Rapid Alcohol Screening Devices. p19

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1 CLIA-WAIVED Product Catalog RAPID DRUG SCREENING DEVICES Rapid Urine Drug Screening Devices. p5 Rapid Alcohol Screening Devices. p19 Complementary Products. p23

2 HELPING YOU MAKE INFORMED DECISIONS ABOUT ABUSE. Better information. Better decisions. 1 of every 11 people in the United States regularly use illicit drugs 1 Alere Toxicology provides a complete line of drug detection products and services that complements industry best practices and enables you to implement a successful testing program. Data from the US National Survey on Drug Use and Health indicate that, in 2011, more than 22.5 million Americans reported the use of illicit drugs. The test device that you select should come from an innovative and trusted leader. We offer numerous CLIA 1 -waived devices intended for a clinical setting, as well as numerous tests for occupational health and medication monitoring. Our rigorous product manufacturing requirements and performance standards ensure that you obtain a proven and accepted device. From rapid screening through confirmation, our flexible and robust solutions also include federally regulated (SAMHSA 2 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 1 of 5 Alere laboratories. 1. Clinical Laboratory Improvement Amendments (CLIA) 2. Substance Abuse and Mental Health Services Administration (SAMHSA) 1. US Department of Health and Human Services. Results from the 2011 National Survey on Drug Use and Health: Summary of National Findings. NSDUH/2k11Results/NSDUHresults2011.htm. Accessed December 27, PRODUCT CATALOG FOR CLINICAL USE 3

3 Rapid Urine Drug Screening Devices Alere provides you with the necessary tools to manage an effective drug detection program. DRUG SCREENS AVAILABLE: Amphetamine (AMP), Barbiturates (BAR), Benzodiazepines (BZO), Buprenorphine (BUP), Buprenorphine glucuronide (BUPG), Cocaine Metabolites (COC), Ecstasy (MDMA), Marijuana (THC), Methadone (MTD), Methamphetamine (mamp, MET), Opiates (MOP, OPI), Oxycodone (OXY), Phencyclidine (PCP), Propoxyphene (PPX), and Tricyclic Antidepressants (TCA). SPECIMEN VALIDITY TESTS: Bleach (BL), 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 more than $400 billion in direct and indirect health care costs. National Institute of Drug Abuse and Addiction PRODUCT CATALOG FOR CLINICAL USE 5

4 Urine Drug Screens Equip yourself with a dependable rapid drug screening device. Alere icup Dx Urine Drug Screening Device with Specimen Validity Test (SVT) The Alere icup Dx is a CLIA-waived tilt-and-read urine drug screen that tests for up to 12 drugs at once. With specimen validity screening and limited urine exposure, this test fits a variety of drug test settings. Alere icup Dx Drug Test Item No. Drug Configurations Qty Per Box I-DXA BZO, COC, MET, OPI, OXY, THC (BL, CR, NI, ph, SG) n Self-contained cup is ideal for sending presumptive positive specimens to the laboratory for confirmation I-DXA AMP, BZO, COC, MET, MTD, OPI, OXY, THC (BL, CR, NI, ph, SG) n Available with specimen validity test (SVT) and temperature strip to help monitor specimen tampering (SVT includes BL, CR, NI, ph, SG) n Results in 5 minutes I-DXA I-DXA AMP, BAR, BZO, COC, MET, MDMA, MTD, OPI, OXY, THC (BL, CR, NI, ph, SG) AMP, BAR, BZO, COC, MET, MDMA, MTD, OPI, OXY, PCP, TCA, THC (BL, CR, NI, ph, SG) Drug screens available: Amphetamine (AMP), Barbiturates (BAR), Benzodiazepines (BZO), Buprenorphine (BUP), Cocaine Metabolites (COC), Ecstasy (MDMA), Marijuana (THC), Methadone (MTD), Methamphetamine (MET), Opiates (OPI), Oxycodone (OXY), Phencyclidine (PCP), and Tricyclic antidepressants (TCA). Specimen validity tests: Bleach (BL), Creatinine (CR), Nitrate (NI), ph (ph), Specific Gravity (SG). For in vitro diagnostic use only. 6 PRODUCT CATALOG FOR CLINICAL USE 7

5 Urine Drug Screens The original 14-panel CLIA-waived drug test cup. Alere icup Dx 14 Urine Drug Screening Device / Specimen Validity Options Available The Alere 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 glucuronide screening combined with low-level opiate cutoffs. n Integrated urine test cup targets 14 illicit and prescription drugs n Buprenorphine screening combined with low-level opiate cutoff makes it ideal for clinical settings n Self-contained cup is ideal for sending presumptive positive specimens to the laboratory for confirmation Alere icup Dx 14 Drug Test Item No. Drug Configurations Qty Per Box I-DX Alere icup Dx 14 AMP500, BAR, BUPG, BZO, COC150, MDMA, MET500, MOP, MTD, OXY, PCP, PPX, TCA, THC I-DXA Alere icup Dx 14 SVT with Specimen Validity Test AMP500, BAR, BUPG, BZO, COC150, MDMA, MET500, MOP, MTD, OXY, PCP, PPX, TCA,THC (BL, CR, NI, ph, SG) Drug screens available: Amphetamine (AMP), Barbiturates (BAR), Benzodiazepines (BZO), Buprenorphine glucuronide (BUPG), Cocaine Metabolites (COC), Ecstacy (MDMA), Marijuana (THC), Methadone (MTD), Methamphetamine (MET), Opiates (MOP), Oxycodone (OXY), Phencyclidine (PCP), Propoxyphene (PPX), and Tricyclic antidepressants (TCA). Specimen validity tests: Bleach (BL), Creatinine (CR), Nitrate (NI), ph (ph), Specific Gravity (SG). n Specimen validity combinations available: BL, CR, NI, ph, SG For in vitro diagnostic use only. 8 PRODUCT CATALOG FOR CLINICAL USE 9

6 Urine Drug Screens Easy-to-use, nontilt auto-activated test cup. Alere icup Dx Pro Urine Drug Screening Device / Specimen Validity Options Available The Alere icup Dx Pro is a CLIA-waived urine drug screen that tests for up to 12 drugs at once. The cup is read standing upright and is auto-activated. With low-level opiate cutoff levels (300 ng/ml), specimen validity screening, and limited exposure to urine, this test fits a variety of drug test settings. n Screens for a wide range of drugs: AMP, BAR, BZO, COC, MET, MDMA, MTD, OPI300, OXY, PCP, TCA, and THC n Self-contained cup is ideal for sending presumptive positive specimens to the laboratory for confirmation n Low-level opiate cutoffs (300 ng/ml) n Simple to use, no need to tilt cup to activate test read results in as little as 5 minutes Alere icup Dx Pro Drug Test Item No. Drug Configurations Qty Per Box I-DXP I-DXP Alere icup Dx Pro AMP, BAR, BZO, COC, MET, MDMA, MTD, OPI300, OXY, PCP, TCA, THC Alere icup Dx Pro with Specimen Validity Test AMP, BAR, BZO, COC, MET, MDMA, MTD, OPI300, OXY, TCA, THC (OX, ph, SG) Drug screens available: Amphetamine (AMP), Barbiturates (BAR), Benzodiazepines (BZO), Buprenorphine (BUP), Cocaine Metabolites (COC), Ecstasy (MDMA), Marijuana (THC), Methadone (MTD), Methamphetamine (MET), Opiates (OPI), Oxycodone (OXY), Phencyclidine (PCP), and Tricyclic antidepressants (TCA). Specimen validity tests: Oxidants (OX), ph (ph), Specific Gravity (SG). n Available with specimen validity test (SVT) and temperature strip helps to monitor specimen tampering Featuring lower opiate cutoff levels (300 ng/ml) For in vitro diagnostic use only. 10 PRODUCT CATALOG FOR CLINICAL USE 11

7 Urine Drug Screens Alere iscreen Dx Drug Test Multiple configurations to meet your clinical testing needs. Alere iscreen Dx Dip Card Urine Drug Screening Device The Alere iscreen Dx Dip card is one of the few brands of dip drug testing devices on the market today that is CLIA-waived. Able to test from 1 to 12 drugs on 1 device, it provides the accuracy and convenience that you need in a clinical setting. Item No. Drug Configurations Qty Per Box IS1 AMP-DX Amphetamine (AMP) Single Dip Device IS1 BAR-DX Barbiturate (BAR) Single Dip Device IS1 BUP-DX Buprenorphine (BUP) Single Dip Device IS1 BZO-DX Benzodiazepine (BZO) Single Dip Device IS1 COC-DX Cocaine (COC) Single Dip Device IS1 MET-DX Methamphetamine (MET) Single Dip Device IS1 MTD-DX Methadone (MTD) Single Dip Device n Rapidly screen for a broad range of illicit and prescription drugs n 1 to 12 configurations available for a fully customized urine testing program n Simple procedure: collect, dip, and read results in as little as 5 minutes n Test device remains in administrator s control IS1 MOP-DX Morphine (MOP) Single Dip Device IS1 OXY-DX Oxycodone (OXY) Single Dip Device IS1 PCP-DX Phencyclidine (PCP) Single Dip Device IS1 MDM-DX Ecstasy (MDMA) Single Dip Device IS1 TCA-DX Tricyclic Antidepressants (TCA) Single Dip Device IS1 THC-DX Marijuana (THC) Single Dip Device IS5 M-DX AMP, COC, MET, MOP, THC IS10-DX AMP, BAR, BZO, COC, MET, MOP, MTD, OXY, TCA, THC IS DX AMP, BAR, BZO, COC, MET, MDMA, MOP, MTD, PCP, THC Featuring buprenorphine test and lower opiate cutoff levels (300 ng/ml) For in vitro diagnostic use only. IS10BUP-DX AMP, BAR, BUP, BZO, COC, THC, MET, MOP, MTD, OXY IS12-DX AMP, BAR, BZO, COC, MET, MDMA, MOP, MTD, OXY, PCP, TCA, THC 12 PRODUCT CATALOG FOR CLINICAL USE 13

8 Urine Drug Screens Designed with the clinical market in mind. Alere icassette Dx Urine Drug Screening Device The Alere icassette Dx Drug Screen is CLIA-waived, easy to administer, and screens 11 commonly abused drugs on 1 device. Alere icassette Dx Drug Test Item No. Drug Configurations Qty Per Box n Rapidly screen for 11 illicit and prescription drugs I-DCB AMP, BAR, BZO, COC, MDMA, OPI, OXY, PCP, PPX, TCA, THC (includes test cassette and pipette) n Integrated positive, negative, and invalid control lines validate test n Simple procedure: collect and pipette to test results in as little as 5 minutes Drug screens available: Amphetamine (AMP), Barbiturates (BAR), Benzodiazepines (BZO), Cocaine Metabolites (COC), Ecstasy (MDMA), Marijuana (THC), Opiates (MOP/OPI300), Oxycodone (OXY), Phencyclidine (PCP), Propoxyphene (PPX), and Tricyclic Antidepressants (TCA). n Administrator remains in control of test device n Cutoff levels optimized for clinical market For in vitro diagnostic use only. 14 PRODUCT CATALOG FOR CLINICAL USE 15

9 Urine Drug Screens Dependable results and simple to administer. Alere icassette Urine Drug Screening Device Available in singles or up to 6 drugs on 1 device, the Alere 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. Alere icassette Drug Test Item No. Drug Configurations Qty Per Box I-DTH-102 Marijuana (THC) Single Dip Device I-DOA-1125 COC, THC (includes test cassette and pipette) n Rapidly screen up to six illicit drugs and prescription drugs I-DOA-1135 COC, mamp, THC (includes test cassette and pipette) n Simple procedure: collect and pipette to test results in as little as 5 minutes n Administrator remains in control of test device I-DOA-1145 I-DOA-1155 I-DOA-2155 COC, mamp, OPI, THC (includes test cassette and pipette) AMP, COC, mamp, OPI, THC (includes test cassette and pipette) AMP, COC, OPI, PCP, THC (includes test cassette and pipette) I-DOA-3155 COC, mamp, OPI, PCP, THC (includes test cassette and pipette) I-DOA-1165 AMP, COC, mamp, OPI, PCP, THC (includes test cassette and pipette) Drug screens available: Amphetamine (AMP), Cocaine Metabolites (COC), Marijuana (THC), Methamphetamine (mamp), Opiates (OPI), and Phencyclidine (PCP). For professional in vitro diagnostic use only. 16 PRODUCT CATALOG FOR CLINICAL USE 17

10 Rapid 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 Department of Transportation (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 PRODUCT CATALOG FOR CLINICAL USE 19

11 Alcohol Screens Simple procedure provides convenient and rapid results. Alere iscreen Saliva Alcohol Test Strips The Alere iscreen Saliva Alcohol Test Strips offer a convenient and rapid preliminary test that detects saliva alcohol concentration (SAC). n Easy to use and rapid results n Gender-neutral collections can be observed n Semiquantitative interpretations at 0.0%, 0.02%, 0.08%, and 0.30% SAC n Results in 2 minutes Results easily interpret the presence of alcohol. QED A150 Saliva Alcohol Test The QED A150 Saliva Alcohol Test 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. n No special equipment or training required n Built-in quality control and calibration n Reads like a thermometer n Results in 2 to 5 minutes n Easy-to-read Interpretation Chart For professional in vitro diagnostic use only. DOT-approved. For professional in vitro diagnostic use only. Item No. Alere iscreen Saliva Alcohol Test Strips Qty Per Box Item No. QED A150 Qty Per Box I-SA-25 Alere iscreen Saliva Alcohol Test Strips QED A150 Saliva Alcohol Test DOT-approved 10 Tests 20 PRODUCT CATALOG FOR CLINICAL USE 21

12 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 costs the US economy more than $193 billion per year National Drug Intelligence Center. PRODUCT CATALOG FOR CLINICAL USE 23

13 Complementary Products Drug Testing Forms Your collection and testing processes 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, photocopy templates, and laboratory test requisition forms (custody and control forms). Item No. Preliminary Results Forms and Photocopy Templates Packaging 2380P 2-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 2390P 2-part Oral Fluid Preliminary Result Forms Pack of P 2-part Oral Fluid Preliminary Result Forms (with iscreen OFD Copy Template) Pack of iscreen OFD Copy Template (single-sheet template) Single sheet Item No. Custody and Control Forms/Lab Requisition Forms Packaging part Urine Laboratory Requisition Form (COC) Pack of part Oral Result & Laboratory Form Single sheet 24 PRODUCT CATALOG FOR CLINICAL USE 25

14 Complementary Products 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 both in 5 ml and 20 ml options, the liquid solution vials are convenient for any office. Refrigeration is required. Testing Supplies 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. Item No. External Controls (packaged individually) Item No. External Controls (packaged individually) Packaging Alere iscreen Drug Control Negative (5 ml) x53 Lidded Cup with Temperature Strip (90 ml) Box of Alere iscreen Drug Control High Positive 3X Cutoff (5 ml) Beaker Cup with Temperature Strip (180 ml) Box of Alere iscreen Drug Control Negative (20 ml) 7875 Instant Bluing Tablets Bottle of Alere iscreen Drug Control High Positive 3X Cutoff (20 ml) 6622 Vinyl Gloves Medium Box of 50 pairs Alere iscreen Urine Drug Control Kit (includes positive and negative vials, 5 ml each) 6623 Vinyl Gloves Large Box of 50 pairs Alere iscreen Urine Drug Control Kit (includes positive and negative vials, 20 ml each) Temperature Strips Sold individually Alere Professional Cup Urine Drug Controls: Negative, Positive (10 ml each) Tamper-Evident Security Seals Sold individually 26 PRODUCT CATALOG FOR CLINICAL USE 27

15 Laboratory Confirmation Services Knowing now matters. From rapid screening devices to full laboratory confirmation testing, we offer a complete solution for all of your drug and alcohol detection needs. Rapid Test Devices CONDUCT ON-SITE TEST REVIEW PRELIMINARY RESULTS NEGATIVE RESULTS PRESUMPTIVE POSITIVE Laboratory Confirmation LAB ACCESSIONING LAB CONFIRMATION RESULT REPORTING Alere allows you to incorporate industry best practices, which may include laboratory confirmation testing at 1 of 3 SAMHSA Certified facilities, or at 2 that are dedicated to medication monitoring. 28 PRODUCT CATALOG FOR CLINICAL USE 29

16 Essential resources. We are dedicated to providing you with reliable solutions and responsive customer support. As drug use trends change and health management evolves, we will continue to assist you in evaluating your detection and monitoring needs. Complete Program Management Rapid Screening Laboratory Test Services Online Training and Certification Frequently Asked Testing Questions Drug Information Library 30 PRODUCT CATALOG FOR CLINICAL USE 31

17 Urine Screening Device Cutoff Levels Test Calibrator Cutoff (ng/ml) Amphetamine (AMP) Amphetamine (AMP 500) d-amphetamine d-amphetamine 1000 ng/ml 500 ng/ml Barbiturates (BAR) Secobarbital 300 ng/ml Benzodiazepines (BZO) Oxazepam 300 ng/ml Buprenorphine (BUP, BUPG) 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, MET) Methamphetamine (mamp 500, MET 500) Methylenedioxymethamphetamine (MDMA), Ecstasy Opiate (MOP, OPI 300) Opiate (OPI) d-methamphetamine d-methamphetamine d,l Methylenedioxymethamphetamine Morphine Morphine 1000 ng/ml 500 ng/ml 500 ng/ml 300 ng/ml 2000 ng/ml Oxycodone (OXY) Oxycodone 100 ng/ml Phencyclidine (PCP) Phencyclidine 25 ng/ml Propoxyphene (PPX) Propoxyphene 300 ng/ml Tricyclic antidepressants (TCA) Nortriptyline 1000 ng/ml Urine drug screen assays 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 judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are indicated. IMPORTANT PROCEDURE NOTE: Refer to product insert for complete instructions, limitations, and warnings. products aleretoxicology.com 2014 Alere. All rights reserved. The Alere Logo, Alere, icassette, icup, and iscreen are trademarks of the Alere group of companies. All other trademarks referenced herein are the property of their respective owners REV3 10/14