CoaguChek & CoaguChek S Strip Insert
Contents
1. _ _CoaguChek a Systems u 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 venous 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 to2. 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 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 m
3. 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 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 3
4. 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 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 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 www coaguchek com 2002 Roche Diagnostics All rights reserved 056194603 1202 CoaguChek Systems e FOR COAGUCHEK S SYSTEM Tests Thi
5. 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 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 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
6. 5 1 5 A 5 8 7 lot 3 79 GA 08 18 z 5 es 0t3 p 4 7 4 4 1 8 0 3 8 5 gt 9 3 lot 3 __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 rcp 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 duplicates 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
7. 3 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 of 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 Resu
8. 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 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
9. 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 0 33 2 76 0 9 0 07 7 67 Venous therapeutic 1 54 19 7 0 56 2 84 27 0 16 6 09 2 50 191 0 40 210 26 0 12 4 80 3 51 19 0 0 59 3 11 2 5 0 17 6 66 Combined 155 19 3 0 52 273 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 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
10. 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 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 Becke
11. ance o 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 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
12. d in a similar way as blood tests using the CoaguChek 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 CoaguChek System Control Values Sheet lf the value is not acceptable see the CoaguChek 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 a SAMPLE ERROR REMOVE STRIP warning 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 contain
13. e 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 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 System wse Cat No 7745 The CoaguChek System Controls are available from your local CoaguChek System dealer or from Roche Diagnostics Control tests are performe
14. e 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 Complexity 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 perform
15. ed 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 foil pouches 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 t
16. emperature 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 e 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 temperature 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
17. eometric 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 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 i
18. f 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 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 displays APPLY SAMPLE 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 yellow 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 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
19. he 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 collection 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 o
20. ing 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 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 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 app
21. ixture 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 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 interpreting a result Any unexpected results should always be followed up with appropriate coagulation studies and inquiries to define the caus
22. lary 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 Level2 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 SD 0 11 0 10 0 37 0 33 CV 5 23 4 44 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 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
23. lied 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 CoaguChek 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 Capil
24. lt gt r o N ah D 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 Lat Int CI 0 10 0 11 ie ve Correlation 0 951 a RSquared 0 904 5 Std Error 0 30 i 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 nu
25. mber 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 S 1 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 Chek 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 2 7 6 6 3 0 4 4 1 1 5 1 3 ps 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 5 4 TA lot 3 8 7 lot 4 77 7 5 1 6 0 6 1 0 0 2 5_ 8 5 lot 3 8 5 lot3 7 9 6 1 0 0 6 0 6 1 8 5 eases 4 7 4 4 0 1 4 7 1 8 0 3 5 gt 9 3 lot 3 gt 9 3 lot 3 ime 6 3 0 gt 1 5 31
26. 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 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 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 bef
27. ore 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 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 t
28. r 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 www coaguchek com 2002 Roche Diagnostics All rights reserved 056194603 1202
29. s 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 used 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 reach
30. s 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 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 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 rang
31. 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 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 g
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