Data Supports Behring Diagnostics' Excellence in Drugs-of-Abuse Testing.

CHICAGO--(HealthWire)--July 31, 1996--In three separate poster sessions delivered at this year's annual meeting of the American Association for Clinical Chemistry (AACC), the Emit(R) II 5B3 THC Assay and the Emit(R) II LSD Assay, available from Behring Diagnostics, a division of Hoechst, demonstrated superiority. The assays are two of the newest additions to Behring Diagnostics' Emit(R) drugs-of-abuse screening tests.

In a study evaluating the new Behring Diagnostics Emit II 5B3 THC Assay for the detection of marijuana (delta 9-THC) and the CEDIA Multi-level Cannabinoid Assay compared with the Emit II THC 50 Assay, both Emit II assays detected more positives than the CEDIA. Conducted by Dr. Pushpa Ramachandran of the Kaiser Permanente Regional Reference Laboratory in California, the study evaluated 207 samples tested on the Boehringer Mannheim Hitachi 717 analyzer. Using the 50 ng/dL cutoff, 155 samples tested positive by the Emit II 5B3 THC Assay, 146 tested positive by the Emit II THC 50 Assay, and 123 tested positive by the CEDIA Multi-level Cannabinoid Assay. All positives were confirmed by alternative methodologies. The effectiveness of the Emit II 5B3 THC Assay over the other methods is due to its precision and increased specificity for the major metabolites of THC. With dual cutoff capabilities and ease of use, the researchers concluded that the Emit II 5B3 THC Assay is an excellent choice for the detection of the major metabolites of delta 9-THC in urine. The assay was made available in the United States in March 1996.

In a separate study, researchers developed protocols for the Emit II 5B3 THC Assay on Boehringer Mannheim's Hitachi 717 and Hitachi 911 and Behring Diagnostics' SYVA-30R Analyzers to utilize the reagents as they are provided, without any dilution. Using the Olympus AU5000 Analyzer as a reference, the researchers evaluated 392 samples, which were run on all four analyzers, and found 100% agreement between the reference analyzer and the three application analyzers. Samples testing positive on the reference analyzer were confirmed by GC/MS, and sample analysis results demonstrated 99% agreement between the reference analyzer and GC/MS. Sample analysis results indicated that the Emit II 5B3 THC Assay detected 9-16% more positives compared with the Boehringer Mannheim's CEDIA, Roche ONLINE and DRI THC Assays. With the detection of an increased number of true positives when applied to the Hitachi 717, Hitachi 911 and Behring Diagnostics' SYVA-30R Analyzers, the Emit II 5B3 THC Assay demonstrated excellent precision and accuracy.

Separately, researchers developed a protocol for the Emit II LSD Assay for use on the SYVA-30R Analyzer to evaluate its effectiveness for high-volume screening of LSD. Introduced in April 1996 in the United States, the Emit II LSD Assay is a monoclonal antibody-based immunoassay designed for ready-to-use liquid reagents and calibrators that reliably detect LSD in urine using a cutoff of 0.5 ng/mL. Analyzing 118 samples with the Emit II LSD Assay on the SYVA-30R Analyzer and the Roche Abuscreen Radioimmunoassay (RIA), 59 samples tested positive and 57 samples tested negative. (Two borderline samples tested positive by the Emit II method and negative by the RIA method.) The researchers concluded that the Emit II LSD assay run on the SYVA-30R Analyzer is a convenient and accurate method for high-volume screening of LSD in urine with clinically insignificant cross reactivity to certain compounds associated with drugs-of-abuse.

Behring Diagnostics, a division of Hoechst, with headquarters in Frankfurt, Germany, manufactures and markets in vitro diagnostic systems used by healthcare professionals in hospitals and laboratories throughout the world. The division has five business lines: the OPUS(R) business line, located in Westwood, Massachusetts; the Syva(R) business line, based in San Jose, California; and plasma proteins, coagulation and microbiology/infectious diseases, three further business lines, based in Marburg, Germany. Behring Diagnostics acquired the former Syva Company in 1995. In 1995, Behring Diagnostics had consolidated net sales of DM 1.027 billion. The division employs approximately 3,000 worldwide. -0- Emit, OPUS and Syva are registered trademarks of Behringwerke AG.

CONTACT: Outside the US:

Jean Luc Devleeschauwer, Behring Diagnostics

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voicemail in the US [phone] box 8033

In the US:

Alan Wollman, Behring Diagnostics Inc.

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