Beckman Coulter Diagnostics Adds 6-Acetylmorphine (6-AM) and Buprenorphine (BUP) Assays to Comprehensive Chemistry Test Menu

Clinical laboratories gain greater confidence in opioid testing with proven high-specificity and high-sensitivity Syva® EMIT® II Plus 6-AM and BUP assays.

BREA, Calif. — (Jan. 4 2018) — Beckman Coulter Diagnostics today announced the addition of 6-Acetylmorphine (6-AM) and Buprenorphine (BUP) assays to its broad menu of drugs-of-abuse tests that meet the demands of onsite testing laboratories. Laboratories worldwide using Beckman Coulter's scalable AU chemistry analyzer solutions (AU480/AU680/AU5800) will now have access to these convenient and easy-to-use assays for fast, accurate and reliable drugs-of-abuse screenings.

Drug abuse is a serious public health problem in the United States, propelled by the surge in opioid usage in the past 15 years. Opioids include the illegal drug heroin, as well as pain relievers available legally by prescription, such as oxycodone, morphine and many others. According to the Centers for Disease Control and Prevention, more than six out of 10 drug-overdose deaths involve an opioid.1 As the rise in drug abuse continues, hospitalizations related to opioid misuse and dependence also have risen, with rates having doubled between the years 2000 and 2012.2

"Overdose with amphetamines requires a different treatment than opioid-related overdose. Therefore, providing hospitals and clinical laboratories with highly specific tests to distinguish between these two classes of drugs is important to ensure that patients receive appropriate care," said Michael Samoszuk, M.D., chief medical officer, Beckman Coulter Diagnostics.

The Syva® EMIT II Plus 6-AM assay provides a convenient and quick way to selectively screen for heroin usage, in place of time-consuming alternative methods like gas chromatography and mass spectrometry (GC/MS). The assay minimizes false positives by demonstrating no cross-reactivity to morphine, morphine metabolites and common analgesics.

The Syva® EMIT® II Plus BUP assay is intended for use in laboratories for the qualitative and/or semi-quantitative analysis of buprenorphine in human urine. The assay also minimizes false positives due to its high specificity for buprenorphine and norbuprenorphine, with no cross-reactivity to commonly abused opiates. With a low cutoff of 5 ng/mL, the BUP assay performs with improved sensitivity to minimize false negative results, as well.

Both the 6-AM and BUP assays deliver greater than 99 percent agreement with the reference method (GC/MS) and enable accurate interpretation of results, providing greater confidence and coverage to meet clinical laboratories' drugs-of-abuse testing needs.

1Rudd RA, Seth P, David F, Scholl L. Increases in Drug and Opioid-Involved Overdose Deaths—United States, 2010-2015. MMWR Morb Mortal Wkly Rep. ePub: 16 December 2016.

2Weiss AJ, Anne F, Marguerite B, Claudia S, Molly B, O'Malley L. Opioid-Related Inpatient Stays and Emergency Department Visits by State, 2009 - 2014. Healthcare Cost and Utilization Project (HCUP) December 2016 (Revised January 2017).

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