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1. al Manufacturer Do not re use Consult instructions for use Expiration Date Date of manufacture Batch code Temperature In vitro diagnostic limitation medical device y Sufficient for CE marking Thank you for purchasing One Step Test for NGAL Colloidal Gold Please Authorized representative in the European Community read this manual carefully before operating to ensure proper use Version 140318 Lotus Global Co Ltd Address 15 Alexsandra Road London UK NWs0DP AD amp MEDICUM SWISS QUALITY Distributor AD MEDICUM D O O Tel 381 62 551 008 E mail v mirkovic ad medicum com Web http www ad medicum com2. followed in accordance with local regulations 7 Carefully follow the instructions and procedures described in this manual SAMPLE COLLECTION AND PREPARATION 1 A urine sample is required for testing with this product 2 Urine sample can be preserved at room temperature only for 4 h please test it as soon as possible If testing cannot be completed immediately the urine sample should be stored up to 3 days at 2 8 C until it can be tested 3 Do not freeze urine sample Urine sample in freezing preservation cannot be used for testing 4 Samples must be recovered to room temperature before testing 5 Avoid heating the samples which can cause protein denaturation 6 SAMPLE VOLUME 120 ul urine TEST PROCEDURE 1 Restore samples and sealed test card foil bags to room temperature before using Open the foil bag label cards with numbers and use the test cards immediately 2 Confirm SD card lot No in accord with test kit lot No Perform QC SD operation Details refer to 8 3 1 of FIA8000 User s Manual when necessary 3 Take 120 ul urine sample drop vertically to the sample port on the test card 4 Wait for 3 minutes insert the card immediately into FIA8000 and press OK button the test card can be detected and the result will be printed automatically Note 1 It is required to perform QC SD operation when using a new batch of kits Only one QC SD operation is required for the same batch 2 Assu
3. GETEIN BIOTECHNOLOGY g One Step Test for NGAL Colloidal Gold For In Vitro Diagnostic Use INTENDED USE One Step Test for NGAL Colloidal Gold applies colloidal gold immunochromatography to detect neutrophils gelatinase associated lipocalin NGAL in urine samples quantitatively This test is used as an aid in the early diagnosis of acute kidney injury risk classification and treatment monitoring SUMMARY The inclining incidence of chronic kidney disease which has led to high mortality and immense medical burden over the past decades has become a distressing concern in epidemiology Unfortunately the number of biomarkers that allow the monitoring of chronic kidney disease CKD is limited NGAL is an emerging biomarker which has been shown to be able to diagnose kidney injuries The evidence for the role of NGAL measurements in a variety of clinical situations leading to AKI cardiac surgery kidney transplantation contrast nephropathy haemolytic uraemic syndrome and in the intensive care setting or to CKD lupus nephritis glomerulonephritides obstruction dysplasia polycystic kidney disease IgA nephropathy is explored The emerging utility of standardized clinical platforms for reliable measurement of NGAL in plasma Triage NGAL Device Biosite Incorporated and urine ARCHITECT analyzer Abbott Diagnostics is also discussed It will be important in future studies to validate the sensitivity and specificity of NGAL concent
4. ample as listed below may interfere with the test and cause erroneous results The maximum allowance concentration of them is as follows Interfering Substance Concentration Max Creatinine 10g L REFERENCES 1 Wasilewska A Taranta Janusz K Debek W et al KIM 1 and NGAL new markers of obstructive nephropathy Pediatr Nephrol 2011 26 4 579 586 2 Clerico A Galli C Fortunato A et al Neutrophil gelatinase associated lipocalin NGAL as biomarker of acute kidney injury a review of the laboratory characteristics and clinical evidences Clin Chem Lab Med 2012 50 9 1505 1517 3 Shemin D Dworkin LD Neutrophil gelatinase associated lipocalin NGAL as a biomarker for early acute kidney injury Crit Care Clin 2011 27 2 379 389 4 EN ISO 18113 1 2009 In vitro diagnostic medical devices Information supplied by the manufacturer labelling Part 1 Terms definitions and general requirements 5 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 DESCRIPTION OF SYMBOLS USED The following graphical symbols used in or found on One Step Test for NGAL Colloidal Gold are the most common ones appearing on medical devices and their packaging They are explained in more detail in the European Standard EN 980 2008 and International Standard ISO 15223 1 2007 Key to symbols used
5. ration measurements in clinical samples from large cohorts and from multiple Clinical situations Such studies will be facilitated by the anticipated widespread availability of standardized commercial tools in the near future PRINCIPLE OF THE EXAMINATION METHOD The test uses an anti human NGAL polyclonal antibody conjugated with colloidal gold and an anti human NGAL monoclonal antibody coated on the test line After the urine sample has been applied to the test strip the gold labelled anti human NGAL polyclonal antibody binds to the NGAL 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 NGAL 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 amout of NGAL in sample Then insert test card into the FIA8000 Quantitative Immunoassay Analyzer hereafter referred to as FIA8000 the concentration of NGAL in sample will be measured and displayed on the screen The values will be stored in FIA8000 and available for downloading on demand The result can be transmitted to the laboratory or hospital information system if it is connected to FIA8000 CONTENTS A kit contains 1 Foil bag which contains one test card and one desiccant ink my nich mmm om Yummy cg mya ifs mg yeaa cw alana ga aw ime S
6. re of card side towards FIA8000 is correct and insert the card completely TEST RESULTS When a purplish red band appears in the control area use the FIA8000 to analyse the test card and get a quantitative result If no purplish red band appears in the control area it indicates that the operation is incorrect or the test card has passed its expiration date In this case please read the manual again carefully and use a new test card to try again if the problem persists please stop using all products of the same batch immediately and contact with your supplier EXPECTED VALUE NGAL concentration is determined using samples obtained from 319 apparently healthy individuals The 95 percentile of the concentration for GETEIN BIOTECHNOLOGY 3 NGAL is 135ng ml PERFORMANCE CHARACTERISTICS Measurement Range 50ng ml 1500ng ml Minimum Detection Limit lt 50ng ml Within Run Precision lt 10 Between Run Precision lt 15 Method Comparison Compared to Abbott I2000 analyzer and matching NGAL test kits with 200 patient urine samples 157 positive samples 43negative samples The correlation coefficient r is 0 989 LIMITATIONS OF THE PROCEDURE 1 The result of the test should be evaluated in the context of all the clinical and laboratory data available In those instances where the laboratory results do not agree with the clinical evaluation additional tests should be performed accordingly 2 Some substances in urine s
7. t 25 2 Pipette aah ire me aay Sata aan rot mia mare ai anh mre maaan acne NENE EENE SEENE EEE E EE E EREE 25 3 Manual Simla atta aa mcm myeloid aude mS a arin tm day meen alien ae E Je ann cay ede aad a ade aaa 1 4 SD card TTT ee re ee ce ee ce ee A rc ire ee Ree nc ea 1 A test card consists of A plastic shell and a reagent strip which is composed of a sample pad nitrocellulose membrane a_ colloidal gold labelled anti human NGAL polyclonal antibody is coated at the border of the nitrocellulose membrane and sample pad the test line is coated with an anti human NGAL monoclonal antibody and the control line is coated with rabbit anti goat IgG antibody CE absorbent paper and liner Note Components from different batches cannot be exchanged MATCHING EQUIPMENT 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 bag is opened WARNINGS AND PRECAUTIONS For n Vitro diagnostic use 2 For use by healthcare professionals 3 Do not use the kit beyond the expiration date printed on the outside of the box 4 Keep the test card in the sealed pouch until ready to use Do not reuse the used cards 5 The pipette should not be used for multiple samples Discard it after single use 6 Patient samples used test cards and pipettes may be potentially infectious Proper handling and disposal methods should be
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