Skip to main content

Medical Laboratory Observer CLR 2025

Page 15

CUTOFF CONCENTRATIONS FOR DRUG TESTS This table was put together by MLO staff and reviewed by Suhash Harwani, PhD, Senior Director of Science for Workforce Health Solutions at Quest Diagnostics. The table refers to federal regulations at 42 CFR Chapter 1, HHS Drug Testing Panel—Urine and 49 CFR part 40, Section 40.85. New to the table this year is fentanyl and norfentanyl due to the prevalence of fentanyl use and overdoses. The table follows:1,2 Initial test analyte

Common street name(s)3

Initial test cutoffA

Confirmatory test analyte

Confirmatory test cutoff concentration

Marijuana metabolites (Δ9THCC)

Marijuana (Pot)

50 ng/mL

Δ9THCC

15 ng/mL.

Cocaine metabolite (Benzoylecgonine)

Cocaine (Coke)

150 ng/mLB

Benzoylecgonine

100 ng/mL.

Codeine/ Morphine

Opiates

2000 ng/mL

Codeine Morphine

2000 ng/mL. 4000 ng/mL.

Hydrocodone/ Hydromorphone

Vicodin/ Dilaudid

300 ng/mL

Hydrocodone Hydromorphone

100 ng/mL. 100 ng/mL.

Oxycodone/ Oxymorphone

OxyContin/ Opana

100 ng/mL

Oxycodone Oxymorphone

100 ng/mL. 100 ng/mL.

6-Acetylmorphine

Heroin

10 ng/mL

6-Acetylmorphine

10 ng/mL.

Phencyclidine

PCP (Angel Dust)

25 ng/mL

Phencyclidine

25 ng/mL.

FentanylC

Fentanyl

1 ng/mL

Fentanyl Norfentanyl

1 ng/mL 1ng/mL

Amphetamine/ Methamphetamine

Meth

500 ng/mL

Amphetamine Methamphetamine

250 ng/mL. 250 ng/mL.

MDMA MDA

250 ng/mL. 250 ng/mL.

MDMA /MDA D

E

Ecstasy

500 ng/mL

REFERENCES 1.

Mandatory guidelines for Federal workplace drug testing programs-authorized testing panels. Federal Register. January 16, 2025. Accessed June 6, 2025. https://www.federalregister.gov/d/2025-00425.

2.

49 CFR part 40 -- procedures for transportation workplace drug and alcohol testing programs. Ecfr.gov. Accessed June 17, 2025. https://www.ecfr.gov/current/ title-49/subtitle-A/part-40.

3.

SAMHSA guidelines - US. Accessed May 2, 2025. https://www.thermofisher. com/us/en/home/clinical/diagnostic-testing/clinical-chemistry-drug-toxicologytesting/drugs-abuse-testing/drug-testing-overview/samhsa.html.

A. 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. For a technology that measures a response from the entire group without differentiating between analytes (e.g., an activity-based assay, a mass spectrometric assay that does not differentiate isobaric compounds), the laboratory must compare the result to the initial test cutoff. In the case of an alternate technology that differentiates and quantifies each analyte in the group, the laboratory must compare each analyte’s result to the confirmatory test cutoff and reflex specimens with a positive initial test result to confirmatory testing. B. Alternate technology (BZE): The confirmatory test cutoff must be used for an alternate technology initial test that is specific for the target analyte (i.e., 100 ng/ mL for benzoylecgonine). C. A fentanyl immunoassay must have at least 5% cross-reactivity to norfentanyl. D. Methylenedioxymethamphetamine (MDMA). E. Methylenedioxyamphetamine (MDA).

ESBL Detection with

NG-Test® CTX-M Multi Hardy Diagnostics releases FDA-cleared NG-Test® CTX-M Multi in the United States. CTX-M Multi is an in vitro, rapid, and visual immunoassay for the qualitative detection of CTX-M enzymes (groups 1, 2, 8, 9, and 25) for the rapid detection of ESBL’s. CTX-M-mediated ESBL-producing bacteria, primarily Escherichia coli, have been identified in various settings, including hospitals and long-term care facilities. While initially thought rate, CTX-M enzymes are now recognized as a significant cause of extended-spectrum cephalosporin resistance.

Using CTX-M Multi provides detection in just 15 minutes from isolated colonies. Hardy Diagnostics is the exclusive distributor in the U.S. and its territories for the NG Biotech lateral flow assay solutions product line.

Scan to learn more HardyDiagnostics.com/CTXM

2508MLO_CLR_15_CutoffConcentrations.indd 15

6/27/25 3:46 PM