User Manual
Contents
1. another anti human PCT monoclonal antibody After the sample has been applied to the test strip the fluorescence latex labelled anti human PCT monoclonal antibody binds with the PCT 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 other anti human PCT monoclonal antibody or the polyclonal antibody The fluorescence intensity of the test line increases in proportion to the amount of PCT in sample Then insert test card into Geteini1100 Immunofluorescence Quantitative Analyzer hereafter referred to as Geteini100 the concentration of PCT in sample will be determined and displayed on the screen The value will be stored in Getein1100 and available for downloading The result can be easily transmitted to the laboratory or hospital information system CONTENTS A kit contains 1 Getein PCT test card in a sealed pouch with desiccant eeeeeceen etenee 25 2 Disposable pipet TEPT CCP ECC ee CCCP CELE RET EEE CR CCC LECCE TREE e ee re eee ee a 25 3 User manual a E A E eo eed 1 4 SD card TERECREECUE Ce eT eRe CPR CEC OR ELECT RENEE CRORE CONE RPE TERETE CR ee ee ea 1 5 Whole blood buffer tee See ee a ee ee eee ee ee eee ee ee 1 A test card consists of A plastic shell and a reagent strip which is composed of a sample pad fluorescence latex pad nitrocellulose membrane one end of the membrane is c2. loading 100 ul sample on the test card 8 Reaction time 15 minutes Insert the test card into Geteini100 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 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 The expected normal value for PCT was determined by testing samples from 500 apparently healthy individuals The 99 percentile of the concentration for PCT is 0 1 ng ml PCT concentration less than 0 1 ng ml can be estimated as normal The table below comes from the research of ACCP SCCM American College of Chest Physicians Society of Critical Care Medicine showing the PCT value and its clinical meaning 1 g GeTein BioMedical Inc PCT concentration Clinical significance Local bacterial infection is possible systemic 0 5 ng ml i ii infection sepsis is not likely Systemic infection sepsis is possible a moderate 2 0 5 and lt 2 ng ml risk of severe sepsis and or septic shock gt 20 naim Sy
3. P randomized controlled trial JAMA Sep 9 2009 302 10 1059 66 3 Briel M Schuetz P Mueller B et al Procalcitonin guided antibiotic use vs a standard approach for acute respiratory tract infections in primary care Arch Intern Med Oct 13 2008 168 18 2000 7 discussion 2007 8 4 Meisner M Procalcitonin PCT A New innovative infection parameter Biochemical and clinical aspects Thieme Stuttgart New York 2000 ISBN 3 13 105503 0 5 EN ISO 18113 1 2009 In vitro diagnostic medical devices Information supplied by the manufacturer labelling Part 1 Terms definitions and general requirements 6 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 PCT 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 DESCRIPTION OF SYMBOLS USED Key to symbols used cl 2 _e ed Consult instructions for use Expiration Date Date of manufacture Batch code In vitro diagnostic medical device Temperature X non VD limitation Thank you for purchasing PCT Fast Test Kit Immunofluorescence Assay Please read this user manual carefully befor
4. e operating to ensure proper use Version WIF DLSM 04 01 Authorized representative in the European Community Sufficient for GeTein BioMedical Inc asl 4640 SW Macadam Avenue Suite 130C Portland 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
5. g GeTein BioMedical Inc PCT Fast Test Kit Immunofluorescence Assay For in vitro Diagnostic Use Cat IF1007 User Manua INTENDED USE PCT Fast Test Kit Immunofluorescence Assay is intended for in vitro quantitative determination of Procalcitonin PCT in serum plasma or whole blood The test is used as an aid in the assessment and evaluation of patients suspected of bacterial infection trauma or shock SUMMARY PCT is a peptide precursor of the hormone calcitonin the latter being involved with calcium homeostasis It is composed of 116 amino acids and is produced by parafollicular cells C cells of the thyroid and by the neuroendocrine cells of the lung and the intestine Measurement of PCT can be used as a marker of severe sepsis and generally grades well with the degree of sepsis although levels of PCT in the blood are very low PCT has the greatest sensitivity and specificity for differentiating patients with systemic inflammatory response syndrome SIRS from those with sepsis PCT levels may be useful to distinguish bacterial infections from nonbacterial infections It has shown that PCT may help guide therapy and reduce antibiotic use which can help save on cost of antibiotic prescriptions and drug resistance PRINCIPLE The test uses an anti human PCT monoclonal antibody conjugated with fluorescence latex For PCT product test line 1 was coated with anti human PCT polyclonal antibody and test line 2 was coated with
6. ma 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 100 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 Geteini100 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 100 ul of sample or 3 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
7. oated with a fluorescence latex labelled anti human PCT monoclonal antibody the test line is coated with another anti human PCT monoclonal antibody or polyclonal antibody and the control line is coated with rabbit anti mouse IgG antibody absorbent paper and liner Whole blood buffer Phosphate buffered saline proteins detergent preservative stabilizer Note Do not mix or interchange different batches of kits 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 whole blood buffer at 0 30 C with a valid period of 24 months CE 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 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 the manual to ensure proper test performance SPECIMEN COLLECTION AND PREPARATION BN oe Se NS 1 This test can be used for serum plasma and whole blood samples Heparin should be used as the anticoagulant for plas
8. stemic neon sepsis is likely a high risk of severe sepsis and or septic shock It is recommended that each laboratory establish its own expected values for the population it serves PERFORMANCE CHARACTERISTICS Measuring Range 0 1 50 0 ng ml Lower Detection Limit lt 0 1 ng ml Within Run Precision lt 10 Between Run Precision lt 15 Method Comparison The assay was compared with Roche E170 automatic immunoassay system and its matching PCT test kits with 200 serum samples 68 positive samples and 132 negative samples The correlation coefficient r for PCT is 0 983 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 5 g L Triglyceride 10 g L 02 g L REFERENCES 1 Balcl C Sungurtekin H G rses E Sungurtekin U Kaptanoglu B Usefulness of procalcitonin for diagnosis of sepsis in the intensive care unit Crit Care 2003 February 7 1 85 90 2 Schuetz P Christ Crain M Thomann R et al Effect of procalcitonin based guidelines vs standard guidelines on antibiotic use in lower respiratory tract infections the ProHOS
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