Applicability of Biochip Array Technology to the Simultaneous Screening of a Broad Range of Drugs in Whole Blood
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2015-02 Toxicology Rapid Testing Panel
SOUTH CAROLINA LAW ENFORCEMENT DIVISION NIKKI R. HALEY MARK A. KEEL Governor Chief FORENSIC SERVICES LABORATORY CUSTOMER NOTICE 2015-02 REGARDING TOXICOLOGY RAPID TESTING PANEL August 12, 2015 This notice is to inform the Coroners of South Carolina of a new testing panel available through the SLED Toxicology Department. On Monday, August 17th, the Toxicology Department will begin offering both a Rapid Testing Panel in addition to the already available Expanded Testing Panel. This Rapid Testing Panel is to be utilized in cases where the Expanded Testing Panel is not warranted, specifically where a cause of death has already been established. The Rapid Testing Panel will consist of volatiles analysis, to include, ethanol, acetone, isopropanol and methanol, drug screens, and drug confirmation/quantitation of positive screens. The cases assigned to the Rapid Testing Panel will have an expedited turnaround time. Targeted turn around times will be two weeks for negative cases and six weeks or less for positive cases. While every effort will be made to adhere to these time frames, additional time may be required on occasion due to the nature of postmortem samples. Submitters will be notified if there is a problem with a particular sample. Please see attachment regarding specifically which substances are covered by the Rapid Testing Panel and the Expanded Testing Panel. As always, a detailed case history and list of drugs suspected is appreciated. Rapid Panel and Expanded Panel will be choices available in iLAB. Please contact Lt. Dustin Smith (803-896-7385) with additional questions. ALI-359-T An Accredited Law Enforcement Agency P.O. -
Review Memorandum
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k062165 B. Purpose for Submission: New device C. Measurand: Barbiturates D. Type of Test: Qualitative and semi-quantitative enzyme immunoassay E. Applicant: Ortho-Clinical Diagnostics, Inc. F. Proprietary and Established Names: VITROS Chemistry Products BARB Reagent VITROS Chemistry Products Calibrator 26 VITROS Chemistry Products FS Calibrator 1 VITROS Chemistry Products DAT Performance Verifiers I, II, III, IV and V G. Regulatory Information: 1. Regulation section: 21 CFR 862.3150, Barbiturates test system 21 CFR 862.3200, Clinical Toxicology Calibrator 21 CFR 862.3180, Clinical Toxicology Control 2. Classification: Class II, (reagent, calibrator) Class I, reserved (control) 3. Product code: DIS, DLJ and DIF 4. Panel: Toxicology (91) 1 H. Intended Use: 1. Intended use(s): See Indications for use. 2. Indication(s) for use: VITROS Chemistry Products BARB Reagent: For in vitro diagnostic use only. VITROS Chemistry Products BARB Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi- quantitative or qualitative determination of barbiturates (BARB) in human urine using a cutoff of 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BARB method are used in the diagnosis and treatment of barbiturates use or overdose. The VITROS Chemistry Products BARB assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result with this assay. Gas Chromatograpy/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positive result. -
Simultaneous Rapid HPLC Determination of Anticonvulsant Drugs in Plasma and Correlation with EMIT®
ANNALS OF CLINICAL AND LABORATORY SCIENCE, Vol. 10, No. 1 Copyright© 1980, Institute for Clinical Science, Inc. Simultaneous Rapid HPLC Determination of Anticonvulsant Drugs in Plasma and Correlation with EMIT® RAYMOND S. RYDZEWSKI, M.S., RICHARD H. GADSDEN, P h .D.,* and CONSTANCE A. PHELPS, A.S.M.T. Division of Clinical Chemistry, Department of Laboratory Medicine, Medical University of South Carolina, Charleston, SC 29403 ABSTRACT A method is presented for measuring simultaneously five anti-convulsants (primidone, ethosuximide, phénobarbital, carbamazepine and diphenyl- hydantoin) in serum and plasma by high-performance liquid chroma tography (H PLC) usingalphenal (5 - allyl - 5 - phenyl - barbituric acid) as the internal standard. All five drugs are separated from each other and, in the case of primidone, from its metabolite, 2 - phenyl - 2 - ethyl - malondiamide. Total HPLC time for the separation is seven minutes. The chromatography is performed on a C-8 reverse phase column with a mobile phase consisting of acetonitrile/phosphate buffer (35/65) at 25°C. The eluted drugs are detected at 220 nm and quantitated from their peak heights relative to that of the internal standard. The lower limits of detection for each drug is 200 ng per ml for primidone, 1000 ng per ml for ethosuximide, 200 ng per ml for phéno barbital, 100 ng per ml for carbamazepine and 200 ng per ml for diphenyl- hydantoin. Analytical recoveries for the five drugs ranged from 97 to 107 percent. Correlation of results for 187 specimens by enzyme-immunoassay (EMIT) was 0.981 for primidone, 0.827 for ethosuximide, 0.975 for phéno barbital, 0.889 for carbamazepine and 0.990 for diphenylhydantoin. -
Drug-Facilitated Sexual Assault Panel, Blood
DRUG-FACILITATED SEXUAL ASSAULT PANEL, BLOOD Blood Specimens (Order Code 70500) Alcohols Analgesics, cont. Anticonvulsants, cont. Antihistamines, cont. Ethanol Phenylbutazone Phenytoin Cyclizine Amphetamines Piroxicam Pregabalin Diphenhydramine Amphetamine Salicylic Acid* Primidone Doxylamine BDB Sulindac* Topiramate Fexofenadine Benzphetamine Tapentadol Zonisamide Guaifenesin Ephedrine Tizanidine Antidepressants Hydroxyzine MDA Tolmetin Amitriptyline Loratadine MDMA Tramadol Amoxapine Oxymetazoline* Mescaline* Anesthetics Bupropion Pyrilamine Methcathinone Benzocaine Citalopram Tetrahydrozoline Methamphetamine Bupivacaine Clomipramine Triprolidine Phentermine Etomidate Desipramine Antipsychotics PMA Ketamine Desmethylclomipramine 9-hydroxyrisperidone Phenylpropanolamine Lidocaine Dosulepin Aripiprazole Pseudoephedrine Mepivacaine Doxepin Buspirone Analgesics Methoxetamine Duloxetine Chlorpromazine Acetaminophen Midazolam Fluoxetine Clozapine Baclofen Norketamine Fluvoxamine Fluphenazine Buprenorphine Pramoxine* Imipramine Haloperidol Carisoprodol Procaine 1,3-chlorophenylpiperazine (mCPP) Mesoridazine Cyclobenzaprine Rocuronium Mianserin* Norclozapine Diclofenac Ropivacaine Mirtazapine Olanzapine Etodolac Antibiotics Nefazodone Perphenazine Fenoprofen Azithromycin* Nordoxepin Pimozide Hydroxychloroquine Chloramphenicol* Norfluoxetine Prochlorperazine Ibuprofen Ciprofloxacin* Norsertraline Quetiapine Ketoprofen Clindamycin* Nortriptyline Risperidone Ketorolac Erythromycin* Norvenlafaxine Thioridazine Meclofenamic Acid* Levofloxacin* Paroxetine -
A Complete Toxicology Screening Procedure for Drugs and Toxic Compounds in Urine and Plasma Using LC-MS/MS
Application Note: 449 A Complete Toxicology Screening Procedure for Drugs and Toxic Compounds in Urine and Plasma Using LC-MS/MS Marta Kozak, Taha Rezai, Thermo Fisher Scientific, San Jose, CA Introduction Key Words Toxicology laboratories commonly use automated Scan Event 1 Scan Event 7 + Full Scan MS – Full Scan MS • ToxSpec immunoassays, gas chromatography-mass spectrometry Analyzer (GC-MS) and high pressure liquid chromatography-diode array detector (HPLC-DAD) techniques to perform • ToxID Software toxicology screening analyses. None of these techniques • LXQ Linear Ion are able to identify all the drugs and toxic compounds Trap that are potentially present in a sample. Implementation of liquid chromatography-mass spectrometry (LC-MS) for • Clinical toxicology screening provides specific and sensitive Toxicology analysis of drugs and toxic substances. The benefits of the • General LC-MS/MS screening methodology include a simple Unknown sample preparation procedure, ease of adding new Screening compounds to the screening method and fewer limitations based on compound volatility and thermal stability. In Scan Event 2-6 Scan Event 8-9 addition, Thermo Scientific ToxID automated toxicology + MS/MS on parent list – MS/MS on parent list screening software is able to automatically generate both Summary and Long Reports, avoiding the need for Figure 1: MS scan events manual analysis of each sample chromatogram. This application note describes the use of the Thermo Scientific LXQ ion trap mass spectrometer equipped with an ESI source and HPLC for identification of unknown compounds in human urine and human plasma. Step 1: Extract analytes from urine or plasma with SPE procedure Goal To develop a complete LC-MS/MS screening methodology which includes a sample preparation method, LC-MS Step 2: Analyze the samples method, spectra library, and data processing and reporting with LC-MS/MS method software. -
Analytical Reference Standards
Cerilliant Quality ISO GUIDE 34 ISO/IEC 17025 ISO 90 01:2 00 8 GM P/ GL P Analytical Reference Standards 2 011 Analytical Reference Standards 20 811 PALOMA DRIVE, SUITE A, ROUND ROCK, TEXAS 78665, USA 11 PHONE 800/848-7837 | 512/238-9974 | FAX 800/654-1458 | 512/238-9129 | www.cerilliant.com company overview about cerilliant Cerilliant is an ISO Guide 34 and ISO 17025 accredited company dedicated to producing and providing high quality Certified Reference Standards and Certified Spiking SolutionsTM. We serve a diverse group of customers including private and public laboratories, research institutes, instrument manufacturers and pharmaceutical concerns – organizations that require materials of the highest quality, whether they’re conducing clinical or forensic testing, environmental analysis, pharmaceutical research, or developing new testing equipment. But we do more than just conduct science on their behalf. We make science smarter. Our team of experts includes numerous PhDs and advance-degreed specialists in science, manufacturing, and quality control, all of whom have a passion for the work they do, thrive in our collaborative atmosphere which values innovative thinking, and approach each day committed to delivering products and service second to none. At Cerilliant, we believe good chemistry is more than just a process in the lab. It’s also about creating partnerships that anticipate the needs of our clients and provide the catalyst for their success. to place an order or for customer service WEBSITE: www.cerilliant.com E-MAIL: [email protected] PHONE (8 A.M.–5 P.M. CT): 800/848-7837 | 512/238-9974 FAX: 800/654-1458 | 512/238-9129 ADDRESS: 811 PALOMA DRIVE, SUITE A ROUND ROCK, TEXAS 78665, USA © 2010 Cerilliant Corporation. -
+1.518.758.8158
When a drug analyte is present in the urine specimen, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the antibody binding sites on the colloidal gold-labeled antibody complex. If a sufficient amount of drug analyte is present, it will fill all of the available binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. The formation of one (1) visible line (control line, no test line) is indicative of a preliminary positive result for the drug. REAGENTS AND MATERIALS SUPPLIED Each case of Rapid TOX contains: 122 Smith Road Kinderhook, NY 12106 1. Fifty (50) Rapid TOX test devices. Each test device is packaged in a sealed foil pouch containing: U.S.: 1.800.227.1243 / Outside the U.S.: +1.518.758.8158 a. One (1) test device with one (1) or two (2) channels containing a test strip www.abmc.com that has immunoassays for up to five (5) different drugs. Each test strip is Product Instructions comprised of a membrane with two (2) attached absorbent pads and a pad containing the immobilized colloidal gold-labeled antibody complex. The INTENDED USE upper pad acts as a reservoir for the specimen after it migrates through the Rapid TOX® is a one-step, lateral flow immunoassay for the simultaneous detection of membrane. The test lines contain a carrier-drug conjugate for the individual up to ten (10) abused drug analytes in urine (each analyte is represented by a separate analytes, dried on the membrane. The control line, containing goat anti- test line in the test window of the cassette). -
Georgia State Forensic Drugs
Comprehensive Forensic FT-IR Collection Library Listing – 4,286 spectra This extensive library contains materials not only of forensic interest but also for general problem solving and identification of unknown substances in industry and academia. The wide range of items include drugs, clandestine lab chemicals, explosives, paints, fabrics, dyes, polymers, inorganic compounds, pigments, adhesives, and other common materials. The library consists of 4,286 spectra that were acquired from a wide range of laboratories involved in forensic investigations. The collection includes the following classes of compounds: • Drugs of abuse, scheduled materials • Pharmaceuticals, vitamins and excipients • Clandestine lab materials and intermediates • Solvents, organic chemicals and hazardous chemicals • Accelerants • Lubricants and natural oils • Explosives, pyrotechnics, primers, powders and boosters • Herbal and plant material and fibers • Automobile paint vehicles, pigments, primers and clear coats • Textiles, natural and man-made fibers, carpet materials • Paints, coatings, varnishes, oils • Dyes and stains • Polymers, monomers, copolymers, plasticizers and rubbers • Inorganics, pigments, minerals and clays • Tape, adhesives, sealants, glues, caulks and putties • Crystal test derivatives and intermediates • Household chemicals, cleaning agents, surfactants and pesticide All spectra were measured using micro or macro Diamond ATR, thin films on salt windows or KBr pellets at 4 cm-1 spectral resolution. Comprehensive Forensic FT-IR Collection Index -
Development of a GC-MS Method for Determination of Benzodiazepine Series Drugs Mass Spectrometry Data Center Kirill Tretyakov1, Aviv Amirav2, Anzor Mikaia1
Development of a GC-MS method for determination of Benzodiazepine Series Drugs Mass Spectrometry Data Center Kirill Tretyakov1, Aviv Amirav2, Anzor Mikaia1 1National Institute of Standards and Technology, USA; 2Tel Aviv University, Tel Aviv, Israel. NOVELTY RESULTS and DISCUSSION 4 4 A GC-MS method for determination of drugs of Oxazepam (R =H) and Lorazepam (R =Cl) under EI do not show peaks of molecular ions while in the spectra of their N(1)-methyl analogs Substituents at 5-phenyl are the major donors of eliminating radicals under EI: benzodiazepine series is developed. Thermal and EI these peaks are present. Peaks of ions due to loss of water can be used for determination of M+· of Oxazepam and Lorazepam. induced decompositions of these compounds are studied However, one can suggest that these molecules are converted to quinazolines in a GC injection port, and GC retention indices and the [1] 2 spectra recorded correspond to dehydration products. It also has been established earlier that toluene or xylene solutions of 2 2 2 R R + by varying sample inlet configurations and ion source R + R + Oxazepam and Lorazepam at 110°C decompose with the formation of corresponding quinazoline aldehydes; they are the products of O O O O N N N N systems. Reliable GC retention index (GCRI) values and 4 water elimination. 3 - R mass spectral data are acquired. R 1 3 1 GC retention index values and mass spectra indicate degradation most of Oxazepam and Lorazepam molecules in a GC injection port R N 1 N R 1 R N R R N 3 CH R 3 and further water elimination in a GC column, and probably in EI source (Figure 1). -
FOOD and DRUGS Is Composed of Nine Volumes
Food and Drugs of 21 code PART 1300 TO END Revised as of April 1, 1996 CONTAINING A CODIFICATION OF DOCUMENTS OF GENERAL APPLICABILITY AND FUTURE EFFECT AS OF APRIL 1, 1996 regulations With Ancillaries Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register federal VerDate 20<JUN>96 10:04 Jul 12, 1996 Jkt 167073 PO 00000 Frm 00001 Fmt 8091 Sfmt 8091 C:\CFR\21V9.FRT pfrm13 1 U.S. GOVERNMENT PRINTING OFFICE WASHINGTON : 1996 For sale by U.S. Government Printing Office Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402±9328 VerDate 20<JUN>96 10:04 Jul 12, 1996 Jkt 167073 PO 00000 Frm 00002 Fmt 8092 Sfmt 8092 C:\CFR\21V9.FRT pfrm13 ?ii Table of Contents Page Explanation ................................................................................................ v Title 21: Chapter IIÐDrug Enforcement Administration, Department of Jus- tice .................................................................................................. 3 Chapter IIIÐOffice of National Drug Control Policy .......................... 271 Finding Aids: Table of CFR Titles and Chapters ....................................................... 325 Alphabetical List of Agencies Appearing in the CFR ......................... 341 List of CFR Sections Affected ............................................................. 351 iii VerDate 20<JUN>96 10:04 Jul 12, 1996 Jkt 167073 PO 00000 Frm 00003 Fmt 8092 Sfmt 8092 C:\CFR\21V9.FRT pfrm13 Cite this Code: CFR To cite the regulations in this volume use title, part and section num- ber. Thus, 21 CFR 1301.01 refers to title 21, part 1301, section 01. iv VerDate 20<JUN>96 10:04 Jul 12, 1996 Jkt 167073 PO 00000 Frm 00004 Fmt 8092 Sfmt 8092 C:\CFR\21V9.FRT pfrm13 Explanation The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agen- cies of the Federal Government. -
Infographics About Synthetic Opioids
UNODC LEADING THE INTERGRATED GLOBAL RESPONSE TO THE OPIOID CRISIS P I L L A R 1 P I L L A R 2 P I L L A R 3 P I L L A R 4 P I L L A R 5 I N T E R N A T I O N A L L A W S T R E N G T H E N I N G C O U N T E R E A R L Y W A R N I N G A N D R A T I O N A L P R E S C R I B I N G A N D S T R E N G T H E N I N G A N D S U P P O R T I N G E N F O R C E M E N T O P E R A T I O N S N A R C O T I C C A P A C I T Y A N D T R E N D A N A L Y S I S A C C E S S T O O P I O I D S P R E V E N T I O N A N D T R E A T M E N T T O D I S R U P T T R A F F I C K I N G I N T E R N A T I O N A L C O O P E R A T I O N IDENTIFYING THE MOST PREVELANT, PERSISTANT AND HARMFUL SYNTHETIC OPIOIDS U N O D C 282 90 E A R L Y TOXICOLOGY COLLABORATING IN COUNTRIES W A R N I N G INFORMED THREATS LABORATORIES A D V I S O R Y ASSESSMENTS PHARMACOLOGICAL INFORMATION L A B O R A T O R I E S A N D D A T A P O I N T S L A B O R A T O R I E S D A T A P O I N T S G L O B A L S M A R T U P D A T E S 21,400+ 120 DATA POINTS FROM COUNTRIES SYNTHETIC SEDATIVE 74 OPIOIDS HYPNOTICS REPORTED MIRRORING TO UNODC SYNTHETIC E A R L Y OPIOID TRENDS W A R N I N G A D V I S O R Y B Y 2019 131% IN THE LAST * * 3 Y E A R S Note: * 2019 data collection not finalized LIST OF SYNTHETIC OPIOIDS REPORTED TO THE UNODC EWA FROM 2009-2019 S C H E D U L E D 2-Fluorofentanyl Furanylfentanyl 4-Fluorobutyrfentanyl Methoxyacetylfentanyl 4-Fluoroisobutyrfentanyl MT-45 S C H E D U L E I Acrylfentanyl Ocfentanil ( 1 9 6 1 ) AH-7921 Tetrahydrofuranylfentanyl Butyrfentanyl U-47700 S C H E D U L E I & I V Cyclopropylfentanyl -
Forensic Toxicology Scope of Testing and Detection Limits
J. RYAN MCMAHON II County Executive INDU GUPTA, MD, MPH MEDICAL EXAMINER’S OFFICE Commissioner of Health FORENSIC TOXICOLOGY LABORATORY CAROLYN H. REVERCOMB, MD, DABP ONONDAGA COUNTY HEALTH DEPARTMENT Chief Medical Examiner KRISTIE BARBA, MS, D-ABFT-FT CENTER FOR FORENSIC SCIENCES Toxicologist Forensic Toxicology Scope of Testing and Detection Limits Table of Contents QUALITATIVE ANALYSES.........................................................................................................2 Volatile Screen by GC/FID .............................................................................................................2 Carbon Monoxide by Microdiffusion..............................................................................................2 Carbon Monoxide by CO-Oximeter ................................................................................................2 Ethylene Glycol by GC/MS.............................................................................................................2 ELISA Buprenorphine by IA for Blood/Urine ................................................................................2 ELISA by IA for Blood ...................................................................................................................3 ELISA by IA for Urine....................................................................................................................4 Gamma Hydroxybutyrate (GHB) by GC/MS..................................................................................5 Gabapentin,