PROFILE-V MEDTOXScan Drugs of Abuse Test System Package
Contents
1. Opiates OPI are a class of natural and semi synthetic sedative narcotic drugs that include morphine codeine and heroin Oxycodone OXY Oxycontin Percodan Percocet is a semi synthetic narcotic analgesic that is prescribed for moderately severe pain It is available in both standard and sustained release oral formulations Oxycodone is metabolized to Oxymorphone and Noroxycodone Phencyclidine PCP is a hallucinogenic drug Propoxyphene PPX is a narcotic analgesic Its primary metabolite is norpropoxyphene 3 Tricyclic Antidepressants TCA are a group of structurally related prescription drugs that are used to manage depression anuara TRG is a hallucinogenic drug derived from the hemp plant Marijuana contains a number of active ingredients collectively known as annabinoids 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 upon2. 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 e 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 Avoid polystyrene containers Do not use preservatives Do not touch test strips in large viewing window of the PROFILE V MEDTOXScan 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 MEDTOXSCcan Test Device Do not write outside of the ID area on the left side of the PROFILE V MEDTOX Scan 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 with 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 MEDTOX Scan Reader sensor Page 2 of 12 6 REAGENTS and MATERIALS PROVIDED STORAGE CONDITIONS The PROFILE V MEDTOX Scan Drugs of Abuse Test System kit contains PROFILE V MEDTOX Scan Test Devices for use with the MEDTOXScan Reader e Each test device has all the reagents necessary to test one u
3. 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 Cross Reactive lt 1 Cross Reactive 600 Cross Reactive lt 1 None Detected None Detected None Detected None Detected Cross Reactive 60 4 2 23 120 100 43 60 lt 1 lt 1 33 lt 1 3 6 None Detected None Detected None Detected None Detected None Detected None Detected None Detected None Detected None Detected None Detected The PROFILE V MEDTOX Scan 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 result 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
4. mL Positive at 5 000 ng mL Positive at 6 000 ng mL Positive at 40 000 ng mL Positive at 2 500 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 Result Positive at 5000 ng mL Positive at 25 000 ng mL Positive at 7 500 ng mL Positive at 50 000 ng mL Positive at 50 000 ng mL Positive at 25 000 ng mL Positive at 100 000 ng mL Positive at 25 000 ng mL Positive at 50 000 ng mL Positive at 100 000 ng mL Positive at 250 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 Page 10 of 12 Cross Reactive 20 1 7 43 7 2 7 None Detected 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 222 80 53 333 143 105 40 53 40 33 5 80 None Detected None Detected None Detected None Detected None Detected None Detected Cross Reactive 2 lt 1 1 lt 1 lt 1 lt 1 lt 1 lt 1 lt 1 lt 1 40 None Detected None Detected
5. ng mL PCP Phencyclidine Phencyclidine 25 ng mL COC Cocaine Benzoylecgonine 150 ng mL PPX Propoxyphene Norpropoxyphene 300 ng mL MAMP Methamphetamine THC Cannabinoids d Methamphetamine 500 ng mL 11 nor 9 carboxy THC SORG MTD Methadone Methadone 200 ng mL TCA Tricyclic Antidepressants Desipramine 300 ng mL Configurations of the PROFILE V MEDTOXScar Test Devices may consist of any combination of the above listed drug analytes Test Devices will have an opiate cutoff of either 100 ng mL or 2000 ng mL 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 MEDTOXScar Positive and Negative QC Test Devices are intended to detect errors associated with the MEDTOX Scan Reader and a contaminated con
6. 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 12 Drug Detection Period Drug Detection Period Amphetamine Opiates Acid Conditions 1 3 days Heroin 1 day Alkaline Condition 3 10 days Morphine 1 3 days Barbiturates Codeine 1 3 days Short Acting Up to 6 days Oxycodone 1 3 days Long Acting Up to 16 days PCP Benzodiazepines 1 12 days Single Use 1 8 days Buprenorphine up to 3 days Chronic Use Up to 4 weeks x Up to 5 days Propoxyphene Up to 1 week Cocaine metabolite 1 3 sie THC Methadone 1 3 days Single Use 1 7 days Methamphetamine Chronic Use Less than 30 days typical Acid Conditions 1 3 days Tricyclic Antidepressants 1 7 days Alkaline Conditions 3 10 days 3 PRINCIPLES OF THE PROCEDURE The PROFILE V MEDTOX Scan Drugs of Abuse Test System includes the one step competitive membrane based immunochromatographic PROFILE V MEDTOX Scan 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 MEDTOX Scan Test Device includes antibody colloidal gold drug conjugates and a control line ANTIBODY COLLOIDAL GOLD Mouse monoclonal antibodies were developed
7. 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 MEDTOX Scan Drugs of Abuse Test System If a common compound name is followed by the abbreviation COC BAR or OPI or OXY it has cross reactivity to the specified drug 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
8. www medtox com or by contacting MEDTOX at 1 800 832 3244 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 MEDTOXScar 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 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 position on the test strip to show Page 3 of 12 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 externa
9. 0 000 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 Positive 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 20 ng mL Positive at 250 ng mL Positive at 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 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 Page 9 of 12 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 None Detected None Detected None D
10. C or 64 77 F Replace the MiniPet if it becomes damaged or does not function properly MiniPet is a trademark of TriContinent Scientific Inc 8 READING AND INTERPRETATION OF THE TEST RESULTS The MEDTOXScan Reader will automatically read the control and test lines at the correct positions and display the test results for each drug Results may also be printed 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 PROFILE V MEDTOXScan Test Devices cannot be visually read 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 Information regarding confirmatory testing may be obtained from
11. MEDTOX PROFILE V MEDTOXScan Drugs of Abuse Test System PACKAGE INSERT 1 INTENDED USE The PROFILE V MEDTOX Scan Drugs of Abuse Test System consists of the PROFILE V MEDTOX Scan Test Devices and the MEDTOX Scar Reader The PROFILE V MEDTOX Scan Test Devices are one step inmunochromatographic tests for the rapid qualitative detection of one or more of the following in human urine Amphetamine Barbiturates Benzodiazepines Buprenorphine Cocaine Methadone Methamphetamine Opiates Oxycodone Phencyclidine Propoxyphene THC Cannabinoids and Tricyclic Antidepressants 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 MEDTOXScar Test Device The PROFILE V MEDTOX Scan Test Devices cannot be visually read The PROFILE V MEDTOXScar Drugs of Abuse Test System is for in vitro diagnostic use and is intended for prescription 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 100 ng mL OPI Opiates Morphine or BAR Barbiturates Butalbital 200 ng mL 2000 ng mL BZO Benzodiazepines Nordiazepam 150 ng mL OXY Oxycodone Oxycodone 100 ng mL BUP Buprenorphine Buprenorphine 10
12. Morphine OPI OXY 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 MEDTOXScar Reader to detect errors associated with the MEDTOX Scan Reader and a contaminated contact imaging sensor CIS and to verify that the CIS cleaning procedure using the MEDTOX Scan 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 negative 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 correctl
13. None Detected None Detected None Detected None Detected None Detected Phencyclidine PCP Phencyclidine 25 ng mL 4 Hydroxyphencyclidine Propoxyphene PPX Norpropoxyphene 300 ng mL Propoxyphene Cannabinoids THC 11 Nor 9 carboxy A THC 50 ng mL A Tetrahydrocannabinol Cannabidiol Cannabinol 11 Hydroxy A THC A Tetrahydrocannabinol Tricyclic Antidepressant TCA Desipramine 300 ng mL Amitriptyline Clozapine Cyclobenzaprine Doxepin Imipramine Maprotiline Nordoxepin Nortriptyline Perphenazine Prochlorperazine Promazine Protriptyline Quetiapine Seroquel Trimipramine Carbamazepine Carbamazepine 10 11 epoxide Chlorpromazine Clomipramine Loxapine Mirtazapine Norclomipramine Olanzapine Phenothiazine Thiothixene Interference pH and Specific Gravity Result Positive at 7 500 ng mL Result Positive at 50 ng mL Result Positive 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 500 ng mL Positive at 7 500 ng mL Positive at 20 000 ng mL Positive at 1 300 ng mL Positive at 250 ng mL Positive at 300 ng mL Positive at 700 ng mL Positive at 500 ng mL Positive at 75 000 ng mL Positive at 50 000 ng mL Positive at 900 ng mL Positive at 50 000 ng mL Positive at 10 000 ng mL Positive at 5 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng mL Negative at 100 000 ng
14. T RESULTS Cutoff P V Value MEDTOXScan GC MS or LC MS MS Value ng mL Test System AMP positive Amphetamine at 277 ng mL AMP positive Amphetamine at 352 ng mL 500 AMP positive Amphetamine at 368 ng mL AMP positive Amphetamine at 463 ng mL AMP negative Amphetamine at 504 ng mL AMP negative Amphetamine at 667 ng mL BAR positive Butalbital at 126 ng mL 200 BAR positive Butalbital at 159 ng mL BAR positive Butalbital at 184 ng mL 150 BZO positive Alprazolam at 146 ng mL COC positive Benzoylecgonine at 114 ng mL 150 COC positive Benzoylecgonine at 121 ng mL COC negative Benzoylecgonine at 180 ng mL COC negative Benzoylecgonine at 278 ng mL 500 mAMP positive Methamphetamine at 483 ng mL mAMP negative Methamphetamine at 554 ng mL MTD positive Methadone at 148 ng mL 200 MTD positive Methadone at 176 ng mL MTD negative Methadone at 250 ng mL OPI positive Morphine at 51 ng mL 100 OPI positive Morphine at 79 ng mL OPI positive Morphine at 92 ng mL 2000 OPI positive Morphine at 1375 ng mL PCP positive Phencyclidine at 19 ng mL 25 PCP positive Phencyclidine at 21 ng mL PCP positive Phencyclidine at 24 ng mL 100 OXY negative Oxycodone at 71 ng mL Oxymorphone at 31 ng mL PPX positive Norpropoxyphene at 172 ng mL 300 PPX positive Norpropoxyphene at 194 ng mL PPX positive Norpropoxyphene at 228 ng mL PPX positive Norpropoxyphene at 271 ng mL TCA positive Nortriptyline at 194 ng mL 300 TCA positive Nortriptyline at 217 ng mL TCA positive Desipramine at 287
15. arbital Talbutal 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 glucuronide Temazepam Temazepam glucuronide Triazolam Triazolam 1 OH 7 Aminoclonazepam 7 Aminoflunitrazepam Chlordiazepoxide Flurazepam Buprenorphine BUP Buprenorphine 10ng mL Buprenorphine glucuronide Norbuprenorphine Norbuprenorphine glucuronide Codeine Diacetylmorphine Hydrocodone Hydromorphone Levorphanol 6 Monoacetylmorphine Morphine Naloxone Naltrexone Oxycodone Oxymorphone Thebaine Cocaine COC Benzoylecgonine 150 ng mL Cocaine Ecgonine Ecgonine Methyl Ester Result 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 Negative at 10
16. by V on the test device 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 7 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 Place the test device in the MEDTOXScan Reader cassette drawer and close the drawer immediately The MEDTOXScar 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 5 Discard disposable yellow MiniPet sample tip Store the MiniPet in a dry secure location at room temperature 18 25
17. e test 4 Place PROFILE V MEDTOXScar Test Devices in MEDTOXScan Reader immediately after adding the sample Once the test device has been read in the MEDTOXScan Reader it must not be reinserted for a repeat reading as the ten minute timing will begin again If a repeat reading is required rerun the sample on a fresh test cassette 5 The PROFILE V MEDTOX Scan 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 7 Gas Chromatography Mass Spectroscopy is the recommended confirmatory method for most drugs HPLC or LC MS MS is the preferred confirmatory method for Tricyclic Antidepressants and Benzodiazepines Any of the drugs being tested for in the PROFILE V MEDTOXScar Drugs of Abuse Test System may give a preliminary positive result if ingested at prescribed therapeutic doses 8 The PROFILE V MEDTOX Scan 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 gl PE MEDTOX Scan Drugs of Abuse Test System detects one or more of the following drugs at the cutoff levels listed bel
18. 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 50 4 2 None Detected None Detected None Detected None Detected None Detected None Detected None Detected None Detected None Detected None Detected None Detected None Detected Cross Reactive 60 None Detected None Detected Methamphetamine mAMP d Methamphetamine 500 ng mL Ephedrine Fenfluramine MDE MDEA MDMA Methamphetamine Phenylephrine Procaine d Amphetamine Amphetamine MDA Phenethylamine 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 Opiates OPI2 Morphine 2000ng mL Codeine Diacetylmorphine Dihydrocodeine Ethylmorphine Hydrocodone Hydromorphone Levorphanol 6 Monoacetylmorphine Morphine 3 B D Glucuronide Morphine 6 B D Glucuronide Norcodeine Thebaine Apomorphine Nalorphine Naloxone Naltrexone Oxycod
19. ff 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 MEDTOXScan Reader and are summarized for each drug in the table below Page 4 of 12 PROFILE V MEDTOX Scan Drugs of Abuse Test System Results vs stratified GC MS or LC MS MS Values Low negative Near Cutoff Near Cutoff by GC MS or Negative Positive High Positive MEDTOXScan LC MS MS between Between greater than Test System Less than 50 and cutoff and 50 50 AMP 500 BAR 200 BZO 150 BUP 10 COC 150 Agreement 96 92 100 94 100 98 100 100 97 97 98 98 0 0 0 0 52 0 0 96 0 0 36 0 0 0 33 mAMP Positive 500 Negative Positive MTD 00 Positive or 10 OF 200 Positive oxy 100 Positive 0 PoP 8 Positive PPX 200 Positive 0 Toa 800 i 0 Positive THC 50 Negative 96 Positive 99 Negative 96 100 94 100 98 98 100 100 93 100 92 100 93 1009 2 loln s o s 0olo n o n nm ao Ja nm R Ofo M wlo AlS n MIN All Drugs Page 5 of 12 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 DISCORDAN
20. ial 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 MEDTOXScar 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 6 566 051 6 376 251 6 653 139 This product does not contain controlled substances This product does not contain hazardous or toxic chemicals as defined by the OSHA Hazard Communication Rule 29 CFR 1910 1200 9 To place an order or for technical support services call 1 800 832 3244 2012 MEDTOX Diagnostics Inc All rights reserved MEDTOX Diagnostics Inc P N 102038 1238 Anthony Road Rev 03 12 Burlington NC 27215 Printed in USA Page 12 of 12
21. in Chlordiazepoxide Chlorothiazide Chlorpheniramine Chlorpromazine Clobazam BZO Clomipramine Clonazepam BZO Clorazepate BZO Clozapine TCA Cocaine COC Codeine OPI OXY Cotinine Cyclobenzaprine TCA Cyclopentobarbital BAR Desalkylflurazepam BZO Desipramine TCA Desmethylchlordiazepoxide BZO Desmethylflunitrazepam BZO Desmethylvenlafaxine Dextromethorphan Diacetylmorphine OPI Diazepam BZO Diclofenac Diethylpropion Digoxin Dihydrocodeine OPI OXY Diphenhydramine Diphenylhydantoin Phenytoin BAR Domperidone Dopamine Doxepin TCA Doxylamine Ecgonine Ecgonine Methyl Ester EDDP Primary metabolite of methadone Efavirenz Sustiva EMDP Secondary metabolite of methadone Related Compounds and Cross Reactants Ephedrine MAMP Erythromycin Ethanol Ethylmorphine OPI OXY Fenfluramine MAMP AMP Fenoprofen Fentanyl Synthetic opiate Flunitrazepam BZO Fluoxetine Prozac Flurazepam Fluvoxamine Furosemide Glutethimide aloperidol exobarbital ydralazine ydrochlorothiazide ydrocodone OPI OXY ydrocortisone ydromorphone OPI OXY ydroxybupropion 11 Hydroxy A THC Hydroxyphencyclidine PCP ydroxyzine Ibuprofen Imipramine TCA Ketamine Ketoprofen Levorphanol OPI Lidocaine Lithium carbonate Loperamide Lorazepam glucuronide BZO Lorazepam BZO Loxapine Lysergic Acid Lysergic Acid Diethylamide LSD Maprotiline TCA MDA AMP MDE MDEA MAMP MDMA MAMP Meperidine Mephobarb
22. 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 MEDTOX Scan 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 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 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 MEDTOX Scan 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
23. ital Mepivacaine Mesoridazine Methadone MTD d Methamphetamine MAMP Methamphetamine MAMP Methaqualone Methcathinone Methocarbamol Methylphenidate Metoprolol Midazolam BZO Mirtazapine 6 Monoacetylmorphine OPI Morphine OPI OXY Morphine 3 B D Glucuronide OPI Morphine 6 B D Glucuronide OPI OXY Nalorphine OPI Naloxone OXY Naltrexone OXY Naproxen Nicotine Nitrazepam BZO 11 Nor 9 carboxy A THC THC Norclomipramine Norcodeine OPI OXY Nordiazepam BZO Nordoxepin TCA Norlysergic Acid Normeperidine Norpropoxyphene PPX Norpseudoephedrine TESE TELL IR Nortriptyline TCA Ofloxacin Olanzapine Orphenadrine Oxaprosin Oxazepam glucuronide BZO Oxazepam BZO Oxycodone OXY Oxymetazoline Oxymorphone OXY Penicillin G Pentazocine Pentobarbital BAR Perphenazine TCA Phencyclidine PCP Phendimetrazine Phenethylamine Pheniramine Phenmetrazine Phenobarbital BAR Phenothiazine Phentermine AMP Phenylbutazone Phenylephrine MAMP Phenylpropanolamine Piroxicam Prednisone Procainamide Procaine MAMP Prochlorperazine TCA Promazine TCA Promethazine Propoxyphene PPX Propranolol Protriptyline TCA d Pseudoephedrine Pyrilamine Quetiapine Seroquel TCA Quinidine Ranitidine Riboflavin Salicylic Acid Secobarbital BAR Sertraline Zoloft Sildenafil Viagra Sulfamethazine Sulindac Talbutal BAR Temazepam glucuronide BZO Temazepam BZO Tetracycline A Tetrahydrocannabinol 0 A Tetrahydrocannabinol THC Tetrahydro
24. itive result respectively The results of the scans are displayed on the MEDTOXScar 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 The binding of the antibody colloidal gold to the drug conjugate generates a line at the corresponding test 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 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 position in the result window to
25. l 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 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 MEDTOX Scan Drugs of Abuse Test System is only for use with unadulterated preservative free 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 Clear polystyrene containers may absorb some drugs use of polypropylene containers is advised 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 th
26. ng mL eee 50 THC positive 11 nor 9 carboxy A THC at 35 ng mL THC positive T1 nor 9 carboxy A THC at 39 ng mL Page 6 of 12 Sensitivity Precision Distribution of Random Error Performance of the PROFILE V MEDTOX Scan 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 Sample Sample Concentration of Number of Concentration of Number of ng mL Cutoff Observations Neg Pos ng mL Cutoff Observations Neg Pos po NEG 24 1 NEG TCT 100 f 20 24 1 4 1 0 100 50 4 1 CT ES a TE VE lt gt VS J o s ss Jim 4 es or ao ie amp Jo fa 70 15 45 0 5 BZO 150 BUP 10 NEG 242 1 8 0 o TJ ne 43 1 45 1 0 75 15 4 1 45 1 01 5 f 50 4 1 45 0 1875 12 24 1 8 1 37 125 i f as o f 4 25 d o 4 0 45 15 d 150 4 0 45 COC 150 NEG 4 1 45 0 0 d NG 24 1 4 0 7 1 4 4 Gp 19 a M I 112 5 75 P20 50 45 27 18 187 5 125 375 75 z Ts ol sl 25 PG CS me amp
27. one Oxymorphone Oxycodone OXY Oxycodone 100 ng mL Codeine Dihydrocodeine Ethylmorphine Hydrocodone Hydromorphone Morphine Morphine 6 B D Glucuronide Naloxone Naltrexone Norcodeine Oxymorphone Apomorphine Diacetylmorphine Levorphanol 6 Monoacetylmorphine Morphine 3 B D Glucuronide Nalorphine Thebaine 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 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 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 900 ng mL Positive at 2 500 ng mL Positive at 3 800 ng mL Positive at 600 ng mL Positive at 1 400 ng mL Positive at 1 900 ng mL Positive at 5 000 ng mL Positive at 3 800 ng
28. ow AMP Amphetamine 500 ng mL BAR Barbiturates Butalbital 200 ng mL BZO Benzodiazepines Nordiazepine 150 ng mL BUP Buprenorphine 10 ng mL COC Benzoylecgonine 150 ng mL MAMP Methamphetamine 500 ng mL MTD Methadone 200 ng mL OPI Morphine 100 ng mL OPI2 Morphine 2000 ng mL OXY Oxycodone 100 ng mL PCP Phencyclidine 25 ng mL PPX Propoxyphene Norpropoxyphene 300 ng mL THC 11 nor 9 carboxy A THC 50 ng mL TCA Tricyclic Antidepressants Desipramine 300 ng mL 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 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 and TCA Concentrations used to assign the cuto
29. rine sample for one or more drugs simultaneously on the MEDTOXScar 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 f 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 36 77 F until the expiration date on the label MEDTOXScan Reader Contents 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 i Urine specimen collection container 2 PROFILE V MEDTOX Scan Positive or High Positive and MEDTOX 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 are available from MEDTOX Diagnostics Inc 7 TEST PROCEDURE 1 Open one pouch for each sample to be tested and mark the PROFILE V MEDTOXScan Test Device with the patient or sample identification ID Make sure you only mark along the left edge of the test device labeled ID gt 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
30. rubin Estriol d 1 Thyroxine Cholesterol Glucose Std Solution Uric Acid Page 7 of 12 Unrelated Compounds Prescription and Over the Counter Medications The following compounds were tested for reactivity to the PROFILE V MEDTOXScan 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 g mL or the highest level tested 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 TCA Amobarbital BAR Amoxapine Amoxicillin d Amphetamine AMP l Amphetamine AMP Ambpicillin Apomorphine Ascorbic Acid Atomoxetine Atropine Sulfate Barbital BAR Barbituric Acid Benzocaine ethyl 4 aminobenzoate Benzoic Acid Benzoylecgonine COC Benzphetamine Benztropine Brompheniramine Buprenorphine BUP Bupropion Butabarbital BAR Butalbital BAR Caffeine Cannabidiol Cannabinol Carbamazepine Carbamazepine 10 11 epoxide Carisoprodol Meprobamate Cephalex
31. s elv er e NY a 350 1 28 24 1 45 0 25 o 25 4 1 45 0 100 50 4 1 34 1 50 1 50 4 1 37 8 150 1 4 1 8 1 37 75 1 75 4 4 4 20 f 12 4 1 0 1 48 125 f 1286 4 S 0 f 4 300 1 150 fT 14 1 150 1 150 45 0 4 o Jf NnG 242 1485 0 0 TJ NG 4 1 45 0 1000 1 50 24 1 45 0 25 f 25 4 1 45 0 mo amp o l mm L e I fa 3000 15 45 o 45 15 12 4 0 4 C 450145 0 J NG 24 1 NEG 4 1 45 0 VE 2 fe ef 125 50 45 31 14 75 45 3l 14 es 17 48 I 1 JA 125 45 43 si Vi 8 jo lel v r amp ol 35 85 05 018 0 S NG 24 1 NEG 4 1 45 0 188 1 30 4 4 op 2 1 f I 9 225 75 37 5 75 375 125 62 5 125 E E E 0 l8 se amp 0 6 Non Cross reactive Endogenous Compounds The PROFILE V MEDTOXScan Drugs of Abuse Test System was evaluated 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 g 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 MEDTOX Scan Test Devices Acetaldehyde Creatinine Hemoglobin Human Acetone Epinephrine Sodium Chloride Albumin Human B Estradiol Tetrahydrocortisone Bili
32. tact imaging sensor CIS and to verify that the CIS cleaning procedure using the MEDTOXScan Cleaning Cassette effectively removed any contamination 2 SUMMARY AND EXPLANATION OF THE TEST Qualitative PROFILE V MEDTOXScan Test Devices utilize a one step solid phase immunoassay technology The PROFILE V MEDTOXScan Drugs of Abuse Test System includes the MEDTOXScar 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 Buprenorphine BUP is a potent analgesic often used in the treatment of opiate abusers 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
33. 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 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 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 pos
34. y 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 MEDTOX Scan 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 Page 11 of 12 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 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 Commerc
35. zoline Thebaine OPI Theophyline Thiopental Thioridazine Thiothixene Tolmetin Tolectin Trazodone Triamterene Triazolam 1 hydroxy BZO Triazolam BZO Trifluoperazine Trimethoprim Trimipramine TCA Tripelennamine Tryptophan Tyramine Valproic Acid Venlafaxine Verapamil 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 Page 8 of 12 Amphetamines AMP d Amphetamine 500 ng mL Amphetamine Fenfluramine MDA Phentermine Ephedrine MDE MDEA MDMA Methamphetamine d Methamphetamine Phenethylamine Pseudoephedrine Tyramine Barbiturate BAR Butalbital 200 ng mL Allobarbital Amobarbital Barbital Butabarbital Cyclopentobarbital Diphenylhydantoin Phenytoin Pentobarbital Phenobarbital Secob
Download Pdf Manuals
Related Search