§40.91 — What are the cutoff concentrations for oral fluid drug tests?As a laboratory, you must use the cutoff concentrations displayed in the following table for initial and confirmatory drug tests for oral fluid specimens. All cutoff concentrations are expressed in nanograms per milliliter (ng/mL). The table follows:Table 1 to §40.91 — Oral Fluid Testing Cutoff ConcentrationsInitial test analyteInitial test cutoff¹Confirmatory test analyteConfirmatory test cutoff concentrationMarijuana (THC)²4 ng/mL³THC2 ng/mL.Cocaine/Benzoylecgonine15 ng/mLCocaineBenzoylecgonine8 ng/mL.8 ng/mL.Codeine/Morphine30 ng/mLCodeineMorphine15 ng/mL.15 ng/mL.Hydrocodone/Hydromorphone30 ng/mLHydrocodoneHydromorphone15 ng/mL.15 ng/mL.Oxycodone/Oxymorphone30 ng/mLOxycodoneOxymorphone15 ng/mL.15 ng/mL.6-Acetylmorphine4 ng/mL³6-Acetylmorphine2 ng/mL.Phencyclidine10 ng/mLPhencyclidine10 ng/mL.Amphetamine/Methamphetamine50 ng/mLAmphetamineMethamphetamine25 ng/mL.25 ng/mL.MDMA
4/MDA
550 ng/mLMDMAMDA25 ng/mL.25 ng/mL.¹For grouped analytes (
i.e., two or more analytes that are in the same drug class and have the same initial test cutoff):
Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the analytes within the group.
Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present (
i.e., with concentrations equal to or greater than the laboratory's validated limit of quantification) must be equal to or greater than the initial test cutoff.²An immunoassay must be calibrated with the target analyte.³
Alternate technology (THC and 6-AM): The confirmatory test cutoff must be used for an alternate technology initial test that is specific for the target analyte (
i.e., 2 ng/mL for THC, 2 ng/mL for 6-AM).
4Methylenedioxymethamphetamine (MDMA).
5Methylenedioxyamphetamine (MDA).[88 FR 27643, May 2, 2023]