Coagpia™APTT-N
Contents
1. Ingredients APTT Reagent Phospholipids rabbit brain origin Ellagic acid Calcium Chloride Calcium chloride Solution Intended Use For the measurement of activated partial thromboplastin time with plasma The activated partial thromboplastin time APTT test is widely used for evaluating intrinsic coagulation factors and coagulation factor inhibitors and monitoring heparin therapy Assay Principle 1 Assay Principle After adding phospholipids and ellagic acid to plasma samples for the full activation of contact factors factor XII prekallikrein and high molecular weight kininogen calcium chloride is added The time taken from the addition of calcium chloride to fibrin precipitation coagulation time seconds is referred to as the activated partial thromboplastin time APTT Procedural Precautions 1 Sample Collection and Storage 1 Samples Plasma citrated plasma can be used Do not use plasma with anticoagulants other than citrate 2 Sample Preparation i Promptly mix 3 2 sodium citrate with blood sample in a 9 1 blood to sodium citrate volume ratio Centrifuge in a refrigerated centrifuge at 1500G for 15 minutes Transfer the plasma into a separate plastic test tube and refrigerate or store on ice ii Avoid contamination with tissue fluid during blood collection using insufficient amount of sodium citrate solution and inadequate mixing as they may yield inaccurate test results 3 Sample Storage Start2. This product marketed by SEKISUI MEDICAL CO LTD Tokyo Japan is manufactured subject to our supervision as stipulated in the Pharmaceutical Affairs Law of Japan and is certified by Registerd Third Party to be marketed in Japan For details please contact us or your local distributors Activated Partial Thromboplastin Time Kit Coagpia APTT N General Precautions 1 This product is for in vitro diagnostic use only and must not be used for any other purposes 2 Clinicians should make a comprehensive clinical decision based on the assay results in conjunction with clinical symptoms and other examination results 3 Influence on assay values resulting from drug administration is described in Precautions for Use in the package insert for the relevant drugs In particular carefully read the section on influence on clinical test results 4 This product should be used only as directed Reliability of values cannot be guaranteed if this product is used for purposes or tested by methods other than those stated 5 If the reagents come in contact with the eyes or mouth rinse thoroughly with water as first aid and seek medical treatment if necessary 6 Read the user s manual of your automated analyzer prior to using this kit Parameters for different automated analyzers are available upon request 7 Perform a quality control test prior to assay to ensure accuracy Description Kit Components Component
3. his product should be stored as directed Avoid freezing Freezing can cause deterioration of the reagents which can produce inaccurate results 2 Do not use expired reagents The reliability of assay values obtained with expired reagents cannot be guaranteed 3 Do not replenish the reagents 4 Do not mix reagents of different lots 5 Do not perform the assay under direct sunlight 3 Precautions for Disposal 1 Before disposal used samples and their containers must be soaked in sodium hypochlorite solutions at a concentration greater than 0 1 for more than an hour or autoclaved at 121 C for 20 minutes 2 To prevent infections from spilled samples or solutions containing samples wipe the spill area thoroughly with disinfectants such as sodium hypochlorite solution at a concentration greater than 0 1 3 The reagents and samples should be disposed in accordance with medial waste disposal regulations or related regulations 4 The reagents should be disposed in accordance with water pollution control regulations or related regulations 5 The calcium chloride solution contains sodium azide as a preservative which may react with lead or copper pipes to produce highly explosive metal azide Therefore the reagents should be flushed out with copious amounts of water when discarding 4 Other Precautions Do not use the containers for any other purposes Storage and Shelf Life 1 Storage temperature 2 10 C 2 Shelf
4. life 2 years from the date of manufacture The expiration date is printed on the outside of the package Package Contents Description Configuration Coagpia APTT Reagent 4 mLx10 APTT N 7 Calcium Chloride i 4 mLx10 Solution Reagents are available in other configurations Contact SEKISUI MEDICAL CO LTD for details References 1 Masamitsu Kanai Clinical examination method summary Kanehara Co LTD 32nd edition pp 410 2005 2 Edited by the Japanese Society for Laboratory Hematology Standard hematologic tests Ishiyaku Publishers Inc pp 75 78 2003 3 Edited by the Japanese Society for Laboratory Hematology Standard hematologic tests Ishiyaku Publishers Inc pp 136 139 2003 4 SEKISUI MEDICAL CO LTD In house data Marketing Authorization Holder SEKISUI MEDICAL CO LTD 13 5 Nihonbashi 3 chome Chuo ku Tokyo Japan international sekisui com Coagpia is a trademark owned by SEKISUI MEDICAL CO LTD JAPAN and is registered in Japan and or other countries Revised Apr 2011 3rd edition
5. other analytical method Performance 1 Sensitivity The APTT of undiluted and four fold diluted normal plasma is 25 35 and 72 119 seconds Revised Apr 2011 3rd edition This product marketed by SEKISUI MEDICAL CO LTD Tokyo Japan is manufactured subject to our supervision as stipulated in the Pharmaceutical Affairs Law of Japan and is certified by Registerd Third Party to be marketed in Japan For details please contact us or your local distributors respectively 2 Accuracy 80 120 of the expected assay value 3 Within run Reproducibility Coefficient of variation lt 10 The test methods used for 1 to 3 are in house methods 4 Measurement Range on Coapresta 2000 20 200 seconds 5 Correlation on Coapresta 2000 1 N 95 r 0 969 y 0 97x 0 9 Reference method Coagulation time method MHLW approved IVD 2 N 92 r 0 955 y 0 98x 0 1 Reference method Coagulation time method MHLW approved IVD Precautions and Warnings 1 Precautions for Handling 1 All samples used in the test should be handled as if potentially infectious for HIV HBV and HCV To prevent infection use disposable gloves and avoid mouth pipetting during the test 2 Calcium chloride solution contains sodium azide as a preservative Therefore if the reagents accidentally come in contact with the eyes mouth or skin rinse immediately with water as first aid and consult a doctor if necessary 2 Precautions for Use 1 T
6. the assay promptly after blood collection For samples stored in the refrigerator or on ice perform the test within 4 hours after collection 2 Interfering Substances 1 Assay results will not be affected by free bilirubin up to 20 mg dL conjugated bilirubin up to 20 mg dL hemoglobin up to 500 mg dL formazin turbidity up to 3 000 units and Intralipos up to 5 2 Increased coagulation time will result due to heparin 3 Increased coagulation time may result due to aminoglycoside antibiotic drugs Assay Procedure 1 Reagent Preparation APTT Reagent Ready to use Calcium Chloride Solution Ready to use 2 Assay Method Coagpia APTT N is compatible with various types of blood coagulation analyzers Below is a general example of the assay procedure Calcium Plasma sample 37 C APTT reagent 37 C chloride 50 uL 50 uL solution 50 pL 3 Opefdtipg Precautiqnintion time 1 Gently mix the reagents by several inversions before use Do not mix vigorously 2 After the completion of assay seal the bottle and store at 2 10 C Assessment of Results 1 Reference Interval 24 39 seconds Each site is recommended to specify its own reference interval of APTT because the interval differs depending on the analyzer used 2 Precautions for Assessment There may be reactions with non target substances or interfering reactions If results appear unreliable repeat the measurement if necessary after dilution or try an
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