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® 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® 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.