Alere™ Triage® MeterPro Troponin I METHOD AND
Contents
1. Alere Triage MeterPro Troponin METHOD AND SAMPLE COLLECTION PURPOSE AND SCOPE The purpose of this document is to describe the procedure for performing a Troponin using the Alere Triage MeterPro analyser The Alere Triage MeterPro analyser is to be used by trained health care professionals in accordance with a facility s policies and procedures This document will be focusing on Troponin from the multi marker panels and further information on the other parameters can be found in the appropriate product inserts HAZARDS Patient Samples All patient samples should be treated as potentially infectious and handled appropriately Some quality control solutions contain human source material Personal Protective Equipment should be worn when processing samples quality control testing and maintenance procedures CLINICAL SIGNIFICANCE Acute Coronary Syndrome ACS is a term used to describe a group of conditions resulting from insufficient blood flow to the heart muscle These conditions range from atypical chest discomfort and non specific electrocardiographic changes toa large ST segment elevation myocardial infarction and cardiogenic shock Symptoms can include chest pain including tightness and heaviness in the chest discomfort in the arms and upper body shortness of breath and other constitutional symptoms including sweating nausea and light headedness Diagnosis of ACS is based on a complete medical history physical exami2. e The meter pulls in the QC Device and scans it The test device may partially move in and out of the meter several times NOTE After the test device has been inserted do not push the device in further or attempt to pull it out The device may be ejected by returning to the Main Menu and pressing the Exit key e When the test is complete the meter will beep eject the device and display a Pass or Fail result on the meter s screen e Press the Print key to make a printed copy of the results Alere Triage MeterPro Troponin Method and Sample Collection IEC Tnl 3 v1 5 4 12 6 e Remove the QC Device from the meter and place in the QC Device Box Do not discard the QC Device NOTE The QC Device is light sensitive and should be stored in its black Opaque case when not in use Keep the QC Device free of contaminants as dust lint fibers and other small particles may interfere with the QC Device e lf the QC Device tests fail wipe the QC Device clean with a lint free cloth to remove any oils dust fibers or fingerprints Do not apply any liquid to the QC Device After cleaning the device repeat the QC Device test NOTE The QC Device does not expire 9 4 Running control solutions The QC Device Code Chip Module should be performed before running a QC Device test as stated in section 9 2 The control solutions has two levels e Alere Triage Total 5 Control 1 e Alere Triage Total 5 Control 2 store the controls frozen at
3. 20 C or colder in a non defrosting freezer Do not store near the freezer door The reagents are stable until the date on the box The reagents should not be refrozen and it is recommended that each tube be used once and discarded Frozen control material must be brought to room temperature at least 30 minutes prior to use Preparing the control solution e Remove the control solution from the freezer and allow to thaw and warm to room temperature 19 25 C for at least 30 minutes NOTE Use within 1 hour of removal from the freezer e Mix thoroughly by inverting the control solution tube Preparing the meter e Power the meter on by pressing the Power key Press the Enter to run self test e Select Run Test using the up down arrow keys and press e Type in your identification number User ID if prompted e Select QC Sample using the up down arrow keys and press the Enter key to confirm selection e Enter the QC lot number from the label on the side of the vial containing the QC Sample and press the Enter key to confirm the number NOTE Only enter the four digit numeric value of the QC lot number Do not enter the preceding alpha character NOTE If you enter a QC lot number for which there is no data in the meter s memory you will see a message on the meter s screen No QC Sample Data in Memory Press Enter to continue and install Code Chip module Alere Triage MeterPro Trop
4. PA Waddell J Azadi L Wilson AJ amp Ruta LM 2011 2011 Addendum to the National Heart Foundation of Australia Cardiac Society of Australia and New Zealand Guidelines for the Management of Acute Coronary Syndromes ACS 2006 Heart Lung and Circulation vol 20 no 8 pp 487 502 Sharma S Jackson PG Makan J 2004 Cardiac Troponins Journal of Clinical Pathology vol 57 no 10 pp 1025 6 Daubert MA Jeremias A 2010 The utility of troponin measurement to detect myocardial infarction review of the current findings Vascular Health and Risk Management vol 6 pp 691 699 Roche Diagnostics 2011 Roche CARDIAC T Quantitative Troponin T Quantitative Test strip package insert Mannheim Germany Radiometer 2011 Radiometer Tnl Test Kit Test cartridge package insert Bronshoj Denmark Keller T Zeller T Peetz D Tzikas S Roth A Czyz E Bickel C Baldus S Warnholtz A Fr hlich M Sinning CR Eleftheriadis MS Wild PS Schnabel RB Lubos E Jachmann N Genth Zotz S Post F Nicaud V Tiret L Lackner KJ Munzel TF Blankenberg S 2009 Sensitive troponin assay in early diagnosis of acute myocardial infarction N Engl J Med vol 361 no 9 pp 868 877 Waxman DA Hecht S Schappert J Husk G 2006 A model for troponin as a quantitative predictor of in hospital mortality J Am Coll Cardiol vol 48 no 9 pp 1755 1762 Alere Triage Me
5. test is in progress The results are displayed on the screen and automatically stored in the meter s memory Results should fall within the expected ranges provided on the Expected Values card provided with the D Dimer Controls Kit Alere Triage MeterPro Troponin Method and Sample Collection IEC Tnl 3 v1 5 4 12 8 10 e lf any of the QC Sample results are out of range the results for that particular analyte will be displayed as light text on a dark background 9 5 Laboratory Comparison lf your policy states you must perform laboratory comparison then perform a venepuncture sample for the laboratory and store in an EDTA blood tube Perform venepuncture and run sample on the Alere Triage MeterPro and send a specimen to the lab for Troponin testing Collection of both samples should occur at the same time Record and compare the results ensuring they are in acceptable range for your organization TEST PROCEDURE To change the meter settings insert the Supervisor CODE CHIP module and refer to the Alere Triage MeterPro User Manual for instructions NOTE Prior to commencing patient testing remove the Supervisor CODE CHIP module from the meter return it to the storage box and place in a safe place for future use 10 1 Performing the Test The Reagent Code Chip Module should be performed before running a patient test as stated in section 9 2 Preparing the meter e Power the meter on by pressing the Power key Pres
6. S 7 1 Storage and handling Perform Troponin tests using the following Test Devices Alere Triage Cardiac Panel CK MB Myoglobin Troponin I Alere Triage CardioProfiler Panel CK MB Myoglobin Troponin amp BNP or the Alere Triage Profiler SOB Panel CK MB Myoglobin Troponin I BNP and D Dimer Unopened Test Devices should be refrigerated at 2 8 C and are stable up to the expiration date Once removed from refrigeration the pouched Alere Triage Cardiac Panel CardioProfiler and SOB Test Devices are stable for up to 14 days at room temperature but not beyond the expiration date printed on the pouch Once equilibrated to room temperature do not return the Test Device to refrigeration Optimal results will be achieved by performing testing at temperatures between 20 24 C Test Devices must be at room temperature before use i e allow the unopened Test Device to sit at room temperature for at least 15 minutes lf a kit containing multiple Test Devices is removed from refrigeration allow the kit to reach room temperature before use This will take a minimum of 60 minutes Keep the Test Device in the sealed pouch until ready for use Discard after single use The transfer pipette should be used for one patient specimen only Discard after single use Alere Triage MeterPro Troponin Method and Sample Collection IEC Tnl 3 v1 5 4 12 4 e Discard the Test Devices if they are past the used by date Expired Test Devices can p
7. after major maintenance and ata minimum of once a month Enrolling in an External Quality Assurance Program is encouraged to objectively compare results with other users using the same method of testing If an External Quality Assurance Program is not available monthly lab comparison is encouraged The Alere Triage MeterPro uses the following methods for quality e Built in QC Check e Code Chip modules e Electronic QC Device test e Control solutions 9 1 Built in internal QC check The Test Devices contains a built in internal QC Check which is performed automatically by the Meter during every assay These assay controls in each test device monitors the assay procedure and the reagent integrity If the results are found to be in specification the result is allowed to be used but if the test device s internal quality control QC results are unacceptable the results for the affected analyte s will not appear on the screen instead will be flagged with an exclamation mark symbol Alere Triage MeterPro Troponin Method and Sample Collection IECTnl 3 v1 5 4 12 5 9 2 Installing the Reagent QC Sample or QC Device Code Chip modules e From the Main Menu select Install Code Chip using the up down arrow keys and press Enter to confirm selection e Use the new Code Chip module that comes with every new box of test devices e Compare the lot number on the code chip with the corresponding lot number on the test strip p
8. de scanner Interface Battery operation Mains connection Number of tests with fully charged batteries Safety class Automatic power off Dimensions Weight Alere Triage MeterPro Troponin Method and Sample Collection IECTnl 3 v1 5 4 12 3 Not stated Place meter on a level vibration free surface away from direct sunlight 0 05 30 ng mL Not stated 750 patient records 200 QC sample results 70 QC device results 250 misc test results 600 User IDs Programmable for 0 5 1 2 or 4 hours 10 85 non condensing 5 2 Storage and transport conditions Temperature range Not stated Meter In original container Relative humidity Not stated SPECIMEN REQUIREMENTS Venous whole blood or plasma collected in EDTA tubes is acceptable Other blood collection tubes containing other additives and other blood specimen types have not been evaluated Venepuncture see suitable anticoagulants above Skin surface must be cleaned with an alcohol swab and dried well prior to collection to ensure there are no substances on the skin surface Ensure sample is properly mixed and at room temperature before testing Test the sample within 1 hour of collection Transport specimens at room temperature or chilled and avoid extreme temperatures Avoid using severely haemolysed specimens whenever possible If a soecimen appears to be severely haemolysed another specimen should be obtained and tested CARTRIDGES REAGENT
9. death in ACS patients is increasing Results from PoCT devices measuring Troponin T amp should always be used in conjunction with clinical presentation history and other diagnostic information TEST PRINCIPLE The Alere Triage Troponin Test is a single use fluorescence immunoassay device designed to determine the concentration of Troponin in EDTA anticoagulated whole blood or plasma specimens The test procedure involves the addition of several drops of an EDTA anticoagulated whole blood or plasma specimen to the sample port on the Test Device After addition of the specimen the whole blood cells are separated from the plasma using a filter contained in the Test Device The specimen reacts with fluorescent antibody conjugates and flows through the Test Device by capillary action Complexes of each fluorescent antibody conjugate are captured on a discrete zone resulting ina binding assay The concentration of Troponin in the specimen is directly proportional to the fluorescence detected therefore a greater amount of fluorescence indicates a higher Troponin concentration Light from a laser hits a test device that has been inserted in the meter which causes the fluorescent dye in the test device to give off energy The more energy the fluorescent dye gives off the stronger the signal The results are displayed on the Meter screen in approximately 20 minutes 4 1 Interference e Severely haemolysed specimens should be avoid
10. ed When a sample appears to be severely haemolysed another specimen should be obtained and tested e As with any assay employing mouse antibodies the possibility exists for interference by human anti mouse antibodies HAMA in the sample The test has been formulated to minimize this interference however specimens from patients who have been routinely exposed to animals or to animal serum products may contain heterophile antibodies which may cause erroneous results e The hematocrit between 30 and 55 had no significant etfect on the recovery of Troponin I e No high dose hook effect was observed with the Alere Triage panel assays for Troponin up to 2 100 ng mL e Further information of substances that were tested can be found in the corresponding Test Device package insert Important It is possible that other substances and or factors not listed above may interfere with the test and cause false results 4 2 Accuracy amp Precision This product fulfills the requirements of the EU Directives Alere Triage MeterPro Troponin Method and Sample Collection IEC Tnl 3 v1 5 4 12 2 9 Specific details for the accuracy and precision for the different Test Panels can be found in the corresponding Test Device package insert INSTRUMENT Product specifications 5 1 Operating Conditions and Technical Data Temperature range Relative humidity Maximum altitude Position Measuring range Sample size Test time Memory Barco
11. erefore these data must be considered when interpreting the results TnI is platform dependent so each site should establish a reference range that is representative of the patient population to be evaluated 11 2 Transferring Data to a printer or computer To review previous results turn on the meter by pressing the Power button Select Recall Results using the up down arrow keys and press the Enter button to confirm Enter your User ID if prompted and press Enter Select Panel Type using the up down arrow keys Use the left right arrow keys to select the desired panel Select the results based on Patient ID Test Device Lot Number L N User ID from date till date Use the left right arrow keys view the results Press the Print key to make a printed copy or press the Enter key to upload the selected results to LIS MAINTENANCE Clean the exterior using a damp sponge or cloth with mild soap and water solution Wipe the meter dry using a soft cloth or absorbent tissue Do not allow water to seep into the printer Alere Triage MeterPro Troponin Method and Sample Collection IEC Tnl 3 v1 5 4 12 W appn e Do not immerse the meter in water or other liquids e f blood or other fluids are not allowed enough time to fully absorb into test devices the device track door may occasionally require cleaning Using a cotton swab dampened with isopropyl alcohol and a pair of tweezers carefully lift
12. ette barrel must flow into the sample port The specimen in the smaller lower bulb will not be expelled Remove the transfer pipette tip from the sample port and then release the larger top bulb Discard the transfer pipette Ensure the specimen has been absorbed completely before moving the Test Device NOTE The Test Device must be inserted into the Meter within 30 minutes from the time the patient specimen was added Inserting the Test Device Hold the Test Device by the edges and gently insert the Test Device into the meter until you feel the Test Device catch on the pin and hear a click and press Enter NOTE After the test device has been inserted do not push the device in further or attempt to pull it out The device may be ejected by returning to the Main Menu and pressing Exit After the test device has been pulled into the meter the meter will display a tick mark indicates tests which are selected and the absence of a tick mark indicates which tests have not been selected The user will be prompted to select desired analyte s or deselect undesired analyte s by pressing the number to the left of the test to toggle between selected or deselected and press the Enter key to confirm selection Press the Enter key to start the test NOTE If no key is pressed on the Select Tests screen the meter waits 30 seconds then proceeds using only the selected default tests Then if no key is pressed on the Confi
13. nation electrocardiogram to evaluate the electrical activity of the heart and blood tests to evaluate the presence of biological markers resulting from cardiac cell injury Troponin T amp are members of a group of cardiac regulatory proteins which function to regulate the calcium mediated interaction of muscle filaments actin and myosin resulting in contraction and relaxation of striated muscle Troponin T is almost exclusive to the myocardium with small amounts expressed in skeletal muscle not detectable in current Troponin T assays Insufficient blood flow and oxygen supply to the heart muscle causes necrosis of the myocardium and subsequent release of Troponin T amp into the bloodstream Troponin T in the bloodstream rises to detectable levels after 4 6 hours peaks at 10 12 hours and can be detected for up to 14 days post infarction Troponin is released from necrotic cardiac myocytes into the bloodstream within hours 4 8 hours after the onset of chest pain The peak TnI concentration is generally reached in 12 48 hours Troponin serum levels can remain elevated for up to 4 7 days The diagnostic utility of Troponin T amp to detect myocardial necrosis and to enable Alere Triage MeterPro Troponin Method and Sample Collection IECTnl 3 v1 5 4 12 risk stratification in patients with ACS is well established Furthermore the use of Troponin T as a prognostic indicator for recurrence of ischaemic events and
14. onin Method and Sample Collection IECTnl 3 v1 5 4 12 7 B 23AM 01020011 RUN TEST PATIENT SAMPLE QC DEVICE RECALL RESULTS QC SAMPLE INSTALL NEW CODE CHIP MISC TEST SELECT WITH v OR AND PRESS ENTER SELECT WITH v OR AND PRESS ENTER PRESS EXIT TO EJECT DEVICE PRESS EXIT TO EJECT DEVICE Applying the control sample NOTE The unopened Test Devices should sit at room temperature for at least 15 minutes before performing a test Open the pouch and label the Test Device Place the Test Device on a level horizontal surface Hold the tube with the tip facing upwards ensuring that all material is at the bottom of the tube Snap off the tab Turn the tube over and dispense the entire contents into the sample port of the Test Device Ensure the specimen has been absorbed completely before moving the Test Device Inserting the Test Device Hold the Test Device by the edges and gently insert the Test Device into the meter until you feel the Test Device catch on the pin and hear a click NOTE After the test device has been inserted do not push the device in further or attempt to pull it out The device may be ejected by returning to the Main Menu and pressing Exit Press Enter to start the test The meter pulls in the test device and scans it NOTE The Test Device must be inserted into the Meter within 30 minutes from the time the sample was added Results NOTE Do not move the meter while a
15. ouch e Insert the Code Chip module into the Code Chip module Port in the lower left front corner of the meter e The meter will display a confirmation message that the information was installed into the meter and press the Enter e Remove the Code Chip module from the Code Chip module Port e Place the Code Chip module back into its original container for storage NOTE The meter will direct the user to install a Code Chip module if it is attempting to run a test and does not have the data in its memory jh ai iat RS eT Leh ae t i a a CODE CHIP module Fort CODE CHIP module NS H f_ 9 3 Electronic QC Device test The QC Device should be run on each day of patient testing The QC Device Code Chip Module should be performed before running a QC Device test as Stated in section 9 2 To perform a QC Device test e Press the Power button to turn on the meter e Select Run Test using the up down arrow keys and press the Enter key to confirm selection e Type in your identification number User ID if prompted e Select QC Device using the up down arrow keys and press the Enter key to confirm selection e Gently insert the QC Device into the meter until you feel the QC Device catch on the pin and hear a click e Press the Enter key to start the test NOTE The meter will prompt the user to install the QC Device Code Chip module if the QC Device has not been run before
16. rmation Screen the test proceeds after waiting 30 seconds Results NOTE Do not move the meter while a test is in progress Alere Triage MeterPro Troponin Method and Sample Collection IEC Tnl 3 v1 5 4 12 10 11 12 The results are displayed on the screen and save to the meter s memory automatically Results displayed below the cut off levels will have no box around the result Results in the indeterminate range have a black border around the result Abnormal results are in a filled black box Results can be printed by pressing the Print button NOTE A panel with multiple analytes will still be able to report patient results on those analytes which passed QC An analyte that failed QC will not be reported on patient tests instead will be flagged with a symbol PAT ID 89547326 PAT ID 89547326 CKMB 21 ngmL CKMB 7 3 ng mL MYO B2 ng mL LEXE ng mL TNI 021 ng mL TNI ng mL PAT RESULT ABNORMAL FESS 1 TO ACCEPT OR 0 TO REJECT PRESS 1 T ACCEPT OR 0 TO REJECT RESULTS 11 1 Interpretation of results Collectively the diagnosis of myocardial infarction should include measurement of cardiac related proteins and other clinical information including patient history and electrocardiographic data Other conditions that may result in elevated cardiac proteins are cardiac contusions myocarditis invasive examination of the heart coronary artery bypass surgery congestive heart failure and unstable angina Th
17. roduce incorrect results e The QC Device is light sensitive and should be stored in its black opaque case when not in use 7 2 Storing information about test devices Meter data is updated via a disposable Code Chip module The Code Chip module contains microchip circuitry embedded into a plastic housing When inserted into the meter Code Chip module port and activated the information is transferred into the meter s memory A Code Chip module typically needs to be installed only once per box of strips and remains in the meter memory A Code Chip module does not need to remain in the meter while performing tests CALIBRATION In the self test mode the meter scans an Internal Calibration Chip Each calibration chip scan is used to validate and adjust if necessary the meter calibration Operator calibration is not necessary Quality CONTROL Quality control material perform as per your organisation protocol Accurately testing known levels of Troponin ensures that the system and your technique used in testing give accurate results on patient tests The control solutions have defined known values The results for these solutions must first fall within a certain acceptable range in order to allow valid patient testing A quality control test should be performed every time a new shipment of test devices are received when a new lot number of test devices are used if the clinical picture does not correlate with the patient test results
18. s the Enter Oey to run self test e Select Run Test using the up down arrow keys and press the Enter key to confirm e Type in your identification number User ID if prompted e Select Patient Sample using the up down arrow keys and press the Enter key to confirm selection e Type or scan the patient s identification Patient ID then press the Enter key to confirm NOTE To correct the patient ID press the Delete key to clear the entire ID or select the incorrect character using the keys Then type in the correct ID 8 23AM 0120011 RUN TEST RECALL RESULTS QC DEVICE E QC SAMPLE INSTALL NEW CODE CHIP MISC TEST SELECT WITH v OR AND PRESS ENTER E E E EEE E PRESS EXIT TO EJECT DEVICE PRESS EXIT TO EJECT DEVICE Applying the blood sample e Open the pouch and label the Test Device with the patient identification number e Place the Test Device on a level horizontal surface Alere Triage MeterPro Troponin Method and Sample Collection IEC Tnl 3 v1 5 4 12 9 Using the transfer pipette squeeze the larger top bulb completely and insert the tip into the specimen Transfer pipette Release the bulb slowly The transfer pipette barrel should fill completely with some fluid flowing into the smaller lower bulb Place the tip of the transfer pipette into the sample port of the Test Device and squeeze the larger bulb completely The entire volume of fluid in the transfer pip
19. terPro Troponin Method and Sample Collection IEC Tnl 3 v1 5 4 12 13
20. the door and clean both front and back of the door Changing Paper e ear off any excess paper sticking out of the Meter e Remove the paper compartment cover by pulling up on the cover as indicate by the arrow on the back of the cover e Remove unused paper or the empty paper spindle from paper compartment e Cutaclean straight edge to feed into the printer Do not cut paper at an angle as the printer must sense the edge of the paper along the feed path e Insert the new roll of paper into the paper compartment e Position the paper such that the paper will feed from under the roll as opposed to over the top of the roll e Insert the paper edge under the paper roller platen until it firmly seats or resistance Is felt e Press the Print key e Replace the cover of the printer and continue operation 13 REFERENCES This method has been adapted from the Alere Triage MeterPro System User Manual Test Device and control solution package inserts 1 Torpy JM Burke AE amp Glass RM 2010 Acute Coronary Syndromes The Journal of the American Medical Association vol 303 no 1 p90 2 Scirica BM 2010 Acute Coronary Syndrome Emerging Tools for Diagnosis and Risk Assessment The Journal of the American College of Cardiology vol 55 no 14 pp 1403 15 Alere Triage MeterPro Troponin Method and Sample Collection IEC Tnl 3 v1 5 4 12 12 Chew DP Aroney CN Aylward PE Kelly A White HD Tideman
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