§ 40.93 What validity tests must laboratories conduct on primary oral fluid specimens?
Current wording, effective June 1, 2023.
LinkAs toa anlaboratory, amendmentif publishedyou atconduct 88validity FRtesting 27643,under May§ 2, 202340.92, you must
(a) As a laboratoryconsiderconduct theit primaryin specimenaccordance towith bethe diluterequirements when:of this section.
(1a) TheYou creatininemay concentrationtest isfor greatera thanbiomarker orsuch equalas toalbumin 2or mg/dLimmunoglobulin butG less than 20 mg/dL, and(2IgG) Theor specifica gravitytest isfor greater than 1.0010 but less than 1.0030 on a singlespecific aliquotadulterant.
(b) AsYou a laboratory, you must considerfollow the primaryapplicable specimenHHS torequirements befor substitutedany whenadditional thevalidity creatinine concentration is less than 2 mg/dL and the specific gravity is less than or equal to 1testing.0010 or greater than or equal to 1.0200 on both the initial and confirmatory creatinine tests and on both the initial and confirmatory specific gravity tests on two separate aliquots.
[6988 FR 6486727643, Nov.May 92, 20042023]
As a laboratory, if you conduct validity testing under § 40.92, you must conduct it in accordance with the requirements of this section.
(a) You may test for a biomarker such as albumin or immunoglobulin G (IgG) or a test for a specific adulterant.
(b) You must follow the applicable HHS requirements for any additional validity testing.
[88 FR 27643, May 2, 2023]
Amendment history
5 distinct wordings on file since Oct. 1, 1996- [88 FR 27643, May 2, 2023]
- [69 FR 64867, Nov. 9, 2004]
- [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.