Internal Information Sheet
Contents
1. Within run Reproducibility Coefficient of variation lt 10 Test methods used for 1 to 3 are in house methods Measurement Range on Coapresta 2000 5 130 Correlation on Coapresta 2000 1 N 138 r 0 994 y 0 96x 1 6 Reference method Coagulation time method MHLW approved IVD 2 N 138 r 0 985 y 1 03x 5 1 Reference method Coagulation time method MHLW approved IVD 6 Standard Calibration Material Pooled plasma of healthy individuals in house standard material N w A an Precautions and Warnings 1 Handling Precautions 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 This product contains sodium azide as a preservative Therefore if the reagents come in contact with the eyes mouth or skin rinse immediately with water as first aid and consult a doctor if necessary Thromboplastin solution should be handled likewise 2 Precautions for Use 1 Store this product as directed Store the prepared thromboplastin solution at 2 10 C with a plug cap on the vial and avoid freezing Freezing can cause deterioration of the reagents which can produce inaccurate results 2 Do not use expired reagents Reliable assay values cannot be obtained if expired reagents are used 3 Do not replenish the reagents 4 Do not mix reagents of differe2. 5 minutes to separate plasma and store ii Avoid contamination with tissue fluid at blood collection using insufficient amount of sodium citrate solution and inadequate mixing they may yield inaccurate test results 3 Sample Storage Start the test promptly after blood collection For sample stored in a refrigerator or on ice perform the test within 4 hours after the 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 Samples from patients on anticoagulation treatment may show a prolonged prothrombin time 3 Plasma contaminated with tissue thromboplastin may show a reduced prothrombin time 3 Other Precautions Use Calibrator N for Coagpia SEKISUI MEDICAL CO LTD as the calibration material Assay Procedure 1 Preparation Thromboplastin solution Reconstitute one vial of thromboplastin reagent with purified water to prepare the thromboplastin solution The solution is stable at 2 10 C for 8 days after reconstitution Stir the solution before using this product use a stirrer if required e g before placing in an analyzer 2 Assay Method This product is compatible with various types of automated analyzers Below is a general example of the assay procedure Revised Jan 2011 3rd edition This product marketed
3. 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 allowed to be sold in Japan For details please contact us or your local distributors Prothrombin Time Kit Coagpia PT 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 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 for 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 Ingredients Thromboplastin Reagent Thromboplastin rabbit br
4. aceutical Affairs Law of Japan and is allowed to be sold in Japan For details please contact us or your local distributors Package Contents Description Configuration Coagpia Thromboplasti 4 mL lyophilized PT N n reagent x 10 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 413 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 136 138 2003 4 Data book of clinical examination IGAKU SHOIN Ltd p p 315 2001 2002 5 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 3 Revised Jan 2011 3rd edition
5. ain origin Calcium Chloride Intended Use For the measurement of prothrombin time with plasma The test is commonly used to assist in the diagnosis of various diseases caused by abnormal extrinsic coagulation function as well as to monitor oral anticoagulation therapy Prothrombin time PT test is a method designed by Quick in 1935 to measure coagulation time and reflects the activities of coagulation factors II prothrombin V VII X and fibrinogen levels The test therefore provides a general overview of these coagulation factors and has been an essential screening test for patients with bleeding tendencies In addition it has been widely used to monitor anticoagulation treatment with an oral anticoagulant warfarin Assay Principle 1 Assay Principle The addition of tissue thromboplastin and calcium to the plasma sample activates factor VII Factors X V II are sequentially activated leading to fibrin precipitation The prothrombin time PT test using this product measures the time taken from the addition of tissue thromboplastin and calcium to fibrin precipitation coagulation time by seconds Procedural Precautions 1 Sample Collection and Storage 1 Samples Plasma citrated plasma can be used Do not use plasma with other anticoagulants than citrate 2 Sampling Method i Promptly mix nine parts of blood sample with one part of 3 2 sodium citrate Centrifuge in a refrigerated centrifuge at 1500G for 1
6. by SEKISUI MEDICAL CO LTD Tokyo Japan is manufactured subject to our supervision as stipulated in the Pharmaceutical Affairs Law of Japan and is allowed to be sold in Japan For details please contact us or your local distributors Plasma sample 37 C gt Thromboplastin solution 50 uL 100 pL pSEG Measurement of coagulation time Calibration material Use Calibrator N for Coagpia value assigned by SEKISUI MEDICAL CO LTD 3 Operating Precautions 1 Bring the thromboplastin reagent to room temperature 15 30 C before reconstitution 2 Add purified water to one vial of thromboplastin reagent cap and gently invert to mix Leave the vial for 30 minutes at room temperature 15 30 C Make sure that the contents are completely dissolved and use after gently mixing by several inversions Do not mix vigorously 3 After the completion of the assay seal the bottle and store at 2 10 C Assessment of Results Reference Interval 80 120 PT activity Precautions for Assessment Reactions with non target substances contained in the sample or interfering reactions may occur in some samples If the assay results seem unreliable confirm the results by repeating the assay or by performing another analytical assay ja N Performance 1 Sensitivity The prothrombin time of undiluted and four fold diluted normal plasma is 14 or less and 25 42 seconds respectively Accuracy 80 120 of the expected assay value
7. nt 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 solution at a concentration of 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 solutions such as sodium hypochlorite solutions at a concentration of greater than 0 1 3 The reagents and samples should be disposed in accordance with medical waste disposal regulations or related regulations 4 The reagents should be disposed in accordance with water pollution control regulations or related regulations 5 This product contains sodium azide as a preservative Sodium azide may react with lead or copper plumbing to produce highly explosive metal azide Therefore reagents should be flushed out with a large amount of water when discarding The prepared thromboplastin solution should be handled similarly 4 Other Precautions Do not use the containers for any other purposes Storage and Shelf Life 1 Storage temperature 2 10 C 2 Shelf life 2 years from the date of manufacture The expiration date is printed on the outside of the package Revised Jan 2011 3rd edition This product marketed by SEKISUI MEDICAL CO LTD Tokyo Japan is manufactured subject to our supervision as stipulated in the Pharm
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