Blind trials of an onsite saliva drug test for marijuana and opiates

The objective of these clinical trials was to calculate the performance, li mit of detection, specificity and sensitivity of a novel, semi-quantitative immunoassay for drugs of abuse in saliva and to determine operator bias wh en measured blind by four different operators. The test is based on lateral flow gold particle technology coupled with digital photography to provide a semi-quantitative end point. The performance of the test was compared wit h that of enzyme immunoassays and GC/MS methods. Volunteers consumed mariju ana or codeine and their saliva was collected 0.25 to 24 h later with the C ozart RapiScan collection device. The sensitivity and specificity of the op iate test were both 100% +/- 10.4% for codeine for 9 h after dosing. The cu toff of the marijuana test at 10 ng/mL THCA was too high to detect marijuan a use for more than a few hours after smoking. There was no operator bias b ecause the results were presented in written form either as "positive" or " negative for each of the five drug classes on the screen of the hand-held r eader.