User Manual
Contents
1. CONTENTS A kit contains 1 Getein cTnl test card in a sealed pouch with desiccant seee 25 2 Disposable pipet Ore ee rere eee e reer ee eee eee eee eee eee eee ee eee eee ee eee ee ee eee eee eee 25 9 User manual trrrrrrrrssssssnnennnnnunnnuuuuuuuuuuuuuuunununnnnnnnnnuuununuuuuuuunnnn 1 4 SD ors 0 rrrrrrrrrrsssnnnunnnnnnnnnnnuuununuuuuuuuuunnnnnnnnnnnuuunuuuuuuuuunnnnnnnnnnnn 1 5 Whole blood buffep sssssss ssssssssssuuununununuuunnnunnnnunnnnuuuunuuuuuuuuunnnn 1 A test card consists of A plastic shell and a reagent strip which is composed of a sample pad a colloid gold pad coated with gold labelled anti human cTnl monoclonal antibody nitrocellulose membrane the test line is coated with anti human cIn monoclonal antibody and the control line is coated with rabbit anti mouse IgG antibody absorbent paper and liner Whole blood buffer composition Phosphate buffered saline proteins detergent preservative stabilizer Note Do not mix or interchange different batches of kits CE APPLICABLE DEVICE FIA8000 Quantitative Immunoassay Analyzer STORAGE AND STABILITY Store the test card at 4 30 C with a valid period of 24 months Use the test card within 1 hour once the foil pouch is opened Store the whole blood buffer at 0 30 C with a valid period of 24 months Store the whole blood buffer at 2 8 C for better results PRECAUTIONS For in vitro diagnostic use only For professional use only Do not2. 1998 36 887 893 2 Antman EM Anbe DT Armstrong PW et al ACC AHA guidelines for the management of patients with ST elevation myocardial infarction a report of the American College of Cardiology American Heart Association Task Force on Practice Guidelines Committee to Revise the 1999 Guidelines for the Manage 2004 3 EN ISO 18113 1 2009 In vitro diagnostic medical devices Information supplied by the manufacturer labelling Part 1 Terms definitions and general requirements 4 EN ISO 18113 2 2009 In vitro diagnostic medical devices Information supplied by the manufacturer labelling Part 2 In vitro diagnostic reagents for professional use ISO 18113 2 2009 CE The following graphical symbols used in or found on Cardiac Troponin Fast Test Kit are the most common ones appearing on medical devices and their packaging They are explained in more details in the European Standard EN 980 2008 and International Standard ISO 15223 1 2007 DESCRIPTION OF SYMBOLS USED Key to symbols used al Bo Do not reuse el Date of manufacture Consult instructions for use Expiration date Batch code In vitro diagnostic medical device XY Temperature limitation Thank you for purchasing Cardiac Troponin I Fast Test Kit Please read this user manual carefully before operating to ensure proper use Version WCGDL SM 01 01 Authorised representative in the European Community Sufficient for GeTein BioMedical I
3. in approximately 8 to 28 hours and remain elevated for 3 to 10 days following AMI Due to the high myocardial specificity and the long duration of elevation cTnl has become an important marker in the diagnosis and evaluation of patients suspected of having an AMI The current guideline of The Joint European Society of Cardiology American College of Cardiology Committee support the use of cTnl as a preferred marker of myocardial injury Several major studies have shown that cTnl is also a predictor of cardiac risk in patients with unstable angina The American College of Cardiology and the American Heart Association s current guidelines recommend using troponin results when making treatment decisions regarding unstable angina and non ST segment elevation MI NSTEMI PRINCIPLE The test uses an anti human cInl monoclonal antibody conjugated with colloidal gold and another anti human cTnl monoclonal antibody coated on the test line After the sample has been applied to the test strip the gold labelled anti human cTnl monoclonal antibody binds with the cTnl in sample and forms a marked antigen antibody complex This complex moves to the test card detection zone by capillary action Then marked antigen antibody complex is captured on the test line by the anti human cTnl monoclonal antibody resulting in a purplish red streak appears on the test line The color intensity of the test line increases in proportion to the amount of cTnl in sample
4. use the kit beyond the expiration date Do not use the test card if the foil pouch is damaged Do not open pouches until ready to perform the test Do not reuse the test card Do not reuse the pipet Handle all specimens as potentially infectious Proper handling and disposal methods should be followed in accordance with local regulations 9 Carefully read and follow user manual to ensure proper test performance SPECIMEN COLLECTION AND PREPARATION oN oo eS Se NS 1 This test can be used for serum plasma and whole blood samples Heparin can be used as the anticoagulant for plasma and whole blood Samples should be free of hemolysis 2 Suggest using serum or plasma for better results 3 Serum or plasma can be used directly For whole blood sample one drop of whole blood buffer must be added before testing 4 If testing will be delayed serum and plasma samples may be stored up to 7 days at 2 8 C or stored at 20 C for 6 months before testing whole blood sample may be stored up to 3 days at 2 8 C 5 Refrigerated or frozen sample should reach room temperature and be homogeneous before testing Avoid multiple freeze thaw cycles 6 Do not use heat inactivated samples 7 SAMPLE VOLUME 120 ul TEST PROCEDURE 1 Collect specimens according to user manual 2 Test card sample and reagent should be brought to room temperature before testing 3 Confirm SD card lot No in accordance with test kit lot No Perform QC
5. SD calibration when necessary Details refer to 8 2 1 of FIA8000 User Manual 4 On the main interface of FIA8000 press ENT button to enter testing interface 5 Remove the test card from the sealed pouch immediately before use Label the test card with patient or control identification 6 Put the test card on a clean table horizontally placed 7 Using sample transfer pipette deliver 120 ul of sample or 4 drops of sample when using disposable pipet into the sample port on the test card for whole blood sample one drop of whole blood buffer must be added after loading 120 ul sample on the test card 8 Reaction time 15 minutes Insert the test card into FIA8000 and press ENT button after reaction time is elapsed The result will be shown on the screen and printed automatically Notes 1 It is required to perform QC SD calibration when using a new batch of kits 2 It is suggested to calibrate once for one batch of kits 3 Make sure the test card insertion is correct and complete TEST RESULTS Valid When a purplish red band appears at the control area C use FIA8000 to analyze the test card and get the result Invalid If no colored band appears in the control area C the test result is invalid The test should be repeated and if the same situation happened again please stop using this batch of products and contact your supplier g GeTein BioMedical Inc EXPECTED VALUE The expected normal v
6. alue for cTnI was determined by testing samples from 500 apparently healthy individuals The 99 percentile of the concentration for cTnl is 0 5 ng ml cTnl concentration less than 0 5 ng ml can be estimated as normal It is recommended that each laboratory establish its own expected values for the population it serves PERFORMANCE CHARACTERISTICS Measuring Range 0 5 50 0 ng ml Lower Detection Limit lt 0 5 ng ml Within Run Precision n 10 lt 10 Between Run Precision lt 15 Recovery Method Comparison The assay was compared with SIEMENS IMMULITE 2000 and its matching cTnl test kits with 200 serum samples 60 positive samples and 140 negative samples The correlation coefficient r for cTnl is 0 952 LIMITATIONS 95 mean 1 As with all diagnostic tests a definitive clinical diagnosis should not be made based on the result of a single test The test results should be interpreted considering all other test results and clinical information such as clinical signs and symptoms 2 Samples containing interferents may influence the results The table below listed the maximum allowance of these potential interferents Interferent Hemoglobin Triglyceride Bilirubin Concentration Max 5 g L 10 g L 0 2 g L REFERENCES 1 Mauro Pantaghini Undefined International Federation of Clinical Chemistry and Laboratory Medicine IFCC Scientific Division Committee on Standardization of Markers of Cardiac Damage Clin Chem Lab Med
7. g GeTein BioMedical Inc Cardiac Troponin I Fast Test Kit For in vitro Diagnostic Use Cat CG1001 User Manua INTENDED USE Cardiac Troponin Fast Test Kit is intended for in vitro qualitative and semi quantitative determination of cardiac Troponin cTnl in serum plasma or whole blood This test is used as an aid in the diagnosis of myocardial injury such as Acute Myocardial Infarction AMI Unstable Angina Acute Myocarditis and Acute Coronary Syndrome ACS SUMMARY Troponin a molecular complex that is bound to the thin filament actin of striated muscle fibers acts with intracellular calcium to control the interaction of the thin filament with the thick filament myosin thus regulating muscle contraction Troponin consists of three subunits T which connects the troponin complex and tropomyosin another cardiac muscle regulatory protein which prevents muscle contraction in the absence of calcium and C which binds calcium Cardiac Troponin MW 22 5 kDa and the two skeletal muscle isoforms of Troponin have considerable amino acid sequence homology but cInl contains an additional N terminal sequence and is highly specific for myocardium Clinical studies have demonstrated the release of cTnl into the blood stream within hours following acute myocardial infarctions AMI or ischemic damage Elevated levels of cInl are detectable in blood within 4 to 6 hours after the onset of chest pain reaching peak concentrations
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