User Manual
Contents
1. 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 10 g L 10 g L REFERENCES 0 2 g L 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 1998 36 887 893 CE 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 DESCRIPTION OF SYMBOLS USED The following graphical symbols us2. 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 o N oY Og 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 SD calibration when necessary Details refer to 8 2 1 of FIA8000 Us
3. ed in or found on One Step Test for CK MB cTnl Myo Colloidal Gold 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 Key to symbols used Manufacturer Do not reuse Consult instructions for use Expiration date Date of manufacture Batch code Temperature limitation In vitro diagnostic medical device Authorized representative in the European Community Sufficient for CE mark Thank you for purchasing One Step Test for CK MB cTnlI Myo Colloidal Gold Please read this user manual carefully before operating to ensure proper use Version WCGDL SM 07 01 GeTein BioMedical Inc aol 4640 SW Macadam Avenue Suite 130C Portland OR 97239 USA Tel 1 971 407 3868 Fax 1 971 407 3868 E mail sales geteinbio com support geteinbio com Website http www geteinbio com
4. er 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 g GeTein BioMedical Inc 8 Reaction time 15 30 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 Itis required to perform QC SD calibration when using a new batch of kits 2 Itis 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 EXPECTED VALUE The expected normal value for CK MB was determined by testing samples from 500 apparentl
5. g GeTein BioMedical Inc One Step Test for CK MB cTnl Myo Colloidal Gold For in vitro Diagnostic Use Cat CG1005 User Manua INTENDED USE One Step Test for CK MB cTnl Myo Colloidal Gold is intended for in vitro quantitative determination of CK MB cTnI Myo in serum plasma or whole blood This test is used as an aid in the clinical diagnosis prognosis and evaluation of myocardial injury such as Acute Myocardial Infarction AMI Unstable Angina Acute Myocarditis and Acute Coronary Syndrome ACS SUMMARY Creatine kinases are dimer isozymes composed of two monomer subunits CK M for skeletal muscle derived and CK B for brain derived which can form all three combinations of monomers CK BB CK MM and CK MB BB is found primarily in the brain Skeletal muscles primarily contain the MM isoform with trace amount of MB around 1 4 of total CK activity Cardiac muscles also contain the MM isoform but higher amount of MB typically around 20 of total CK activity CK MB is a more sensitive marker of myocardial injury than total CK activity because it has a lower basal level and a much narrower normal range Medical literatures commonly state that CK MB levels are elevated in 4 to 6 hours peak at 10 to 24 hours and return to normal within 3 to 4 days after an acute myocardial infarction Classically an increase of the myocardial specific enzyme CK MB is considered as the hallmark of acute myocardial infarction and increased level
6. ittee PRINCIPLE Mixed monoclonal antibodies against human CK MB cTnl and Myo were conjugated with colloidal gold and another set of anti human CK MB cTnI Myo monoclonal antibodies were coated on different test lines respectively After the sample has been applied to the test strip the gold labelled anti human CK MB cTnl and Myo monoclonal antibodies will bind with the CK MB cTnl and Myo in sample respectively and form marked antigen antibody complexes These complexes move to the test card detection zone by capillary action Then marked antigen antibody complexes will be captured on different test lines by another set of monoclonal antibody against human CK MB cTInl or Myo respectively resulting in purplish red streaks appear on the test lines The color intensity of each test line increases in proportion to the amount of CK MB cTnl or Myo in sample Then insert test card into FIA8000 Quantitative Immunoassay Analyzer hereafter referred to as FIA8000 the concentrations of CK MB cTnl and Myo in sample will be determined and displayed on the screen The value will be stored in FIA8000 and available for downloading The result can be easily transmitted to the laboratory or hospital information system CONTENTS A kit contains CE 1 Getein CK MB cTnl Myo test card in a sealed pouch with desiccant 25 2 Disposable pipet TOPeECECCECECOOCOCECOOOCOCOCOOCOCOOEOCOOOOOOCOOCOOeOOO Cee eT eee ee eee ee 25 3 User manual ussnuuununununun
7. s are frequently interpreted by the clinician as objective evidence of myocardial cell damage Troponin complex consists of three regulatory proteins 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 cTnl contains an additional N terminal sequence and is highly specific for myocardia 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 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 Myoglobin is a small monomeric protein which serves as an intracellular oxygen storage site It is found in abundance in the muscle and can get through into the blood circulation directly when myocardial cell is damaged mildly Therefore myoglobin has been advocated as a sensitive marker for early acute myocardial injury by American College of Cardiology Comm
8. uNunNNNNNNNNNNNENENEENNNENNNENNNENENENENENENEEENEENNNEEEE 1 4 SD card SePEECEEOPCECOOCOCOCOOCOCOCOOCOOOCCOCOCOOCOOOOOOOOOOOOO ESOS eee eee ee ee eee ee ee eee 1 5 Whole blood buffer UPR TCCOPCECCOCOCOCCOCOCOCOOOOOOCOOCOOOCEOOeOOCeO eee eee ee eee ee ee 1 A test card consists of A plastic shell and a reagent strip which is composed of a sample pad a colloidal gold pad coated with gold labeled anti human CK MB cTni and Myo monoclonal antibodies nitrocellulose membrane with 3 test lines the test line T is coated with another anti human CK MB monoclonal antibody T2 is coated with another anti human cTnl monoclonal antibody T3 is coated with another anti human Myo monoclonal antibody and the control line C 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 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 not use the kit beyond the expiration date Do not use the test card if
9. y healthy individuals The 99 percentile of the concentration for CK MB is 5 0 ng ml CK MB concentration less than 5 0 ng ml can be estimated as normal The expected normal value for cTnl 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 The expected normal value for Myo was determined by testing samples from 500 apparently healthy individuals The 95 percentile of the concentration for Myo is 50 ng ml Myo concentration less than 50 ng ml can be estimated as normal The 97 5 percentile of the concentration for Myo is 70 ng ml Myo concentration less than 70 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 30 0 600 0 ng ml Lower Detection Limit lt 2 5 ng ml lt 0 5 ng ml lt 30 0 ng ml 95 mean 95 mean Within Run Precision lt 10 Method Comparison The assay was compared with OLYMPUS AU5400 HITACHI7600 and its matching CK MB test kits SIEMENS IMMULITE 1000 2000 and its matching cTni and Myo test kits with 200 serum samples 60 positive samples and 140 negative samples The correlation coefficient r for CK MB is 0 928 the correlation coefficient r for cTnl is 0 952 the correlation coefficient r for Myo is 0 938 LIMITATIONS 1 As with
Download Pdf Manuals
Related Search