The NGAL Test Reagent Kit

Transcription

1 PERFORMANCE DATA AND APPLICATION NOTE FOR SIEMENS DIMENSION VISTA The NGAL Test Reagent Kit REF/Cat. No. ST00CA ST00CA ST00CA Product name The NGAL Test Reagent Kit The NGAL Test Calibrator Kit The NGAL Test Control Kit 0, 00, 00, 000, 000 ng/ml Low and High x ml x ml x ml x ml x levels Number of determinations: ml of immunoparticle suspension provides 0 cuvette readings with the provided settings in this application. The dead volume of the analyzer and reagent container should be added when calculating the required amount of reagent. INTENDED USE The presented application note is intended for the quantitative determination of NGAL on Siemens Dimension Vista analyzer in human urine samples only. Do not use plasma samples. To use BioPorto s The NGAL Test on the Siemens Dimension Vista chemistry analyzer the reagents must be transferred into a new container. The appropriate containers are called Flex Reagent Cartridges and can be ordered from your local Siemens representative. Please make sure to acquire the following item: Item Cat. No. Product name Reagent container KS999 Flex Reagent Cartridges Order from Siemens Please read the Dimension Vista System Operator s Guide and instruction for Siemens Flex Reagent Cartridge before transferring the reagents and loading the cartridge into the instrument. FILLING THE SIEMENS EMPTY FLEX REAGENT CARTRIDGE: To fi ll the cartridge, the clear fi lm that covers the individual wells will need to be punctured. The cartridge well must be vented before fi lling with reagents. For that, puncture the fi lm at a corner of the well () and then fi ll the well from the opposite corner (). Take care to minimize the size of the vent holes and fi lling without tearing the fi lm. Fill the well with the reagents as listed in the table below (the volumes shown are rounded up, allowing easier removal): 9 0 Reagent Volume per Well Tests per Well LOADING AND IDENTIFICATION OF THE FLEX : Place the reagent fi lled Flex cartridge into the Reagent Load area and press [LOAD] the cartridge will be identifi ed as EMPTY Press [ADVANCED] icon and then [INVENTORIES] list displays onboard Flexes Select the REAGENT INVENTORY from the menu and then click on the line of the reagent EMPTY in the NAME column open the confi guration window of the cartridge Select the method XNGAL in the list of methods open channels Select the lot number or create a new one If new batch, enter the Lot ID and expiration date and [FINISH] to accept the data the reagent cartridge is marked XNGAL now Phone (+) Fax (+) /DIMENSION VISTA/e Revision APP0-0 IVD

2 PRECAUTIONS Do not pipette by mouth. Do not shake the reagents. Use only clean containers if transferring reagents. Do not pour reagents back into their original containers once transferred. Do not use reagents after the expiry date on the labels. Do not switch caps on reagent containers as it may cause contamination or mix-up. Reagents with different lot numbers should not be mixed. All solutions supplied should be handled carefully and disposed of in accordance with national and local regulations. PERFORMANCE DATA The performance data shown were obtained by the manufacturer for this particular analyzer model. For additional performance data and product application, please read the instructions for use accompanying the product carefully. Each individual laboratory should validate the use of The NGAL Test on its system. LIMIT OF DETECTION (LoD) The limit of detection was estimated as ng/ml on Siemens Dimension Vista system. LIMIT OF QUANTIFICATION (LoQ) The LoQ was determined to be ng/ml on which was verifi ed on this analyzer model. Observed results: RANGE The measuring range of The NGAL Test is ng/ml on Siemens Dimension Vista system. ng/ml Mean (ng/ml) SD CV % n Accept < 0% SECURITY RANGE The NGAL Test showed no effect of antigen excess for NGAL concentrations below 0,000 ng/ml. PRECISION Mean SD CV % n Acceptance (ng/ml) ST00CA Low... 0 < % ST00CA High < % CALIBRATION The NGAL Test Calibrator Kit ( ST00CA) should be used the following way: Calibration point Kit calibrator Level Calibrator (0 ng/ml)* 0 ng/ml Calibrator (0 ng/ml) 0 ng/ml Calibrator (00 ng/ml) 00 ng/ml Calibrator (00 ng/ml) 00 ng/ml Calibrator (000 ng/ml) 000 ng/ml SAMPLE MATERIAL NGAL concentrations can be determined only in human urine samples on the Siemens Dimension Vista chemistry analyzer. METHOD COMPARISON NGAL measurements have been compared to measurements on a Hitachi 9. Data is available on request. CALIBRATION STABILITY It is recommended to recalibrate every weeks, when reagent lots change or quality control results fall outside the range as established by the individual laboratory. TROUBLE SHOOTING If performance is unacceptable, try to recalibrate. Check reagents and procedure. If the problem persists, please contact instrument supplier or reagent supplier.. Dimension Vista and Flex are registered trademarks of Siemens Healthcare Diagnostics Inc., New York, USA. * Special on-board dilution, consult settings below. NB: ST00CA Calibrator (000 ng/ml) is not used for calibration on Siemens Dimension Vista system. Phone (+) Fax (+) /DIMENSION VISTA/e Revision APP0-0 IVD

3 METHOD PARAMETERS, CLICK ON THE FOLLOWING Main Menu [Advanced] [Setup] [user-defi ned methods] [Create] Enter the following parameters: Method name XNGAL Reagents needed Ref ID Enter code ST00 NGAL reagents R Units ng/ml ST00 NGAL calibrator R Mode Nephelometry Delivery Time Component Remix Component Mix Chase Volume total D - R 00 µl none -- 0 µl none 0 µl Gentle Mix S 0 S µl µl Moderate D 9 R µl none -- 0 µl none µl Moderate D µl none -- 0 µl none 0 µl 0 none S S 0 µl 0 µl 0 none Volume total µl Well Reagent Test Life (h) Vol On board stability (hours) R 90 0 R 90 0 Phone (+) Fax (+) /DIMENSION VISTA/e Revision APP0-0 IVD

4 Format VLIN Start read End read Pre-reaction - - Reaction 0 0 Reaction - - Reaction end - - Offset (secondes) Start time 0 End time 0 Interval (days) 0 Calibrator levels Calibrator dilutions Level Weight Replicates Create Component Diluent Dilution factor Minimum Aspiration.00 L L Water..00 L.00 L.00 L.00 L Phone (+) Fax (+) /DIMENSION VISTA/e Revision APP0-0 IVD

5 Serum Predilute Autodilution Low High Above Below Assay Range 0 0 Sample Vol 0 Sample Vol 0 0 Reference Range 0 0 Dilution factor Dilution factor 0 0 Expiration (min) Diluent SDIL Diluent SDIL Plasma Predilute Autodilution Low High Above Below Assay Range 0 0 Sample Volume 0 Sample Volume 0 0 Reference Range 0 0 Dilute factor Factor 0 0 Expiration (min) Diluent SDIL Diluent SDIL Urine Predilute Autodilution Low High Above Below Assay Range Sample Volume 0 Sample Volume 0 0 Reference Range 0 0 Dilute factor 0 Factor 0 0 Expiration (min) 0 Diluent SDIL Diluent Water Phone (+) Fax (+) /DIMENSION VISTA/e Revision APP0-0 IVD