DRUGS OF ABUSE DRI BARBITURATE SERUM TOX (SBRX) DRI BARBITURATE SERUM TOX (SBRX) FOR THE UniCel DxC SYNCHRON CLINICAL SYSTEMS The DRI Barbiturate Serum Tox Assay is intended for the qualitative and semi-quantitative determination of barbiturates in human serum or plasma, using a 1µg/mL cutoff calibrator. Various barbiturates, such as secobarbital (short-acting) and phenobarbital (long-acting), are subject to abuse. Barbiturate abuse can lead to respiratory depression or coma in severe cases. Therapeutic serum concentration and toxic level for each barbiturate are different. In addition, patients who have used barbiturates habitually, particularly those who are addicted to such agents, may tolerate far larger dosages than persons who are not habitual users. Because of the wide variations in individual tolerance and variation in toxic levels associated with each barbiturate, serum tox immunoassays are useful primarily to establish the presence of the agent. An alternate chemical method should be used to determine the identity and exact concentration of the specific barbiturate. Being able to determine the type of barbiturate ingested will facilitate an effective course of treatment for barbiturate intoxication.1 Although the detection of barbiturates in urine can be used as an indication of barbiturates usage, the serum and plasma and barbiturate assay can be extremely important in emergency situations where a urine sample may be difficult to obtain. Many conventional techniques, such as TLC, GC, GLC and HPLC, are available for testing abused drugs in biological fluids. Immunoassays, based on the specific recognition of antigen (abused drugs) by the corresponding antibody, are available for high volume screening applications. DRI Barbiturate Serum Tox Assay is a homogeneous enzyme immunoassay using ready-to-use, liquid reagents.2 The assay uses specific antibodies which can detect most barbiturates in serum. FEATURES OF THE DRI BARBITURATE SERUM TOX (SBRX) › Choice of qualitative or semi-quantitative measuring method › Serum and plasma as acceptable sample types › Ready-to-use, liquid reagents › On-board reagent stability of 60 days › Calibration stability of 14 days › Total imprecision of <11% CV › Cutoff of 1000 ng/mL LAB FORWARD DRI BARBITURATE SERUM TOX (SBRX) PERFORMANCE CHARACTERISTICS Analytical Sensitivity DxC The following tables present the sensitivity results generated from the UniCel DxC systems: 0.063 µg/mL Typical Precision A properly operating UniCel DxC system should exhibit precision values less than or comparable to the following: Total Run Precision (Qualitative) Within-Run Precision (Qualitative) DxC DxC Mean (mA/min) SD %CV Mean (mA/min) SD %CV Serum Tox Cal 1 (0.5 µg/mL) 159.2 1.01 0.63 Serum Tox Cal 1 (0.5 µg/mL) 159.2 1.21 0.76 Cutoff Calibrator (1.0 µg/mL) 171.8 1.00 1.58 Cutoff Calibrator (1.0 µg/mL) 171.8 1.18 0.69 Serum Tox Cal 3 (3.0 µg/mL) 199.2 1.12 0.56 Serum Tox Cal 3 (3.0 µg/mL) 199.2 1.72 0.86 Within-Run Precision (Semi-Quantitative) Total Precision (Semi-Quantitative) DxC DxC Mean (µg/mL) SD %CV Mean (µg/mL) SD %CV Serum Tox Cal 1 (0.5 µg/mL) 0.498 0.029 5.88 Serum Tox Cal 1 (0.5 µg/mL) 0.498 0.045 9.03 Cutoff Calibrator (1.0 µg/mL) 0.997 0.055 5.53 Cutoff Calibrator (1.0 µg/mL) 0.997 0.088 8.84 Serum Tox Cal 3 (3.0 µg/mL) 2.99 0.123 4.12 Serum Tox Cal 3 (3.0 µg/mL) 2.99 0.285 9.52 BECKMAN COULTER REFERENCE NUMBER ITEM A45320DRI Barbiturate Serum Tox Reagent Kit (25 mL / 8 mL) A45326 DRI Serum Tox Negative Calibrator (10 mL) A45327 DRI Serum Tox Calibrator 1 A45328 DRI Serum Tox Calibrator 2 A45331 DRI Serum Tox Calibrator 3 A45332 DRI Serum Tox Calibrator 4 442835 User Defined Reagent Cartridges (pkg of 12)* A45333 Instructions for Use** QUALITATIVE SEMI-QUANTITATIVE Yes No Yes No Yes Yes Yes Yes Yes Yes *Sold separately **Ordered separately 1.Hadden J. et al. Acute barbiturate intoxication. 1969;209:893-900. 2.Rubenstein KE, Schneidter RS, EF Ullman. Homogeneous enzyme immunoassay: a new immunochemical technique. Biochem Biophys Res Commun 1972;47:846-851. DRI® is a registered trademark of Thermo Fisher Scientific Corporation. Distributed by: Beckman Coulter, Inc. for UniCel DxC Synchron Clinical Systems Manufactured by: Thermo Fisher Scientific Diagnostic Division, Seradyn Products 7998 Georgetown Road, Suite 100 Indianapolis, IN 46268 U.S.A. Beckman Coulter, the stylized logo, UniCel and Synchron are trademarks of Beckman Coulter Inc. and are registered in the USPTO. For Beckman Coulter’s worldwide office locations and phone numbers, please visit www.beckmancoulter.com/contact DS-11627B B2013-14560 © 2013 Beckman Coulter, Inc. www.beckmancoulter.com PRINTED IN U.S.A.
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