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Published:
Journal of Analytical Toxicology,
ISSN 0146-4760,
Volume 27, Number 7, October 2003,
pp. 407-411
Cozart® RapiScan Oral Fluid Drug Testing System: An
Evaluation of Sensitivity, Specificity, and Efficiency for Cocaine Detection
Compared with ELISA and GC–MS Following Controlled Cocaine Administration
Erin A. Kolbrich[1], Insook Kim[1], Allan J. Barnes[1],
Eric T. Moolchan[1], Lisa Wilson[2], Gail A. Cooper[2], Claire Reid[2], Dene
Baldwin[2], Chris W. Hand[2],
and Marilyn A. Huestis[1]
[1]Chemistry and Drug Metabolism Section, Intramural Research Program, NIDA,
NIH, 5500 Nathan Shock Drive, Baltimore, Maryland 21224 and
[2]Cozart Bioscience,
Ltd., 45 Milton Park, Abingdon, Oxfordshire OX14 4RU, United Kingdom
Oral fluid has become a widely
accepted alternative matrix for drugs of abuse detection. Immunoassays have been
developed for on-site
testing of cocaine and metabolites in oral fluid. The performance of the Cozart
RapiScan Oral Fluid Drug Testing System (CRS) was evaluated in comparison with
Cozart Microplate Enzyme Immunoassay Cocaine Oral Fluid Kit (COC ELISA) and gas
chromatography–mass spectrometry (GC–MS) at several screening and
confirmation cutoffs, including those proposed by SAMHSA and those currently
in use in the U.K. Oral fluid samples (n = 1271) were collected prior to and
following controlled clinical cocaine administration. CRS provides a qualitative
screen at a preset cutoff of 30 µg/L. Sensitivity, specificity, and efficiency
for CRS (30 µg/L) as compared with COC ELISA with a cutoff of 30 µg/L
were 92.1%, 91.8%, and 92.0%. The comparison of CRS (30 µg/L) with the
8-mg/L proposed SAMHSA confirmation cutoffs for cocaine and/or benzoylecgonine
exhibited a sensitivity of 82.7%, a specificity of 94.5%, and an efficiency of
87.6%. For this study, an alternative CRS cutoff of 20 µg/L was also evaluated.
Performance characteristics of CRS (20 µg/L) at the proposed SAMHSA confirmation
cutoffs were 89.9%, 89.7%, and 89.8%, respectively. At cutoffs in use in the
U.K., 30-µg/L CRS screen and 15-µg/L GC–MS cutoffs for cocaine,
benzoylecgonine, and/or ecgonine methyl ester sensitivity, specificity, and efficiency
were 89.4%, 92.2%, and 90.7%, respectively. Cozart RapiScan had performance similar
to the COC ELISA assay for the detection of cocaine exposure and suitable sensitivity
and specificity at the proposed SAMHSA cutoffs.
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