and a suitable column for the identification or quantitation, or both, of drugs or
compounds other than ethanol.
(b) Gas chromatograph method using a gas chromatograph
that
has
satisfactory accuracy, precision, sensitivity, and a suitable column for direct injection
or head-space gas chromatography for ethyl alcohol and other volatiles.
(c) Gas chromatography/mass spectrometry method using a gas chromatograph and
mass spectrometer that have satisfactory accuracy, precision, sensitivity, and a
suitable column for direct injection or head-space gas chromatography for
identification or quantitation, or both, of drugs or compounds other than ethanol.
(d) Spectrophotometric methods as follows:
(i) Williams, Louis A. Manual of Analytical Toxicology, I. Sunshine ed., CRC
Press, Cleveland, OH, 1971, pp. 309-312.
(ii) Freireich A. et al. Methodology for Analytical Toxicology, I. Sunshine ed.,
CRC Press, Cleveland, OH, 1975, pp. 67-69.
(e) Enzymatic and immunological methods as follows:
(i) "Stiles, et al.," Am J Clin Path., 46:608, 1966.
(ii) "Bonnichsen and Lundgren," J Acta Pharmacol Toxicol., 13:256, 1957.
(f) Analyzers as follows:
(i) Abbott Diagnostics AxSym Autoanalyzer and reagent systems.
(ii) Randox Evidence Biochip Array Analyzer and reagent systems.
(g) Analyzers or kits employing indicator-labeled immunoassays in which an
indicator is attached to an antigen or antibody to demonstrate that antigen-antibody
binding has occurred, thereby allowing measurement of a drug or other compound in a
sample. These include the following:
(i) Enzyme immunoassay (EIA), in which an enzyme is used to label an antibody or
antigen.
(ii) Enzyme-linked immunosorbent assay (ELISA), in which an enzyme-labeled
antibody or antigen competes in binding with an unknown substance.
(iii) Enzyme-multiplied immunoassay technique (EMIT), which is a form of EIA
used frequently for assays of drugs and hormones, as well as for viral antigens.
(iv) Fluorescence immunoassay (FIA), in which a fluorescent label is used in a
competitive-binding assay.
(v) Fluorescence polarization immunoassay (FPIA), which employs
fluorescent indicators that produce or detect the polarization of light.
(vi) Radioimmunoassay (RIA), which employs a radiolabeled antigen or
antibody.
(vii) Chemiluminescence, in which analyte binding to an antibody is coupled to the
chemical production or reduction of light output.
(viii) Any assay that uses a combination of the techniques in paragraphs (i) to (vii) of
this subdivision.
History: 1993 AACS; 2005 AACS; 2011 AACS; 2017 AACS.
R 325.2674 Calibration.
Rule 4. Calibration of the method or equipment used to test for alcohol or other
drugs for which quantitative analysis is performed in blood, urine, or other biological or
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