§ 40.91 What are the cutoff concentrations for oral fluid drug tests?
Current wording, effective June 1, 2023.
As a laboratory, when you conductmust validityuse testingthe undercutoff §concentrations 40.89,displayed youin mustthe conductfollowing ittable infor accordanceinitial withand theconfirmatory requirementsdrug oftests thisfor sectionoral fluid specimens.
(a)YouAll mustcutoff testconcentrations eachare primaryexpressed specimenin fornanograms creatinine.per Youmilliliter must(ng/mL). alsoThe determinetable itsfollows:
Initial specifictest gravityanalyte Initial iftestcutoff you1 Confirmatory findtest thatanalyte Confirmatory thetest creatininecutoff concentration
Marijuana is(THC) less2 4 thanng/mL 203 THC 2 mgng/dLmL.(b)Cocaine/Benzoylecgonine 15 Young/mL CocaineBenzoylecgonine 8 mustng/mL.8 measureng/mL.
Codeine/Morphine 30 theng/mL CodeineMorphine 15 pHng/mL.15 ofng/mL.
Hydrocodone/Hydromorphone 30 eachng/mL HydrocodoneHydromorphone 15 primaryng/mL.15 specimenng/mL.(c)Oxycodone/Oxymorphone 30 Young/mL OxycodoneOxymorphone 15 mustng/mL.15 testng/mL.
6-Acetylmorphine 4 eachng/mL primary3 6-Acetylmorphine 2 specimenng/mL.
Phencyclidine 10 tong/mL Phencyclidine 10 determineng/mL.
Amphetamine/Methamphetamine 50 ifng/mL AmphetamineMethamphetamine 25 itng/mL.25 containsng/mL.
MDMA substances4/MDA that5 50 mayng/mL MDMAMDA 25 beng/mL.25 usedng/mL.
1 toFor adulterategrouped theanalytes specimen(i.e., Yourtwo testsor mustmore haveanalytes that are in the capabilitysame ofdrug determiningclass whetherand anyhave substancethe identifiedsame ininitial currenttest HHScutoff):
Immunoassay: requirementsThe ortest specimenmust validitybe guidancecalibrated iswith presentone inanalyte from the specimen.group
(d)Ifidentified youas suspect the presencetarget ofanalyte. anThe interferingcross substance/adulterantreactivity thatof couldthe makeimmunoassay ato testthe resultother invalid,analyte(s) butwithin youthe aregroup unablemust tobe identify80 itpercent (e.g.,or agreater; newif adulterant)not, youseparate immunoassays must, asbe theused firstfor laboratory,the sendanalytes within the specimengroup.
Alternate totechnology: anotherEither HHSone certifiedanalyte laboratoryor thatall hasanalytes from the capabilitygroup ofmust doingbe so.used
(e)Iffor youcalibration, identifydepending aon substancethe intechnology. aAt specimenleast thatone appearsanalyte towithin bethe angroup adulterant,must buthave whicha isconcentration notequal listedto inor currentgreater HHSthan requirementsthe initial test cutoff or, guidancealternatively, youthe mustsum reportof the findinganalytes inpresent writing(i.e., with concentrations equal to ODAPCor andgreater than the Divisionlaboratory's validated limit of Workplacequantification) Programs,must HHS,be withinequal threeto businessor days.greater Youthan mustthe alsoinitial completetest testingcutoff.
2 ofAn theimmunoassay specimenmust forbe drugs,calibrated towith the extenttarget technically feasibleanalyte.
3 Alternate technology (fTHC and 6-AM): YouThe confirmatory test cutoff must conservebe asused muchfor asan possiblealternate oftechnology initial test that is specific for the specimentarget analyte (i.e., 2 ng/mL for possibleTHC, future2 testingng/mL for 6-AM).
4 Methylenedioxymethamphetamine (MDMA).
5 Methylenedioxyamphetamine (MDA).
[88 FR 27643, May 2, 2023]
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:
| Initial test analyte | Initial testcutoff 1 | Confirmatory test analyte | Confirmatory test cutoff concentration |
|---|---|---|---|
| Marijuana (THC) 2 | 4 ng/mL 3 | THC | 2 ng/mL. |
| Cocaine/Benzoylecgonine | 15 ng/mL | CocaineBenzoylecgonine | 8 ng/mL.8 ng/mL. |
| Codeine/Morphine | 30 ng/mL | CodeineMorphine | 15 ng/mL.15 ng/mL. |
| Hydrocodone/Hydromorphone | 30 ng/mL | HydrocodoneHydromorphone | 15 ng/mL.15 ng/mL. |
| Oxycodone/Oxymorphone | 30 ng/mL | OxycodoneOxymorphone | 15 ng/mL.15 ng/mL. |
| 6-Acetylmorphine | 4 ng/mL 3 | 6-Acetylmorphine | 2 ng/mL. |
| Phencyclidine | 10 ng/mL | Phencyclidine | 10 ng/mL. |
| Amphetamine/Methamphetamine | 50 ng/mL | AmphetamineMethamphetamine | 25 ng/mL.25 ng/mL. |
| MDMA 4/MDA 5 | 50 ng/mL | MDMAMDA | 25 ng/mL.25 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., 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. | |||
| 2 An 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). | |||
| 4 Methylenedioxymethamphetamine (MDMA). | |||
| 5 Methylenedioxyamphetamine (MDA). |
[88 FR 27643, May 2, 2023]
Amendment history
5 distinct wordings on file since Oct. 1, 1996- [88 FR 27643, May 2, 2023]
- [65 FR 79526, Dec. 19, 2000, as amended at 69 FR 64867, Nov. 9, 2004]
- [65 FR 79526, Dec. 19, 2000, as amended at 69 FR 64867, Nov. 9, 2004]
- Oct. 1, 1996 → Oct. 1, 2001annual editions 1996–2000
A new entry appears whenever the regulatory words change between government snapshots. Day-precise from the eCFR (2017 onward); before that, one snapshot per annual CFR edition (revised as of October 1). Bracketed citations are the Federal Register history printed with the section. Set a case date in the header to read any earlier wording.