Proficiency testing (external quality assessment) of drug detection in oral fluid

Eighteen external quality assessment (proficiency testing) samples were prepared from client specimens collected with the Intercept (R) oral fluid collection device and by spiking drug-free oral fluid. Samples were circulated in pairs at quarterly intervals to 13 UK and USA based laboratories for analysis by a panel of OraSure micro-plate Intercept (R) enzyme immunoassay kits and hyphenated mass spectrophotometric techniques. During the survey, there was a single case of non-specificity in a false report for methadone. The major errors were of lack of sensitivity relative to the concentration thresholds specified for the immunoassays. The sensitivity for overall 'present'/'not found' reports calculated as true positives/(true positives + false negatives) were for the amfetamine specific assay 50%, methyl-amfetamines 93%, barbiturates 64%, cannabinoids 73%, cocaine and metabolites 100%, benzodiazepines 69%, methadone 95%, opiates 79% (opiates excluding oxycodone 93%), phencyclidine 93% and human gamma-globulin 97%. A small number of the sensitivity errors were attributable to errors in chromatographic confirmation techniques. (c) 2005 Elsevier Ireland Ltd. All rights reserved.