Accuracy of five on-site immunoassay drugs-of-abuse testing devices

Many current "on-site" urine drug-testing products claim performance equivalent to laboratory testing. Five commercially available products (PharmScreen, Roche TestCup, Accusign DOA 2, Status DS, and American Bio Medica-Rapid Drug Screen) were challenged with quality-control specimens of known drug metabolite concentrations, 25% above and 25% below the SAMHSA cutoffs, and with known positive and negative donor specimens previously analyzed by immunoassay and gas chromatography-mass spectrometry. The results indicate discrepancies between claims and performance for all products, particularly with amphetamines. The implications for employer-based drug testing are discussed.