User Manual - Diagnostik Nord
Contents
1. Toxicology TROP OPK20 Troponin rapid test with buffer For professional in vitro diagnostic use only INTENDED USE The Diagnostik Nord Troponin Test is a rapid one step chromatographic immunoassay for the qualitative detection of human cardiac Troponin in whole blood serum or plasma as an aid in the diagnosis of myocardial infarction MI SUMMARY Cardiac Troponin cTnl is a protein found in cardiac muscle with a molecular weight of 22 5 kDa 1 Troponin is part of a three subunit complex comprising of Troponin T and Troponin C Along with tropomyosin this structural complex forms the main component that regulates the calcium sensitive ATPase activity of actomyosin in striated skeletal and cardiac muscle 2 After cardiac injury occurs cInl is released into the blood 4 6 hours after the onset of pain The release pattern of cInl is similar to CK MB but while CK MB levels return to normal after 72 hours cInl levels remain elevated for 6 10 days thus providing a longer window of detection for cardiac injury The high specificity of cInl measurements for the identification of myocardial damage has been demonstrated in conditions such as the perioperative period after marathon runs and blunt chest trauma 3 cTnl release has also been documented in cardiac conditions other than acute myocardial infarction AMI such as unstable angina congestive heart failure and ischemic damage due to coronary artery bypass surg2. contact you local distributor QUALITY CONTROL As internal procedural control the Diagnostik Nord Troponin Test includes the control line It is only formed if sufficient specimen volume has been added and the chromatography has been finished successfully Control standards are not supplied with this kit yet we recommend that positive and negative controls should be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance LIMITATIONS 1 The cInl Rapid Test Device Whole Blood Serum Plasma is for professional in vitro dia gnostic use and should only be used for the qualitative detection of cardiac Troponin No meaning should be inferred from the color intensity or width of any apparent lines The cInl Rapid Test Device Whole Blood Serum Plasma will only indicate the presence of Troponin in the specimen and should not be used as the sole criteria for the diagnosis of myocardial infarction N o3 If the test result is negative and clinical symptoms persist additional testing using other clini cal methods is recommended The minimum detection limit of the assay is 1 0 ng mL of cTnl in specimens Thus a negative result does not at anytime rule out the existence of Troponin in blood because the protein concentration may be below the minimum detection level of the test Please keep in mind that the rise of Troponin takes place several hours after the onset of p
3. ain If the testing takes place too early cInl concentrations might still be too low to be detected by the assay A negative test result does not exclude the possibility of myocardial infarction at any time gt Like with all diagnostic tests a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated 5 Some specimens containing unusually high titers of heterophile antibodies or rheumatoid factor RF may affect expected results Even if the test results are positive further clinical evaluation should be considered with other clinical information available to the physician In rare cases it is possible that the antigen antibody reaction of the test is inhibited by the presence of auto antibodies in the patient s blood which block the binding sites False ne gative test results might be the consequence Please note that this is a general problem with all detection methods based on an antigen antibody reaction for the detection of proteins TEST PERFORMANCE Analytical sensitivity The minimum detection limit of the assay is 1 0 ng cTnl ml For the regular control of the mi nimum detection limits standard materials of Hytest are used free cInl Please note that due to the heterogeneity of commercially available standard materials the sensitivity of the assay might vary slightly with ditferent standard preparations Analytical Specificity Sera containing known am
4. characteristics of the test Therefore we recommend to take only 2 drops of whole blood General comments Separate serum or plasma from blood as soon as possible to avoid hemolysis Heparin blood as well as EDTA or citrate blood plasma can be used but it is recommended to take citrate blood also for plasma since EDTA leads to a fast breakdown of the Troponin complex Heparin is under debate to reduce the amount of Troponin in Plasma as well 7 You can also directly use anticoagulated blood for the test Use only clear non hemolyzed specimens Testing should be performed immediately after specimen collection Do not leave the spe cimens at room temperature for prolonged periods Serum and plasma specimens may be stored at 2 8 C for up to 3 days For long term storage specimens should be kept below 20 C Whole blood collected by venipuncture should be stored at 2 8 C if the test is to be run within 2 days of collection Do not freeze whole blood specimens Whole blood collected by fingertip should be tested immediately Bring specimens to room temperature prior to testing Frozen specimens must be comple tely thawed and mixed well prior to testing Specimens should not be frozen and thawed repeatedly If specimens are to be shipped they should be packed in compliance with local regulations covering the transportation of etiologic agents MATERIALS PROVIDED e Diagnostik Nord Troponin Test devices e Disposable pipettes in
5. ery 4 Because of its high specificity and sensitivity in the myocardial tissue cInl has recently become the most preferred biomarker for myocardial infarction 5 The Diagnostik Nord Troponin Test is a simple test that utilizes a combination of particle conjugated anti cInl antibodies and capture reagent to selectively detect cInl in whole blood serum or plasma The minimum detection level is 1 0 ng mL PRINCIPLE The Diagnostik Nord Troponin Test is a qualitative membrane based immunoassay for the detection of cInl in whole blood serum or plasma The membrane is pre coated with capture reagent on the test line region of the test During testing the Troponin in the whole blood serum or plasma specimen reacts with two specific anti cIn antibodies One of the antibodies mediates binding to the capture reagent the other antibody is color labelled The mixture migrates upward on the membrane by capillary action In the test line region the cT nl antibody complex is captured by the immobilised capture reagent so that a red line is gene rated The presence of a red line in the test line region indicates a positive result If the sampled does not contain cTnl no line will form in the test result line region indicating a negative result In addition a red line must form in the control line region C independent of the cTnl concent ration in the sample The control line serves as a procedural control and indicates that sufficient volume of s
6. es bound to the cardiac thin filament 3 J Biol Chem 266 966 1991 4 Adams et al Diagnosis of Perioperative myocardial infarction with measurements of cardiac troponin I N Eng J Med 330 670 1994 5 Hossein Nia M et al Cardiac troponin release in heart transplantation Ann Thorac Surg 61 227 1996 6 Joint European Society of Cardiology American College of Cardiology J Am Coll Cardio 36 3 Myocardnial Infarction Redefined 2000 7 Stiegler et al 2000 Lower Cardiac troponin T and results in heparin plasma than in serum Clinical chemistry sep 46 9 1338 44 SYMBOLS For in vitro diagnostic use only Q For single use only 30 C li Carefully read package insert A Store at room temperature 2 C gia Keep dry catalogue number Rev 02 06 2015 JM replaced 09 12 2014 JM Y Content n Lot number o lt Expiry date PRODUCER Diagnostik Nord GmbH Telefon 49 0 385 208409 0 MecklenburgstraBe 97 Fax 49 0 385 208409 29 19053 Schwerin E Mail info diagnostik nord de Germany Internet Www diagnostik nord de
7. k Nord Troponin Test Add 1 drop of buffer and start the clock 12 holds for 3a 3c Q Start the timer Wait for the red line s to appear The result should be read at 10 mi nutes Do not interpret the result later than 20 minutes after sample addition false positive results possible INTERPRETATION OF RESULTS NEGATIV One red line appears in the control line region C No apparent red line appears in the test line region T Confirm negatiuve results after 15 20 min NOTE In some cases the sensitivity of the assay can increase up to 15 min but at the same time the probability increases that blood from the sample stains the result cq window red ja POSITIVE Two red lines appear One line forms in the control line region C and another line forms in the test line region T NOTE The intensity of the red color in the test line region T will vary depending on the concentration of cTnl present in the speci men Therefore also faint reddish test result lines T should be considered positive INVALID The control line C is not formed In this case the result is invalid even if the test result is visible Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure Review the test procedure and repeat the assay with a new test device If the problem E i persists discontinue using the test kit imme diately and
8. ounts of cTnl antigen have been tested with 10 000 ng ml Skeletal Troponin 2 000 ng ml Troponin T and 20 000 ng ml Cardiac Myosin No cross reactivity was observed indicating that Diagnostik Nord Troponin Test has a high degree of specificity for cardiac Troponin cTnl Cross Reactivity The Diagnostik Nord Troponin Test has been tested and no interference was observed in specimens containing 110 ug ml human albumin 6 mg ml bilirubin 1 mg ml haemoglobin 100 pg ml cholesterol and 10 mg ml triglycerides Inter lot variation Three independent batches were tested with different samples spiked with different concentra tions of fresh and negative samples There were no differences observed between the results of the different batches All results obtained were as expected Compatibility with other devices The performance of the Diagnostik Nord Troponin Test has been compared with a commer cially available test accredited for the sale in the EU of another manufacturer The results of the study de monstrated an overall accuracy of gt 99 for the tested specimens Specimen without cInl consistently yielded negative results with both test Specimen with cInl concentrations abo ve the detection limit showed positive results with both assays LITERATURE 1 Adams et al Biochemical markers of myocardial injury Immunoassay Circulation 88 750 763 1993 2 Mehegan JP Tobacman LS Cooperative interaction between troponin molecul
9. p IHR PARTNER FUR IN VITRO DIAGNOSTIKA SPECIMEN COLLECTION AND PREPARATION The Diagnostik Nord Troponin Test can be performed using whole blood from venipuncture or fingertip serum or plasma Whole blood from fingertip e Wash the hand of the patient with soap and warm water or clean the puncture site thoroughly with alcohol e Massage the hand in direction of the fingertip of the middle finger or ring finger without touching the puncture e Prick the fingertip with a sterile lancet Wipe the first drop of blood e Rub the hand from the wrist to the palm and to the finger to form a round drop at puncture Collection of whole blood from fingertip using a capillary e Take a blood sample filling the capillary with 120 pl of the sample Avoid air pockets e Put the dispensary bulb at the top of the capillary and press it to dribble blood sample in the specimen well S of the test device Dispensary of whole blood from fingertip by hanging drops e Position the finger of the patient exactly above the specimen well S of the test device e Drop 2 hanging drops of whole blood from the puncture of the finger into the specimen well S The finger of the patient can be moved over the specimen well so that the drop has contact with the well A direct contact of the finger and the specimen well should be avoided Please note that whole blood is less suitable than serum or plasma since individual coagula tion can reduce the flow
10. pecimen has been added and membrane wicking has occurred PRECAUTIONS e For professional in vitro diagnostic use only e Do not use after expiration date e The test should remain in the sealed bag until use e Humidity and temperature can adversely affect results e Do not use the test if the pouch is damaged e The used test should be discarded in accordance with the regulations e All specimen might be potentially infectious Proper handling and disposal methods should be established Wear protective clothing such as laboratory coats disposable gloves and eye protection when specimens are being tested In a clinical suspicion of a myocardial infarction the test results should only be used as first indication the patient should be in any case brought to hos pital for further investigation since the blood may contain even in case of ami ctni concentrations below the detection limit a negative result cannot prove the absence of ami always also other measures must be taken and the result of the test is never to be regarded as a prof alone STORAGE AND STABILITY Store the tests as packaged in the sealed pouch and the buffer in its bottle at room temperature 230 C 36 86 F The Diagnostik Nord Troponin Test is stable until the expiration date printed on the sealed pouch or buffer bottle The test device must remain in the sealed pouch until use e Do not freeze e Do not use beyond the expiration date Diacnostik Nor
11. side pouch e Phosphate buffer e Package insert MATERIALS REQUIRED BUT NOT PROVIDED Tubes for taking blood samples e Centrifuge for plasma serum Lancets only for whole blood from fingertip e Heparinised capillaries and dispensary bulb only for whole blood from fingertip e Timer TESTING PROCEDURE O Allow the Diagnostik Nord Troponin Test device specimen and or controls to equilibrate to room temperature 15 30 C 59 86 F prior to testing 2 Remove the test device from the sealed pouch and use it as soon as possible Best results will be obtained if the assay is performed within one hour Place the Diagnostik Nord Troponin Test device on a clean and level surface 3 Serum or plasma or venipuncture blood Hold the provided pipette vertically and transfer 3 drops of serum or plasma ca 120 pl into the round speci men well S of the Diagnostik Nord Troponin Test Start the clock or 3 Venipuncture Whole Blood with without citrate etc Hold the provided pipette vertically and transfer 3 drops of whole blood into the round specimen well S of the Diagnostik Nord Troponin Test Add 1 drop of buffer and start the clock or G Fingertip Whole Blood Transfer 2 3 hanging drops of whole blood from the fingertip puncture or approximately 120 pl whole blood from the heparinised capillary into the round specimen well S of Diagnosti
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