Test Instructions - Drug testing supplies from CLIA waived,Inc, drug
Contents
1. Monitor to Monitor 0 70 3 0 0 23 6 4 Strip to Strip 1 14 5 0 0 39 10 5 Total 1 69 7 3 0 55 15 1 Between Monitor Precision The following charts represent between monitor precision for capillary and venous blood Between Monitor Precision for Venous Blood 10 ag iT a z 44 O _ __ 2SD 4 F o D g 3 ad cea O am dea oco 3 og RE CRRA OSA 4 Ti GED oO PEE Gea o miae oO O 2 Oo o Bo p o 2SD ae a Dog a d o zad kag T T T T T T T 1 oo 1 ip 16 at ig aa va aa Average of CaaguteckS Malers HR Between Monitor Precision for Capillary Blood 1 0 4a as E i Eo a P p 7 Z aq oD oo 28D mM o O00 a o 2o os E a J F TD oo fm o 2 id amp oomoo o ao o Z o 2 SD aa Oo ga 1 0 T T T T T T T T 7 ao 1o ib aa ag aa ao 7a ao Average al CaaguChet S Meleri HR Return Policy If there is a problem with the CoaguChek Systems Tests you may be asked to return them along with the Test Strip Code Chip to Roche Diagnostics Before returning call the Point of Care Technical Service Center at 1 800 428 4674 You will be mailed a return authorization label which must be put on the shipping carton Packages received without this label will be returned at your expense References 1 Plonsey R Collin RE Magnetic field in material bodies In Principles and applications of electromagnetic fields New York McGraw Hill Book Co p 226 572. 1961 2 Oberhardt BJ Taylor M Alkadi ZY Dermott SC Diagnostic assay system for convenient monitoring of oral anticoagulant therapy Abstract Thromb Haemostas 1989 62 327 3 Loeliger EA van den Besselaar AMHP and Lewis SM Reliability and clinical impact of the normalization of the prothrombin times in oral anticoagulant control Thromb Haemostas 1985 53 148 154 4 Kaatz SS White RH Hill J Mascha E Humphries JE and Becker DM Accuracy of Laboratory and Portable Monitor International Normalization Ratio Determinations Arch Intern Med 1995 155 1861 1867 5 Moll S and Ortel TL Monitoring Warfarin Therapy in Patients with Lupus Anticoagulants Annals of Internal Medicine 1997 127 177 185 Additional Information Refer to the CoaguChek S User s Manual for additional information about your system If you still have questions call Point of Care Technical Service Center at 1 800 428 4674 24 hours a day 7 days a week The CoaguChek S System monitor and test strips and its use are covered by one or more of the following U S Patents 4 849 340 5 110 727 5 164 598 5 300 779 5 522 255 5 710 622 5 789 664 5 792 944 and 5 886 252 The test strips are covered by U S Patent No 5 488 816 and 5 975 153 COAGUCHEK is a trademark of a Member of the Roche Group Coumadin is a trademark of DuPont Pharmaceutical Company Manufactured for Roche Diagnostics Corporation 9115 Hague Road Indianapolis IN 46256
3. see the CoaguChek S System Control package insert instructions Call Point of Care Technical Service Center at 1 800 428 4674 24 hours a day 7 days a week if you have any questions Limitations of Procedure The CoaguChek Systems Test uses only fresh capillary or venous whole blood Plasma or serum cannot be used Use only plastic syringes without anticoagulants or additives Glass tubes or syringes must not be used The blood drop must be a minimum of 10 uL in volume Low sample volume will cause an error message This test measures PT results in persons on warfarin type Coumadin therapy This test should not be used to monitor persons on heparin therapy n vitro studies showed the CoaguChek Systems Tests are sensitive to levels of heparin over 0 15 U mL When a patient is on intravenous infusion therapy do not collect sample from arm receiving infusion line Hematocrit ranges between 32 52 do not significantly affect test results No interference was found in lipemic samples containing up to 500 mg dL of triglycerides Testing performed with in vitro spiked samples indicated bilirubin up to 20 mg dL and hemolysis up to 500 mg dL did not significantly affect test results The presence of anti phospholipid antibodies APAs such as Lupus antibodies LA can potentially lead to prolonged clotting times i e elevated INR values A comparison to an APA insensitive laboratory method is recommended if the presence of APAs is known or
4. you will need e Lancets e Lancet device e CoaguChek Capillary Blood Collection System Cat No 461 optional For venous specimen collection you will need e Plastic syringe free of anticoagulants e Syringe needle should be 23 gauge or larger A 21 gauge or larger needle is recommended e Tourniquet 1 If you are using test strips from a new unopened box you will need to change the Test Strip Code Chip The first three numbers after the lot symbol on the test strip pouch should match the numbers on the Test Strip Code Chip To install the Test Strip Code Chip e Turn the monitor off e Remove and discard the old Code Chip if one is installed e Insert the new Test Strip Code Chip until it snaps into place Make sure the label side with code number is up e Refer to the CoaguChek User s Manual for additional information 2 Remove foil pouch from refrigerator Test strips must be out of the refrigerator for at least five minutes before use 3 For capillary sample collection Prepare lancet device according to manufacturer s instructions e Set aside until needed Prepare capillary collection device optional e Firmly insert end of capillary tube into the capillary bulb With each new bulb be sure to completely insert the capillary tube into the bulb e Set aside until needed 4 For venous sample collection e Prepare a plastic syringe that is free of anticoagulants The sample must be used immediately after collectio
5. and time you ll use Press c The year flashes Press c The hour flashes l these buttons Ml to change a setting Press and hold the ON OFF button 7 or to ape a setting Make sure all the letters numbers If the meter is not already in Setup to change the month then c to change the minutes then c and symbols on the display appear 4 Check the Display to change the year then to change the hour then mode press x eee The date format flashes in the upper 3 anes a oer i 4 Release O a let ida eee Turn the meter off D PREPARING FOR A TEST amp 1 Gather Items 2 Match Code 3 Insert Code Chip 4 Wash Hands r rw e Have the patient wash his or her e CoaguChek XS Meter Make sure the meter is off e Container of test strips ode chip must With the code number facing up hands i in warm soapy water Or clean Test strip code chip insert the code chip into the code chip the fingertip with an alcohol wipe Each box of test strips comes with a slot until it snaps into place Make sure the fingertip is thoroughly dry e CoaguChek lancet TESTING amp matching code chip Every time you open a new box of test strips you must replace the code chip Before continuing review these tips for getting a good blood drop Increasing the blood flow in the finger will help you get a good drop of blood so keep in mind these tips e Warm the hand Have the patient hold it under his or
6. fingertip Press the blue area on the test strip Weber l 3 trigger button Hold the blood drop to the test strip until n HOUrgiass appears as the Meler WaIMS Ceni squeeze from the base of the you hear a beep The flashing blood drop up A flashing test strip and blood drop appear when ready for a sample You have 120 seconds to apply blood to the test strip finger to develop a hanging drop of blood symbol will disappear 6 Record Result Note If during testing the meter displays an error message refer to the Error Messages section of the User Manual for an explanation and steps on how to proceed CLIA walvedcom For more information please contact CLIAwaived Inc at 4332 Corte de la Fonda m San Diego CA 92130 Record the result Place the used test strip and lancet in an approved container Turn the meter off D If the meter is dirty wipe it clean with a CoaguWipe Bleach Towel Tel 858 481 5031 m Toll Free 888 882 7739 E mail info cliawaived com trademarks of Roche Visit us on the web at www cliawaived com l 2006 Roche Diagnostics COAGUCHEK and COAGUWIPE are All rights reserved 04837983001 0906 Distributed by CLIAwaived Inc CoaguChek Systems wu FOR COAGUCHEK SYSTEM Tests This is a CLIA waived system These test strips are to be used with the CoaguChek System Intended Use For quantitative prothrombin time PT testing in fresh capillary or v
7. of electromagnetic fields New York McGraw Hill Book Co p 226 57 1961 2 Oberhardt BJ Taylor M Alkadi ZY Dermott SC Diagnostic assay system for convenient monitoring of oral anticoagulant therapy Abstract Thromb Haemostas 1989 62 327 3 Loeliger EA van den Besselaar AMHP and Lewis SM Reliability and Clinical impact of the normalization of the prothrombin times in oral anticoagulant control Thromb Haemostas 1985 53 148 154 4 Kaatz SS White RH Hill J Mascha E Humphries JE and Becker DM Accuracy of Laboratory and Portable Monitor International Normalization Ratio Determinations Arch Intern Med 1995 155 1861 1867 5 Moll S and Ortel TL Monitoring Warfarin Therapy in Patients with Lupus Anticoagulants Annals of Internal Medicine 1997 127 177 185 Additional Information Refer to the CoaguChek User s Manual for additional information about your system If you still have questions call Point of Care Technical Service Center at 1 800 428 4674 24 hours a day 7 days a week CLIA walvedcom CLIAwaived com 4332 Corte de la Fonda San Diego CA 92130 Toll Free 888 882 7739 Phone 858 481 5031 FAX 801 720 7568 www cliawaived com This system monitor and test strips and its use are covered by one or more of the following U S Patents 4 849 340 5 110 727 5 164 598 5 300 779 5 522 255 5 686 659 5 710 622 5 789 664 5 792 944 5 832 921 5 886 252 and Des 361 129 The test strips a
8. sample collection If blood gets into the ca during sample collection discard the bulb e Put finger over hole at the top of the capillary bulb monitor displays APPLY SAMPLE hold the capillary tu the sample target area of the test strip While keeping the hole gently push down the top of the bulb until the sam channel surrounding the yellow target zone The entire targe the test strip must be completely filled e Apply sample to test strip within 15 seconds of lancing the fingertip Note Blood may also be applied directly from the finger to the sample target area The entire target area must be filled completely with one hanging drop of blood Method B Venous sample collection e When the monitor displays APPLY SAMPLE draw the venous sample into a plastic syringe free of anticoagulants e Discard the first four drops of blood from the needle then immediately place one drop of blood from syringe needle directly onto the center of the sample target of the test strip Make sure the test strip is flat when testing Make sure the sample touches the channel surrounding the yellow target zone The entire target area of the test strip must be completely filled 6 When the blood enters the testing area of the strip the monitor will display TESTING along with a progress bar Do not add more blood or touch the test strip while TESTING is displayed The strip should not be disturbed until the monitor displays the PT value
9. seconds This corresponds to an INR of 1 0 The ISI of the system is defined as 2 0 The physician must determine the best PT level depending on the reason for anticoagulant treatment and how each individual responds to treatment based on Prothrombin Time Each physician should establish expected values for his or her patient population or individual patients In the field of prothrombin testing variations in reaction mixture composition thromboplastin tissue type and system sensitivity may cause some variation in results when comparing results from different laboratory methodologies on the same patient Unusual Results If the patient s PT value seems unusually low or high and you have performed the testing procedure correctly run liquid controls as described in the Quality Control section below If the controls are out of the acceptable range the following can cause unusually low or high results Control used after expiration date Foil pouch opened and strip not used within four minutes Sealed foil pouch stored improperly Foil pouch damaged Maintenance and cleaning procedures have not been followed See the CoaguChek S System User s Manual for these procedures If the controls are in the acceptable range the system is working properly If the result does not match the clinical symptoms repeat the patient test to rule out procedural error There are many reasons why the patient may demonstrate unusual resul
10. 7 Remove the test strip 8 The monitor stores the PT value in memory along with the date and time the test was performed You may also record the PT value in a log book 9 Carefully discard lancet and capillary tube or needle and syringe and the used test strip according to proper infection control guidelines Expected Results CoaguChek System test results are displayed in units equivalent to laboratory plasma measurements Results may be displayed in the International Normalized Ratio INR PT Median Normal PT seconds Quick a unit used mainly by healthcare professionals in Europe and as a ratio relative to normal PT Median Normal PT Normal PT levels vary from person to person The median normal PT MNPT from at least 30 healthy warfarin free individuals is determined for each lot of reference reagent to which each strip lot is calibrated to 12 0 seconds or a ratio of 1 This corresponds to an INR of 1 0 The median PT is usually a good approximation of the geometric mean Patient results in seconds are that which would be expected for a reagent and instrument system with an International Sensitivity Index ISI of 2 0 INRs derived from the CoaguChek System are a result of Calibration to a plain rabbit brain thromboplastin reagent tested on an optical instrument having an ISI of about 2 0 The physician must determine the best PT level depending on the reason for anticoagulant treatment and how each individual responds
11. CoaguChek XS GETTING STARTED Follow these steps to get started using the meter 1 Watch the CoaguChek XS System Video It will help you get comfortable VS em with the CoaguChek XS Meter and the testing procedure 2 With this CoaguChek XS System Getting Started guide by the meter follow the steps to perform your first test ae Then as necessary refer to the User Manual The CoaguChek XS System User Manual is a comprehensive guide to the meter and test strips It is designed to provide answers to your questions Getting Started about the meter s operation and use INSTALLING BATTERIES amp SETUP amp 1 Open Compartment 2 Insert Batteries Open the battery compartment on the Insert 4 AAA batteries according to back of the meter the diagram inside the battery compartment Right after you insert the batteries you ll need to set the date and time The date and time settings are important Each time you run a test the meter compares its date with the test strip s expiration date If the test strip is expired This is a CLIA waived system the meter displays an error message and prevents you from running a test Whenever you put batteries in the meter it automatically goes to Setup mode where you set the date and time You can also go to Setup mode at any time by pressing the SET button SETTING DATE AND TIME gt 1 1 Start Setu Setup 2 2 Set Date Date 3 Set Time S r set the date
12. Lat Int CI 0 10 0 11 ie ve Correlation 0 951 a RSquared 0 904 5 Std Error 0 30 f CoaguChek S INR Dade C INR on MLA Analyzers High INR Accuracy Additional studies were performed at two sites to collect high INR data gt 6 0 INR Site 4 used two different CoaguChek S Monitors and two different lot numbers of test strips to test venous samples Site 5 used two different CoaguChek S Monitors and one lot number of test strips to test venous samples A single venipuncture was used to obtain duplicate results Site 5 also performed capillary blood testing using a single fingerstick and one CoaguChek S Monitor At each site a patient s sample was collected by the same operator The INR of each sample was compared to the INR of venous plasma samples measured on an MLA 900 Analyzer The patient clinical conditions included number of patients valve replacement 6 stroke 1 and other heart related disorders 1 There is generally better agreement among prothrombin time methods within the therapeutic range lt 3 4 INR and poorer agreement at higher INRs The precision and accuracy of CoaguChek S System diminish above an INR of 6 0 INR Result 1 1 INR Result 1 CoaguChek S MLA 900 Differences 2 Coagu Coagu Coagu Plasma Dade Chek S1 Chek S1 Chek S 2 Method 1 Dade C Innovin vs vs vs vs Method Method Coagu Plasma Plasma Plasma Site Result 1 Result 2 1 2 C
13. enous whole blood with the CoaguChek System by professional healthcare providers Cat No 3116247 48 Test Strips 1 Code Chip Introduction Blood coagulation is one of the body s protective responses Blood clots thrombi form as a direct response to vessel injury preventing excessive loss of blood Certain disease conditions require oral anticoagulants sometimes known as blood thinners Warfarin which is sometimes known as Coumadin is a commonly used anticoagulant Patients on warfarin must be carefully monitored to ensure the anticoagulant level is maintained in the therapeutic range One method for monitoring the anticoagulant level is by using the one stage Prothrombin Time PT Test The CoaguChek Systems Test uses a modified version of this method Test Principle The CoaguChek Systems Test used as directed with the CoaguChek Monitor will accurately measure blood PT values After placing a drop of fresh whole blood on the test strip the blood is drawn into the reaction chamber and mixed with reagents that cause coagulation to begin In the test strip tiny iron particles are mixed with the sample Alternating magnetic fields cause the iron particles to move within the sample The endpoint is reached when the blood clot stops the iron particles from moving The PT result is then displayed by the monitor Read the CoaguChek System User s Manual for complete instructions If you have questions call Point of Care Technica
14. erpreting a result Any unexpected results should always be followed up with appropriate coagulation studies and inquiries to define the cause of the unusual result Call Point of Care Technical Service Center at 1 800 428 4674 24 hours a day if you have any questions Quality Control Quality control testing ensures the user s technique integrity of the test strips and performance of the monitor and strips together Daily control testing is good laboratory practice and required by most states Always check with the appropriate licensing or accrediting bodies to ensure your quality control program meets the established standards Frequency of Testing Requirements Waived Testing e Daily Requirements Two levels of Electronic Quality Control or two levels of liquid quality control Cat No 7745 must be tested to verify proper monitor performance e Additional Requirements 1 Two levels of liquid controls must be tested and results must be within the designated range for the following situations You open a new box of test strips You suspect improper storage or handling of the strips Patient PT results are unusually high or low 2 Two levels of Electronic Quality Control or two levels of liquid quality control must be tested if the monitor is dropped or mishandled The results must be within the designated range Frequency of Testing Requirements Moderate Complexity Testing Daily quality control testing is good laboratory pract
15. est strip is flat when testing Make sure the sample touches the channel surrounding the target zone The entire target area of the test strip must be completely filled 6 When the blood enters the testing area of the strip the monitor enters the testing mode Do not add more blood or touch the test strip during testing The strip should not be disturbed until the monitor displays the PT result 7 Remove the test strip 8 The monitor stores the PT value in memory along with the date and time the test was performed 9 Carefully discard lancet and capillary tube or needle and syringe and the used test strip properly according to infection control guidelines Expected Results The CoaguChek S System Monitor displays test results in units equivalent to laboratory plasma measurements Results may be displayed in the International Normalized Ratio INR PT Mean Normal PT seconds Quick a unit used mainly by health care professionals in Europe and as a ratio relative to normal PT Median Normal PT Normal PT levels vary from person to person When the CoaguChek Systems Test was performed using the CoaguChek S Monitor on 123 normal healthy coumarin free individuals using venous samples 95 of the prothrombin times ranged from 10 6 to 13 4 seconds A subset of these individuals n 17 using capillary blood gave results ranging from 10 4 to 12 5 seconds For the purpose of calculating INR or ratio values normal is defined as 12 0
16. ests are sensitive to levels of heparin over 0 15 U mL l When a patient is on intravenous infusion therapy dosnotycolle from arm receiving infusion line Hematocrit ranges between 32 52 do not signifieantl results No interference was found in lipemic samples containin mg dL of triglycerides Testing performed with in vitro spike ples indicated bilirubin up to 20 mg dL and hemolysis up to 500 mg L did not significantly affect test results o The presence of anti phospholipid antibodies APAs such as ufis antibodies LA can potentially lead to prolonged clotting times elevated INR values A comparison to an APA insensitive ee O method is recommended if the presence of APAs is known or susp Sources of error If problems occur when performing tests please check the following e Have you used a wrong Test Strip Code Chip The first three numbers after the lot symbol on the test strip pouch should match the numbers on the Test Strip Code Chip e The test result may be affected by hematocrit values outside the range 32 to 52 e In rare cases patients with long clotting times gt 8 INR gt 33 9 sec may produce a test error If test errors persist results must be confirmed with an alternative test method Contact the patient s physician e Have you performed the test in accordance with the User s Manual and this package insert e Have you used correctly stored test strips see Storage and Stability e Have you
17. f each Factor Level Samples were assayed on the CoaguChek S System and Dade C Plus on the MLA 900 Analyzer The results are shown in the following graphs E coaguChek s Dade C on MLA 900 1 4 1 2 1 0 Average INR Result P dD oo 100 80 60 50 40 20 Factor Il 1 8 1 6 1 4 1 2 1 0 Average INR Result r o CoaguChek S INR 100 80 60 50 Factor V 40 20 Average INR Result gt r amp O amp O N BR Oo 100 60 50 40 30 20 Factor VII 1 4 1 2 1 0 Average INR Result P a 0 100 60 50 40 30 20 Factor X Accuracy 219 venous samples were collected from outpatients at three external sites The INR of each sample was compared to the INR of a venous plasma sample measured on MLA 700 1600 Analyzers using Dade C reagent The patient clinical conditions included number of patients normal 55 atrial fibrillation 35 valve replacement 36 stroke TIA 24 DVT 14 other heart related disorders 32 other clotting disorders 23 Slope Conf Intercept Intercept Site N Slope Int INR Conf Int Correlation 1 78 0 909 _ 0 85 0 97 0 04 0 13 0 21 0 956 2 69 0 990 0 91 1 07 0 07 0 27 0 14 0 946 3 72 0 919 _ 0 85 0 99 0 02 0 15 0 19 0 954 Combined 219 0 935 0 89 0 98 0 005 0 10 0 11 0 951 CoaguChek S Venous Data from All Sites Lot 1 vs Dade C on MLA Analyzers N 219 y 0 935x 0 005 a Slope CI 0 89 0 98
18. guChek vs MLA 700 Plasma Reference n 81 y 0 825x 1 6 r 0 985 Venous Whole Blood CoaguChek vs MLA 700 Plasma Reference n 81 n 81 y 0 862x 0 2 y 0 859x 1 3 r 0 984 r 0 985 CoaguChek CoaguChek Venous vs Capillary Venous vs Capillary n 81 n 81 y 1 077x 0 07 y 1 036x 0 2 r 0 992 r 0 995 Precision Within Day Commercial Control Material INR Scale Seconds Scale Level 1 Level 2 Level Level 2 n 20 20 20 20 Mean 1 03 3 66 12 24 23 01 SD 0 05 0 48 0 33 1 43 CV 4 56 12 98 2 70 6 23 Day To Day Commercial Control Material INR Scale Seconds Scale Level 1 Level 2 Level Level2 n 20 20 20 20 n 48 48 48 48 Mean 1 07 3 72 12 56 23 19 SD 0 07 0 31 0 47 0 94 CV 6 66 8 41 3 71 4 06 Whole Blood Precision of Patient Duplicate Measurements INR Scale Seconds Scale Capillary Venous Capillary Venous n 81 81 81 81 Mean 2 16 2 26 17 2 17 6 0 11 0 10 5 23 4 44 0 37 0 33 2 17 1 89 Return Policy If there is a problem with the CoaguChek Systems Tests you may be asked to return them along with the Test Strip Code Chip to Roche Diagnostics Before returning call the Point of Care Technical Service Center at 1 800 428 4674 You will be mailed a return authorization label which must be put on the shipping carton Packages received without this label will be returned at your expense References 1 Plonsey R Collin RE Magnetic field in material bodies In Principles and applications
19. hek S 2 Method 1 Method 1 Method 2 4 5 2 lot 1 6 3 lot 2 5 9 5 2 1 1 0 7 0 4 0 7 4 6 5 lot 1 6 1 lot a 7 6 6 3 0 4 4 1 1 5 1 3 r 4 4 7 lot 3 6 2 5 2 1 5 1 0 2 4 6 1 lot 3 8 0 lot 4 6 9 7 0 1 9 0 8 1 1 0 1 2 4 4 lot 3 8 7 lot 4 77 7 5 4 6 0 6 4 0 0 2 5 8 5 lot 3 8 5 lot3 7 9 6 1 0 0 6 0 6 1 8 5 eats 4 7 4 4 0 1 4 7 1 8 0 3 5 gt 9 3 lot 3 gt 9 3 lot 3 7 8 6 3 o gt 1 5 gt 1 5 1 5 a 5 8 7 lot 3 79 GA 08 18 z 5 6 5 lot3 p 4 7 4 4 1 8 0 3 8 5 gt 9 3 lot 3 1 7 8 6 3 21 5 1 5 1 Results are shaded if INR 6 0 8 0 2 Results are shaded if difference gt 0 5 INR Seventy eight paired capillary and venous samples were collected at one external site Capillary blood samples were assayed on the CoaguChek S Monitor with CoaguChek Systems Tests and venous plasma samples were measured on an MLA 700 Analyzer with Dade C reagent The results comparison is as follows Slope Conf Intercept Intercept Site N Slope Int INR Conf Int Correlation 1 78 0 889 0 83 0 95 0 04 0 11 0 20 0 960 CoaguChek S Capillary Data from Site 1 Lot 1 vs Dade C on MLA 700 N 78 Ba Th Y 0 889x 0 04 r a ue os Correlation 0 960 e RSquared 0 922 Pa 0 Std Error 0 26 ae Wt 35 Fb 5 J AR 4a 45 30 55 b 70 7 bp Dade C on MLA 700 Precision Whole blood imprecision for venous samples was determined from sample duplica
20. her arm use a hand warmer and or wash with warm water e Have the patient let that arm hang by his or her side Take a test strip out of the container Slide the test strip into the test strip e Massage the finger from its base Close the container tightly guide in the direction of the arrows Use these techniques until the fingertip Do not open a vial of test strips or touch a time IE Stops has good color test strip with wet hands or gloves This The meter turns on may damage the test strips You have 10 The code number of the inserted code minutes to use a test strip once you chip flashes on the display remove it from the container 3 Match Code ect Sample 5 Apply Sample i gib h mm 2 Confirm that the number displayed Twist the protective cap off the Find the target area on the test strip Do not add more blood to the test matches the number on the test strip CoaguChek lancet You can dose from the side or top strip Do not touch the test strip container then press Fl Massage the finger until you see See the User Manual for more The result appears in about 1 minute lf the numbers are different first make increased color in the fingertip information sure that the correct code chip Is inserted Keeping the hand down press the Within 15 seconds of sticking the If you are using the correct code chip tip of the lancet firmly against the fingertip apply the blood to the target ne eri s don t match see the side of the
21. ice It is also required by most states and by CLIA 88 regulations Check with the appropriate sing or accrediting bodies to ensure that your quality control program established standards ily Requirements A two level Electronic Quality Control device Cat No 2032155 or Liquid on oE may be tested to verify proper monitor performance ALi quid Quality Control Level 1 or 2 should be tested when 1 A new shipment of test strips is received 2 Anew lot number of strips is opened 3 Improper storage or handling of the strips is suspected 4 Patient PT resul are unusually high or low This testing is ingaddition to the daily EQC testing The results must be within the d ranges use the appropriate controls for your system CoaguChek i Use Cat No 7745 a similar way as blood tests using the instead of blood The control instructions ig the controls The system is working properly ed by the monitor is within the acceptable lution tested The acceptable control range can ieceptable see the CoaguChek Control Point of Care Technical Service Center ay 4 days a week if you have any questions Limitations of Proced ure The CoaguChek Systems Test uses onl blood Plasma or serum canngi esh capillary or venous whole Use only plastic syringes withoui or syringes must not be used The blood drop must be a minimun volume will cause a SAMPLE ERRORe sREN jersons on heparin aguii ystems T
22. ity Testing Daily quality control testing is good laboratory practice It is also required by most states and by CLIA 88 regulations Check with the appropriate licensing or accrediting bodies to ensure that your quality control program meets established standards e Daily Requirements A two level Electronic Quality Control device Cat No 2032155 or Liquid Quality Controls may be tested to verify proper monitor performance e Additional Requirements A Liquid Quality Control Level 1 or 2 should be tested when 1 Anew shipment of test strips is received 2 Anew lot number of strips is opened 3 Improper storage or handling of the strips is suspected 4 Patient PT results are unusually high or low This testing is in addition to the daily EQC testing The results must be within the designated ranges Be sure to use the appropriate controls for your system CoaguChek S System Use Cat No 3033384 CoaguChek S System Controls are available from your local CoaguChek S System dealer or from Roche Diagnostics Control tests are performed in a similar way as blood tests using the CoaguChek S System Control instead of blood The control instructions should be read before using the controls The system is working properly if the control value displayed by the monitor is within the acceptable range for the control solution tested The acceptable control range can be found in the control package on the Control Value Sheet If the value is not acceptable
23. l Service Center at 1 800 428 4674 24 hours a day 7 days a week Reagents Each test strip contains rabbit thromboplastin stabilizers and preservatives Precautions and Warnings 1 For in vitro diagnostic use Do not take internally 2 Exercise the normal precautions required for handling all blood specimens and laboratory reagents Follow your facility s infection control guidelines 3 CoaguChek Systems Tests may be performed with fresh capillary whole blood from a fingerstick or fresh venous whole blood drawn in an anticoagulant free plastic syringe 4 Never add more blood to the test strip after the test has begun or perform another test using the same fingerstick Storage and Stability e Keep strips in the original sealed foil pouches e Store strips in refrigerator at 2 C to 8 C 36 F to 46 F until ready to use Do not freeze Test strips are stable for 60 days or until the expiration date whichever comes first when stored at room temperature below 32 C or 90 F e Remove only the necessary number of foil pouches from the refrigerator needed to perform a test s Test strips must be out of the refrigerator for at least five minutes before use e Once the foil pouch has been opened use the strip within four minutes Before Testing Gather the necessary materials e CoaguChek Monitor e CoaguChek Systems Tests e Test Strip Code Chip e Alcohol wipe e Cotton ball For capillary specimen collection
24. moved the test strip between sample application and the display of the result Do not touch or move the test strip after having applied the drop of blood Also do not attempt to apply additional blood to the test strip once a first drop has been applied no double dosing In either case the monitor displays an error message and a measurement with a new test strip will be necessary e Are the test strip guide and the door clean Performance Characteristics Verified Clinical Range In clinical trials patients tested in the 9 6 to 33 9 second range 0 6 to 8 0 INR Performance outside this range has not been verified Sensitivity The CoaguChek System is sensitive to deficiencies of Factors Il V VII and X Accuracy The CoaguChek System was compared against the CoaguChek Plus Protime Test System and the MLA 700 Analyzer The following accuracy data was obtained INR Scale Capillary Whole Blood CoaguChek vs CoaguChek Plus n 81 y 0 864x 0 002 r 0 966 Venous Whole Blood CoaguChek vs CoaguChek Plus n 81 y 1 022x 0 2 r 0 952 Capillary Whole Blood CoaguChek vs MLA 700 Plasma Reference n 81 y 0 793x 0 2 r 0 983 Venous Whole Blood CoaguChek vs MLA 700 Plasma Reference Seconds Scale Capillary Whole Blood CoaguChek vs CoaguChek Plus n 81 y 0 945x 0 1 r 0 970 Venous Whole Blood CoaguChek vs CoaguChek Plus n 81 y 1 033x 0 8 r 0 962 Capillary Whole Blood Coa
25. mperature 18 32 C or 65 90 F before opening and performing a test 3 For capillary sample collection e Prepare lancet device according to manufacturer s instructions Set aside until needed e Prepare capillary collection device optional Firmly insert end of capillary tube into the capillary bulb With each new bulb be sure to completely insert the capillary tube into the bulb Set aside until needed 4 For venous sample collection e Prepare a plastic syringe that is free of anticoagulants The sample must be used immediately after collection Plasma or serum cannot be used as a testing sample Glass tubes or syringes must not be used Testing The CoaguChek Systems Test uses only fresh capillary or venous non anticoagulated whole blood Depending on the sample collection method use method A or B as they apply below Monitor should be on a flat surface free of vibrations when testing 1 Turn the monitor on Follow the prompts to insert a strip 2 Open the foil pouch at the tear mark on the side and remove the test strip 3 Insert the strip into the monitor printed side up and push it in until it stops 4 Wait until you are prompted to apply the sample 5 Prepare to collect the fresh whole blood Method A Capillary sample collection e Clean finger with alcohol wipe or use soap and warm water Dry finger thoroughly e Stick the fingertip by placing the tip of lancet device against the bottom side of
26. n e Plasma or serum cannot be used as a testing sample e Glass tubes or syringes must not be used Testing The CoaguChek Systems Test uses only fresh capillary or venous non anticoagulated whole blood Depending on the sample collection method use method A or B as they apply below 1 Place monitor on a flat horizontal surface free of vibrations before testing 2 Turn the monitor on When PERFORM TEST appears on the display press the YES button and the instruction INSERT STRIP will appear 3 Open foil pouch at the tear mark on the side of the pouch and remove test strip 4 Insert strip into monitor printed side up Make sure you insert the test strip in the direction of the printed arrows You will see the yellow sample target area through the strip The monitor displays IS THIS A CONTROL Press the NO button The monitor then displays PLEASE WAIT The monitor will warm the strip for about 45 seconds 5 When monitor displays APPLY SAMPLE prepare to collect the fresh whole blood sample Method A Capillary sample collection e Clean finger with alcohol wipe or use soap and warm water Dry finger thoroughly e Stick the fingertip by placing the tip of lancet device against the bottom side of the finger and pushing the trigger button Gently squeeze finger until a hanging drop of blood forms e Touch the capillary tube to the blood drop Fill the capillary halfway Avoid getting air bubbles into the sample D bulb during
27. oil pouches e Store strips in refrigerator at 2 C to 8 C 36 F to 46 F until ready to use Do not freeze Test strips are stable for 60 days or until the expiration date whichever comes first when stored at room temperature below 32 C or 90 F e Remove only the necessary number of foil pouches from the refrigerator needed to perform a test s Allow at least five minutes for the sealed pouch to reach room temperature before opening the foil pouch for testing e Once the foil pouch has been opened use the strip within four minutes Before Testing Gather the necessary materials e CoaguChek S System Monitor e CoaguChek Systems Tests Test Strip Code Chip e Alcohol wipe e Cotton ball For capillary specimen collection you will need e Lancets e Lancet device e CoaguChek Capillary Blood Collection System Cat No 461 optional For venous specimen collection you will need e Plastic syringe free of anticoagulants e Syringe needle should be 23 gauge or larger A 21 gauge or larger needle is recommended e Tourniquet 1 If you are using test strips from a new unopened box you will need to change the Test Strip Code Chip The first three numbers after the lot symbol on the test strip pouch should match the numbers on the Test Strip Code Chip To install the Test Strip Code Chip follow the instructions in your User s Manual 2 Remove foil pouch from refrigerator and allow at least five minutes to reach room te
28. re covered by U S Patent No 5 488 816 and 5 975 153 COAGUCHEK is a trademark of a Member of the Roche Group Coumadin is a trademark of DuPont Pharmaceutical Company Manufactured for Roche Diagnostics Corporation 9115 Hague Road Indianapolis IN 46256 www coaguchek com 2002 Roche Diagnostics All rights reserved 056194603 1202 CoaguChek Systems O FOR COAGUCHEK S SYSTEM Tests This is a CLIA waived system These test strips are to be used with the CoaguChek S System Intended Use The CoaguChek System is intended for quantitative prothrombin time PT testing for monitoring of warfarin therapy using fresh capillary or venous whole blood by professional healthcare providers Cat No 3116247 48 Test Strips 1 Code Chip Introduction Blood coagulation is one of the body s protective responses Blood clots thrombi form as a direct response to vessel injury preventing excessive loss of blood Certain disease conditions require oral anticoagulants sometimes known as blood thinners Warfarin which is sometimes known as Coumadin is a commonly used anticoagulant Patients on warfarin must be carefully monitored to ensure the anticoagulant level is maintained in the therapeutic range One method for monitoring the anticoagulant level is by using the one stage Prothrombin Time PT Test The CoaguChek Systems Test uses a modified version of this method Test Principle The CoaguChek Systems Test u
29. sed as directed with the CoaguChek S System Monitor will accurately measure blood PT values After placing a drop of fresh whole blood on the test strip the blood is drawn into the reaction chamber and mixed with reagents that cause coagulation to begin In the test strip tiny iron particles are mixed with the sample Alternating magnetic fields cause the iron particles to move within the sample The endpoint is reached when the blood clot stops the iron particles from moving The PT result is then displayed by the monitor Read the CoaguChek S System User s Manual for complete instructions If you have questions call Point of Care Technical Service Center at 1 800 428 4674 24 hours a day 7 days a week Reagents Each test strip contains rabbit thromboplastin stabilizers and preservatives Refer to the Expected Results Section for ISI information Precautions and Warnings 1 For in vitro diagnostic use Do not take internally 2 Exercise the normal precautions required for handling all blood specimens and laboratory reagents Follow your facility s infection control guidelines 3 CoaguChek Systems Tests may be performed with fresh capillary whole blood from a fingerstick or fresh venous whole blood drawn in an anticoagulant free plastic syringe 4 Never add more blood to the test strip after the test has begun or perform another test using the same fingerstick Storage and Stability e Keep strips in the original sealed f
30. suspected Sources of error If problems occur when performing tests please check the following e Have you used a wrong Test Strip Code Chip The first three numbers after the lot symbol on the test strip pouch should match the numbers on the Test Strip Code Chip e The test result may be affected by hematocrit values outside the range 32 to 52 e In rare cases patients with long clotting times gt 8 INR gt 33 9 sec may produce a test error as indicated by ERROR and a flashing test strip icon If test errors persist results must be confirmed with an alternative test method Contact the patient s physician e Have you performed the test in accordance with the User s Manual and this package insert e Have you used correctly stored test strips see Storage and Stability e Have you moved the test strip between sample application and the display of the result Do not touch or move the test strip after having applied the drop of blood Also do not attempt to apply additional blood to the test strip once a first drop has been applied no double dosing In either case the monitor displays an error message and a measurement with a new test strip will be necessary e Are the test strip guide and the door clean Performance Characteristics Measuring Range The CoaguChek S System has a PT reportable range of 0 6 to 8 0 INR and 9 6 to 33 9 seconds sec Sensitivity Internal studies were performed utilizing four replicates o
31. tes at three external sites For capillary blood the data was collected from sample duplicates using a single fingerstick at one external site The following data was obtained and the analysis was performed using a one factor ANOVA model Sample Mean SD CV Mean SD CV Type Site N Sec Sec INR INR Capillary normal 1 17 11 6 0 37 3 23 0 9 0 08 8 66 Capillary therapeutic 1 54 19 4 0 43 2 21 2 6 0 13 4 91 Venous normal 1 17 11 7 0 35 2 98 0 9 0 07 7 83 2 19 11 8 0 24 2 01 0 9 0 06 6 49 3 17 119 0 38 3 23 1 0 0 08 8 63 Combined 53 11 8 033 2 76 0 9 0 07 7 67 Venous therapeutic 1 54 19 7 0 56 2 84 27 0 16 6 09 2 50 19 1 0 40 210 26 0 12 4 80 3 51 19 0 0 59 3 11 2 5 0 17 6 66 Combined 155 193 052 273 26 0 15 5 91 Testing was performed in duplicate therefore mean refers to the mean of samples SD and CV are the SD and CV of the replicates The monitor to monitor lot to lot and strip to strip variability was assessed during internal studies which used two levels of liquid controls with three test strip lots across nine CoaguChek S Monitors The following data was obtained Level 1 Mean 15 0 Mean 1 5 Seconds INR SD CV SD CV Lot to Lot 0 58 3 9 0 10 6 4 Monitor to Monitor 0 21 1 4 0 04 2 6 Strip to Strip 0 54 3 6 0 12 7 5 Total 0 82 5 5 0 16 10 2 Level 2 Mean 23 1 Mean 3 7 Seconds INR SD CV SD CV Lot to Lot 1 03 4 5 0 32 8 8
32. the finger and pushing the trigger button Gently squeeze finger until a hanging drop of blood forms e Touch the capillary tube to the blood drop Fill the capillary tube halfway Avoid getting air bubbles into the sample Do not touch the bulb during sample collection If blood gets into the capillary bulb during sample collection discard the bulb e Put finger over hole at the top of the capillary bulb When the monitor prompts for sample application hold the capillary tube directly over the sample target area of the test strip While keeping finger over the hole gently push down the top of the bulb until the sample has been expelled onto the sample target of the test strip Make sure the test strip is flat when testing Make sure the sample touches the channel surrounding the target zone The entire target area of the test strip must be completely filled e Apply sample to test strip within 15 seconds of lancing the fingertip Note Blood may also be applied directly from the finger to the sample target area The entire target area must be filled completely with one hanging drop of blood Method B Venous sample collection e When the monitor prompts for sample application draw the venous sample into a plastic syringe free of anticoagulants e Discard the first four drops of blood from the needle then immediately place one drop of blood from syringe needle directly onto the center of the sample target of the test strip Make sure the t
33. to treatment based on Prothrombin Time Each physician should establish expected values for his or her patient population or individual patients In the field of prothrombin testing variations in reaction mixture composition thromboplastin tissue type and system sensitivity may cause some variation in results when comparing results from different laboratory methodologies on the same patient Unusual Results If the patient s PT value seems unusually low or high and you have performed the testing procedure correctly run a control If the control is out of the acceptable range the following can cause unusually low or high results Control used after expiration date Foil pouch opened and strip not used within four minutes Sealed foil pouch stored improperly Foil pouch damaged Maintenance and cleaning procedures have not been followed See the CoaguChek System User s Manual for these procedures If the control is in the acceptable range the system is working properly If the result does not match the clinical symptoms repeat the patient test to rule out procedural error There are many reasons why the patient may demonstrate unusual results In the field of prothrombin testing certain drugs may affect PT results by affecting warfarin pharmacology The potential effect of a drug interaction with warfarin or the effect of underlying diseases e g liver disease congestive heart failure must be considered when int
34. ts In the field of prothrombin testing certain drugs may affect PT results by affecting warfarin pharmacology The potential effect of a drug interaction with warfarin or the effect of underlying diseases e g liver disease congestive heart failure must be considered when interpreting a result Any unexpected results should always be followed up with appropriate coagulation studies and inquiries to define the cause of the unusual result Call Point of Care Technical Service Center at 1 800 428 4674 24 hours a day 7 days a week if you have any questions Quality Control Quality control testing ensures the user s technique integrity of the test strips and performance of the monitor and strips together Frequency of Testing Requirements Waived Testing e Daily Requirements Two levels of Electronic Quality Control EQC or two levels of liquid quality control must be tested to verify proper monitor performance e Additional Requirements 1 Two levels of liquid controls must be tested and results must be within the designated range for the following situations e You open a new box of test strips e You suspect improper storage or handling of the strips e Patient PT results are unusually high or low 2 Two levels of Electronic Quality Control or two levels of liquid quality control must be tested if the monitor is dropped or mishandled The results must be within the designated range Frequency of Testing Requirements Moderate Complex
35. www coaguchek com 2002 Roche Diagnostics All rights reserved 056194603 1202
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