A comparison of Roche Kinetic Interaction of Microparticles in Solution (KIMS) assay for cannabinoids and GC-MS analysis for 11-nor-9-carboxy-delta9-tetrahydrocannabinol

Abstract

In this study, we investigated the effectiveness of the Roche Kinetic Interaction of Microparticles in Solution (KIMS) screening assay for cannabinoid metabolites. Urine specimens (N = 1689) were collected during elimination of cannabinoids from 25 subjects with a history of marijuana use. Specimens were analyzed concurrently for cannabinoid metabolites by a customized Department of Defense (DOD) cannabinoid KIMS kit (50-ng/mL cutoff) and for 11-nor-9-carboxy-delta9-tetrahydrocannabinol (THC-COOH) by GC-MS (15-ng/mL cutoff). As compared to GC-MS results, the sensitivity, specificity, and efficiency of the KIMS assay were 69.7%, 99.8%, and 88.6%, respectively. Many of the false-negative results had GC-MS concentrations between 15 and 26 ng/mL (N = 151). The cannabinoid screening results for the DOD samples tested by the laboratory during the same 8-month period were also evaluated. The linear regression analyses of GC-MS results in the 15-50 ng/mL range and KIMS data resulted in regression coefficients of 0.689 for the research specimens and 0.546 for DOD specimens. The results suggest that the KIMS cannabinoid screening assay is deficient in detecting positives around the cutoff (15-25 ng/mL THC-COOH). This limitation of the KIMS cannabinoid screening method compromises the identification of true positive specimens, therefore reducing the effectiveness of the assay. The success of the DOD program is dependent on sensitive and specific screening assays; the high prevalence of false-negative cannabinoid results compromises the program's primary objective of drug deterrence.