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

LinkAs toa anlaboratory, amendmentwhen publishedyou atconduct 88validity FRtesting 27643,under May§ 2, 202340.
(a) As a laboratory86, you must useconduct theit cutoffin concentrationsaccordance displayedwith in the followingrequirements tableof forthis initial and confirmatory drug testssection. All cutoff concentrations are expressed in nanograms per milliliter
(ng/mLa). TheYou tablemust follows:
Initialdetermine testthe analyte
Initialcreatinine test cutoff
1
Confirmatory test analyte
Confirmatory test cutoff concentration
Marijuana metaboliteson (THCA)
2 50each ng/mL
3 THCA 15primary ng/mLspecimen.
Cocaine metaboliteYou (Benzoylecgonine) 150must ng/mL
3 Benzoylecgonine 100also ng/mL.
Codeine/
Morphine 2000determine ng/mL Codeine
Morphine 2000its ng/mL.
2000specific ng/mL.
Hydrocodone/
Hydromorphone 300gravity ng/mL Hydrocodone
Hydromorphone 100if ng/mL.
100you ng/mL.
Oxycodone/
Oxymorphone 100find ng/mL Oxycodone
Oxymorphone 100the ng/mL.
100creatinine ng/mL.
6-Acetylmorphine 10concentration ng/mL 6-Acetylmorphine 10to ng/mL.
Phencyclidine 25be ng/mL Phencyclidine 25less ng/mL.
Amphetamine/
Methamphetamine 500than ng/mL Amphetamine
Methamphetamine 25020 ngmg/mLdL.
250 ng/mL.
MDMA
4/MDA
5 500 ng/mL MDMA
MDA 250 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 cutoffb):
Immunoassay: TheYou test must bedetermine calibrated with one analyte from the grouppH identified as the target analyte. The cross-reactivity of theeach immunoassayprimary to the other analytespecimen.
(sc) withinYou the group must beperform 80one percent or greater;more ifvalidity not,tests separate immunoassays must be used for theoxidizing analytesadulterants withinon theeach groupprimary specimen.
Alternate(d) technology:You Either one analyte or all analytes from the group must beperform usedadditional forvalidity calibration,tests depending on the technology.primary Atspecimen leastwhen one analyte within the groupfollowing mustconditions haveare a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present observed:
(i.e., equal to or greater than the laboratory's validated limit of quantification1) mustAbnormal bephysical equal to or greater than the initial test cutoff.characteristics;
2 An immunoassay must be calibrated with the target analyte, Δ-9-tetrahydrocannabinol-9-carboxylic acid (THCA2).
3 AlternateReactions technologyor (THCAresponses andcharacteristic Benzoylecgonine):of When using an alternateadulterant technologyobtained initialduring test for the specific target analytes of THCA and Benzoylecgonine, the laboratory must use the same cutoff for the initial andor confirmatory drug tests (i.e.g., 15non-recovery ng/mLof forinternal THCAstandards, andunusual 100ng/mL for Benzoylecgonineresponse).
4; Methylenedioxymethamphetamine or
(MDMA3).
5 MethylenedioxyamphetaminePossible (MDA)unidentified interfering substance or adulterant.
(be) OnIf an initial drug test, you mustdetermine reportthat a result below the cutoffspecimen concentration as negative. If the result is atinvalid orand aboveHHS theguidelines cutoffdirect concentration, you mustto conductcontact athe confirmation test.
(c) On a confirmation drug testMRO, you must reportcontact a result below the cutoffMRO concentration as negative and atogether resultdecide atif ortesting above the cutoffprimary concentrationspecimen asby confirmedanother positive.
(d)HHS Youcertified mustlaboratory reportwould quantitativebe valuesuseful forin morphinebeing orable codeineto atreport 15,000a ng/mLpositive or aboveadulterated test result.
[65 FR 79526, Dec. 19, 2000, as amended at 7569 FR 4986264867, AugNov. 169, 2010;2004. 77Redesignated FRand 26473,amended Mayat 4,88 2012; 82 FR 5224427643, Nov.May 132, 20172023]