Section 325.2673. Acceptable techniques.

Rule  3.  The  following  are  acceptable  techniques   and   analyzers   for determining the presence or concentration, or both, of alcohol and   other drugs in blood, urine, or other various matrices or media.

(a)    Direct distillation/dichromate oxidation methods as follows:

(i)     "Dubowski and Withrow," Proc. Am. Acad for Sci, 2:323, 1952.

(ii)     "Shupe and Dubowski," Am J Clin Path., 22:901, 1952.

(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 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 sub-division.

History: 1993 AACS; 2005 AACS; 2011 AACS.