§ 40.87 - What validity tests must laboratories conduct on primary urine specimens?

§ 40.87 What are the cutoff concentrations for drug tests?

Cross Reference

Link to an amendment published at 88 FR 27643, May 2, 2023.

(a)

validity tests must laboratories conduct on primary urine specimens?

As a laboratory, when you

must use the cutoff concentrations displayed in the following table for initial and confirmatory drug tests. All cutoff concentrations are expressed in nanograms per milliliter (ng/mL). The table follows: Initial test analyte Initial test cutoff¹ Confirmatory test analyte Confirmatory test cutoff concentration Marijuana metabolites (THCA)² 50 ng/mL³ THCA15 ng/mL. Cocaine metabolite (Benzoylecgonine)150 ng/mL³ Benzoylecgonine100 ng/mL. Codeine/ Morphine2000 ng/mLCodeine Morphine2000 ng/mL. 2000 ng/mL. Hydrocodone/ Hydromorphone300 ng/mLHydrocodone Hydromorphone100 ng/mL. 100 ng/mL. Oxycodone/ Oxymorphone100 ng/mLOxycodone Oxymorphone100 ng/mL. 100 ng/mL. 6-Acetylmorphine10 ng/mL6-Acetylmorphine10 ng/mL. Phencyclidine25 ng/mLPhencyclidine25 ng/mL. Amphetamine/ Methamphetamine500 ng/mLAmphetamine Methamphetamine250 ng/mL. 250 ng/mL. MDMA⁴/MDA⁵ 500 ng/mLMDMA MDA250 ng/mL. 250 ng/mL.

¹ For 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., equal to or greater than the laboratory's validated limit of quantification) must be equal to or greater than the initial test cutoff.

² An immunoassay must be calibrated with the target analyte, Δ-9-tetrahydrocannabinol-9-carboxylic acid (THCA).

³ Alternate technology (THCA and Benzoylecgonine): When using an alternate technology initial test for the specific target analytes of THCA and Benzoylecgonine, the laboratory must use the same cutoff for the initial and confirmatory tests (i.e., 15 ng/mL for THCA and 100ng/mL for Benzoylecgonine).

⁴ Methylenedioxymethamphetamine (MDMA).

⁵ Methylenedioxyamphetamine (MDA).

(b) On an initial drug test, you must report a result below the cutoff concentration as negative. If the result is at or above the cutoff concentration, you must conduct a confirmation test.

(c) On a confirmation drug test, you must report a result below the cutoff concentration as negative and a result at or above the cutoff concentration as confirmed positive.

(d) You must report quantitative values for morphine or codeine at 15,000 ng/mL or above

conduct validity testing under § 40.86, you must conduct it in accordance with the requirements of this section.

(a) You must determine the creatinine concentration on each primary specimen. You must also determine its specific gravity if you find the creatinine concentration to be less than 20 mg/dL.

(b) You must determine the pH of each primary specimen.

(c) You must perform one or more validity tests for oxidizing adulterants on each primary specimen.

(d) You must perform additional validity tests on the primary specimen when the following conditions are observed:

(1) Abnormal physical characteristics;

(2) Reactions or responses characteristic of an adulterant obtained during initial or confirmatory drug tests (e.g., non-recovery of internal standards, unusual response); or

(3) Possible unidentified interfering substance or adulterant.

(e) If you determine that the specimen is invalid and HHS guidelines direct you to contact the MRO, you must contact the MRO and together decide if testing the primary specimen by another HHS certified laboratory would be useful in being able to report a positive or adulterated test result.

[65 FR 79526, Dec. 19, 2000, as amended at 75 69 FR 4986264867, AugNov. 16, 2010; 77 FR 26473, May 4, 2012; 82 FR 52244, Nov. 13, 20179, 2004. Redesignated and amended at 88 FR 27643, May 2, 2023]