Thermo Scientific’s DRI Hydrocodone Assay received FDA 510(k) clearance; it also has the requisite sensitivities to meet the newly proposed Substance Abuse and Mental Health Services Administration guidelines (using a 300 ng/mL cutoff). SAMHSA oversees the testing of federally regulated employees, and many organizations follow the guidelines set forth by this agency.
The DRI Hydrocodone Assay is a homogeneous enzyme immunoassay that specifically detects hydrocodone at the 300 ng/mL cutoff and has excellent cross-reactivity to the major metabolites hydromorphone and hydromorphone-glucuronide. It uses liquid, ready-to-use reagents, which can be run in both qualitative and semiquantitative modes. Calibrators and controls are sold separately.
The assay demonstrates good correlation with LC-MS/MS and has excellent specificity and sensitivity, making it an easy-to-use screening tool for hydrocodone in urine samples with applications for a variety of clinical chemistry analyzers.
Thermo Fisher, 510-979-5157