PROFILE®-V MEDTOX Scan® Drugs of Abuse Test System
Contents
1. MDE MDEA MDMA Methamphetamine d Methamphetamine Phenethylamine Pseudoephedrine Tyramine Barbiturate BAR Butalbital 200 ng mL Allobarbital Amobarbital Barbital Butabarbital Cyclopentobarbital Diphenylhydantoin Phenytoin Pentobarbital Phenobarbital Secobarbital Talbutal Positive at 50 000 ng mL Positive at 10 000 ng mL Positive at 250 ng mL Positive at 7 500 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Result Positive at 250 ng mL Positive at 800 ng mL Positive at 2 500 ng mL Positive at 400 ng mL Positive at 250 ng mL Positive at 2 000 ng mL Positive at 300 ng mL Positive at 1 250 ng mL Positive at 50 ng mL Positive at 50 ng mL Page 7 of 9 Cross Reactive 1 5 200 7 None Detected None Detected None Detected None Detected None Detected None Detected None Detected None Detected Cross Reactive 80 25 8 50 80 10 67 16 400 400 Barbituric Acid Glutethimide Hexobarbital Mephobarbital Thiopental Benzodiazepine BZO Nordiazepam 150ng mL Alprazolam Alprazolam 1 OH Clobazam Clonazepam Clorazepate Desalkylflurazepam Desmethylchlordiazepoxide Desmethylflunitrazepam Diazepam Flunitrazepam Lorazepam Lorazepam glucuronide Midazolam Nitrazepam Oxazepam Oxazepam glucur2. MDE MDEA MAMP Mephobarbital Methadone MTD Methaqualone Methylphenidate Mirtazapine Morphine 3 B D Glucuronide OPI Nalorphine OPI Nicotine Norclomipramine Nordoxepin Norpropoxyphene Ofloxacin Oxaprosin Oxycodone Penicillin G Perphenazine Phenethylamine MAMP Phenobarbital BAR Phenylbutazone Piroxicam Procainamide Promethazine Protriptyline Quetiapine Seroquel Riboflavin Sertraline Zoloft Sulindac Temazepam glucuronide BZO A Tetrahydrocannabinol Theophyline Thiothixene Triamterene Trifluoperazine Tripelennamine Valproic Acid The following metabolites and reacting compounds were evaluated for the specified test on the PROFILE V MEDTOXScan Drugs of Abuse Test System Reference standards for the various metabolites and compounds were prepared in negative urine samples Results are expressed as the minimum concentration expected to produce a positive result in the indicated assay Compounds that reacted with the test are listed first and related compounds that did not react with the highest concentration tested are listed second as Negative at 100 000 ng mL Cross Reactive values were calculated from the cut off level for the calibrator used for each test approximate 50 positive rate divided by the lowest reported level found to react in the same test greater than 66 positive rate Amphetamines AMP d Amphetamine 500 ng mL Result Amphetamine Fenfluramine MDA Phentermine Ephedrine
3. THC positive 11 nor 9 carboxy A9 THC at 39ng mL Page 5 of 9 Sensitivity Precision Distribution of Random Error Performance of the PROFILE V MEDTOXScan Drugs of Abuse Test System around the specific cutoff for each drug was evaluated by testing standard drug solutions diluted in drug free urine in triplicate on 5 different intervals by 3 in house operators using different readers 45 determinations for each level Drug free urine was also tested on each interval The results were interpreted at ten minutes by the MEDTOXScan Reader and are summarized for each drug in the table below re IE Concentration of Number of Concentration of Number of ng mL Cutoff Observations Neg Pos ng mL Cutoff Observations Neg Pos 500 BAR 200 NEG 45 4 0 0 O 100 50 4 4 0 250 12 4 1 0 4 150 4 o 4 187 5 125 45 8 37 187 5 125 45 f Jf 4 150 45 0o 4 150 iw NS is 2 a 0 mor amp 4 65 350 f 2m 4 4 ol 32 o 7 24 8 30 a tm 4 o 45 _ 23 300 so 4 o 4 o mo amp Tao 0 mo s Tapo o 625 m 4 4 0 8 a 25 lt 4 o 45 3125 15 4 o 45 _ 150 4 0o 4 150 45 0 45 THC 50 0 0 6 45 5 Non Cross reactive Endogenous Compounds The PROFILE V MEDTOXScan Drugs of Abuse Test System was evalua
4. Troubleshooting Section below External quality control materials are available from MEDTOX Contact MEDTOX at 1 800 832 3244 for further information 10 LIMITATIONS OF THE PROCEDURE 1 The PROFILE V MEDTOXScan Drugs of Abuse Test System is only for use with unadulterated human urine samples Urine samples that are either extremely acidic below pH 4 0 or basic above pH 9 0 may produce erroneous results If adulteration is suspected obtain an additional specimen and re test 2 A presumptive positive result for any drug does not indicate the level of intoxication administration route or concentration of that drug in the urine specimen 3 A negative result may not necessarily indicate drug free urine Negative results can be obtained when drug is present but below the cut off level of the test 4 Test results detected by the MEDTOXScan Reader after 10 minutes may not be consistent with the original result obtained at 10 minutes 5 The PROFILE V MEDTOXScan Drugs of Abuse Test System is not intended for use in point of care settings 6 There is a possibility that other substances and or factors e g technical or procedural errors may interfere with the test and cause false results T Gas Chromatography Mass Spectroscopy is the recommended confirmatory method for most drugs HPLC or LC MS MS is the preferred confirmatory method for Benzodiazepines Any of the drugs being tested for in the PROFILE V MEDTOXScan Drugs of Abu
5. are performing the test correctly A control line internal control is included on each PROFILE V MEDTOXScar test strip Whether or not drug is present in the sample a line must form at the Control C position on the test strip to show that enough sample volume was used and that the reagents are migrating properly If a Control line does not form the test is invalid The Control line consists of immobilized anti mouse antibody that reacts with the antibody colloidal gold as it passes this region of the membrane Formation of a line detectable by the MEDTOXScan Reader verifies the Control line antibody antigen reaction occurred External controls are urine based control materials that contain the drugs to be tested at concentrations above the cutoff positive control or contain no drug negative control Run external controls as if they were patient samples Refer to the instructions that accompany the external controls You should run external controls routinely or as needed for any of the following reasons 1 to practice the test with a known control 2 when you open a new lot of devices 3 once a week 4 if you suspect that the reader or test device is not working properly 5 if you have had a repeated unexpected test result or 6 if you suspect that the test devices have been stored improperly Should control results indicate a problem with the PROFILE V MEDTOXScan Drugs of Abuse Test System please follow the instructions in the
6. for no more than two days Urine may be frozen at 20 C 4 F or colder for storage Stored urine must be brought to ambient temperature 18 to 25 C 64 to 77 F and mixed well to assure a homogeneous sample prior to testing Page 2 of 9 5 PRECAUTIONS e The PROFILE V MEDTOXScan Drugs of Abuse Test System is for in vitro diagnostic use only e Do not use PROFILE V MEDTOXScan Test Devices after the expiration date printed on the package label e The PROFILE V MEDTOXScan Test Device should remain in its original sealed foil pouch until ready to use If the pouch is damaged do not use the test e If PROFILE V MEDTOXScar Test Devices have been stored refrigerated bring to ambient temperature 18 25 C 64 77 F prior to opening foil pouch Do not store the test kit at temperatures above 25 C 77 F Do not freeze Avoid cross contamination of urine samples by using a new urine specimen container and a fresh pipette tip for each urine sample Do not touch test strips in large viewing window of the PROFILE V MEDTOXScar Test Device Do not use PROFILE V MEDTOXScan Test Device if strips are damaged or dirty Do not apply labels or tape to the PROFILE V MEDTOXScan Test Device Do not write outside of the ID box on the PROFILE V MEDTOXScan Test Device top Urine specimens and all materials coming in contact with them should be handled and disposed of as if infectious and capable of transmitting infection Avoid contact w
7. test see Related Compounds and Cross Reactants and therefore was not assayed for interference for that drug test Samples were evaluated in triplicate by in house operators None of the common drugs listed in the following table affected the expected results Common Drugs Evaluated with the PROFILE V MEDTOXScan Drugs of Abuse Test System Acetylsalicylic Acid Chlorpheniramine Morphine OPI Acetaminophen Cocaine COC Phenobarbital BAR Brompheniramine maleate Dextromethorphan Phenytoin Diphenylhydantoin BAR Caffeine Doxylamine d Pseudoephedrine Carbamazepine Ibuprofen Salicylic Acid 12 TROUBLESHOOTING Use the QC Test Devices provided with the MEDTOXScan Reader to detect errors associated with the MEDTOXScan Reader and a contaminated contact imaging sensor CIS and to verify that the CIS cleaning procedure using the MEDTOXScan Cleaning Cassette effectively removed any contamination dirt dust or sample The QC Test Devices function as an optical performance system check for the MEDTOXScan Reader only not for the PROFILE V MEDTOXScan Drugs of Abuse Test System and they are not intended to replace the need for the external controls The QC Test Devices have been designed to simulate the end points that are generated in the PROFILE V MEDTOXScar Test Device when external positive and negative QC controls are run The QC Test Devices consist of artificial control lines and test lines n
8. to the drug s in the urine it cannot bind to the drug conjugate immobilized on the membrane and no line is generated at the drug specific position in the result window The MEDTOXScan Reader will scan each test position and if no line is detected it will return POS on the display screen or print out next to the abbreviation for the drug test indicating a preliminary positive result Control Line Valid or Invalid results Each test strip has an internal procedural control A line must form at the Control C position in the result window to indicate that sufficient sample was applied and that the reagents are migrating properly If a Control line does not form the test is invalid The MEDTOXScan Reader scans each control line and returns VALID to the right of the drug test result to confirm that the control line was detected If no control line is detected it will return INVALID on the display screen or print out next to the abbreviation for the invalid drug test and no result will be given for that drug test 4 SAMPLE COLLECTION AND PREPARATION The urine sample should be collected in a clean dry container Approximately 75 uL is required for each sample well Collection of 30 mL of urine is more than sufficient for initial and subsequent testing No preservatives should be added Urine may be tested immediately following collection If it is necessary to store the urine store under refrigeration at 2 to 8 C 36 to 46 F
9. MEDTOX PROFILE V MEDTOXScan Drugs of Abuse Test System INSERT 1 INTENDED USE The PROFILE V MEDTOXScan Drugs of Abuse Test System consists of the PROFILE V MEDTOXScan Test Devices and the MEDTOXScan Reader The PROFILE V MEDTOXScan Test Devices are one step immunochromatographic tests for the rapid qualitative detection of one or more of the following in human urine Amphetamine Barbiturates Benzodiazepines Cocaine Methadone Methamphetamine Opiates Phencyclidine and THC Cannabinoids or their metabolites The PROFILE V MEDTOXScan Test Devices can only be used with the MEDTOXScan Reader The MEDTOXScan Reader is an instrument used to interpret and report the results of the PROFILE V MEDTOXScan Test Device The PROFILE V MEDTOXScan Test Devices cannot be visually read The PROFILE V MEDTOXScan Drugs of Abuse Test System is for in vitro diagnostic use and is intended for professional use only It is not intended for use in point of care settings The PROFILE V MEDTOXScan Drugs of Abuse Test System detects drug classes at the following cutoff concentrations AMP Amphetamine d Amphetamine 500 ng mL MTD Methadone Methadone 200 ng mL BAR Barbiturates Butalbital 200 ng mL OPI Opiates Morphine 100 ng mL BZO Benzodiazepines Nordiazepam 150 ng mL PCP Phencyclidine Phencyclidine 25 ng mL COC Cocaine Benzoylecgonine 150 ng mL THC Cannabinoids 11 nor 9 carboxy 9 THC 50 ng mL MAMP Methamphe
10. Pseudoephedrine Quinidine Salicylic Acid Sildenafil Viagra Talbutal BAR Tetracycline Tetrahydrozoline Thiopental Tolmetin Tolectin Triazolam BZO Trimethoprim Tryptophan Venlafaxine Related Compounds and Cross Reactants Diazepam BZO Digoxin Diphenylhydantoin Phenytoin BAR Doxepin Ecgonine Methyl Ester EMDP Secondary metabolite of methadone Ethanol Fenoprofen Fluoxetine Prozac Fluvoxamine Hexobarbital Hydrocodone OPI Hydroxybupropion Hydroxyzine Ketamine Lidocaine Lorazepam BZO Lysergic Acid MDA AMP Meperidine Mesoridazine Methamphetamine MAMP Methocarbamol Midazolam BZO Morphine OPI Naltrexone Naproxen 11 Nor 9 carboxy A THC THC Nordiazepam BZO Normeperidine Nortriptyline Orphenadrine Oxazepam glucuronide BZO Oxymorphone Pentobarbital BAR Phendimetrazine Phenmetrazine Phentermine AMP Phenylpropanolamine Procaine MAMP Promazine Propranolol Pyrilamine Ranitidine Secobarbital BAR Sulfamethazine Temazepam BZO A Tetrahydrocannabinol THC Thebaine OPI Thioridazine Trazodone Triazolam 1 hydroxy BZO Trimipramine Tyramine Verapamil Diclofenac Dihydrocodeine OPI Domperidone Doxylamine EDDP Primary metabolite of methadone Ephedrine MAMP Ethylmorphine OPI Fentanyl Synthetic opiate Flurazepam Glutethimide Hydralazine Hydrocortisone 11 Hydroxy A THC Ibuprofen Ketoprofen Lithium carbonate Lorazepam glucuronide BZO Lysergic Acid Diethylamide LSD
11. and 50 of cutoff Near Cutoff Negative samples that fell between 50 of the cutoff concentration and the cutoff concentration Near Cutoff Positive samples that fell between the cutoff concentration and 150 of the cutoff concentration and High Positive samples that were greater than 150 of cutoff concentration Drug concentrations were assayed by GC MS or LC MS MS for BZO Concentrations used to assign the cutoff ranges for each drug were determined by summing the GC MS and LC MS MS levels measured for all test specific analytes found in the sample The testing was performed by in house operators The results were interpreted at ten 10 minutes by the MEDTOX Scan Reader and are summarized for each drug in the table below PROFILE V MEDTOXScan Drugs of Abuse Test System Results vs stratified GC MS or LC MS MS Values Low negative Near Cutoff Near Cutoff P V by GC MS or Negative Positive High Positive MEDTOXScan No Drug LC MS MS between Between greater than Agfeement Test System Less than 50 and cutoff and 50 50 cutoff 50 Positive 5 4 96 sd a0 Positive 36 100 BAR con nege a sm Te 5 1 4 0 4 0 4 0 3 0 3 0 0 98 97 98 0 0 0 0 0 0 Positive 0 de 500 Negative 0 0 0 0 6 0 0 0 0 0 i 4 i 4 r 5 BZO 150 ri 100 i 5 A MTD 200 Positi ve Negative Positive OP1 100 Negative ve ve 94 93 ee S 96 357 98 5 ee Positi Ne
12. can Test Devices utilize a one step solid phase immunoassay technology The PROFILE V MEDTOXScan Drugs of Abuse Test System includes the MEDTOXScan Reader for a convenient automated result This test system may be used to screen urine samples for one or more of the following drug classes prior to confirmatory testing The amphetamines are a group of drugs that are central nervous system stimulants This group includes amphetamine and methamphetamine Amphetamine d amphetamine is detected on the Test Device only at the AMP position methamphetamine MAMP is detected at the MAMP position Barbiturates BAR are a group of structurally related prescription drugs that are used to reduce restlessness and emotional tension induce sleep and to treat certain convulsive disorders Benzodiazepines BZO a group of structurally related central nervous system depressants are primarily used to reduce anxiety and induce sleep Cocaine COC is a central nervous system stimulant Its primary metabolite is benzoylecgonine Methadone MTD is a synthetic opioid used clinically as a maintenance drug for opiate abusers and for pain management Opiates OPI are a class of natural and semi synthetic sedative narcotic drugs that include morphine codeine and heroin Phencyclidine PCP is a hallucinogenic drug Marijuana THC is a hallucinogenic drug derived from the hemp plant Marijuana contains a number of active ingredients collectively known as Can
13. ce the test device in the MEDTOXScan Reader cassette drawer and close the drawer The MEDTOXScan Reader will read the barcode on the test device and determine its part number and test configuration It will prompt the user to enter Lot User ID and Specimen ID which can all be entered using the MEDTOXScan Reader keypad or hand held barcode scanner The MEDTOXScan Reader will begin timing the assay once it detects the barcode and results will be displayed after the scan and analysis are complete 6 Alternatively the reader can be set on User Timed mode where it will scan the test device as soon as it detects its barcode see MEDTOXScan Reader User Manual In this case the PROFILE V MEDTOXScan Test Device should be inserted into the MEDTOXScan Reader 10 minutes after adding the urine sample MiniPet is a trademark of TriContinent Scientific Inc Page 3 of 9 8 READING AND INTERPRETATION OF THE TEST RESULTS The PROFILE V MEDTOXScan Test Devices are labeled horizontally with the names of the test on each strip and vertically with C and the symbols T1 T4 The letter C represents the control lines T1 T4 refers to Test Position 1 to Test Position 4 from top to bottom of viewing window The test position of each test is indicated on the label above the strip The MEDTOXScan Reader will automatically read the control and test lines at the correct test position and display the test results for each dru
14. drug s in the urine and the drug s conjugated to the protein compete to bind to the antibody colloidal gold A test line will form when drug in the sample is below the detection threshold negative result The MEDTOXScan Reader scans the test device and utilizes a contact imaging sensor CIS to capture relative line intensities Software algorithms and barcodes are used to identify the test device the drug tests associated with the test device and whether the presence or absence of a line is associated with a negative or positive result respectively The results of the scans are displayed on the MEDTOXScan Reader screen or optionally can be printed Negative Samples When no drug s is present in the urine sample the reddish purple antibody colloidal gold solutions migrate along the strip and bind to the respective drug conjugate s immobilized on the membrane Each strip has up to 4 drug test lines labeled T1 T4 The binding of the antibody colloidal gold to the drug conjugate generates a line at the corresponding test T position on the strip The MEDTOXScan Reader will scan each test position and if a line is detected it will return NEG on the display screen or print out next to the abbreviation for the drug test indicating a negative result Positive Samples When drug s is present in the urine sample the antibody colloidal gold binds to the drug s before it migrates along the strip When the antibody colloidal gold binds
15. egative or artificial control lines and no test lines positive printed on a membrane and placed in the PROFILE V MEDTOXScan Test Device plastic housing The QC Test Devices are not intended to evaluate all components of the test system from specimen preparation through generation of results They are intended to function as a troubleshooting device to determine that the reader optics are functioning correctly You should run the QC Test Devices 1 if you suspect the MEDTOXScan Reader is not functioning properly or 2 if you suspect the CIS is dirty or 3 if the MEDTOXScan Reader has been dropped or damaged Consult the MEDTOXScan Reader User Manual for details on troubleshooting cleaning procedure and explanation of MEDTOXScan Reader error messages Contact MEDTOX Technical Support if you need any additional help at 1 800 832 3244 13 BIBLIOGRAPHY 1 Blum K Handbook of Abusable Drugs Gardener Press Inc New York New York 1984 pp 305 349 2 DeCresce R P Lifshitz M S Mazura A C and Tilson J E Drug Testing in the Workplace ASCP Press American Society of Clinical Pathologists Chicago Illinois 1989 pp 105 109 3 Baselt R C Disposition of Toxic Drugs and Chemicals in Man Seventh Edition Biomedical Publications Foster City California 2004 4 White R M and Black M L Pain Management Testing Reference AACC Press Washington DC 2007 5 Cary P L The Marijuana Detection Window Determining the Length
16. etected None Detected None Detected Cross Reactive 150 lt 1 200 17 75 25 15 200 200 300 13 15 3 300 75 6 167 20 20 2 None Detected None Detected None Detected None Detected Cross Reactive 60 None Detected None Detected Cross Reactive 20 1 7 43 7 20 2 7 None Detected None Detected None Detected None Detected None Detected None Detected None Detected Cross Reactive None Detected None Detected None Detected Cross Reactive 200 200 133 200 25 13 4 29 133 20 lt 1 1 lt 1 None Detected None Detected None Detected None Detected None Detected Cross Reactive lt 1 Cross Reactive lt 1 Cannabidiol Negative at 100 000 ng mL Cannabinol Negative at 100 000 ng mL 1 1 Hydroxy A9 THC Negative at 100 000 ng mL A8 Tetrahydrocannabinol Negative at 100 000 ng mL None Detected None Detected None Detected None Detected Interference pH and Specific Gravity The PROFILE V MEDTOXScan Drugs of Abuse Test System was assayed with three negative clinical samples with pH values of 4 0 7 0 and 9 0 0 1 Each sample was assayed in triplicate The pH samples were fortified with drug concentrations that were the maximum level to give a strong negative 95 or greater negative result 10 50 of cut off see Sensitivity data and the minimum level above the cut off to give a strong positive 95 or greater positive re
17. g A printer is also available The MEDTOXScan Reader displays the results as either NEG for a negative result POS for a preliminary positive result or INVALID for an invalid result VALID will be displayed if valid results are obtained Valid The control line must be present for the test to be valid NEG A NEGATIVE test result for a specific drug indicates that the sample does not contain the drug drug metabolite above the cutoff level POS A preliminary POSITIVE test result for a specific drug indicates that the sample may contain drug drug metabolite near or above the cutoff level It does not indicate the level of intoxication or the specific concentration of drug in the urine sample Positive samples should be sent to a reference laboratory for more definitive testing Invalid The control line must be present for the test to be valid The absence of a control line indicates the test is invalid The urine sample should be retested on a new test device 9 QUALITY CONTROL The purpose of quality control is to ensure accuracy and reliability of results and to detect errors MEDTOX recommends a Quality Control Program for monitoring the performance of the PROFILE V MEDTOXScan Test Devices and the MEDTOXScan Reader that uses a combination of internal controls and external controls Users should follow government regulations for the running of QC material Internal controls ensure that the test is working and that you
18. gative Positi THC 50 50 Negative Positive PCP 25 98 96 1 1 2 0 0 4 0 3 1 For samples giving preliminary positive results below the cutoff and negative results above the cutoff the assayed values are detailed in the table below ACCURACY SUMMARY OF DISCORDANT RESULTS Cutoff P V Value MEDTOXScan GC MS or LC MS MS Value ng mL ng mL Test System AMP positive Amphetamine at 277ng mL AMP positive Amphetamine at 352ng mL 500 AMP positive Amphetamine at 368ng mL AMP positive Amphetamine at 463ng mL AMP negative Amphetamine at 504ng mL AMP negative Amphetamine at 667ng mL BAR positive Butalbital at 126ng mL 200 BAR positive Butalbital at 159ng mL BAR positive Butalbital at 184ng mL 150 BZO positive Alprazolam at 146ng mL COC positive Benzoylecgonine at 114ng mL 150 COC positive Benzoylecgonine at 121ng mL COC negative Benzoylecgonine at 180ng mL COC negative Benzoylecgonine at 278ng mL 500 mAMP positive Methamphetamine at 483ng mL mAMP negative Methamphetamine at 554ng mL MTD positive Methadone at 148ng mL 200 MTD positive Methadone at 176ng mL MTD negative Methadone at 250ng mL OPI positive Morphine at 51ng mL 100 OPI positive Morphine at 79ng mL OPI positive Morphine at 92ng mL PCP positive Phencyclidine at 19ng mL 25 PCP positive Phencyclidine at 21ng mL PCP positive Phencyclidine at 24ng mL 50 THC positive 11 nor 9 carboxy A9 THC at 35ng mL
19. ine Amoxicillin d Amphetamine AMP l Amphetamine AMP Ampicillin Apomorphine Ascorbic Acid Atomoxetine Atropine Sulfate Barbital BAR Barbituric Acid Benzoic Acid Benzocaine ethyl 4 aminobenzoate Benzoylecgonine COC Benzphetamine Benztropine Brompheniramine Buprenorphine Bupropion Butabarbital BAR Butalbital BAR Caffeine Cannabidiol Cannabinol Carbamazepine Carbamazepine 10 11 epoxide Carisoprodol Meprobamate Cephalexin Chlordiazepoxide Chlorothiazide Chlorpheniramine Chlorpromazine Clobazam BZO Clomipramine Clonazepam BZO Clorazepate BZO Clozapine Cocaine COC Codeine OPI Cotinine Cyclobenzaprine Cyclopentobarbital BAR Desalkylflurazepam BZO Desipramine Desmethylchlordiazepoxide BZO Desmethylflunitrazepam BZO Desmethylvenlafaxine Dextromethorphan Page 6 of 9 Diacetylmorphine OPI Diethylpropion Diphenhydramine Dopamine Ecgonine Efavirenz Sustiva Erythromycin Fenfluramine MAMP AMP Flunitrazepam BZO Furosemide Haloperidol Hydrochlorothiazide Hydromorphone OPI 4 Hydroxyphencyclidine PCP Imipramine Levorphanol OPI Loperamide Loxapine Maprotiline MDMA MAMP Mepivacaine d Methamphetamine MAMP Methcathinone Metoprolol 6 Monoacetylmorphine OPI Morphine 6 B D Glucuronide OPI Naloxone Nitrazepam BZO Norcodeine OPI Norlysergic Acid Norpseudoephedrine Olanzapine Oxazepam BZO Oxymetazoline Pentazocine Phencyclidine PCP Pheniramine Phenothiazine Phenylephrine MAMP Prednisone Prochlorperazine Propoxyphene d
20. ith broken skin e Avoid contaminating the top of the test device with urine sample Clean any urine off the top of the test device using a dry wipe to prevent contamination of the MEDTOXScan Reader sensor 6 REAGENTS and MATERIALS PROVIDED STORAGE CONDITIONS The PROFILE V MEDTOXScan Drugs of Abuse Test System kit contains PROFILE V MEDTOXScan Test Devices for use with the MEDTOXScan Reader e Each test device has all the reagents necessary to test one urine sample for one or more drugs simultaneously on the MEDTOXScan Reader e Each test device holds one or more test strips composed of a membrane strip coated with drug conjugate and a pad coated with antibody colloidal gold in a protein matrix Kit Contents 1 Twenty five 25 test devices in individual foil packages 2 Twenty five 25 disposable pipette tips 3 One Quick Reference guide Storage Conditions The kit in its original packaging should be stored at 2 25 C 36 77 F until the expiration date on the label MEDTOXScan Reader Contents 1 Positive and Negative QC Test Devices 2 Cleaning Cassette 3 MiniPet pipettor 4 Quick Set Up guide 5 User Manual MATERIALS REQUIRED BUT NOT PROVIDED 1 Urine specimen collection container 2 PROFILE V MEDTOXScan Positive and Negative Control Solutions external controls OPTIONAL MATERIALS 1 Thermal Printer and Printer paper 2 Hand held Barcode Scanner NOTE Specimen containers and external control solutions a
21. itive at 1 000 ng mL Positive at 5 000 ng mL Positive at 50 ng mL Positive at 200 ng mL Positive at 2 500 ng mL Positive at 90 ng mL Positive at 750 ng mL Positive at 750 ng mL Positive at 10 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Result Positive at 250 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Result Positive at 2 500 ng mL Positive at 50 000 ng mL Positive at 7 500 ng mL Positive at 1 150 ng mL Positive at 7 500 ng mL Positive at 2 500 ng mL Positive at 25 000 ng mL Positive at 7 500 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Result Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Result Positive at 50 ng mL Positive at 50 ng mL Positive at 75 ng mL Positive at 50 ng mL Positive at 400 ng mL Positive at 800 ng mL Positive at 2 500 ng mL Positive at 350 ng mL Positive at 75 ng mL Positive at 500 ng mL Positive at 50 000 ng mL Positive at 10 000 ng mL Positive at 25 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Result Positive at 7 500 ng mL Result Positive at 100 000 ng mL Page 8 of 9 None Detected None Detected None D
22. nabinoids Many factors influence the length of time required for drugs to be metabolized and excreted in the urine A variety of factors influence the time period during which drug metabolites are detected in urine These include the rate of urine production the volume of fluid consumption the amount of drug taken the urine pH and the length of time over which drug was consumed Drinking large volumes of liquid or using diuretics to increase urine volume will lower the drug concentration in the urine and may decrease the detection period Lower detection levels may increase the detection time window Although the detection period for these drugs varies widely depending upon the compound taken dose and route of administration and individual rates of metabolism some general times have been established and are listed below Page 1 of 9 Drug Detection Period Drug Detection Period Amphetamine Methamphetamine Acid Conditions 1 3 days Acid Conditions 1 3 days Alkaline Condition 3 10 days Alkaline Conditions 3 10 days Barbiturates Opiates Short Acting Up to 6 days Heroin 1 day Long Acting Up to 16 days Morphine 1 3 days Codeine 1 3 days Benzodiazepines 1 12 days PCP Cocaine metabolite Up to 5 days Single Use 1 8 days 1 to 3 days typical Chronic Use Up to 4 weeks Methadone 1 3 days THC Single Use 1 7 days Chronic Use Less than 30 days typical 3 PRINCIPLES OF THE PROCEDURE The PROFILE V MEDTOXScan Drugs of Abuse Test S
23. of Time Cannabinoids will Remain Detectable in Urine Following Smoking A Critical Review of Relevant Research and Cannabinoid Detection Guidance for Drug Courts Drug Court Review Volume V 1 2005 pp 23 58 6 Smith M L Shimomura E T Summers J Paul B D Nichols D Shippee R Jenkins A J Darwin W D and Cone E J Detection Times and Analytical Performance of Commercial Urine Opiate Immunoassays Following Heroin Administration Journal of Analytical Toxicology Volume 24 7 October 2000 pp 522 529 14 LIMITED EXPRESS WARRANTIES The manufacturer makes no express warranty other than the diagnostic test kit will measure certain drugs and or drug metabolites when used in accordance with the manufacturer s printed instructions The use of the kit for any other purpose is outside the intended use of this product The manufacturer gives no express warranty as to what the legal or clinical significance is of the levels of drug s drug metabolites detected by the PROFILE V MEDTOXScan Drugs of Abuse Test System The manufacturer disclaims any and all implied warranties of merchantability fitness for use or implied utility for any other purposes Any and all damages for failure of the kit to perform to its instructions are limited to the replacement value of the kit Covered by one or more patents Patents Pending U S Patent Nos 5 202 268 6 566 051 6 376 251 6 653 139 This product does not contain controlled substance
24. onide Temazepam Temazepam glucuronide Triazolam Triazolam 1 OH 7 Aminoclonazepam 7 Aminoflunitrazepam Chlordiazepoxide Flurazepam Cocaine COC Benzoylecgonine 150 ng mL Cocaine Ecgonine Ecgonine Methyl Ester Methamphetamine mAMP d Methamphetamine 500 ng mL Ephedrine Fenfluramine MDE MDEA MDMA Methamphetamine Phenethylamine Phenylephrine Procaine d Amphetamine Amphetamine MDA Phentermine Phenmetrazine Pseudoephedrine Tyramine Methadone MTD Methadone 200 ng mL Buprenorphine MTD Replacement EDDP Primary metabolite EMDP Secondary metabolite Opiates OPI Morphine 100ng mL Codeine Diacetylmorphine Dihydrocodeine Ethylmorphine Hydrocodone Hydromorphone Levorphanol 6 Monoacetylmorphine Morphine 3 B D Glucuronide Morphine 6 B D Glucuronide Nalorphine Norcodeine Thebaine Apomorphine Naloxone Naltrexone Oxycodone Oxymorphone Phencyclidine PCP Phencyclidine 25 ng mL 4 Hydroxyphencyclidine Cannabinoids THC 1 1 Nor 9 carboxy A THC 50 ng mL A9 Tetrahydrocannabinol Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Result Positive at 100 ng mL Positive at 25 000 ng mL Positive at 75 ng mL Positive at 900 ng mL Positive at 200 ng mL Positive at 600 ng mL Positive at 1 000 ng mL Positive at 75 ng mL Positive at 75 ng mL Positive at 50 ng mL Positive at 1 200 ng mL Pos
25. re available from MEDTOX Diagnostics Inc 7 TEST PROCEDURE 1 Open one pouch for each sample to be tested and mark the PROFILE V MEDTOXScar Test Device with the patient or sample identification ID Make sure you only mark within the ID box on the test device You may notice a reddish purple color in the sample well This is normal do not discard the test 2 Dispense 75uL of urine into sample well indicated by V on the test device e Place a disposable yellow sample tip securely onto the end of the green 75uL MiniPet Grasp the MiniPet under its collar using the index and middle fingers With the thumb depress the plunger completely Holding the MiniPet vertically straight up down lower the yellow tip no more than into the urine specimen With tip in the urine specimen slowly and smoothly release the plunger allowing it to rise completely Visually inspect the urine sample in the tip Ensure there are no air bubbles and that no excess urine is on the outer surface of the tip Hold the pipette tip directly over sample well Depress plunger completely to dispense the entire contents of urine into one sample well of the testing device 3 Repeat Step 2 for all sample wells with a V above them 4 Discard disposable yellow sample tip Store the MiniPet in a dry secure location at room temperature 18 25 C or 64 77 F Replace the MiniPet if it becomes damaged or does not function properly 5 Pla
26. s This product does not contain hazardous or toxic chemicals as defined by the OSHA Hazard Communication Rule 29 CFR 1910 1200 g To place an order or for technical support services call 1 800 832 3244 2009 MEDTOX Diagnostics Inc All rights reserved MEDTOX Diagnostics Inc P N 102038 1238 Anthony Road Rev 02 09 Burlington NC 27215 Printed in USA Page 9 of 9
27. se Test System may give a preliminary positive result if ingested at prescribed therapeutic doses 8 The PROFILE V MEDTOXScan Drugs of Abuse Test System cannot distinguish between abused drugs and certain prescribed medications A positive test may be obtained from certain foods or food supplements 9 The PROFILE V MEDTOXScan Test Devices must be used only with the MEDTOXScan Reader They cannot be visually read 11 PERFORMANCE CHARACTERISTICS re ET MEDTOXScan Drugs of Abuse Test System detects one or more of the following drugs at cutoff levels listed below AMP Amphetamine 500 ng mL BAR Barbiturates Butalbital 200 ng mL BZO Benzodiazepines Nordiazepine 150 ng mL COC Benzoylecgonine 150 ng mL MAMP Methamphetamine 500 ng mL MTD Methadone 200 ng mL OPI Morphine 100 ng mL PCP Phencyclidine 25 ng mL THC 11 nor 9 carboxy A THC 50 ng mL Page 4 of 9 Accuracy Accuracy and Comparison to GC MS or LC MS MS The accuracy of the PROFILE V MEDTOXScan Drugs of Abuse Test System was evaluated by assaying a panel of blind coded clinical urine samples containing varying concentrations of drugs and comparing to GC MS or LC MS MS results The samples were obtained from MEDTOX Laboratories and grouped in the following manner Negative samples that screened negative by KIMS Kinetic Interaction of Microparticles in Solution and not confirmed by GC MS Below Cutoff Negative samples that fell between limit of detection or quantitation
28. sult 125 150 of cut off see Sensitivity data All three pH samples gave negative results when fortified to the maximum strong negative level for each drug and all gave positive results when fortified to the minimum strong positive level for each drug The PROFILE V MEDTOXScan Drugs of Abuse Test System was assayed with three samples with specific gravity values of 1 003 1 015 and 1 030 0 001 Each sample was assayed in triplicate The specific gravity samples were fortified with drug concentrations as described above for pH to give strong negative and strong positive results All three specific gravity samples gave negative results when fortified to the maximum strong negative level for each drug and all gave positive results when fortified to the minimum strong positive level for each drug Common Drugs Following the study of M L Smith et al drug free urine samples were spiked with drug concentrations that were the maximum level to give a strong negative 95 or greater negative result 10 50 of cut off see Sensitivity data and the minimum level above the cut off to give a strong positive 95 or greater positive result 125 150 of cut off see Sensitivity data 100 000 ng mL of the common drugs were then added to the preparation and assayed by the PROFILE V MEDTOXScan Drugs of Abuse Test System If a common compound name is followed by the abbreviation COC BAR or OPI it has cross reactivity to the specified drug
29. tamine d Methamphetamine 500 ng mL Configurations of the PROFILE V MEDTOXScar Test Devices may consist of any combination of the above listed drug analytes Refer to specific product labeling for the combination of drug tests included on that test device THE PROFILE V MEDTOXScan DRUGS OF ABUSE TEST SYSTEM PROVIDES 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 HIGH PERFORMANCE LIQUID CHROMATOGRAPHY HPLC 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 OBTAINED The MEDTOXScan Reader includes a Positive QC Test Device a Negative QC Test Device and a Cleaning Cassette The MEDTOXScan Positive and Negative QC Test Devices are intended to detect errors associated with the MEDTOXScan Reader and a contaminated contact imaging sensor CIS and to verify that the CIS cleaning procedure using the MEDTOXScan Cleaning Cassette effectively removed any contamination see Troubleshooting section Information regarding confirmatory testing may be obtained from www medtox com or by contacting MEDTOX at 1 800 832 3244 2 SUMMARY AND EXPLANATION OF THE TEST Qualitative PROFILE V MEDTOXS
30. ted for cross reactivity with fifteen endogenous compounds The compounds were dissolved in appropriate solvents at a concentration of at least 1 0 mg mL Each compound was further diluted to 100 ug mL except for albumin 20 mg mL and bilirubin 200 pg mL None of these compounds showed cross reactivity at the referenced concentrations to any of the PROFILE V MEDTOXScan Test Devices Acetaldehyde Creatinine Hemoglobin Human Acetone Epinephrine Sodium Chloride Albumin Human B Estradiol Tetrahydrocortisone Bilirubin Estriol d 1 Thyroxine Cholesterol Glucose Std Solution Uric Acid Unrelated Compounds Prescription and Over the Counter Medications The following compounds were tested for reactivity to the PROFILE V MEDTOX Scan Drugs of Abuse Test System Listed compounds were dissolved in appropriate solvents and then added to drug free urine for testing Unless otherwise noted by a drug name abbreviation such as AMP or BAR etc all of the listed compounds were negative in each of the tests at 100 ug mL If a drug name is followed by an abbreviation such as AMP or BAR etc check the Related Compounds and Cross Reactants listing for the drug in question under the appropriate heading AMP BAR etc to find its level of cross reactivity to that test Acetaminophen Acetylsalicyclic Acid Allobarbital BAR Alprazolam BZO Alprazolam 1 Hydroxy BZO 7 Aminoclonazepam 7 Aminoflunitrazepam Amitriptyline Amobarbital BAR Amoxap
31. ystem includes the one step competitive membrane based immunochromatographic PROFILE V MEDTOXScan Test Device and the MEDTOXScan Reader which interprets and reports the test results automatically A single urine sample can be evaluated for the presence of each of the classes of drugs specified in a single PROFILE V MEDTOXScar Test Device The PROFILE V MEDTOXScan Test Device includes antibody colloidal gold drug conjugates and a control line ANTIBODY COLLOIDAL GOLD Mouse monoclonal antibodies were developed that bind specifically to the drug class being tested The individual monoclonal antibodies were adsorbed to colloidal gold and dried onto the test device DRUG CONJUGATES Drugs from each class to be tested were individually conjugated to bovine serum albumin BSA or IgG Each drug conjugate is immobilized on a test line at a designated position on the membrane strip CONTROL LINE Each test strip has anti mouse antibody immobilized at the Control C position of the membrane strip The anti mouse antibody will bind excess antibody colloidal gold indicating that the reagents are working properly When the urine sample is placed in the sample well of a test strip the dried antibody colloidal gold on the sample pad dissolves and the urine wicks up the white strips carrying the reddish purple antibody colloidal gold with it The PROFILE V MEDTOXScan Drugs of Abuse Test System will detect specific classes of drugs in urine because
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