Tox Tuesday: Federal guidelines could set the stage for workplace oral fluid testing

January 21, 2020

In recent years, drug tests on oral fluid have been a major topic of discussion, especially in the realm of roadside testing. But their applications for workplace drug testing have too been important, and in the new year, the U.S. will see new regulations regarding their usage in federal workplaces, possibly setting the stage for other employers that wish to use the relatively new method.

A new rule from the U.S. Department of Health and Human Services (HHS) — Mandatory Guidelines for Federal Workplace Drug Testing Programs (OFMG) — takes effect January 1, 2020. The rule outlines important details regarding circumstances in which oral fluid may be collected, requirements for split-sample collection, updated oral fluid drug testing panels and requirements for collection devices.

Under what circumstances may oral fluid specimens be collected?

A federal agency can collect oral fluid specimens for the following reasons:

  • Federal agency applicant/pre-employment test
  • Random test
  • Reasonable suspicion/cause test
  • Post-accident test
  • Return-to-duty test
  • Follow-up test

How is each oral fluid specimen collected?

For federal workplace testing, oral fluid must be collected as a split specimen. The two specimens can be collected either simultaneously via a single device capable of storing two samples or serially using multiple devices. Read about the methods in detail in sections 2.5 and 8.8 of the document.

What volume of oral fluid should be collected?

According to the document:

A volume of at least 1 mL of undiluted (neat) oral fluid for each oral fluid specimen (designated “Tube A” and “Tube B”) is collected using a collection device. If the device doesn’t include a diluent (or other component, process or method that modifies the volume of the testable specimen), the A and B tubes must have a volume marking clearly noting a level of 1 mL.

What kind of device must be used to collect oral fluid?

The key requirement of an oral fluid collection device is that it must be reliable. According to the document, it must “maintain the integrity” of the specimens completely, all the way through storage, transport and all the way to a certified laboratory. Ideally, the devices are sealable and non-leaking.

All such devices must be Food and Drug Administration-cleared, single-use, and originally created with the intent of collecting oral fluid.

The document also specifies that the collection device must:

  • Have an indicator that shows that enough oral fluid has been collected
  • Be made of components that ensure drug and drug metabolite stability before testing, and that also don’t affect the composition of the drug/drug metabolites within the specimen

What are the minimum performance requirements for a collection device?

At minimum, an oral fluid collection device must be able to reliably collect at least 1 mL of undiluted oral fluid. If the device contains a diluent (or something else that modifies the specimen volume), oral fluid must compose at least 1.0 mL ± 10%, and the volume of diluent in the device should be within ± 2.5% of the diluent target volume.

The document also specifies:

a)   Stability (recoverable concentrations ≥80% of the concentration at the time of collection) of the drugs and/or drug metabolites for five days at room temperature (64–77°F/18–25°C) and under the manufacturer’s intended shipping and storage conditions; and

b)   Recover ≥80% (but no more than 120%) of drug and/or drug metabolite in the undiluted (neat) oral fluid at (or near) the initial test cutoff (see chart above).

Putting aside the new rule: Why choose oral fluid testing?

All types of drug tests have their pros and cons, and there are plenty of reasons why some might choose oral fluid testing over other formats, including:

  • Oral fluid has a short average detection window of about 12–50 hours, depending on the target substance, making it useful for detecting recent drug usage, especially for post-accident and roadside driving-under-the-influence testing.
  • Oral fluid samples are easy to collect — no need for bathrooms or medical facilities (as is the case for blood drug tests).
  • Oral fluid samples are difficult to adulterate because sample collection can easily be observed, whereas there’s a booming market for synthetic urine to cheat drug tests.

Neogen offers a range oral fluid drug testing solutions, including oral fluid-specific immunoassays and multiple oral fluid collection devices. If your laboratory is interested in learning more about Neogen’s solutions for oral fluid testing, please reach out to Dan Grubb, Diagnostics Product Manager,


Category: Toxicology, Toxicology, Toxicology