User Manual
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1. L g3 GeTein BioMedical Inc can be estimated as normal CRP The expected normal value for CRP was determined by testing samples from 500 apparently healthy individuals The 95 percentile of the concentration for CRP is 10 mg L CRP concentration is less than 10 mg L can be estimated as normal CRP concentration higher than 10 mg L can be estimated as inflammation or infection It is recommended that each laboratory establish its own expected values for the population it serves PERFORMANCE CHARACTERISTICS Measuring Range 0 5 200 mg L Lower Detection Limit lt 0 5 mg L Within Run Precision lt 10 Between Run Precision lt 15 Method Comparison The assay was compared with HITACHI7600 OLYMPUS AU5400 and its matching hs CRP test kits with 200 serum samples 61 positive samples and 139 negative samples The correlation coefficient r for hs CRP is 0 941 LIMITATIONS 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 Concentration Max Hemoglobin 10 g L Triglyceride 10 g L 02 gf REFERENCES 1 Danesh J Whincup P Wslker M et al Low grade inflammation and2. coronary heart disease prospective study and updated neta analyses BJM 2000 321 199 204 2 Rifai N Ridker PM Proposed cardiovascular risk assessment algorithm using high sensitivity C reactive protein and lipid screening Clin Chem 2001 47 28 30 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 used in or found on hs CRP Fast Test Kit Immunofluorescence Assay 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 cl 2 _e Ey Consult instructions for use Expiration Date Date of manufacture Batch code In vitro diagnostic medical device XY Temperature limitation Thank you for purchasing hs CRP Fast Test kit Immunofluorescence Assay Please read this user manual carefully before operating to ensure proper use Authorized representative in the European Community Sufficient for Version WIF DLSM 03 01 GeTein BioMedical Inc asl 4640 SW Macadam Avenue Suite 130C Po
3. g GeTein BioMedical Inc hs CRP Fast Test Kit Immunofluorescence Assay For in vitro Diagnostic Use Cat IF1003 User Manua INTENDED USE hs CRP Fast Test Kit Immunofluorescence Assay is intended for in vitro quantitative determination of C reactive protein CRP in serum plasma or whole blood Measurement of CRP is useful for the detection and evaluation of infection tissue injury and inflammatory disorders Measurement of high sensitivity CRP hs CPR when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes ACS may be useful as an independent marker of prognosis for recurrent events in patients with stable coronary disease or ACS SUMMARY C reactive protein is an acute phase reactant that precipitated with Pneumococcal C polysaccharide and is a non specific immune response component CRP has wide distribution in our body and is an acute phase protein produced in the liver in response to microbic infection or tissue injury and the hs CRP can be used to detect lower concentrations of CRP in serum or plasma Studies revealed hs CRP levels seem to be correlated with Atherosclerosis and Acute Myocardial Infarction And the hs CRP is an inflammation marker for ACS patient and is helpful for primary prevention and risk assessment of cardiovascular disease Its combination with the ratio of total cholesterol to HDL C is more accurate than other risk factor in predicting cardiovascular di
4. i100 User Manual 4 On the main interface of Getein1100 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 10 ul of sample into one tube of sample diluent mix gently and thoroughly Then drop 100 ul of sample mixture or 3 4 drops of sample mixture when using disposable pipet into the sample port on the test card 8 Reaction time 3 minutes Insert the test card into Getein1100 and press ENT button after reaction time is elapsed The result will be shown on the screen and printed automatically RN oo Sey Notes 1 It is required to perform SD Card Calib 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 Geteini100 can scan the test card automatically and display the result on the screen Please follow the procedure in user manual of Getein1100 for result printing For additional information please refer to the user manual of Getein1100 EXPECTED VALUE hs CRP The expected normal value for hs CRP was determined by testing samples from 500 apparently healthy individuals The 95 percentile of the concentration for hs CRP is 3 mg L hs CRP concentration less than 3 mg
5. n1100 and available for downloading The result can be easily transmitted to the laboratory or hospital information system CONTENTS A kit contains 1 Getein hs CRP test card in a sealed pouch with desiccant eseese 25 2 Disposable pipet Pe ni ne Nan i a Ni a eee 25 3 User manual r e RET ee Teer Cre ere eee Ree eee eee Th 1 4 SD card TERT CCECCCE CPR CE TERE TRC EERE PTE EREC RR CREE NEC eR CCR TE Ree Ee ce eee are 1 5 Sample diluent STRLC SCRA C RTA R CTE CTT A EEEE 25 A test card consists of A plastic shell and a reagent strip which is composed of a sample pad nitrocellulose membrane one end of the membrane is coated with a fluorescence latex labelled anti human hs CRP monoclonal antibody the test line is coated with another anti human hs CRP monoclonal antibody and the control line is coated with rabbit anti mouse IgG antibody absorbent paper and liner Sample diluent Phosphate buffered saline proteins detergent preservative stabilizer Note Do not mix or interchange different batches of kits CE APPLICABLE DEVICE Getein1100 Immunofluorescence Quantitative 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 sample diluent at 0 30 C with a valid period of 24 months Store the sample diluent at 2 8 C for better results PRECAUTIONS For in vitro diagnostic use only For professional use o
6. nly Do not 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 1 This test can be used for serum plasma whole blood and fingertip blood samples Heparin sodium citrate and EDTA can be used as the anticoagulant for plasma whole blood and fingertip blood Samples should be free of hemolysis 2 Suggest using serum or plasma for better results 3 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 4 Refrigerated or frozen sample should reach room temperature and be homogeneous before testing Avoid multiple freeze thaw cycles 5 Do not use heat inactivated samples 6 SAMPLE VOLUME 10 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 SD Card Calib calibration when necessary Details refer to 8 5 2 of Getein
7. rtland OR 97239 USA Tel 1 971 407 3868 Fax 1 971 407 3868 E mail sales gp diagnostics com support gp diagnostics com Website www gp diagnostics com
8. sease The American Heart Association and US Centers for Disease Control and Prevention have advocated hs CRP as a predictor of cardiovascular disease CVD to define risk groups less than 1 0mg L indicates low risk 1 0 to 3 0 mg L means moderate risk and the amount above 3 0 mg L lower than 10mg L strongly suggests a high risk of CVD Moreover higher CRP levels are found in late pregnant women mild inflammation and viral infections 10 40 mg L active inflammation bacterial infection 40 200 mg L severe bacterial infections and burns gt 200 mg L PRINCIPLE The test uses an anti human hs CRP monoclonal antibody conjugated with fluorescence latex and another anti human hs CRP monoclonal antibody coated on the test line After the sample has been applied to the test strip the fluorescence latex labelled anti human hs CRP monoclonal antibody binds with the hs CRP 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 hs CRP monoclonal antibody The fluorescence intensity of the test line increases in proportion to the amount of hs CRP in sample Then insert test card into Geteini1100 Immunofluorescence Quantitative Analyzer hereafter referred to as Getein1100 the concentration of hs CRP in sample will be determined and displayed on the screen The value will be stored in Getei
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