Does a Laboratory Run Validity Tests on a DOT Oral Fluid Specimen?

A laboratory may run validity tests on a DOT oral fluid specimen, but Part 40 does not require them on every specimen as it does for urine. Under 49 CFR 40.92(a), oral fluid validity testing evaluates whether the specimen is consistent with normal human oral fluid and whether adulterants or foreign substances were added or the oral fluid was altered.

Under 40.92(b), the laboratory may conduct validity testing if the specimen does any of the following:

• Shows abnormal characteristics, such as unusual odor or color
• Causes reactions or responses characteristic of an adulterant during the initial or confirmatory drug tests
• Contains an unidentified substance that interferes with the confirmatory analysis

Under 49 CFR 40.93, a laboratory that conducts validity testing may test for a biomarker such as albumin or immunoglobulin G (IgG), or for a specific adulterant, and follows the applicable HHS requirements for any additional validity testing. Under 40.92(c), if the specimen is invalid and HHS guidelines direct the laboratory to contact the MRO, the two decide together whether testing at another HHS-certified laboratory would be useful.

Under 49 CFR 40.97(b)(2)(vi), an invalid oral fluid result is reported with remarks and the numerical values of the validity tests that support it. The urine rules are covered in What Validity Tests Does a Laboratory Run on a DOT Urine Specimen?.

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