title: Development of application protocols of the Emit® II Plus 6-Acetylmorphine Assay on the ADVIA® 1800 and 2400 Chemistry Systems.
abstract: New application protocols for the Emit(®) II Plus 6-Acetylmorphine Assay for human urine screening have been developed on the ADVIA(®) 1800 and 2400 Chemistry Systems. Precision was evaluated at the cutoff and ±25% controls. Recovery and linearity were studied by spiking 6-acetylmorphine (6-AM) into human urine pools. Method comparison was evaluated using urine specimens and the results were compared to those obtained from the predicate Analyzer (V-Twin(®)). Cross-reactivity with structurally related drugs was assessed at high cross-reactant concentrations. Potential interferences were assessed in the presence of 7.5 and 12.5 ng/mL of 6-AM. The qualitative repeatability coefficients of variation (CV's) ranged from 0.40 to 0.90% and the within-lab CV's ranged from 1.3 to 3.5%. In analyte units (ng/mL), the repeatability CV's ranged from 1.9 to 4.3% and the within-lab CV's ranged from 3.7 to 6.1%. The limit of detection of the assay was found to be 2.5 ng/mL on both instruments. Recovery was within 20% of expected value. Linearity was 2.5-20 ng/mL. Method comparison showed 100% agreement with the predicate analyzer. The assay had minimal cross-reactivity to structurally related opioids including with morphine, morphine-3-glucuronide, morphine-6-glucuronide. No interference was observed with endogenous interferences.
authors.affiliation: Siemens Healthcare Diagnostics Inc., Newark, DE, United States.
authors.forename: Julie A
authors.initials: JA
authors.lastname: Warren
authors.affiliation: Siemens Healthcare Diagnostics Inc., Newark, DE, United States.
authors.forename: Gerald
authors.initials: G
authors.lastname: Siefring
authors.affiliation: Siemens Healthcare Diagnostics Inc., Newark, DE, United States. Electronic address: nihmat.morjana@siemens.com.
authors.forename: Nihmat
authors.initials: N
authors.lastname: Morjana
mesh_terms: D017248:Enzyme Multiplied Immunoassay Technique / Q000295:instrumentation*; D053593:Forensic Toxicology / Q000295:instrumentation; D006556:Heroin Dependence / Q000175:diagnosis*; D006801:Humans; D057230:Limit of Detection; D009022:Morphine Derivatives / Q000652:urine*; D009294:Narcotics / Q000652:urine*; D015203:Reproducibility of Results; D015813:Substance Abuse Detection / Q000295:instrumentation*
chemical_list: D009022:Morphine Derivatives; D009294:Narcotics; C026979:6-O-monoacetylmorphine
keywords: 6-Acetylmorphine; Drugs of abuse; Enzyme multiplied immunoassay technique (Emit(®)); Heroin metabolite; Random access chemistry systems