title: Signify ER Drug Screen Test evaluation: comparison to Triage Drug of Abuse Panel plus tricyclic antidepressants.
abstract: Signify ER Drug Screen Test (Signify ER) and Triage Drug of Abuse Panel plus TCA (Triage DOA Panel) rapid drug screening devices were compared at four laboratories. Both assay systems are point of care immunoassays, measuring phencyclidine, barbiturates, amphetamine, cocaine metabolite, methamphetamine, tricyclic antidepressants, opiates, marijuana metabolite, and benzodiazepines in human urine. The performance of these two assay systems, including a cutoff verification and cross-reactivity using spiked urine specimens and accuracy using clinical urine samples, was investigated. The cutoff verification study showed that the Signify ER had 95.4% precision for all drugs tested at concentrations of 50%, 75%, 125%, 150%, and 200% of cutoffs compared to 90% precision obtained with Triage DOA Panel. Accuracy studies testing 53 negative urine samples demonstrated that both Signify ER and Triage DOA Panel have 100% specificity. Testing of 693 positive urine samples demonstrated that Signify ER and Triage DOA Panel have sensitivities of 99.8% and 99.3%, respectively, with an accuracy of 99.9% and 99.6%. A total of 527 compounds were tested for the cross-reactivity study. Eighty-seven structurally related drugs and metabolites were found to cross-react with at least one of the nine tests of the Signify ER. Four hundred forty structurally unrelated compounds that can be found in human urine were shown not to cross-react with the Signify ER. In terms of operating characteristics, the Signify ER device is simpler since only a single pipetting step is required, and reaction completed within 8 min.
authors.affiliation: University of North Carolina Hospitals, McLendon Clinical Labs, Department of Pathology and Laboratory Medicine, 101 Manning Drive, Chapel Hill, NC 27514, USA. jane.phillips@roche.com
authors.forename: Jane Ellen
authors.initials: JE
authors.lastname: Phillips
authors.forename: Stuart
authors.initials: S
authors.lastname: Bogema
authors.forename: Paul
authors.initials: P
authors.lastname: Fu
authors.forename: Wieslaw
authors.initials: W
authors.lastname: Furmaga
authors.forename: Alan H B
authors.initials: AH
authors.lastname: Wu
authors.forename: Vlasta
authors.initials: V
authors.lastname: Zic
authors.forename: Catherine
authors.initials: C
authors.lastname: Hammett-Stabler
mesh_terms: D000929:Antidepressive Agents, Tricyclic / Q000652:urine*; D006801:Humans; D013287:Illicit Drugs / Q000652:urine*; D007118:Immunoassay; D015813:Substance Abuse Detection / Q000379:methods*
chemical_list: D000929:Antidepressive Agents, Tricyclic; D013287:Illicit Drugs