ADVIA Centaur® XP Immunoassay System Calibration Online Training

Welcome to the ADVIA Centaur® XP Immunoassay System Calibration Online Training course.  Calibration is required when a new lot of reagent is added to the system and when the calibration interval expires.  We will discuss the required steps to schedule and review calibrations in this course. Select Next to review the course objectives. Describe the process required to review calibration status Discuss the accept option Identify the steps required to scan Calibrator and Master Curve definition cards List the steps required to schedule a calibration Review calibration data After completing this course, you will be able to: Select Next to contiue. 为了维护过程中，选择维护活动，按程序按钮。 在线帮助窗口会打开，显示的程序。 该程序可能包含正确完成的活动是有帮助的影像。 如果需要，维护过程，从这个窗口可以打印。 选择下面的链接，了解有关访问维护程序。 Congratulations you have completed the ADVIA Centaur® XP Immunoassay System Calibration Online Training course. Listed below are the key points that have been presented.  Take time to review the material before you proceed to the final quiz.  In this online training course, you have learned to: Describe the process required to review Calibration Status The Primary Reagent and Calibration Summary windows can be used to determine if the calibration status is Valid, Invalid or Verify.                     Identify the steps required to scan Calibrator and Master Curve definition cards Calibrator definition cards are scanned in the Calibrator Definition window when the system has a Ready status.  The Scan Data button is selected and the barcode scanner is used to scan the card from the top to the bottom. The Master Curve definition card is scanned in the Master Curve Definition window when the system status is Ready or Inprocess.  From this window the Scan Data button is selected and the card is scanned from the top to the bottom.  List the steps required to schedule a Calibration Calibrations are ordered in the Worklist Schedule window.  The assay to be calibrated and the calibrator lot are selected in this window. Review Calibration Data The Worklist Summary window will display the status of the calibration that was processed.  The Calibration Evaluation Ranges window can be used to view the specific results of the Calibration Evaluation Criteria that the system used to determine the validity of the calibration. Discuss the Accept Option The accept option can be used when a calibration has a status of Verify.  Verify indicates that the calibration exceeded the observed ranges but is within the defined ranges.  The calibration can be accepted from the Calibration Data window. Select Next to continue.   Calibration Status Calibration Summary window – Used to determine when a calibration is due and to resolve problems with calibrations Primary Reagent window – Used to determine when a calibration is expired, required or due Check Calibration Status Learn how to check calibration status. Tab TitleTextCalibration Summary Window Calibration Summary Window                                            Access the Calibration Summary window from the Calibration dropdown menu. View the  assay, lot number, status and expiration date in this window. Calibration Status Messages: Cal Required No valid calibration exists for the reagent lot Current The calibration is valid Due The calibration interval for the test will expire within 24 hours or within 25% of the calibration interval, whichever is shorter Expired The calibration for the reagent lot is expired Invalid The calibration exceeded either the defined or the observed range for one or more calibration expected values No Master Curve No Master Curve exists for the reagent lot   Primary Reagent Status Window Primary Reagent Status Window Use the Reagent Status button to access the Primary Reagent Status window. View calibrations that are due, expired or required from this window. Calibration Status Messages: No Master Curve No Master Curve exists for the reagent lot Cal Required No valid calibration exists for the reagent lot Cal Due The calibration interval for the test will expire within 24 hours or within 25% of the calibration interval, whichever is shorter Cal Expired The calibration for the reagent lot is expired   When complete, select the X in the upper-right corner to close the window and continue.   New Calibrator Lots Calibrator Definition window Calibrator definition cards are located in the calibrator kit   New Reagent Lots Master Curve Definition window Master Curve definition cards are located in the reagent kit Scanning Calibrator Cards Learn how to scan Calibrator cards. Checklist TitleChecklist TypeChecklist ContentLocate the Calibrator Definition CardHTML The Calibrator Definition card is located in the calibrator kit. It is labeled ADVIA Centaur®and has a purple bar at the top. Select each checkbox to learn more about Calibrator definitions.  Open the Calibrator Definition ScreenHTML Select Calibrator Definition window from the Calibration dropdown menu.  Press Scan DataHTML Press the Scan Data button at the bottom of the window. Note: The Calibrator definition card cannot be scanned if the system is in process.  Scan the Calibrator Definition CardHTML Use the barcode scanner to enter the information. Scan all barcodes from top to bottom.  Note: If defined for the first time, you will need to enter an LIS Code, typically it is the same as the calibrator ID. Press SaveHTML Press the Save button. When complete, select the X in the upper-right corner to close the window and continue.   Scanning Master Curve Card Learn how to scan Master Curve cards. Checklist TitleChecklist TypeChecklist ContentLocate the Master Curve Definition CardHTML Locate the Master Curve definition card in the primary reagent box.  Select the ADVIA Centaur® side of the card.  Select each checkbox to learn more about how to scan Master Curve cards.  Open the Master Curve Definition ScreenHTML Open the Master Curve Definition screen from the Calibration menu.  Press Scan DataHTML Press Scan Data.    Scan the Master CurveHTML Scan the barcodes on the ADVIA Centaur® side of the card into the system with the barcode scanner from top to bottom.  Press SaveHTML Press the Save button.   When complete, select the X in the upper-right corner to close the window and continue.   Calibrate an assay when: The calibration interval expires A calibration is invalid A new lot of assay reagent is used Controls are repeatedly out of range Note: Refer to the Instructions for Use (IFU) for calibrator preparation and storage requirements. Schedule a Calibration Learn how to schedule a calibration. Checklist TitleChecklist TypeChecklist ContentSelect Schedule from Worklist MenuHTML Select Schedule from the Worklist Menu.   Note: You must load the reagent lot you want to calibrate before you schedule a calibration.  Select each checkbox to learn more about scheduling a calibration.  Choose Calibrator OptionHTML Select the Calibrator radio button.  Select an AssayHTML Select an assay.   Note: Only one assay can be scheduled at a time.  Select the Calibrator LotHTML Select the correct calibrator lot.  Select Reagent LotHTML This is an optional step.   If more than one reagent lot is on the system, use the Reagent Lot drop-down menu to select the appropriate lot.  The lot that requires a calibration will have an asterisk next to it.  Select SaveHTML Select the Save button. When complete, select the X in the upper-right corner to close the window and continue.   Scheduling Calibrations without Barcode Labels Learn how to schedule calibrations without barcode labels. Checklist TitleChecklist TypeChecklist ContentSelect ScheduleHTML Select Schedule from the Worklist Menu. Note: You must load the reagent lot you want to calibrate before you schedule a calibrator. Select each checkbox to learn more about scheduling a calibration without barcode labels.  Select CalibratorHTML Select the Calibrator radio button.  Select Schedule by RackHTML Select Schedule by Rack on the right side of the window.  Select an AssayHTML Select an assay. Note: You can only schedule one assay at a time.  Select Calibrator LotHTML Select the appropriate calibrator lot.  Select Reagent LotHTML This is an optional step. If more than one reagent lot is on the system, use the Reagent Lot drop-down menu to select the appropriate lot.  The lot that requires a calibration will have an asterisk next to it.  Enter Rack IDHTML Enter the rack ID and location in the Rack fields for the low and high calibrators.  Select SaveHTML Select the Save button. When complete, select the X in the upper-right corner to close the window and continue.   You have just learned about scheduling a calibration.  Select the link below to practice what you have learned. Your Turn Practice scheduling a calibration. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90003321/sim_CXP_ScheduleCal800x604_9/sim_CXP_ScheduleCal800x604_9.swfHTML5 File:/content/generator/Course_90003321/sim_CXP_ScheduleCal800x604_9/index.htmlPDF File: Review Calibration Data Calibration Summary window Calibration Data window   Reviewing Calibration Data Learn how to review calibration data. Checklist TitleChecklist TypeChecklist ContentAccess Worklist SummaryHTML Select Summary from the Worklist dropdown menu.  Choose Calibrators from the View menu.  A Valid calibration indicates that the Calibration Evaluation Criteria have passed.  An Invalid calibration indicates that one of the criteria did not pass and further investigation will be required.  Select each checkbox to learn more about reviewing calibration data.   Open Calibration SummaryHTML   To access the Calibration Summary window, select the Calibration button.  A Current calibration indicates that the Calibration Evaluation Criteria have passed.  An Invalid calibration indicates that one of the criteria did not pass and further investigation will be required.   View Calibration DataHTML The Calibration Data window is accessed from the Calibration Summary window. The assay lot number, calibrator lot number, calibration date and other information are available on this page. If a calibration was Invalid, the cause of the failure is listed in the Flag area.  Observe Calibration Evaluation RangesHTML The results of each calibration evaluation criteria are viewed on the Calibration Evaluation Ranges window. The defined ranges, that were entered when the Master Curve card was scanned are listed on this screen. If observed ranges exist, they are displayed here. An observed range is developed by the system after there are four calibrations with the same reagent and calibrator lot combination. When complete, select the X in the upper-right corner to close the window and continue.    Invalid Calibrations Learn about invalid calibrations. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90003321/sim_CXP_Invalid800x622_9/sim_CXP_Invalid800x622_9.swfHTML5 File:/content/generator/Course_90003321/sim_CXP_Invalid800x622_9/index.htmlPDF File: Accepting a Calibration: Verify status Outside of observed ranges but within defined ranges Observed ranges:  After 4 calibrations of the same reagent lot and calibrator lot combination, the system calculates observed ranges  Defined ranges: The values for Slope, Ratio, Low Cal Deviation and High Cal Deviation entered from the Master Curve card   Accepting Calibrations Learn how to accept calibrations. Checklist TitleChecklist TypeChecklist ContentOpen the Worklist SummaryHTML Open the Worklist Summary. Notice that the status of the calibration is Verify. Select each checkbox to learn more about accepting calibrations.  Open the Calibration Summary WindowHTML Open the Calibration Summary window. Notice that the calibration is Invalid in this window.  Review Calibration DetailsHTML Select the calibration and press Data to review calibration details. Replicate results, status messages and flags will be displayed in this window.  Accept the CalibrationHTML Select the Accept button to allow the instrument to calculate results for samples using this calibration. Results for this test will be flagged as Cal Accepted. When complete, select the X in the upper-right corner to close the window and continue.   Accepting a Calibration Practice accepting a calibration. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90003321/sim_CXP_Accept800x639_9/sim_CXP_Accept800x639_9.swfHTML5 File:/content/generator/Course_90003321/sim_CXP_Accept800x639_9/index.htmlPDF File: Two-point calibration: Uses low and high calibrators Eliminates the need to measure a full standard curve or calibrate every time the assay is performed.     Select Next to continue. Calibration Evaluation Criteria Precision Slope Ratio Deviation of low and high calibrators Calibration Evaluation Ranges window displays: Calculated calibration values Defined ranges of calibration evaluation criteria Observed ranges of calibration evaluation criteria Note: Refer to the ADVIA Centaur® XP Immunoassay System Operator's Guide for more information about the calibration evaluation criteria. . Calibration Evaluation Ranges Learn about the calibration evaluation ranges window. Base ImageHotspotsText BlocksImage FileSlope is a comparison of high and low calibrator RLUs to the Master Curve. Ratio is a comparison of low and high calibrator RLUs.The Low and High Cal Deviations are a measure of how well the high and the low calibrator RLUs fit the Master Curve.CV is the precision of the calibrator replicates based on RLUs.Defined ranges are the values for Slope, Ratio, Low Cal Deviation and High Cal Deviation you enter form the Master Curve Card when you define a Master Curve for a reagent lot.  Since these ranges are reagent lot specific, the relatively narrow limits of the ranges ensure quality calibration monitoring.Acceptable CV is the maximum CV that is acceptable for a valid calibration.After 4 calibrations for a reagent lot and calibrator lot combination, the system calculates Observed ranges for Slope, Ratio, Low Cal Deviation and High Cal Deviation. Performing new calibrations using the same reagent/calibrator lot combination, the system compares results to the defined ranges from the Master Curve definition and also the observed ranges determined by the system.  Critical Precision determines whether an outlier is too far out to automatically exclude it.