INTENDED USE - AD MEDICUM DOO
Contents
1. 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 and 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 SD card calibration operation when using a new batch of kits Only one SD card calibration is required for the same batch 2 Assure 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 the2. 3 Manual e E E E E A E E syabn jaiersl duaiyay alaaneralieoarSriahwfai ertalGngveyjakecetaltabeoaea 1 4 SD card Cece ce Te eT cr ct ee er reer eo eae race ee I ict 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 labelled anti human mAlb polyclonal antibody nitrocellulose membrane the test line is coated with an mAlb recombinant antigen and the control line is coated with rabbit anti goat IgG antibody absorbent paper and liner Note Components from different batches cannot be exchanged MATCHING EQUIPMENT CE FIA8000 Quantitative Inmunoassay 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 1 For In 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 followed in accordance with local regulations 7 Carefully follow the instructions and procedures described in this manual SAMPLE COLLECTION AND PREPARATION
3. 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 mAlb concentration is determined using samples obtained from 500 apparently healthy individuals The 99th percentile of the concentration for mAlb is 20 0 mg L PERFORMANCE CHARACTERISTICS Measurement Range 10 0mg L 200 0mg L Minimum Detection Limit lt 10mg L Within Run Precision lt 10 Between Run Precision lt 15 Method Comparison GETEIN BIOTECHNOLOGY g Compared to Olympus AU5400 analyzer and matching Randox mAlb test kits with 200 patient urine samples 62 positive samples 138 negative samples The correlation coefficient r is 0 980 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 sample as listed below may interfere with the test and cause erroneous results The maximum allowance concentration of them is as follows In
4. GETEIN BIOTECHNOLOGY g One Step Test for mAlb Colloidal Gold For In Vitro Diagnostic Use Manual INTENDED USE One Step Test for mAlb Colloidal Gold applies colloidal gold immunochromatography to detect microalbuminuria mAIb in urine samples quantitatively An elevated mAlb concentration below the proteinuric level has long been recognized as a marker of kidney disease and increased cardiovascular risk in diabetic nephropathy SUMMARY Albumin is one of the major plasma proteins In normal circumstances albumin molecules are too large to cross the glomerular basement membrane Therefore albumin is usually present in very low concentration in urine Damage to the glomerular basement membrane can alter its permeability Albumin is then able to enter the urine Sustained elevations of urinary albumin concentrations are called Microalbuminuria mAIb mAlb arises from increased leakage of glomerular basement membrane So mAlb is recognized as a marker of kidney damage Recent years determination of mAlb is linked with increased risk for cardiovascular events rather than progression to end stage kidney disease It is a valuable tool for the detection of cardiovascular risk of diabetic nephropathy Early detection of microalbuminuria in diabetes is critical because immediate intervention can slow the progression of disease The epidemiology of microalbuminuria reveals a close association between systemic endothelial dysfunction an
5. d vascular disease also implicating glomerular endothelial dysfunction in microalbuminuria PRINCIPLE OF THE EXAMINATION METHOD The test uses an anti human mAlb polyclonal antibody conjugated with colloidal gold and mAlb recombinant antigen coated on the test line After the urine sample has been applied to the test strip the gold labelled anti human mAlb polyclonal antibody binds to the mAlb in sample and forms a marked antigen antibody complex The complex and unbonded gold labelled anti human mAlb polyclonal antibody move to the test card detection zone by capillary action Then the mAlb in sample and mAlb recombinant antigen on the test line compete to bind gold labelled anti human mAlb polyclonal antibody The color intensity of the test line is in inverse proportion to the amout of mAlb in sample Then insert test card into the FIA8000 Quantitative Immunoassay Analyzer hereafter referred to as FIA8000 the concentration of mAlb 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 a yaa wip a ey vat vate ya are Clie ence wal ea a vasa eau sm A E E nsovte ent Laman Menr aca E E evel a Bhat 25 2 Pipette TTC eee eee ee eee ee ee ee ee ee ee ee ee eer eee ee 25
6. te 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 mAlb Colloidal Gold Please Authorized representative in the European Community read this manual carefully before operating to ensure proper use Version 140317 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 com
7. terfering Substance Concentration Max Creatinine 10g L REFERENCES 1 Col M Ocaktan E Ozdemir O et al Microalbuminuria prevalence in hypertensives and diabetics Acta Med Austriaca 2004 31 1 23 29 2 McTaggart MP Price CP Pinnock RG et al The diagnostic accuracy of a urine albumin creatinine ratio point of care test for detection of albuminuria in primary care Am J Kidney Dis 2012 60 5 787 794 3 Denis Sviridov Glen L Hortin Urine aloumin measurement Effects of urine matrix constituents Clinica Chimica Acta 2009 404 2 140 143 4 Reboldi G Gentile G Angeli F et al Microalbuminuria and hypertension Minerva Med 2005 96 4 261 75 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 DESCRIPTION OF SYMBOLS USED The following graphical symbols used in or found on One Step Test for mAlb 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 all Manufacturer Do not re use Consult instructions for use Expiration Da
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