SOP_Final 573-1051_XS Pro_Plus with UMDC
Contents
1. Precision Whole blood precision was determined for venous and capillary blood from sample duplicates collected at three sites The following charts represent whole blood precision for venous and capillary blood Sample N Mean INR SD CV Venous 357 2 59 0 06 2 42 Capillary 344 2 09 0 11 4 35 Whole Blood Precision for Venous Blood N o a ow o0 o0 e a o a o 0 OOO eoor eaae a m Oo o EGE HEESSE ESSA SSS SSS SEE EEEH E E rT cooo SO0056005005 060 o o Glo topo oa eo a omo oop o o o 8 0o00 o0 o o m T o D m 1 2 3 4 9 6 7 8 Mean of Replicates Whole Blood Precision for Capillary Blood 1 0 8 a e 6 o T 5 p 4 o o oo oe o oO o o lt 2 OOo A Lo ov Coo ao oO T co o Oona o ooon o s 0 AEA EAR ERA RRA ERA rer E D o ononon aonana oo to eA 2 oo ooon coo o a o 8 oo oOo o m o _ lt 5 4 m o cb E 6 o 0 A o 8 m 0 1 2 3 4 5 6 7 8 Mean of Replicates Built In Controls and Diagnostics The CoaguChek XS 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 The meter automatically runs its own quality control test as part of every blood test For more information about the built in quality control functions see the CoaguChek XS System User Manual References 1 Moll S and Ortel TL Monitoring Warfarin Therapy in Patients with Lupus Anti2. coagulants Annals of Internal Medicine 1997 127 177 185 2 Loeliger EA van den Besselaar AMHP Lewis SM Reliability and Clinical Impact of the Normalization of the Prothrombin Times in Oral Anticoagulant Control Thromb Haemostas 1985 53 148 154 Return Policy lf 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 Additional Information The CoaguChek XS System User Manual contains more information If you still have questions call Roche Diagnostics Technical Service Center at 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 Med Watch 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 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 mate
3. including Hirudin Lepirudin Bivalirudin and Argatroban The CoaguChek XS PT Test uses only fresh capillary or nonanticoagulated 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 test strip after test has begun or perform another test using the same fingerstick When a patient is on intravenous infusion therapy do not collect sample from arm receiving the infusion line Hematocrit ranges 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 phospholipid antibodies APAs such as Lupus anti bodies 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 s the meter displaying E
4. 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 conditions included number of patients normal not on warfarin 62 atrial fibrillation 174 valve replacement 35 stroke TIA 28 DVT 16 other heart related disorders 4 other clotting disorders 6 other 30 Venous Data N Slope Intercept Correlation Site 1 232 1 129 0 10 0 983 Site 2 230 1 111 0 11 0 971 Site 3 248 0 984 0 03 0 986 All 710 1 034 0 02 0 974 Venous Data from All Sites 710 Samples from 355 Patients y 1 034x 0 02 8 7 Slip CI 1 017 1 053 Int CI 0 04 0 01 Correlation 0 974 CoaguChek XS INR Dade Innovin INR 05967694001 02 V1 R1 black 2013 05 Accuracy 700 capillary samples were collected from 357 outpatients at three external sites Capillary blood samples were assayed on the CoaguChek XS meter with the CoaguChek XS PT Test and venous plasma samples were measured on a Dade Sysmex 560 Analyzer using Dade Innovin ISI 1 02 The results comparison is as follows Capillary Data N Slope Intercept Correlation Site 1 230 1 111 0 10 0 973 Site 2 229 1 081 0 068 0 979 Site 3 24 0 952 0 02 0 985 All 700 1 006 0 032 0 971 Capillary Data from All Sites 700 Samples from 357 Patients y 1 006x 032 8 4 Slp Cl 0 990 1 023 Int Cl 0 01 0 06 Correlation 0 971 CoaguChek XS INR Dade Innovin INR
5. RROR 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 coagu lation 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 CoaguChek XS Meter 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 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 Normal INR levels vary from person to person When the CoaguChek XS PT Test was performed using the CoaguChek XS Meter on 121 normal healthy warfarin free individuals using venous and capillary samples 97 of the INRs ranged from 0 9 to 1 1 For the purpose of
6. e on the container Handling the Test Strips When you are ready to test remove 1 test strip from the container 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 Close the container tightly 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 capillary tube to collect the fingerstick blood sample You may also use the CoaguChek XS System to test venous blood See Optional Testing Methods in the CoaguChek XS 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 Meter CoaguChek XS PT Test Strip Test Strip Code Chip CoaguChek Lancet 04348150001 Follow the manufacturer s instructions for use If you are using test strips from a new unopened box you must change the Test Strip Code Chip The 3 number code on the test strip container must match the 3 number code on the code chip To install the code chip follow the instructions in the Code Chip section of the CoaguChek XS System User Manual Place the meter on a flat surface like a table or counterto
7. eter set up with the correct date and time Certain drugs may affect 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 Also changes in the patient s diet can cause unusually low or high results Any unusual result should always be followed up with appropriate coagulation studies and inquiries to define the cause of the unusual result lf the result does not match the clinical symptoms repeat the patient test to rule out procedural error Performance Characteristics Measuring Range The CoaguChek XS 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 below represent the typical CoaguChek XS PT Test sensitivity to Factors Il V VII and X CoaguChek XS Factor Sensitivity Factor C Factorii WW FactorV gm Factor Vil gg Factor X Normal Range Expected Waiver Performance Accuracy 710 venous samples were collected from 355 outpatients at three external sites The INR
8. meter begins a countdown You have 180 seconds to apply blood to the test strip 7 Use the lancet to perform a fingerstick 8 Apply 1 drop of blood to the top or side of the target area You must apply blood to the test strip within 15 seconds of lancing the finger 9 Do not add more blood Do not touch or remove the test strip when a test Is in progress The flashing blood drop symbol changes to an hourglass symbol when the meter detects sufficient sample If the meters beeper is turned on a beep sounds as well 10 The result appears in about 1 minute Record the result 11 Properly dispose of the used lancet and test strip 12 Power the meter OFF lf you need to repeat a test use a new lancet a new test strip and a different finger Technical Information How the Test Works The CoaguChek XS PT Test used as directed with the CoaguChek XS 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 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 System should not be used for patients being treated with any direct thrombin inhibitors
9. p 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 Before you lance the finger try the following techniques until you see that the fingertip has good 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 that the hand is below the 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 Allow the patient s finger to dry completely before performing the fingerstick 2 Take a test strip out of the container Close the container tightly 3 Insert test strip as far as you can The meter powers ON 4 Confirm that the number displayed matches the number on the test strip container then press M If the numbers are different make sure you are using the code chip that came with the test strips you are using 5 An hourglass flashes as the meter warms the test strip which takes up to 30 seconds 6 When the test strip is warmed a flashing test strip and blood drop symbol appear and the
10. providing universal INR results the Mean Normal Prothrombin Time MNPT has been established as 12 seconds for healthy volunteers 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 CoaguChek XS System to those obtained using common clinical laboratory reagents shows that the CoaguChek XS System correlates 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 CoaguChek XS System Unusual Results If the meter displays an error message refer to the Error Messages section of the CoaguChek XS System User Manual f the meter displays an unusual test result other than an error message check the following items s the correct code chip in the meter The 3 number code on the test strip container must match the 3 number code on the code chip s the m
11. rial and workmanship until the expiration date printed on the label THIS LIMITED 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 05967694001 02 R1 black
12. ye oa CoaguChek XS PT Test wu 04625315160 48 Test Strips and 1 Code Chip FOR USE WITH THE COAGUCHEK XS SYSTEM This is a CLIA Waived test system A Certificate of CLIA Waiver or higher is required to perform the test Information on obtaining CLIA certificates can be found at www cms hhs gov clia Any modifications and or failure to follow test system instructions including those for limitations intended use and performance of QC testing as a failure alert mechanism results in use that is considered high complexity and sub ject to all applicable CLIA requirements Purpose The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for monitoring warfarin therapy The CoaguChek XS System uses fresh capillary or nonanticoagulated venous whole blood Caution For in vitro diagnostic use Before You Start Testing If you are new to the CoaguChek XS System watch the CoaguChek XS System Training DVD and read the CoaguChek XS System User Manual and Getting Started Guide before testing Storing the Test Strips Store the test strips in their original container with the cap tightly 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 dat
Download Pdf Manuals
Related Search