Insulin
Contents
1. ABEI contains BSA 0 2 NaNs3 FITC Label anti Insulin monoclonal antibody labeled FITC contains BSA 0 2 NaN3 Please Rehydrate the calibrator before using Accessories required but not provided Maglumi Reaction module Maglumi Starter kit 1 2 Maglumi Light check Maglumi Wash System Liquid 4 2 Preparation of the Reagent Integral Before the sealing is removed gentle and careful horizontal shaking of the Reagent Integral is essential avoid foam formation Remove the sealing and turn the small wheel of the magnetic microbeads compartment to and fro 1 2 until the colour of the suspension has changed into brown Place the Integral into the reagent area and let it stand there for 30 mins During this time the magnetic microbeads are automatically agitated and completely resuspended Do not interchange Nano Magnetic Microbeads from different reagents 4 3 Storage of the Reagents Integral e Sealed Stored at 2 8 C until the expiry date e Opened Stable for 4 weeks After this period it is still possible to keep on using the Reagent Integral provided that the controls are found within the expected ranges e Keep upright for storage e Keep away from direct sunlight 5 Origin of Calibrators Calibrators in the Reagent Kit are from Sigma Biological root synthetic materials processed by HPLC purification with a purity 299 No HBsAg anti HCV and anti HIV is found 6 Calibration 6 1 2 point recalibration V2. MAGLUMI Insulin CLIA 130205002M 100 Shenzhen New Industries Lotus Global Co Ltd Biomedical Engineering Co Ltd 15 Alexandra Road 4F Wearnes Tech Bldg Science amp Ilndustry Park London UK NW8 ODP Nanshan Shenzhen China 518057 Tel 86 755 26508518 Fax 86 755 26508339 Tel 44 20 75868010 Fax t 44 20 79006187 CE R PROFESSIONAL USE ONLY Store at 2 8 C COMPLETELY READ THE INSTRUCTIONS BEFORE PROCEEDING SYMBOLS USED ON LABELS EP z C Ad CONT j 1S ad ml N O O fe Z D 130205002M v1 0 EN Authorized Representative in Europe Manufacturer Attention See Instructions For Use Contents of kit In vitro diagnostic medical device In vitro diagnostic use Lot number Catalogue Code Expiry date Use by Temperature limitation store at 2 8 C Number of tests Keep away from sunlight Biological risks 1 INTENDED USE The kit has been designed for the quantitative determination of Insulin in human serum The method can be used for samples over the range of 0 200uIU ml The test has to be performed on the Maglumi fully auto analyzer Including Maglumi 1000 Maglumi 2000 Maglumi 2000 plus 2 SUMMARY AND EXPLANATION OF THE TEST Human insulin is a polypeptide hormone originating in the beta cells of the pancreas and serving as a principal regulator for the storage and production of carbohydrates Its secretion is norm
3. ally stimulated by increases in the amount of glucose in circulation This leads to higher insulin levels and more rapid tissue assimilation of glucose followed by a decline in the insulin level as the glucose level subsides In a number of conditions notably insulinoma and diabetes this relationship is impaired Insulin tends to circulate at inappropriately high levels in patients with insulin secreting pancreatic tumors such tumors can thus be a cause of hypoglycemia Accordingly insulin immunoassays used sometimes in connection with provocative doses of tolbutamide or calcium play an essential role in the identification and localization of insulinomas The finding of fasting hypoglycemia in association with an inappropriately high serum insulin concentration is considered diagnostic Insulin levels do not figure in the subclassification of diabetes worked out by the National Diabetes Data Group Nevertheless when obtained in the course of a glucose tolerance test they appear to be of some prognostic value in predicting the benefits of insulin therapy and the likelihood of progression to insulin dependence and the complications such as retinopathy characteristic of diabetes The application of insulin immunoassay to patients already undergoing insulin therapy is complicated by the fact that such therapy typically leads to the formation of anti insulin antibodies capable of interfering with the assay Some investigators have sought t
4. e in serum so there is no interferon which can affect the result If the operation is in accordance with the user s manual and the control is within the range of the user s manual there is no need of performing a validation assay 13 Performance Characteristics 13 1 Accuracy Consider calibrator high of known concentration as a sample dilute it by 1 2 ratio with diluent and measure its diluted concentration for 10 times Then calculate the recovery of measured concentration and expected concentration The recovery should be within 90 110 13 2 Precision Intra assay coefficient of variation was evaluated on Calibrator High repeatedly measured 10 times in the same assay calculating their coefficient of variation the results should lt 10 Inter assay coefficient of variation was evaluated on three batches of kit repeatedly measured 10 times of Calibrator High calculating three batches of kit for Calibrator High between the measured values of the coefficients of variation the results should lt 15 13 3 Sensitivity The sensitivity is defined as the concentration of Insulin equivalent to the mean RLU of 20 replicates of the zero standard plus two standard deviations corresponding to the concentration from the standard curve The sensitivity is typically less than 3 00uIU ml 13 4 Specificity The result of Proinsulin assay should accord with the following description When Proinsulin 200uIU ml the detection results of Insulin
5. fore be disposed of in accordance with the prevailing regulations and guidelines of the agencies holding jurisdiction over the laboratory and the regulations of each country Disposable materials must be incinerated liquid waste must be decontaminated with sodium hypochlorite at a final concentration of 5 for at least half an hour Any materials to be reused must be autoclaved using an overkill approach USP 24 2000 p 2143 A minimum of one hour at 121 C is usually considered adequate though the users must check the effectiveness of their decontamination cycle by initially validating it and routinely using biological indicators e The calibrators in this kit are prepared from bovine serum products However because no test method can offer complete assurance that HIV Hepatitis B Virus or other infectious agents are absent these reagents should be considered a potential biohazard and handled with the same precautions as applied to any serum or plasma specimen 9 Test Procedure To ensure proper test performance strictly adhere to the operating instructions of the Maglumi Fully Auto analyzer Each test parameter is identified via a RFID tag on the Reagent Integral For further information please refer to the Maglumi Fully Auto Operator s Manual Sample calibrator or controls ABEI Label FITC Label Nano magnetic microbeads 400ul each time Cycle washing 130205002M v1 0 EN 10 Quality Control e Observe quality control guideline
6. herefore to measure insulin in urine or in serum samples subjected to column chromatography or PEG precipitation But the measurement of free insulin remains of limited interest as a technique for monitoring insulin therapy in the absence of statistics establishing therapeutic or toxic ranges So far it appears that glucose control in diabetics cannot in general be achieved by normalizing the insulin profile Nor is it known at what point abnormally high insulin levels become dangerous 3 PRINCIPLE OF THE TEST Sandwich immunoluminometric assay Use an anti Insulin monoclonal antibody to label ABEI and use another monoclonal antibody to label FITC Sample Calibrators or Control ABEI Label FITC Label and nano magnetic microbeads coated with sheep anti FITC are mixed thoroughly and incubated at 37 C forming a sandwich after sediment in a magnetic field decant the supernatant then cycle washing it for 1 time Subsequently the starter reagents are added and a flash chemiluminescent reaction is initiated The light signal is measured by a photomultiplier as RLU within 3 seconds and is proportional to the concentration of Insulin present in controls or samples 4 KIT COMPONENTS 4 1 Material supplies Reagent Integral for 100 determinations Nano magnetic microbeads Tris buffer 1 2 w v 0 2 NaN3 coated with sheep anti FITC polyclonal antibody Calibrator low Calibrator high ABEI Label anti Insulin monoclonal antibody labeled
7. ia the measurement of calibrators the predefined master curve is adjusted recalibrated to a new instrument specific measurement level with each calibration 6 2 Frequency of Recalibration e After each exchange of lot Reagent Integral or Starter Reagents e Every week and or each time a new Integral is used recommendation e after each servicing of the Maglumi Fully Auto analyzer e lf controls are beyond the expected range 7 Sample Collection Material and Storage e Collect samples using standard procedures e Sample material serum e Store at 2 8 C 24 hours e For longer storage periods freeze to below 20 C e Avoid repeated freezing and thawing cycles e Stored samples should be thoroughly mixed prior to use Vortex mixer e Vacuum tubes a Blank tubes are recommended type for collecting samples b If plasma sample is needed EDTA tube is conformed has no effect on the results RLUs c Liquaemin Sodium tube is found to increase the sample RLU and cause test results deviation d Please ask SNIBE for advice if special additive must be used in the sample blood 8 WARNING AND PRECAUTIONS FOR USERS e For use in JN V TRO diagnostic procedures only e Do not interchange reagents from different lots Do not use kit components beyond their labeled expiry date e All samples biological reagents and materials used in the assay must be considered potentially able to transmit infectious agents They should there
8. lt 6ulU ml 13 5 Linearity Conduct a logarithmic transform to the RLU value and concentration value of 6 standards After a double logarithmic fitting the absolute value of its linearity should exceed 0 9800 14 References 1 Binder C amp Faber OK Residual Beta cell Function and Its Metabolic Consequences Diabetes 1978 27 Suppl 1 226 229 2 Blix PM et al Urinary C Peptide An Indicator of B Cell Secretion under Different Metabolic Conditions J Clin Endocrinol Metab 1982 54 574 580 3 Horwitz DL Starr JI Mako ME et al Proinsulin insulin and C Peptide Concentrations in Human Portal and Peripheral Blood J Clin Invest 1975 55 1278 1283 2 2
9. s for medical laboratories e Use suitable controls for in house quality control 11 Results 11 1 Calculation of Results e The analyzer automatically calculates the Insulin concentration in each sample by means of a calibration curve which is generated by a 2 point calibration master curve procedure The results are expressed in ulU ml For further information please refer to the Maglumi Fully Auto Operator s Manual 11 2 Interpretation of Results e Reference values 4 03 IU ml 23 46 IU ml before meal e Results may differ between laboratories due to variations in population and test method Each laboratory should establish its own reference range 12 Limitations of the procedure 12 1 A skillful technique and strict adherence to the instructions are necessary to obtain reliable results Bacterial contamination of samples or repeated freeze thaw cycles may affect the test results Assay results should be utilized in conjunction with other clinical and laboratory data to assist the Clinician in making individual patient management decisions 12 2 HAMA Patient samples containing human anti mouse antibodies HAMA may give falsely elevated or decreased values Although HAMA neutralising agents are added extremely high HAMA serum concentrations may occasionally influence results 12 3 High Dose Hook No high dose hook effect was seen for Insulin concentrations up to 2000 ylU ml ABEI is a synthetic organic compound not a substanc
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