Coagpia™ Fbg
Contents
1. 2009 5th 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 allowed to be sold in Japan For details please contact us or your local distributors Package Contents Description Configuration Sample Dilution edi ia Solution omeo 8 Thrombin Reagent 3 mL x 10 References 1 The Japanese Society for Laboratory Hematology Standard Laboratory Hematology p136 139 Ishiyaku Pub Inc 2003 2 The Japanese Society for Laboratory Hematology Standard Laboratory Hematology p75 78 Ishiyaku Pub Inc 2003 3 Kanai Masamitsu Clinical examination method summary p 419 Kanehara Co Ltd 2005 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 3 Revised Jan 2009 5th edition2. Please contact SEKISUI MEDICAL CO LTD for information Assay Procedure 1 Preparation 1 Sample Dilution Solution Ready to use 2 Thrombin Reagent Ready to use 2 Assay Method This product is compatible with various types of automated analyzers Below is a general example of the assay procedure Revised Jan 2009 5th 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 allowed to be sold in Japan For details please contact us or your local distributors Preparation of Samples Reference Method Coagulation time method wr MHLW approved IVD Plasma Sample dilution 6 Standard Calibration Material sample solution _ 37 C Sample NIBSC standard material 98 612 10 pL 90 uL 100 uL Precautions and Warnings 1 Handling Precautions M tof C lation Ti iS SUT MP CEE Dae W ALOU OME 1 All samples used in the test should be handled Thrombin as if potentially infectious for HIV HBV and Sample Teagent 37 C Measure HCV To prevent infection use disposable 100 pL 50 uL Coagulation time gloves and avoid mouth pipetting during the test 2 ProClin300 which possesses skin irritative potential has been added as an antiseptic agent in both the sample dilution solution and the thrombin reagent Therefore if the reagents come in contact with skin or clothes rinse immediately with water and con
3. 1 Samples Plasma citrated plasma can be used Do not use plasma containing anticoagulants other than sodium citrate 2 Sample Preparation Promptly mix nine parts of blood sample with one part of 3 2 sodium citrate Centrifuge in a refrigerated centrifuge at 1500G for 15 minutes to separate plasma Transfer the plasma into a separate plastic test tube and refrigerate or store on ice 3 Sample Storage i Start the assay promptly after blood collection If the sample has been stored at 2 10 C perform assay within 3 days and if it has been stored at 28 C or below perform assay within 4 days Bring samples to room temperature 15 30 C before use ii To prevent denaturing of fibrinogen thaw frozen samples quickly at 37 C Avoid repeated freezing and thawing which can produce inaccurate results 2 Interfering Substances 1 Assay results will not be affected by free bilirubin up to 25 mg dL conjugate bilirubin up to 25 mg dL hemoglobin up to 500 mg dL formazin turbidity up to 3000 units intralipose up to 4 and heparin sodium up to 8 U mL 3 Other Precautions 1 Use Calibrator for Coagpia SEKISUI MEDICAL CO LTD as the calibration material 2 When the concentration of a sample exceeds the measurement range dilute the plasma 20 fold with sample dilution solution and repeat the measurement 3 Other dilution solutions can be used in place of the sample dilution solution
4. 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 Fibrinogen Assay Kit e Coagpia Fbg 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 Thrombin reagent contains ingredients derived from human blood tested negative for HIV antibody HCV antibody and HBsAg However please handle this product as if potentially infectious 6 If the reagents come in contact with the eyes or mouth rinse thoroughly with water as first aid and seek medical treatment if necessary 7 Read the user s manual of your automated analyzer prior to using this kit Parameters for different automated analysers are available upon reques
5. nt was added Some measuring instruments blood coagulation analyzers may automatically carry out steps 1 4 ye cada the Bbrinosen coucentrabon neal 2 To prevent infections from spilled samples or Precautions for Use After completing the assay seal the bottle and ae leontine solutions Wipe me Spill ass store at 2 10 C thoroughly with sodium hypochlorite solutions at concentration of greater than 0 1 EROE 3 The reagents and samples should be disposed as 1 Reference Interval medical waste or industrial waste in accordance 200 400 mg dL with waste disposal regulations 4 The reagents should be disposed in Performance consideration of water pollution control 1 Sensitivity regulations or related regulations Coagulation Time 4 Other Precautions Normal plasma diluted 10 fold per fibrinogen Do not use the containers for any other purposes 300 mg dL 7 13 seconds Normal plasma diluted 20 fold per fibrinogen Storage and Shelf Life 150 mg dL 15 24 seconds 1 Storage temperature 2 10 C 2 Accuracy 2 Shelf life 2 years from the date of manufacture 80 120 of the expected assay value The expiration date is printed on the outside of 3 Within run Reproducibility the package Coefficient of variation lt 10 Test methods used for 1 3 are in house methods 4 Measurement Range on Coaglex 800 blood coagulation analyzer 40 800 mg dL 5 Correlation N 87 r 0 990 y 1 03x 0 68 2 Revised Jan
6. sult a doctor if skin irritation develops Precautions for Use 1 This 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 Reliable assay values cannot be obtained if expired reagents are used 3 Do not replenish the reagents 4 Do not perform the assay under direct sunlight 3 Precautions for Disposal 1 Before disposal used samples and containers must be soaked in sodium hypochlorite solution of concentration greater than 0 1 for more than an hour or autoclaved at 121 C for 20 minutes Calibration material Calibrator for Coagpia value assigned by SEKISUI MEDICAL CO LTD 3 Calculation of Fibrinogen Concentration mg dL 1 Use sample dilution solution to perform 5 10 and 20 fold dilutions of Coagpia calibrator 2 Add thrombin reagent to each of the above diluted specimens and measure coagulation 2 time 3 Plot fibrinogen concentrations mg dL on the x axis and coagulation times on the y axis to prepare a calibration curve 5 10 and 20 fold diluted fibrinogen concentration values are double equal to and half the indicated values respectively 4 Dilute the plasma sample 10 times with sample dilution solution Calculate the concentration of fibrinogen mg dL using a pre prepared calibration curve based on the coagulation time measurements that were performed after thrombin reage
7. t 8 Perform a quality control test prior to assay to ensure accuracy Description Kit Components Component Ingredients Sample Dilution HEPES Buffer Solution Solution Thrombin Reagent Thrombin Intended Use For the measurement of fibrinogen in plasma Fibrinogen is an acute phase reactive protein that is synthesized by hepatic parenchymal cells Fibrinogen plasma concentrations increase due to infectious diseases malignant tumours and thrombotic diseases in the acute phase and decrease due to hepatic parenchymal lesions due to decreased production disseminated intravascular coagulation DIC syndrome due to progressive fibrinogen consumption and other conditions Fibrinogen measurements are used to understand the pathological condition and to supplement the diagnosis of these diseases Assay Principle 1 Assay Principle Coagpia Fbg is a reagent that determines fibrinogen concentrations in plasma based on the principle of the thrombin time method After a certain amount of thrombin is added to a diluted plasma sample the time taken for fibrin to form from blood fibrinogen coagulation time sec is measured Since coagulation time is dependent on the fibrinogen concentration in the test sample fibrinogen concentration mg dL is determined by using a calibration curve prepared from plasma containing known fibrinogen concentrations Procedural Precautions 1 Sample Collection and Storage
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