 3).4

 

Although this is not common, it may occur in some individuals and should not adversely affect the Oral-Eze specimen.

 

  • Yes. Based on workplace positivity rates, oral fluid positivity rates were comparable or slightly higher than urine. Overall drug positivity for oral fluid was 5.06% compared to 4.1% for urine.1
  • Thermo Fisher Scientific compared each of its assays to a confirmatory method, LC-MS/MS. The table below shows 100% agreement with the LC-MS/MS.4
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.

References
  1. United States, Congress, Substance Abuse and Mental Health Services, and Secretary of Health and Human Services. “Mandatory Guidelines for Federal Workplace Drug Testing Programs.” Mandatory Guidelines for Federal Workplace Drug Testing Programs, vol. 80, No. 94, Federal Register, 2015, pp. 28054–28101. www.gpo.gov/fdsys/pkg/FR-2015-05-15/pdf/2015-11523.pdf.

  2. Allen, Keith R. “Screening for Drugs of Abuse: Which Matrix, Oral Fluid or Urine?” Ann Clin Biochem, vol. 48, no. 6, 1 September 2011, pp. 531–541., doi:10.1258/acb.2011.011116.

  3. Drummer, O.  “Drug Testing in Oral Fluid.”  Clin Biochem Rev Vol 27 August 2006

  4. Thermo Scientific, Package Inserts:
    Collection of Oral-Fluid Samples with the Oral-Eze Oral-Fluid Collection System
    CEDIA Amphetamine OFT Assay
    CEDIA Cocaine OFT Assay
    CEDIA Methamphetamine OFT Assay
    CEDIA Opiate OFT Assay
    CEDIA PCP OFT Assay
    CEDIA Cannabinoids OFT Assay
    CEDIA Barbiturates OFT Assay
    CEDIA Benzodiazepines OFT Assay
    CEDIA Buprenorphine OFT Assay
    CEDIA Methadone OFT Assay
    CEDIA Oxycodone OFT Assay

  5. United States, Congress, “Medical Devices; Exemptions From Premarket Notification: Class II Devices.” Medical Devices; Exemptions From Premarket Notification: Class II Devices, Federal Register, 11 July 2017. www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices.

  6. Quest Diagnostics. A Comprehensive Guide to Establishing a Workplace Drug Testing Program, 2016, www.employer-solutions-resources.com/whitepaper/drug-testing-guide. 39962-FIN-Drug_Testing_Toolkit_Webinar-Digital.pdf

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