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ADVIA Centaur® CP Immunoassay System Calibration Online Training

Calibration includes performing the calibration procedure, as well as reviewing and accepting calibration data to ensure proper assay performance. This clinical laboratory training qualifies for continuing education units (CEU).

Welcome to the ADVIA Centaur® CP Calibration Online Training course. The procedures covered in this course include: The principles underlying calibration When and how to do a calibration Select Next to continue. Describe the accept option Describe the process required to review calibration status Identify Master Curve and Two-Point calibration principles List the steps required to perform a calibration Review calibration data Upon successful completion of this course, you will be able to: Select Next to continue. Congratulations. You have completed the ADVIA Centaur® CP Calibration Online Training course. Listed below are the key points that have been presented. Take time to review the material as needed before proceeding to the final quiz. Identify Master Curve and Two-Point Calibration Principles: The Master Curve: determined when the reagent lot is manufactured Two-point Calibration: Performed initially and at assay-specific intervals Describe the process required to review calibration status: Reagent and Calibration Stability - alert generated when a calibration is due or expired Primary Reagent window - yellow box beneath pack indicates that a calibration is required Results Current Calibrations tab - displays status and expiration date of calibrations Valid - the calibration has passed Invalid - the calibration has failed Expired - the calibration has exceeded its calibration interval Verify - the calibration is outside of the observed ranges, but within the defined ranges List the Steps Required to Perform a Calibration: Master Curve cards are scanned in with every new reagent lot number.  Scan the card in the Definition Master Curves tab Calibrator Definition cards are scanned in with every new calibrator lot.  Scan the card in the Definition Calibrators tab Load calibrator samples and access the Primary Reagent window Select the pack to be calibrated and press the Calibrate button Review Calibration Data: Access the Results Current Calibrations tab To review specific data, select the calibration and then select Details In the Calibration Details window, the calibration evaluation criteria that have passed are marked with a green check mark  The criteria that have failed the calibration evaluation criteria are marked with yellow exclamation point in a red circle To print a calibration report, select the calibration and then select the Print button.  Select the appropriate options and the type of report and then press OK Describe 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 by accessing the Results Current Calibrations tab, selecting the calibration with the Verify status, selecting the Details button and choose Accept Calibration Select Next to continue. A two-point calibration is performed at periodic assay-specific intervals. It minimizes variability: Between instruments Due to environmental factors Due to reagent age     . Calibration Principles Learn about Calibration Principles. Slide NumberText BlocksCalloutsAudio ScriptImage File1 The multi-point Master Curve: Determined by measuring the relative light unit or RLU response (on the Y-axis) at multiple concentration levels of the analyte (on the X-axis) Concentrations and corresponding RLUs become the lot-specific Master Curve values Values are provided as barcodes on the Master Curve card Select Next to continue.   Note: If audio does not automatically start, select the play arrow in the top left to begin.The multi-point Master Curve is established as part of the manufacturing process for each primary reagent lot number. The curve is determined by measuring the relative light unit or RLU response on the y-axis at multiple concentration levels. These concentrations and corresponding RLUs become the lot-specific Master Curve values that are provided as barcodes on the Master Curve card. When a new lot of reagent is placed on the system, the Master Curve card values are scanned into the software as the reference for determining results.2 High and low calibrator levels are processed in replicate through the system. If the calibrators meet defined validity criteria, the system compares the average RLUs for each calibrator to the Master Curve and calculates a system-specific adjustment formula containing slope and intercept factors. Select Next to continue.     When an assay requires calibration, the Two-point calibration is performed at the system. High and low calibrator levels are processed in replicate through the system. If the calibrators meet defined validity criteria, the system compares the average RLUs for each calibrator to the Master Curve and calculates a system-specific adjustment formula containing slope and intercept factors. 3 RLU value is automatically adjusted with this formula and matched to the corresponding analyte concentration from the Master curve to determine the result. Select Next to continue   When complete, select the X in the upper-right corner to close the window and continue.When a patient or quality control sample is assayed, its RLU value is automatically adjusted by comparing the average RLUs for each calibrator to the corresponding analyte concentration from the Master curve to determine the result. Two-point calibration is required when: A new lot of reagent is used The calibration interval expires (from 3 to 60 days) A calibration is Invalid Controls are repeatedly out of range You may also perform a calibration in response to a “Calibration Due” message.   Select Next to continue.   Calibration Status: Primary Reagent window Reagent and Calibration Stability window Current Calibrations tab in Results window Checking calibration status Learn about checking calibration status. Tab TitleTextPrimary Reagent Window Primary Reagent Window Access the Primary Reagent window by selecting the Primary Reagent Compartment at the workspace. A yellow LED under the reagent pack indicates that a calibration is required. Reagent and Calibration Stability Reagent and Calibration Stability A yellow Reagent and Calibration Stability status button could indicate that a calibration has expired.  To investigate this situation, select the button from the status bar.  Calibration Expired indicates that the calibration has passed its calibration interval.  Calibration due to expire in 24 hours.Current Calibration Tab Current Calibration Tab in Results Access by selecting Results and then Current Calibrations.  Calibration status, worklist date and expiration date are displayed. Valid: The calibration is acceptable Invalid:  The calibration did not pass Expired: The calibration has passed its calibration interval Verify: The calibration has exceeded the observed ranges but is within the defined ranges To perform a calibration: Locate the Master Curve card and enter the values into the software.  Scan in calibrator values from the Calibrator Assigned value card.  Prepare and load calibrator material into the Sample Compartment.  Start the calibration run.  Select Next to continue.   This test consists of an automated blood cell count and a photometric determination of hemoglobin concentrations (red blood pigment). It provides information about the white and red blood cells and blood platelets. Test parameters of the blood cells include number, size, shape, type and several physiological characteristics. Within one or two minutes the analyzer can count thousands of red or white blood cells and blood platelets, and then compare these results with established standard values.   Scan the Master Curve card when new lot of reagent is loaded. To scan the Master Curve card: Locate Master Curve card in reagent box Access the Definition window Select the Master Curves tab Scan the Master Curve card   Entering Master Curve Card Values Learn about entering Master Curve Card values into the software. Checklist TitleChecklist TypeChecklist ContentReceive Master Curve MessageHTML If you load a new lot of reagent onto the system, a message will appear if the master curve has not been scanned yet. Select each checkbox to learn more about scanning the Master Curve Values.Locate the Master Curve CardHTML Open the reagent box to find the Master Curve Card. The Master Curve Card is specific to the reagent lot number and is developed during the manufacturing process. Use the ADVIA Centaur® CP side of the card. Access Definition ScreenHTML To access the Definition Screen, select the Definition button on the workspace and then the Master Curves tab.Select ScanHTML Select the Scan button.  The Scan Master Curve window will open.Scan the CardHTML Remember to scan the barcodes from top to bottom with the handheld scanner.   Note: This card can be scanned in even while the instrument is processing samples.Close the WindowHTML Once you have scanned the data, the Master Curve Details window appears. Select Close to exit the window.   When complete, select the X in the upper-right corner to close the window and continue. Scan Calibrator Definition card when a new lot of calibrators is in use. To scan the Calibrator Definition card: Locate the Calibrator Definition card in the calibrator kit Access the Definition screen Scan the Calibrator Definition card   Scan Calibrator Value Learn about scanning the Calibrator Definition card into the software. Checklist TitleChecklist TypeChecklist ContentDetermine calibrator materialHTML Look at the reagent box. Both the reagent box and the individual reagent pack indicate the calibrator type to use. Be sure to choose the correct calibrator material for the reagent. In this example, you need Calibrator type B to calibrate Total hCG.    Select each checkbox to learn more about scanning the Calibrator Definition card.Locate Calibrator Definition cardHTML Open the box of calibrator material and locate the Calibrator Definition card. Select the card that is labeled ADVIA Centaur® CP.Access Definition windowHTML At the workspace, select the Definition button.  Select the Calibrators tab. Note: This card can be scanned in even while the system is processing samples.Select ScanHTML Press the Scan button.  The Scan Calibrator window will open.Scan CardHTML Use the handheld barcode scanner to scan the barcodes from top to bottom.Select CloseHTML When the software has successfully received all the data, the Calibrator Details window opens. Select Close. When complete, select the X in the upper-right corner to close the window and continue. To schedule a calibration: Load the calibrators into the sample compartment Access the Reagent Compartment screen Select the reagent pack Select Calibrate   Note: Refer to the calibrator Instructions for Use for preparation and storage requirements. How to start the Calibration Learn about scheduling a calibration. Checklist TitleChecklist TypeChecklist ContentLoad CalibratorsHTML Load the calibrators into the sample compartment.   Select each checkbox to learn more about scheduling a calibration.Access Primary Reagent screenHTML Select the primary reagent compartment from the workspace.Select the Reagent PackHTML Select the reagent pack that needs to be calibrated.  Make sure there is sufficient reagent in the pack to perform the calibration. Each level of calibrator is run in triplicate during initial calibration and in duplicate during recalibration. If there is not enough reagent, load a fresh pack. If there is more than one pack of the same lot number on the system, only one pack from that lot needs to be calibrated.  The reagent lot can be viewed in the Reagent Lot field when the pack is selected.Select Calibrate buttonHTML To schedule the calibration, select the Calibrate button. Make sure to select the button only once per assay lot to avoid scheduling multiple calibrations on the same assay.  View Most Recent Calibration columnHTML The calibration will start automatically when Calibrate is selected.  Information about the calibration run will now appear in the Most Recent Calibration column.    When complete, select the X in the upper-right corner to close the window and continue. Schedule a Calibration Run Practice scheduling a calibration. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90003351/sim_CP_ScheduleCalibration800x600_9/sim_CP_ScheduleCalibration800x600_9.swfHTML5 File:/content/generator/Course_90003351/sim_CP_ScheduleCalibration800x600_9/index.htmlPDF File: Schedule a calibration without barcodes Learn about scheduling a calibration without barcodes. Checklist TitleChecklist TypeChecklist ContentLoad CalibratorsHTML Load the calibrators into the sample compartment. Select each checkbox to learn more about schedule a calibration without barcodes.Access Sample Compartment screenHTML Select the sample compartment from the workspace.Enter Calibrator Sample IDsHTML Select the lane containing the sample rack with the calibration material.  The calibrators without barcodes will be displayed as white boxes on the Sample Compartment screen. Enter the calibrator sample IDs.  The ID for a calibrator always start with a letter C followed by the letter indicating the calibrator type, then the lot number followed by an L for the low level and an H for the high level.  In this example, CA74L is the low level for calibrator A lot number 74. Once the information is in the sample ID field, the sample type indicator automatically displays "cal" to indicate the system recognizes the sample as a calibrator.Access the Primary Reagent screenHTML Select the primary reagent compartment from the workspace.Select the Reagent PackHTML Select the reagent pack that needs to be calibrated.Select Calibrate buttonHTML To schedule the calibration, select the Calibrate button. View Most Recent Calibration columnHTML The calibration will start automatically when Calibrate is selected.  Information about the calibration run will appear in the Most Recent Calibration column. When complete, select the X in the upper-right corner to close the window and continue. Information should appear in the “Most Recent Calibration” column.  If it does not, something is preventing the run from starting. Check the Event Log.   The following conditions cause a failure to start calibration: Calibrators are not defined Master Curve is not defined Reagent has expired Calibrator material is in not in the sample compartment Calibrator material has reached the expiration date. Correct the condition.   Select  “Calibrate”  button.   Select Next to continue.   To print calibration results, first make sure the system is connected to a local or network printer. Then follow these steps: Select the calibration Select Print and enter options Select the report type Select OK Printing Calibration Results Learn how to Print Calibration Results. Checklist TitleChecklist TypeChecklist ContentSelect the calibrationHTML From the Current Calibrations tab, select the calibration you would like to print. Multiple calibrations can be selected by first selecting the check box on the right of the window.   Select each checkbox to learn more about How to Print Calibration Results.Select Print & OptionsHTML Select Print to open the Print Calibration window.  Options can be selected from this window as needed including: Today’s records, All records, or a Range of records.  Select ReportHTML Select the Report type: Calibration Summary - a list of calibrations and their status Calibration Details - calibration status and calibration evaluation criteria Select the OK button to print the report. When complete, select the X in the upper-right corner to close the window and continue. Accepting a calibration:  Verify status Outside of observed instrument 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 Accept a Calibration Practice accepting a calibration. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90003351/sim_CP_Accept_800x600_9/sim_CP_Accept_800x600_9.swfHTML5 File:/content/generator/Course_90003351/sim_CP_Accept_800x600_9/index.htmlPDF File: Accepting a Calibration Learn about accepting a calibration. Checklist TitleChecklist TypeChecklist ContentAccess Current Calibrations tabHTML Select Results from the workspace and then select the Current Calibrations tab. Select each checkbox to learn more about accepting a calibration.Select the CalibrationHTML Selection the calibration that is in the Verify status.  Press the Details button.Select Accept CalibrationHTML Select the Accept Calibration button to allow the instrument to calculate results for samples using this calibration.Review StatusHTML The status changes to Accepted and results for this test will be flagged as Calibration Accepted. When complete, select the X in the upper-right corner to close the window and continue. The Control Entry screen allows the you to identify control material run on the IMMULITE 2000 XPi System.  To access the Control Entry screen, select QC from the Horizontal Toolbar and then Data Entry from the QC window. Select the link below to learn about the Control Entry screen. The Results area has two tabs for Calibration: All Calibrations tab: displays both current and historic calibration data Current Calibrations tab: displays a summary list of the current calibrations on the analyzer To see if the two-point calibration met the criteria and was successful, select the Current Calibrations tab.   Specific information about each calibration is displayed including Assay name, reagent lot, calibrator lot, Status, Worklist Date, and Expiration Date.   Status Column: Indicates if a calibration was successful: Valid : calibration passed the criteria Expired : the current calibration has passed the expiration date Invalid : the calibration was unsuccessful. Verify : a calibration that needs to be reviewed and accepted before it is considered Valid. Reviewing calibration data Learn about reviewing calibration data. Checklist TitleChecklist TypeChecklist ContentAccess Results screenHTML Select the Results button from the workspace. Select each checkbox to learn more about reviewing calibration data.Select Current Calibrations tabHTML To view the status of calibrations, select the Current Calibrations tab.Select Details buttonHTML Select the Details button to open the Calibration Details window.  The top of the window displays information about the calibrator lot, the reagent lot and the type of calibrator used.  To the right, the date and time of the calibration run is displayed along with the calibration status.View Calibration ResultsHTML The Calibration Results area shows the low and high calibrator data.  This information is helpful when troubleshooting an Invalid calibration. The green check marks indicate that specific calibration evaluation criteria were within range. The Master Curve or defined ranges that were entered when the Master Curve card was scanned are listed in the Limits area.  If Instrument or 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 upper-right corner to close the window and continue. Invalid calibration simulation Learn about Invalid calibrations. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90003351/sim_CP_Invalid800x600_9/sim_CP_Invalid800x600_9.swfHTML5 File:/content/generator/Course_90003351/sim_CP_Invalid800x600_9/index.htmlPDF File: Before leaving the first chapter, let's summarize some facts in an exercise. Calibration Evaluation Criteria: CV Ratio Slope Low and High Calibrator Deviations Note: Criteria that are within the defined ranges will have a green check on the Calibration Details screen. Calibration Evaluation Criteria Learn about Calibration Evaluation Criteria. Base ImageHotspotsText BlocksImage File Slope is a comparison of high and low calibrator RLUs to the Master Curve. Ratio is a comparison of low and high calibrator RLUs. CV is the precision of the calibrator replicates based on RLUs. Master Curve: These are the defined ranges that were entered from the Master Curve card. Instrument: These are observed ranges.  After 4 calibrations of the same reagent lot and calibrator lot combination, the system calculates observed ranges.  When you perform subsequent calibrations on the same reagent and calibrator lot combination, the system compares results to the Master Curve defined ranges and the observed ranges determined by the system.  The system recalculates the observed range with each valid calibration. Low and High Calibrator Deviations are a measure of how well the high and low calibrator RLUs fit the Master Curve. Critical Precision is a value used by the system to determine whether an outlier is too far out to be automatically excluded.

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