B-280 Performance Evaluation of the Emit II Plus Oxycodone, Buprenorphine, and 6-acetylmorphine Assays on the Atellica DT 250 System

Abstract Background Oxycodone, buprenorphine, and heroin are members of the opiate class of drugs. All three act as narcotic analgesics and are associated with a high potential for abuse and addiction. The Emit II Plus Oxycodone (Oxy), Buprenorphine (Bup), and 6-acetylmorphine (6-AM, a primary heroin metabolite) assays can be used to detect the presence of these drugs in human urine at cutoffs of 100 and 300 ng/mL (Oxy), 5 ng/mL (Bup), and 10 ng/mL (6-AM). The assays consist of liquid, ready-to-use reagents and provide both qualitative and semiquantitative results. Protocols for these assays have been developed on the new Atellica DT 250 System. The data presented here was generated on the Atellica DT 250 System. Methods Precision was evaluated at the cutoffs and ±25% controls (±40% for Bup) according to CLSI EP5-A3. Recovery for each assay was evaluated by spiking drug into human urine at levels that span the assay’s range. Specimens were analyzed and the results were compared to those of the Viva-E/V-Twin/Viva-ProE Drug Testing Systems. On-instrument stability was assessed by testing the assay controls over time. Results Precision was evaluated at the cutoffs and ±25% controls (±40% for Bup) according to CLSI EP5-A3. Recovery for each assay was evaluated by spiking drug into human urine at levels that span the assay’s range. Specimens were analyzed and the results were compared to those of the Viva-E/V-Twin/Viva-ProE Drug Testing Systems. On-instrument stability was assessed by testing the assay controls over time. Results Precision evaluation demonstrated qualitative repeatability CVs (rate) for all assays ranging from 0.3 to 0.6%, and within-lab CVs ranging from 0.7 to 1.3%. CVs determined for semiquantitative repeatability ranged from 1.7 to 3.9% and within-lab CVs ranged from 2.7 to 5.5%. Semiquantitatively, the assays quantified drug-spiked samples within ±20% of nominal values for sample concentrations between 50 and 400 ng/mL for Oxy (100 ng/mL cutoff), 100 and 1000 ng/mL for Oxy (300 ng/mL cutoff), 2 and 25 ng/mL for Bup, and 2.5 and 18 ng/mL for 6-AM. Percent agreement for specimens run on the Atellica DT 250 and Viva-E/V-Twin/Viva-ProE Systems was 100% with all assays. On-instrument stability for 6-AM on the Atellica DT 250 System was 30 days, however for Oxy and Bup, on-instrument stability was found to be up to 8 weeks. Conclusion The Emit II Plus Oxycodone, Buprenorphine, and 6-acetlymorphine assays on the new Atellica DT 250 System are suitable screening methods for urine specimens for both qualitative and semiquantitative analyses.