Quick Reference Guide
Contents
1. Key will return the interface to the welcome screen and cancel the test Follow the Cleaning Cassette Procedure to clean the contaminated sensor The MEDTOXScan Reader will display an error message when a problem is detected TROUBLESHOOTING PROCEDURES For Test System If you suspect that the PROFILE V MEDTOXScan Test Device or MEDTOXScan Reader is not working properly or if you have had an unexpected test result then 1 Be sure that the PROFILE V MEDTOXScan Test Devices have not expired 2 Run the positive and negative external controls 3 If both controls pass run the QC Test Device for the MEDTOXScan Reader see flowchart below If both pass the MEDTOXScan Reader is operating properly If one or both QC Test Devices fail check to see if the failed device is scratched or damaged If scratches or damage are observed contact Technical Support at 1 877 643 5703 If the QC Test Devices are not scratched or damaged proceed with the Cleaning procedure using the Cleaning Cassette or contact Technical Support 4 If either positive or negative external controls fail be sure that the controls have not expired 5 If controls have not expired repeat the controls If both controls pass report the results If either control fails contact Technical Support NOTE Invalid or incorrect results may also be due to adulterated or improperly stored urine samples or error in performing the test MED2. 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 PROFILE V Reader System 1 MATERIALS PROVIDED with PROFILE V MEDTOXScan TEST KIT 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 NOTE Specimen containers external control solutions disposable gloves and urine temperature strips ar
3. 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 MEDTOXScan 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 unexpecte
4. IS 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 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 MEDTOXScan 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 MEDTOXScan Reader is 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 See Troubleshooting procedures continued on next page 5 Contaminated Sensor This error will appear when the MEDTOXScan Reader determines that the contact imaging sensor CIS is contaminated Pressing OK
5. MEDTOXScan Test Device and closing the drawer a progress bar will show that the test device is being detected WARNING Do not eject device while MEDTOXScan Reader is scanning It may damage the instrument 2 Enter Lot Number Once the test device is detected the Enter Device Lot screen appears Enter the Device Lot Number using the MEDTOXScan Reader keypad or use the hand held barcode scanner 3 Enter User ID Next the Enter User ID screen appears Enter the User ID with the keypad or barcode scanner 4 Enter Specimen ID Next the Enter Specimen ID screen appears Enter the Specimen ID with the keypad or barcode scanner 5 Scanning The scanning screen will appear after the Specimen ID has been entered The timer at the bottom of the screen will show how much time remains until the test is complete 3 Continued from previous page 6 View Results The Results Screen appears when the test is complete Scroll down to see all the results If Auto Print mode is turned on the results will be printed automatically on the thermal printer Choose Prt Result to print manually 7 Press CANCEL to return to the WELCOME screen QUALITY CONTROL of the PROFILE V MEDTOXScan Reader System 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
6. Quick Reference Instructions 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 Buprenorphine Cocaine Methadone Methamphetamine Opiates Oxycodone Phencyclidine Propoxy phene THC Cannabinoids and Tricyclic Antidepressants or their metabolites The PROFILE V MEDTOXScan Test De vices 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 prescription use only It is not intended for use in point of care settings In Canada it is for Laboratory use only The PROFILE V MEDTOXScan Drugs of Abuse Test System detects drug classes at the following cutoff concentrations Configurations of the PROFILE V MEDTOXScan 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
7. TOX Diagnostics Inc 1238 Anthony Road Burlington North Carolina 27215 E mail Sales medtoxdiagnostics com Fax 336 227 7302 The MEDTOXScan Reader has been designed to provide you with reliable and worry free service If for any reason you have a problem with your equipment please call MEDTOX Technical Support at 1 877 643 5703 For complete product information refer to the PROFILE V MEDTOXScan Package Insert Rev 03 12 available at http www medtox com ProductTraining aspx or contact Technical Support at 1 877 643 5703 P N 102035 Rev 02 14 6 2014 MEDTOX Diagnostics Inc All rights reserved
8. an 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 4 WARNINGS 1 Avoid liquid spills on the components MEDTOXScan Reader Printer Scanner etc 2 Do not drop or damage the components 3 Do not open or tamper with the components Only MEDTOX authorized personnel may service repair the components 4 Keep the components clean and serviceable to assure continued reliability and performance ROUTINE MAINTENANCE amp CLEANING MEDTOX recommends isopropyl alcohol wipes for routine cleaning of the exterior of the MEDTOXScan Reader and the dev
9. d 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 and other commercial sources Contact MEDTOX at 1 877 643 5703 for further information Urine Collection and Handling Use fresh urine specimens Urine specimens do not require any special handling or pretreatment It is best to test urine specimens immediately after collection If necessary urine specimens may be refrigerated at 2 to 8 C for two days or frozen at 20 C or colder for longer periods Stored Urine must be brought to ambient temperature 18 25 C or 64 77 F and mixed well to assure a homogeneous sample prior to testing Use a new urine cup and test for each urine specimen READING AND INTERPRETATION OF THE TEST RESULTS The PROFILE V MEDTOXScan Test Devices are labeled with a barcode that identifies which tests are present on the device being run Refer to specific product labeling for the combination of drug tests included on that test device PROFILE V MEDTOXScan Test Devices cannot be visually read The MEDTOXScan Reader will auto matically read the control and test lines at the correct test position and display the test results for each drug Results may also be printed The MEDTOXSc
10. e available from MEDTOX Diagnostics Inc Before performing the test refer to the PROFILE V MEDTOXScan Drugs of Abuse Test System Insert and MEDTOXScan User Manual for complete operating instructions and QC recommendations MATERIALS PROVIDED with MEDTOXScan Reader 1 Positive and Negative QC Test Devices 2 Cleaning Cassette 3 MiniPet pipettor 4 Quick Set Up guide 5 User Manual Optional Materials 1 Thermal Printer and Printer paper 2 Hand held Barcode Scanner MATERIALS REQUIRED BUT NOT PROVIDED 1 Urine specimen collection container 2 PROFILE V MEDTOXScan Positive or High Positive and MEDTOX Negative Control Solutions AMP Amphetamine d Amphetamine 500 ng mL OPI Opiates Morphine 100 ng mL or 2000 ng mL BAR Barbiturates Butalbital 200 ng mL BZO Benzodiazepines Nordiazepam 150 ng mL OXY Oxycodone Oxycodone 100 ng mL BUP Buprenorphine Buprenorphine 10 ng mL PCP Phencyclidine Phencyclidine 25 ng mL COC Cocaine Benzoylecgonine 150 ng mL PPX Propoxyphene Norpropoxyphene 300 ng mL MAMP Methamphetamine d Methamphetamine 500 ng mL THC Cannabinoids 11 nor 9 carboxy 9 THC 50 ng mL MTD Methadone Methadone 200 ng mL TCA Tricyclic Antidepressants Desipramine 300 ng mL PRECAUTIONS The PROFILE V MEDTOXScan Drugs of Abuse Test System is for in vitro diagnostic use only Do not use PROFILE V MEDTOXScan Test Devices after the ex
11. ice drawer Refer to the MEDTOXScan Reader User Manual A specialized Cleaning Cassette is included for cleaning the internal sensor The Cleaning Cassette is solely intended to clean the contact imaging sensor CIS in the MEDTOXScan Reader The Cleaning Cassette should be used in conjunction with the MEDTOXScan QC Test Devices to confirm that the cleaning proce dure has worked Please refer to the MEDTOXScan Cleaning Cassette Quick Reference Guide for more de tailed instructions ERROR MESSAGES Part Number Not Recognized This error appears if the device code is un known or cannot be read by the instrument The device code may be a new test type or the bar code may be damaged If the bar code is damaged the device code can be entered with the keypad Press the OK Key to continue once the code has been entered If the code is valid the test procedure will resume and the User ID screen will appear Update Needed This error will appear if the device code is not found Pressing OK Key will return the interface to the welcome screen and cancel the test Please refer to the complete MEDTOXScan User Manual for error messages relating to the hardware software and printer If you do not recognize the error message call Technical Support at 1 877 643 5703 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 C
12. nsor 2 Operation Run the Test Power on the MEDTOXScan Reader Obtain urine sample Open foil pouch and remove PROFILE V MEDTOXScan Test Device You may notice a reddish purple color in the sample well this is normal do not discard test Write the Specimen ID in the ID area ID on the left side of the Test Device Place a disposable yellow sample tip securely onto the end of the green 75 L MiniPet pipette Wait for the Reader Welcome screen Add 75 L of urine to each sample well indicated by a on the Test Device Expect to observe reddish color flowing up the strips Wipe off any spills on device Place the Test Device in the MEDTOXScan Reader cassette drawer Close Reader drawer immediately Reader automatically reads results after 10 min Use Menu Setup to configure MEDTOXScan Reader options such as print mode results beep etc See MEDTOXScan Reader User Manual for details Cancel goes back one step OK accepts item 4 way direction keys to move cursor or select items Menu brings up menu screen A Z toggles the entry option between numbers and letters Keypad for entering letters or numbers for sample or operator ID Keypad Overview Eject button opens the drawer to insert or remove the test device Operation To Read A Test in the MEDTOXScan Reader 1 Insert Device After inserting the PROFILE V
13. piration date printed on the package label 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 If PROFILE V MEDTOXScan Test Devices have been stored refrigerated bring to ambient temperature 18 25 C or 64 77 F prior to opening foil pouch Stored urine must be brought to ambient temperature and mixed well before testing 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 MEDTOXScan Test Device Do not write outside of the ID area on the left side of 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 with broken skin Avoid contaminating the top of the 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 se
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