SOP_Final 573-1051_XS Pro_Plus with UMDC
Contents
1. 2 4 o 8 4 p 6 oo s A 10 a2 1 4 0 1 2 3 4 5 6 7 8 9 Mean of Replicates Built In Controls and Diagnostics The CoaguChek XS Plus 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 Plus System User Manual Roche Diagnostics has available optional liquid quality controls 04625382160 for the CoaguChek XS Plus 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 facility References 1 Moll S Ortel TL Monitoring Warfarin Therapy in Patients with Lupus Anticoagulants 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 Additional Information The CoaguChek XS Plus 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 experie2. the result 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 Plus 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 Plus 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 c
3. CoaguChek XS PT Test 04625315160 48 Test Strips FOR USE WITH THE COAGUCHEK XS PLUS SYSTEM 1 Code Chip This insert is for healthcare professional use These test strips are to be used with the CoaguChek XS Plus 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 Facilities performing testing must have a CLIA Certificate of Waiver 42 USC 263a c 2 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 subject to all applicable CLIA requirements All applicable state and local laws must be met Laboratories with a certificate of waiver must follow the manufacturer s instructions for performing a test 42 CFR 493 15 e 1 Intended Use The CoaguChek XS Plus System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy The system uses fresh capillary or non anticoagulated venous whole blood Caution For in vitro diagnostic use Before You Start Testing If you are new to the CoaguChek XS Plus System watch the CoaguChek XS Plus System Training DVD and read the CoaguChek XS Plus System Getting Started Guide and CoaguChek XS Plus System User Ma
4. atory reagents shows that the CoaguChek XS Plus 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 Plus System 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 diseases 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 Measuring Range The CoaguChek XS Plus 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 o
5. f 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 J Factor Il i Factor V Factor Vil W Factor X 77 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 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 Site 1 287 Site 2 286 Site 3 238 All 811 N 811 y 1 090x 0 2 Sip Cl 1 073 1 1 Int CI 0 2 0 1 CoaguChek XS Plus INR NO ise gt o1 lop N foe co _ Slope 1 071 1 091 1 111 1 090 Intercept Correlation 0 2 0 969 0 1 0 975 0 1 0 983 0 2 0 974 Venous Data from All Sites 811 Samples from 412 Patients 11 Correlation 0 974 E m a ma aan a 4 5 6 7 8 9 Dade Innovin INR Accuracy 822 capillary samples were collected from 413 outpatients at three external sites Capillary blood samples were assayed on the C
6. guChek 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 Before 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 f needed immediately after lancing gently squeeze the finger from its base to encourage blood flow Step 3 Performing the Test 1 Wash the patients 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 fro
7. m 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 and Patient ID 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 number 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
8. nced 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 Plus meter notify CMS at http www cms hhs gov clia ro map asp For Return Policy and Limited Warranty refer to the other side of this insert Distribution in USA by Roche Diagnostics Indianapolis IN US Customer Technical Support 1 800 428 4674 www poc roche com 059677 16001 04 V1 R1 black 2013 05
9. nual 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 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 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 gloves 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 non anticoagulated plastic capillary tube to collect the fingerstick blood sample You may also use the CoaguChek XS Plus System to test venous blood See the CoaguChek XS Plus 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 Plus Meter Coa
10. oaguChek 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 from All Sites 822 Samples from 413 Patients 97 1 N 822 8 y 1 075x 0 1 J Slp CI 1 059 1 Correlation 0 CoaguChek XS Plus INR NO wo gt o1 o 092 J Int Cl 0 2 0 1 972 oa 4 5 6 7 8 9 Dade Innovin INR Capillary Data N Slope Intercept Correlation Site 1 287 1 048 0 1 0 959 Site 2 207 1 071 0 1 0 974 Site 3 238 1 111 0 1 0 988 All 822 1 075 0 1 0 972 Precision Whole 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 on S 61 S o CELS amp f 2 1 E 0 lt 1 O o damn anowonmModanao O O O O 2 4 o o o S o gt 6 m 8 1 0 T T T T T T T T T T T E T T T T T T T T T T T T T T T T T T T T T T T T T T T T T T T T 0 1 2 3 4 5 6 7 8 9 Mean of Replicates Whole Blood Precision for Capillary Blood 1 4 Mize o g 10 8 e o l ce O oa oO Q S 24 oo0go0m momoo o o 5 q1 oD CoD DsSG O O D 0 m mm on an n n n oa D an o o o a B 4 oO S
11. ollect 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 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 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 clo
12. tting 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 5 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 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 CoaguChek XS Plus System to those obtained using common clinical labor
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