10 CFR § 26.163 - Cutoff levels for drugs and drug metabolites.
(a) Initial drug testing.
(1) HHS-certified laboratories shall apply the following cutoff levels for initial testing of specimens to determine whether they are negative for the indicated drugs and drug metabolites, except if validity testing indicates that the specimen is dilute or the licensee or other entity has established more stringent cutoff levels:
Initial Test Cutoff Levels for Drugs and Drug Metabolites
|Drug or metabolites||Cutoff level [nanograms (ng)/mL]|
(2) At the licensee's or other entity's discretion, as documented in the FFD program policies and procedures, the licensee or other entity may require the HHS-certified laboratory to conduct special analyses of dilute specimens as follows:
(i) If initial validity testing indicates that a specimen is dilute, the HHS-certified laboratory shall compare the responses of the dilute specimen to the cutoff calibrator in each of the drug classes;
(ii) If any response is equal to or greater than 50 percent of the cutoff, the HHS-certified laboratory shall conduct confirmatory testing of the specimen down to the LOD for those drugs and/or drug metabolites; and
(iii) The laboratory shall report the numerical values obtained from this special analysis to the MRO.
(b) Confirmatory drug testing.
(1) A specimen that is identified as positive on an initial drug test must be subject to confirmatory testing for the class(es) of drugs for which the specimen initially tested positive. The HHS-certified laboratory shall apply the confirmatory cutoff levels specified in this paragraph, except if the licensee or other entity requires the special analysis of dilute specimens permitted in paragraph (a)(2) of this section or the licensee or other entity has established more stringent cutoff levels.
Confirmatory Test Cutoff Levels for Drugs and Drug Metabolites
1 As delta-9-tetrahydrocannabinol-9-carboxylic acid.
2 As benzoylecgonine.
3 Test for 6-AM when the confirmatory test shows a morphine concentration exceeding 2,000 ng/mL.
4 Specimen must also contain amphetamine at a concentration equal to or greater than 200 ng/mL.
(2) Each confirmatory drug test must provide a quantitative result. When the concentration of a drug or metabolite exceeds the linear range of the standard curve, the laboratory may record the result as “exceeds the linear range of the test” or as “equal to or greater than <insert the value for the upper limit of the linear range>,” or may dilute an aliquot of the specimen to obtain an accurate quantitative result when the concentration is above the upper limit of the linear range.
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