SOP_Final 573-1051_XS Pro_Plus with UMDC
Contents
1. Normal INR levels vary from person to person For the purpose of providing universal INR results the Mean Normal Prothrombin Time MNPT has been established as 12 seconds and the International Sensitivity Index ISI for the system has been established as 1 The physician must determine the best INR 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 Differences in reagents instruments and pre analytical variables can affect prothrombin time results These factors should be considered when comparing different prothrombin time test methods Experience comparing results obtained using the Systems to those obtained using common clinical laboratory reagents shows that the Systems correlate well with the following clinical laboratory reagents Dade Innovin Ortho Recomboplastin and Dade Thromboplastin C Other clinical laboratory reagents may not consistently correlate with the Systems Unusual Results If the meter displays an error message refer to the Error Messages section of the User Manual If the meter displays an unusual test result other than an error message check the following items Certain drugs may affect results by interfering with warfarin pharmacology The potential effect of a drug interaction with warfarin or the effect of underlying diseases2. e g liver disease congestive heart failure must be considered when interpreting a result Changes in the patient s diet can cause unusually low or high results Any unusual result should always be followed up with inquiries to define the cause of the unusual result If the result does not match the clinical symptoms repeat the patient test to rule out procedural error Performance Characteristics The following performance characteristics are representative for both CoaguChek XS Pro meter and CoaguChek XS Plus meter Measuring Range Each system has a reportable range of 0 8 to 8 0 INR Sensitivity The CoaguChek XS PT Test is sensitive to various clotting factors as determined by in vitro tests Single factor depleted plasma was combined with a normal plasma pool to produce a series of diluted plasma samples These plasma samples were then tested using three representative lots of the CoaguChek XS PT Test across 16 CoaguChek XS meters The results as seen in the graph represent the typical CoaguChek XS PT Test sensitivity to Factors Il V VII and X CoaguChek XS Factor Sensitivity 100 75 50 25 12 5 6 25 Factor C Factor Il Mj FactorV W Factor Vil Mi Factor X Normal Range Accuracy 811 venous samples were collected from 412 outpatients at three external sites The INR of each sample was compared to the INR of a venous plasma sample measured on a Dade Sysmex 560 Analyzer using Dade Innovin ISI 1 02 The patient clinical
3. facility References are listed on the other side of this insert Additional Information The CoaguChek XS Pro System User Manual contains more information If you need technical help call Roche Diagnostics Technical Service Center 1 800 428 4674 24 hours a day 7 days a week 365 days a year Any adverse reactions experienced with the use of this product and or quality problems should also be reported to the FDAs MedWatch Adverse Event Reporting program online at www fda gov MedWatch report htm by phone 1 800 FDA 1088 or by returning the postage paid FDA form 3500 which may be downloaded from www fda gov MedWatch getforms htm by mail to MedWatch 5600 Fishers Lane Rockville MD 20852 9787 or fax 1 800 FDA 0178 If there are any problems with the CoaguChek XS Pro meter notify CMS at http www cms hhs gov clia ro map asp Return Policy If there is a problem with the CoaguChek XS PT Test Strips you may be asked to return them along with the Test Strip Code Chip to Roche Diagnostics Before returning call Roche Diagnostics Technical Service Center at 1 800 428 4674 You will be mailed a return authorization label which must be placed on the shipping carton Limited Warranty Roche Diagnostics warrants that this product will meet the specifications stated in the labeling when used in accordance with such labeling and will be free from defects in material and workmanship until the expiration date printed on the label THIS LIMIT
4. the Test Strip The test strip contains reagent human recombinant thromboplastin 1 5 U as well as stabilizers preservatives and additives Limitations of Procedure The CoaguChek XS Pro System should not be used for patients being treated with any direct thrombin inhibitors including Hirudin Lepirudin Bivalirudin and Argatroban The CoaguChek XS PT Test uses only fresh capillary or non anticoagulated 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 8 uL in volume Low sample volume will cause an error message Never add more blood to the test strip after the test has begun or perform another test using the same fingerstick When a patient is on intravenous infusion therapy do not collect the sample from the arm receiving the infusion line Hematocrit values between 25 55 do not significantly affect test results Testing performed with the following in vitro spiked samples or native blood samples triglycerides indicated no significant effect on test results Bilirubin up to 30 mg dL Lipemic samples containing up to 500 mg dL of triglycerides Hemolysis up to 1000 mg dL Heparin concentrations up to 0 8 U mL Low molecular weight heparins LMWH up to 2 IU anti factor Xa activity mL Clopidogrel up to 20 mg dL Fondaparinux up to 5 mg L The presence of anti phosp
5. CoaguChek XS PT Test REF 04625315160 48 Test Strips FOR USE WITH THE COAGUCHEK XS PRO SYSTEM 1 Code Chip Purpose The CoaguChek XS Pro System is intended for use by professional healthcare providers for quantitative prothrombin time testing for monitoring warfarin therapy The CoaguChek XS Pro System uses fresh capillary or non anticoagulated venous whole blood The term System s hereafter will refer to both the CoaguChek XS Pro System and the CoaguChek XS Plus System Caution For in vitro diagnostic use Before You Start Testing If you are new to the CoaguChek XS Pro System watch the CoaguChek XS Pro System Training DVD and read the CoaguChek XS Pro System Getting Started Guide and CoaguChek XS Pro System User Manual Read the CoaguChek XS Pro PT Controls package insert and this entire insert Storing the Test Strips Store the test strips in their original container with the cap closed You can store the test strips at room temperature or in the refrigerator 2 30 C or 36 86 F When stored properly the test strips can be used until the expiration date printed on the test strip container Discard the test strips if they are past the expiration date on the container Handling the Test Strips When you are ready to test open the test strip container and remove 1 test strip Immediately close the container Make sure it seals tightly MPORTANT Do not open a container of test strips or touch a test strip with wet hands or wet glove
6. ED WARRANTY IS IN LIEU OF ANY OTHER WARRANTY EXPRESS OR IMPLIED INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE FOR INCIDENTAL INDIRECT SPECIAL OR CONSEQUENTIAL DAMAGES COAGUCHEK is a trademark of Roche All other product names and trademarks are the property of their respective owners Significant additions or changes are indicated by a change bar in the margin 2013 Roche Diagnostics Roche Diagnostics GmbH Sandhofer Strasse 116 D 68305 Mannheim www roche com www poc roche com Distribution in USA by Roche Diagnostics Indianapolis IN US Customer Technical Support 1 800 428 4674 05967716001 04 V1 R1 black 2013 05
7. conditions included number of patients not on warfarin 61 atrial fibrillation 163 valve repair replacement 44 stroke TIA 5 DVT 75 pulmonary embolism 22 cardiovascular accident 15 other heart related disorders 9 other clotting disorders 13 other 5 The results are as follows Venous Data N Slope Intercept Correlation Site 1 287 1 071 0 2 0 969 Site 2 286 1 091 0 1 0 975 Site 3 238 1 111 0 1 0 983 All 811 1 090 0 2 0 974 Venous Data from All Sites 811 Samples from 412 Patients N 811 y 1 090x 0 2 Slp Cl 1 073 1 111 Int Cl 0 2 0 1 Correlation 0 974 no wo A a 0 N CO CO CoaguChek XS Plus INR 6 7 8 9 0 1 2 3 4 5 Dade Innovin INR Accuracy 822 capillary samples were collected from 413 outpatients at three external sites Capillary blood samples were assayed on the CoaguChek XS Plus Meter with the CoaguChek XS PT Test and venous samples were measured on a Dade Sysmex 560 Analyzer with Dade Innovin ISI 1 02 The results are as follows Capillary Data N Slope Intercept Correlation Site 1 287 1 048 0 1 0 959 Site 2 297 1 071 0 1 0 974 Site 3 238 1 111 0 1 0 988 All 822 1 075 0 1 0 972 Capillary Data from All Sites 822 Samples from 413 Patients 9 3 N 822 8 7 y 1 075x 0 1 Sip Cl 1 059 1 092 Int Cl 0 2 0 1 Correlation 0 972 q 6 5 J 4 3 2 CoaguChek XS Plus INR Dade Innovin INR Precision Who
8. fore you lance the finger try the following techniques until you see that the fingertip has increased color Warm the hand by having the patient hold it under his or her arm use a hand warmer and or wash the hand with warm water Have the patient hold his or her arm down to the side so hand is below waist Massage the finger from its base If needed immediately after lancing gently squeeze the finger from its base to encourage blood flow Step 3 Performing the Test 1 Wash the patient s hands with warm soapy water or wipe the finger with alcohol Dry the patient s hands completely Make sure your hands and gloves are dry before proceeding 2 When you are ready to test remove 1 test strip from the container and immediately close the container Make sure it seals tightly Do not open a container of test strips or touch a test strip with wet hands or wet gloves This may damage the test strips 3 Insert test strip as far as you can into the meter This powers the meter ON 4 Press Patient Test on the meter display The meter warms the test strip Then the meter begins a countdown You have 180 seconds to apply a blood sample to the test strip If your facility procedures require use of the Operator ID Patient ID and the barcode scanner refer to the User Manual 5 The meter automatically checks to see if you have the right Test Strip Code Chip The three number code on the test strip container must match the three numbe
9. holipid 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 Is the meter displaying ERROR 6 Sporadically occurring ERROR 6 are generally due to an activation of the system fail safe mechanisms that are designed to prevent the release of wrong measurement results However in rare cases ERROR 6 may be received with patients who are under treatment with warfarin vitamin K antagonists in combination with antibiotics and or chemotherapeutics leading to extremely high coagulation times gt 10 INR lt 5 Quick In this case and if ERROR 6 is displayed repeatedly the result must be checked using another method In rare cases patients with long clotting times gt 8 INR may receive an ERROR 7 message on the meter display If this error message appears again when the test is repeated the result must be checked using another method Expected Results The meter displays test results in units equivalent to laboratory plasma measurements Results may be displayed in three ways the International Normalized Ratio INR PT Mean Normal PT seconds and Quick a unit used mainly by healthcare professionals in Europe Each lot of test strips is calibrated to a reference lot that is traceable to the WHO International Reference Preparations
10. le blood precision was determined for venous and capillary blood from sample duplicates collected at three sites The following results represent whole blood precision for venous and capillary blood Sample N Mean INR SD CV Venous 399 2 32 0 046 2 00 Capillary 399 2 26 0 077 3 39 Whole Blood Precision for Venous Blood 1 0 8 4 N g 6 cS 2 j CEE J ze 2 1 8 J 0 n D m ommo arormopmmModoao a O O o 0 co 2 4 m a m o S 4 E e A 8 0 1 2 3 4 5 6 7 8 9 Mean of Replicates Whole Blood Precision for Capillary Blood 14 1 2 o o o Dn oo oO o oO moo0o O oo O Difference Between Replicates O F N ONeAQ 0 1 2 3 4 5 6 7 8 Mean of Replicates Built In Controls and Diagnostics The CoaguChek XS Pro System has quality control functions integrated into the meter and test strips so you do not have to run quality control tests with liquid quality controls A two level on board quality control test is performed within the test chamber as part of every blood test For more information about the built in quality control functions see the CoaguChek XS Pro System User Manual Roche Diagnostics has available optional liquid quality controls 04625382160 for the CoaguChek XS Pro System These controls are provided to assist with meeting regulatory compliance requirements as applicable to your facility Frequency and necessity of liquid quality control tests are at the discretion of each individual
11. r code on the code chip before the test can be run If you are using test strips from a new unopened container you must change the Test Strip Code Chip 6 Use a CoaguChek lancet to perform a fingerstick 7 Hold the finger very close to the target area clear area of the test strip Apply 1 drop of blood to the top or side of the target area and wait until you hear the beep if the beeper is enabled You must apply blood to the test strip within 15 seconds of lancing the finger 8 Do not add more blood Do not touch or remove the test strip while the test is in progress The flashing blood drop symbol changes to an hourglass symbol when the meter detects sufficient sample 9 The result appears in approximately one minute Record the result You may add comments to the test result about the test conditions or the patient Refer to the User Manual 10 Properly dispose of the used lancet and test strip 11 Power the meter OFF NOTE If you need to repeat a test use a new test strip and lancet and a different finger Technical Information How the Test Works The CoaguChek XS PT Test used as directed with the CoaguChek XS Pro Meter will provide an electrochemical measurement of prothrombin time following activation of blood coagulation with human recombinant thromboplastin In simple terms blood works with the chemicals in the test strip to produce a small electric current in the test strip that measures blood clotting time Contents of
12. s This may damage the test strips You must use the test strip within 10 minutes of removing it from the container Otherwise you may get an error message and you will have to repeat the test Sample Collection and Preparation The steps that follow apply to collecting a blood sample from a fingerstick Optionally you may use a nonanticoagulated plastic capillary tube to collect the fingerstick blood sample You may also use the CoaguChek XS Pro System to test venous blood See the CoaguChek XS Pro System User Manual for more information When collecting any type of sample follow universal blood collection precautions and guidelines Step 1 Getting Ready to Test Gather supplies CoaguChek XS Pro Meter CoaguChek XS PT Test Strip and Test Strip Code Chip CoaguChek Lancet 04348150001 Follow manufacturer s instructions for use If you are using test strips from a new unopened container you must change the Test Strip Code Chip The three number code on the test strip container must match the three number code on the code chip To install the code chip follow the instructions in the Code Chip section of the User Manual Place the meter on a flat surface like a table or countertop or hold it roughly horizontal so that it will not vibrate or move during testing Vibrations or other movement can result in an error message Step 2 Getting a Good Drop of Blood Increasing the blood flow in the finger will help you get a good drop of blood Be
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