2013 Clinical drug and alcohol testing solutions. Product Catalog. CLIA-waived point of care test devices

Transcription

1 2013 Clinical drug and alcohol testing solutions Product Catalog CLIA-waived point of care test devices

2 HELPING YOU MAKE INFORMED DECISIONS ABOUT ABUSE. Substance abuse testing with more substance. 2 of every 22 People in the United States regularly use illicit drugs 1 Alere Toxicology provides a complete line of drug detection products and services that compliment industry best practices, and enable you to implement a successful testing program. The latest data from the US National Survey on Drug Use and Health (NSDUH) indicates that, in 2011, over 22.5 million Americans reported the use of illicit drugs. 1 The test device you select should be from an innovative and trusted leader. We offer numerous CLIA-waived devices intended for a clinical setting, as well as numerous tests for occupational health, medication monitoring, or forensic use. Our rigorous product manufacturing requirements and performance standards ensure you obtain a proven and accepted device. From rapid screening through confirmation, our flexible and robust solutions also include, federally regulated (SAMHSA certified) laboratory testing, complete IT integration, data management tools, product training certifications, and more. Take the first step in detection with Alere rapid drug screening devices. Confirm presumptive positives at one of five Alere laboratories. 1. US Department of Health and Human Services. Results from the 2011 National Survey on Drug Use and Health: Summary of National Findings. Available at: data/nsduh/2k11results/nsduhresults2011.htm. [Accessed December 27, 2012.] 2 Product Catalog for Clinical Use 3

3 Urine Drug Screening Devices We provide you the necessary tools to manage an effective drug detection program. Drug SCREENS available: Amphetamine (AMP), Barbiturates (BAR), Benzodiazepines (BZO), Buprenorphine (BUP), Cocaine Metabolites (COC), Marijuana (THC), MDMA (Ecstasy), Methadone (MTD), Methamphetamine (M-AMP), Opiates (MOP, OPI), Oxycodone (OXY), Phencyclidine (PCP), Propoxyphene (PPX) and Tricyclic Antidepressants (TCA). Specimen validity tests: Creatinine (CR), Glutaraldehyde (GL), Nitrate (NI), Oxidants (OX), ph (PH), Specific Gravity (SG) Take the first step in detection with Alere rapid drug screening devices. Each year, addiction results in over $400 billion in direct and indirect healthcare costs. National Institute of Drug Abuse and Addiction

4 Urine Drug Screens icup Dx icup Dx Equip yourself with a dependable point of care test device. The icup Dx is a CLIA-waived tilt-and-read urine drug screen that tests for up to 12 drugs at once. With built-in validity screening and limited urine exposure, this test fits a variety of drug test settings. Self-contained cup is ideal for sending presumptive positive specimens to the lab for confirmation Available with specimen validity test (SVT) and temperature strip help to monitor specimen tampering (SVT includes Bl, Cr, Ni, ph, SG) Fast results in five minutes Long shelf-life I-DXA I-DXA I-DXA I-DXA icup Dx BZO, COC, mamp, OPI, OXY, THC (CR, NI, PH, BL, SG) (CLIA-waived) AMP, BZO, COC, mamp, MTD, OPI, OXY, THC (CR, NI, PH, BL, SG) (CLIA-waived) AMP, BAR, BZO, COC, mamp, MDMA, MTD, OPI, OXY, THC (CR, NI, PH, BL, SG) (CLIA-waived) AMP, BAR, BZO, COC, mamp, MDMA, MTD, OPI, OXY, PCP, TCA, THC (CR, NI, PH, BL, SG) (CLIA-waived) 25 per box Made in the U.S.A. For in vitro diagnostic use only. 6 Product Catalog for Clinical Use 7

5 Urine Drug Screens icup Dx 14 icup Dx 14 First and only 14 panel CLIA-waived all inclusive cup. The icup Dx 14 is a CLIA-waived tilt-and-read urine drug screen that tests for up to 14 drugs at once. With limited urine exposure, this test fits a variety of drug test settings such as buprenorphine screening combined with low-level opiate cutoffs. Screens for a wide range of drugs: AMP, BAR, BUP, BZO, COC, MDMA, MET, MTD, OPI, OXY, PCP, PPX, THC, TCA Self-contained cup is ideal for sending presumptive positive specimens to the lab for confirmation Fast results in five minutes I-DX icup Dx 14 (does not include specimen validity test) AMP500, BAR300, BUP10, BZO300, COC150, MAMP500, MDMA500, MTD300, OPI300, OXY100, PCP25, PPX300, THC50, TCA1000 (CLIA-waived) 25 per box Made in the U.S.A. For in vitro diagnostic use only. 8 Product Catalog for Clinical Use 9

6 Urine Drug Screens iscreen Dx Dip Card iscreen The iscreen Dx Dip cards are one of the few brands of dip drug testing devices on the market today that are CLIA-waived. Able to test from 1-12 drugs on one device, they provide the accuracy and convenience you need in a clinical setting. Rapidly screen for a broad range of illicit and prescription drugs 1-12 configurations available for a fully customized urine testing program Simple procedure: collect, dip and read results in as little as five minutes Administrator remains in control of test device Long shelf-life Dx Dip Card Multiple configurations to meet your clinical testing needs. Featuring Buprenorphine test and lower Opiate cutoff levels (300 ng/ml) Made in the U.S.A. For in vitro diagnostic use only. IS1 AMP-DX IS1 BAR-DX IS1 BUP-DX IS1 BZO-DX IS1 COC-DX IS1 MET-DX IS1 MTD-DX IS1 MOP-DX IS1 OXY-DX IS1 PCP-DX IS1 MDM-DX IS1 TCA-DX IS1 THC-DX IS5 M-DX IS10-DX IS DX IS10BUP-DX IS12-DX iscreen Dx Dip Card Amphetamine (AMP) Single Dip Device (CLIA-waived) Barbiturate (BAR) Single Dip Device (CLIA-waived) Buprenorphine (BUP) Single Dip Device (CLIA-waived) Benzodiazepine (BZO) Single Dip Device (CLIA-waived) Cocaine (COC) Single Dip Device (CLIA-waived) Methamphetamine (MET) Single Dip Device (CLIA-waived) Methadone (MTD) Single Dip Device (CLIA-waived) Morphine (MOP-300) Single Dip Device (CLIA-waived) Oxycodone (OXY) Single Dip Device (CLIA-waived) Phencyclidene (PCP) Single Dip Device (CLIA-waived) Ecstacy (MDMA) Single Dip Device (CLIA-waived) Tricyclic Antidepressants (TCA) Single Dip Device (CLIA-waived) Marijuana (THC) Single Dip Device (CLIA-waived) AMP, COC, MET, MOP-300, THC (CLIA-waived) AMP, BAR, BZO, COC, MET, MOP-300, MTD, OXY, TCA, THC (CLIA-waived) AMP, BAR, BZO, COC, MET, MDMA, MOP-300, MTD, PCP, THC (CLIA-waived) AMP, BAR, BUP, BZO, COC, THC, MET, MOP-300, MTD, OXY (CLIA-waived) AMP, BAR, BZO, COC, MET, MDMA, MOP-300, MTD, OXY, PCP, TCA, THC (CLIA-waived) 25 per box 10 Product Catalog for Clinical Use 11

7 Urine Drug Screens icassette Dx icassette Dx Drug Screen Designed with the clinical market in mind. The icassette Dx Drug Screen is CLIA-waived, easy to administer, and screens 11 commonly abused drugs on one device. Rapidly screen for 11 illicit and prescription drugs Integrated positive, negative, and invalid control lines validate test Simple procedure: collect and pipette to test results in as little as five minutes Administrator remains in control of test device Cutoff levels optimized for clinical market Long shelf-life I-DCB icassette Dx (includes cassette pipette) AMP, BAR, BZO, COC, MDMA, MOP, OXY, PCP, PPX, TCA, THC (CLIA-waived) 25 per box For in vitro diagnostic use only. 12 Product Catalog for Clinical Use 13

8 Urine Drug Screens icup Drug Screen icup Drug Screen The world s leading drug screening cup. icup I-DOA-1237 COC, mamp, THC (CLIA-waived) The icup drug screen minimizes urine exposure and tests for up to seven drugs in one device. The test device provides fast and reliable results that can be photocopied for result recording. For expanded features, try the icup A.D. Drug Screen with a specimen validity test. I-DOA-3137 I-DOA COC, OPI, THC (CLIA-waived) AMP, COC, mamp, MDMA, OPI, PCP, THC (CLIA-waived) 25 per box Test cup screens for 3-7 prescription and illicit drugs Self-contained cup minimizes exposure to urine Fast results in five minutes Specimen validity combinations available: OX, PH, SG I-DUA I-DUA I-DUA I-DUA icup A.D. (features specimen validity test) COC, mamp, OPI, THC (OX, PH, SG) (CLIA-waived) AMP, COC, mamp, OPI, THC (OX, PH, SG) (CLIA-waived) AMP, COC, OPI, PCP, THC (OX, PH, SG) (CLIA-waived) COC, mamp, OPI, PCP, THC (OX, PH, SG) (CLIA-waived) I-DUA AMP, COC, mamp, OPI, PCP, THC (OX, PH, SG) (CLIA-waived) 25 per box For in vitro diagnostic use only. 14 Product Catalog for Clinical Use 15

9 Urine Drug Screens Integrated E-Z Split Key Cup Integrated E-Z Split Key Cup DOA E-Z Split Key Cup COC, mamp, THC (CLIA-waived) Split specimen collections in a reliable drug screening cup. DOA DOA COC, mamp, OPI, THC (CLIA-waived) AMP, COC, mamp, OPI, THC (CLIA-waived) The Integrated E-Z Split Key Cup provides rapid screening in a convenient cup that targets up to six drugs. This rapid testing device requires minimal training and provides results in just five minutes. For added confidence, check out the E-Z Split Key Cup A.D. with specimen validity test. DOA DOA DOA AMP, COC, OPI, PCP, THC (CLIA-waived) COC, mamp, OPI, PCP, THC (CLIA-waived) AMP, COC, mamp, OPI, PCP, THC (CLIA-waived) 25 per box Integrated cup screens for 3-6 prescription and illicit drugs Begin testing at your convenience with unique key activator Reserved split-specimen ideal for additional confirmation testing Rapid test results in five minutes Specimen validity combinations available: CR, GL, NI, OX, PH, SG DUA DUD DUD E-Z Split Key Cup A.D. (features specimen validity test) COC, mamp, OPI, THC (OX, PH, SG) (CLIA-waived) AMP, COC, mamp, OPI, THC (CR, GL, NI, OX, PH, SG) (CLIA-waived) AMP, COC, OPI, PCP, THC (CR, GL, NI, OX, PH, SG) (CLIA-waived) 25 per box For professional in vitro diagnostic use only. 16 Product Catalog for Clinical Use 17

10 Urine Drug Screens icassette icassette Dependable results and simple to administer. Available in singles or up to six drugs on one device, the icassette drug screen is amazingly accurate and is one of the best values in drug testing. It requires a small amount of urine (3 ml specimen) to run, and results are available in minutes. I-DTH-102 I-DOA-1125 icassette (includes test cassette and pipette) Marijuana (THC) Single Test Cassette (CLIA-waived) COC, THC (CLIA-waived) Rapidly screen up to six illicit drugs and prescription drugs Simple procedure: collect and pipette to test results in as little as five minutes I-DOA-1135 I-DOA-1145 I-DOA-1155 I-DOA-2155 I-DOA-3155 COC, mamp, THC (CLIA-waived) COC, mamp, OPI, THC (CLIA-waived) AMP, COC, mamp, OPI, THC (CLIA-waived) AMP, COC, OPI, PCP, THC (CLIA-waived) COC, mamp, OPI, PCP, THC (CLIA-waived) Administrator remains in control of test device I-DOA-1165 AMP, COC, mamp, OPI, PCP, THC (CLIA-waived) 25 per box For professional in vitro diagnostic use only. 18 Product Catalog for Clinical Use 19

11 Alcohol Screening Devices Detect alcohol conveniently and confidently with our easy to administer rapid test devices. Multiple rapid screening device options are available for detecting the presence of alcohol in breath or oral fluid, including some devices that are DOT-approved. In a few simple steps, alcohol-screening results can be obtained at any location. Convenient and rapid tests that detect the presence of alcohol 35 million Americans are at risk of abusing illicit drugs, prescriptions, and alcohol each year National Drug Threat Assessment

12 Alcohol Screens Saliva Alcohol Testing & QED A150 iscreen Saliva Alcohol Test Strips QED A150 Simple procedure provides convenient and rapid results. Results are easy to interpret the presence of alcohol. The iscreen Saliva Alcohol Test Strips offer a convenient and rapid preliminary test that detects saliva alcohol concentration (SAC). Easy to use, and rapid results Gender-neutral collections can be observed Semi-quantitative interpretations at 0.0%, 0.02%, 0.08% and 0.30% SAC Results in two minutes The QED A150 Saliva Alcohol Screen is a simple-to-use alcohol test that runs like a thermometer. In addition to being DOT-approved, it also gives you quantitative results within a few minutes. No special equipment or training required Built-in quality control and calibration Reads like a thermometer Results in 2-5 minutes Easy to read Interpretation Chart For professional in vitro diagnostic use only. DOT-approved. For professional in vitro diagnostic use only. iscreen Saliva Alcohol Test Strips QED A150 I-SA-25 iscreen Saliva Alcohol Test Strips (CLIA-waived) QED A150 - Saliva Alcohol Test DOT-approved (CLIA-waived) 25 per box 10 per box 22 Product Catalog for Clinical Use 23

13 Complementary Products We offer a selection of external controls, laboratory confirmation kits, testing supplies and more. Wide selection of ancillary products, reagents and supplies. Illicit drug use cost the U.S. economy more than $193 billion a year National Drug Intellegence Center.

14 Complementary Products External Controls External Controls Our external controls are intended for use as quality control urine to monitor the precision of laboratory urine toxicology testing procedures for the analytes listed in the package insert. The external quality controls are designed to work with any of our urine drug screens. Available in both 5 ml and 20 ml options, the liquid solution vials are convenient for any office. Refrigeration is required. External Controls (packaged individually) iscreen Drug Control Negative (5 ml) iscreen Drug Control High Positive 3X Cutoff (5 ml) iscreen Drug Control Negative (20 ml) iscreen Drug Control High Positive 3X Cutoff (20 ml) iscreen Urine Drug Control Kit (includes a positive and negative vial, 5 ml each) iscreen Urine Drug Control Kit (includes a positive and negative vial, 20 ml each) 26 Product Catalog for Clinical Use 27

15 Complementary Products Forms & Supplies Drug Testing Forms Testing Supplies Your collection and testing process can be performed quicker, easier, and more efficiently with many of our drug testing forms. Select from a wide range of preliminary result pads ideal for recording rapid test results, photo-copy templates, and laboratory test requisition forms (custody and control forms). Requirements for specimen collection and testing vary according to the purpose for which the results will be used. Ensure that you have an ample supply of the testing materials you need: collection bottles, bluing tablets, security seals, and gloves. Preliminary Results Forms & Photocopy Templates Packaging part Urine Preliminary Result Forms Pack of P 2-part Urine Preliminary Result Forms (with icup Copy Template) Pack of icup Copy Template (single sheet template) Single Sheet part Oral Fluid Preliminary Result Forms Pack of part Oral Fluid Preliminary Result Forms (with iscreen OFD Copy Template) Pack of iscreen OFD Copy Template (single sheet template) Single Sheet Custody and Control Forms/Lab Requisition Forms Packaging Testing Supplies Packaging x53 Lidded Cup with Temperature Strip (90 ml) Box of Beaker Cup with Temperature Strip (180 ml) Box of Instant Bluing Tablets Bottle of Vinyl Gloves - Medium Box of 50 Pairs 6623 Vinyl Gloves - Large Box of 50 Pairs Temperature Strips Sold Individually Tamper Evident Security Seals Sold Individually part Urine Lab Requisition Form (COC) Single Sheet part Oral Result & Lab Form Single Sheet 28 Product Catalog for Clinical Use 29

16 Laboratory Confirmation Services URINE SCREENING DEVICE CUTOFF LEVELS Test Calibrator Cutoff (ng/ml) Amphetamine (AMP) Amphetamine (AMP 500) d-amphetamine d-amphetamine 1,000 ng/ml 500 ng/ml Barbiturates (BAR) Secobarbital 300 ng/ml Benzodiazepines (BZO) Oxazepam 300 ng/ml Buprenorphine (BUP) Buprenorphine 10 ng/ml Cocaine (COC) Cocaine (COC 150) Benzoylecgonine Benzoylecgonine 300 ng/ml 150 ng/ml Marijuana (THC) 11-nor- 9-THC-9-COOH 50 ng/ml Methadone (MTD) Methadone 300 ng/ml Methamphetamine (mamp) Methamphetamine (mamp 500) Methylenedioxymethamphetamine (MDMA) Ecstasy Opiate (MOP) Opiate (OPI) d-methamphetamine d-methamphetamine d,l Methylenedioxymethamphetamine Morphine Morphine 1,000 ng/ml 500 ng/ml 500 ng/ml 300 ng/ml 2,000 ng/ml Oxycodone (OXY) Oxycodone 100 ng/ml From rapid screening devices to full lab confirmation testing, we offer a complete solution for all of your drug and alcohol detection needs. Phencyclidine (PCP) Phencyclidine 25 ng/ml Propoxyphene (PPX) Propoxyphene 300 ng/ml Tricyclic Antidepressants (TCA) Nortriptyline 1,000 ng/ml Rapid Test Devices Conduct on-site test Review preliminary results Negative results Presumptive Positive *Specimen validity tests: Creatinine (CR), Glutaraldehyde (GL), Nitrate (NI), Oxidants (OX), ph (PH), Specific Gravity (SG) Urine drug screen assay s provide only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Laboratory Confirmation Lab accessioning Lab confirmation Result reporting IMPORTANT PROCEDURE NOTE: Refer to product insert for complete instructions, limitations, and warnings. Alere allows you to incorporate industry best practices, which may include laboratory confirmation testing at one of three SAMHSA Certified facilities, or two that are dedicated to medication monitoring. 30 Product Catalog for Clinical Use 31

17 products aleretoxicology.com 2013 Alere. All rights reserved. The Alere Logo, Alere, iscreen, icup, icassette, and E-Z Split Key Cup are trademarks of the Alere group of companies. All other trademarks referenced herein are the property of their respective owners REV1 6/13