Comparison of the immunoassay method with the commercial and in-house LC-MS/MS methods for substance abuse in urine

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Abstract Objectives The aim of this study was to compare the analytical performance of the KIMS (kinetic interaction of microparticles in solution) immunochemical method with a validated in-house and a commercial LC-MS/MS method. Methods The urine samples of the 100 subjects were included in the present study. The urine samples were analysed with Roche DAT immunochemical method based on KIMS method. In-house LC-MS/MS method was validated for 58 parameters according to the CLSI C62-A recommendations with the following parameters: matrix effect, lower limit of quantification (LLOQ), linearity, intra-day and inter-day precision and accuracy. Eureka Lab Division Drugs of Abuse kit was used as the commercial LC-MS/MS method. Results The immunochemical method had a satisfactory performance with specificity, sensitivity and accuracy values above 80 % and met the DRUID recommendation except benzodiazepines. The sensitivity and specificity of the immunochemical method were between 97–100 % and 84–100 %, respectively (except for benzodiazepines). The bias obtained for THC-COOH, morphine and codeine parameters were −17.5, 24.6 and 43.6 between two LC-MS/MS methods. The commercial method had a tendency to have a negative bias except for cannabinoids. Conclusions The analytical performance of the KIMS-based urine immunochemical method was found to be satisfactory for the intended use, except for benzodiazepines. The validated urine in-house LC-MS/MS method was found to be a good alternative for confirmation of substance abuse.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.