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IMMULITE® 2000 XPi Immunoassay System Kit Entry and Adjustment Online Training

Kit entry and adjustment includes following the steps required to successfully load and adjust kit components for optimal assay performance. This clinical laboratory training qualifies for continuing education units (CEU).

Welcome to the IMMULITE® 2000 XPi System Kit Entry and Adjustment Online Training course.  This course introduces you to: The critical procedures of loading kit components The required steps to perform adjustments The guidelines used to validate an adjustment Select Next to continue. Describe how adjustment is part of the calibration process Identify kit components List the adjustment validation guidelines Load and order adjustors Load kit components Scan kit barcodes Upon successful completion of this course, you will be able to: Select Next to continue. Congratulations. You have completed the IMMULITE 2000 XPi System Kit Entry and Adjustment 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.   Key Points In this online training course, you learned how to:   Identify kit components: Kit Barcode - The kit barcode is located on the box flap inside the kit and must be entered the first time a kit lot is used. IFU - Contains specific information regarding the assay, including how to handle and store kit components Important Notice - Contains information regarding usage of the assay kit components Reagent Wedge - Can remain on the system until they are empty or expired. The onboard stability of reagent wedges is 90 days. Bead Pack - Can remain on the system until they are empty or expired. The onboard stability of bead packs is 90 days. Adjustors - Each kit contains one or two adjustors. Kits with two adjustors have a low and a high adjustor. The adjustor can be in either liquid or lyophilized form. Each kit also contains adjustor barcode labels, which are used to identify the sample tube as an adjustor for that particular test.   Scan kit barcodes.  This which must be done before loading beads and reagents from a new kit lot onto the system.  Kit barcodes can be scanned into the database from any screen.  To scan the kit barcode: Hold the scanner five to seven inches away from the kit barcode. Keep the angled face of the scanner parallel to the barcode. Press and hold the trigger button on the scanner and point the scanner beam at the center of the barcode. Hold the scanner button until a tone sounds to indicate that the barcode was read successfully. When the barcode is successfully scanned, the Kits screen appears, displaying the information about the kit lot. Load the bead pack and reagent wedge kit components onto the system.  To load a bead pack or reagent wedge, first pause the system and then select the position to load on either the Bead or Reagent screen. Loading reagent wedges: Before loading a reagent wedge onto the system: Remove the clear tape and foil seal  from the wedge Check the wedge for bubbles and ensure that the top of the wedge and the glide are dry Ensure the glide moves back and forth smoothly on top of the wedge To load a reagent wedge: Tilt the barcode side of the wedge down as the wedge is placed in a carousel slot Press down on the narrow side of the wedge to lock it in place Ensure the glide moves freely Close the reagent carousel cover Loading bead packs:    Place the bead pack in a carousel slot with the barcode facing out    Tilt down the side of the bead pack opposite to the barcode label    Snap down the barcoded side of the bead pack to lock it in place    Close the bead carousel cover Load and order adjustors.  An adjustment must be run before using a new kit lot, and kits must be readjusted periodically according to the schedule in the kit's IFU.  To run adjustors: Load adjustor tubes onto the system Select Worklist Select Next Enter kit lot number Select Accept Adjustor Review Display/Edit screen Describe how adjustment is part of the calibration process and list the adjustment validation guidelines. The three Adjustment Validation Guidelines are: QC results obtained after an adjustment should fall within the laboratory expected range and should not show a consistent large bias. The Slope of the adjustment needs to be evaluated.  If it is an initial adjustment, the slope should fall within the instrument’s slope range.  If it is a re-adjustment, the slope should fall within plus or minus ten percent of the previous slope for that assay. The adjustment Intercept needs to be evaluated.  If the absolute value of the intercept exceeds the intercept guideline, QC results should be used to determine if the adjustment is valid. Select Next to continue. The components that make up an IMMULITE 2000 XPi System kit include the following: IFU Kit Barcode Important Notice Bead Pack Reagent Wedge Adjustors Note:  Some kits will also have kit specific controls included in the kit (for example, Insulin and some infectious disease kits).   Kit Components Learn more about Kit Components. Base ImageHotspotsText BlocksImage File IFU The IFU (Instructions for Use) contains specific information regarding the assay, including how to handle and store kit components. It is good practice to read the IFU before using a new kit.  Kit Barcode The kit barcode is located on the box flap inside the kit. Information specific to the kit lot is included in the barcode and must be entered the first time a kit lot is used.  Important Notice Important notices contain information regarding usage of the assay kit components. If a particular kit box contains an important notice, a sticker on the outside of the kit package alerts you that an important notice is enclosed.  Bead Pack A bead pack contains the assay-specific beads, which are the solid phase of the reaction. During test processing, a single bead is dropped into a reaction tube. Bead packs can remain on the system until they are empty, have reached the expiration date, or have exceeded the 90 day onboard stability limit.     Reagent Wedge A barcoded reagent wedge contains an assay-specific enzyme conjugate. During test processing, the reagent is pipetted into the reaction tube. The reagent wedges in allergy kits contain an anti-immunoglobulin reagent used for allergy tests with all allergens.  Reagent wedges can remain on the system until they are empty, have reached the expiration date, or have exceeded the 90 day onboard stability limit.    Adjustors Each kit contains one or two adjustors. Kits with two adjustors have a low and a high adjustor, which contain different concentrations of analyte. The adjustor can be in either liquid or lyophilized form. Each kit also contains adjustor barcode labels, which are used to identify the sample tube as an adjustor for that particular test.  Before using a new kit lot, the kit barcode for the new lot must be entered on the system using the hand-held 2D barcode scanner.  The kit barcode should be scanned before loading beads and reagents from the new lot onto the system.   Scanning Kit Barcodes Learn about scanning kit barcodes.   Select the play arrow to begin the video.  When complete, select the X in the upper-right corner to close the window and continue.    The following components need to be loaded on the system for each test being run: Reagent wedge Bead pack Loading Kit Components Learn how to load kit components. Checklist TitleChecklist TypeChecklist ContentPause the SystemHTML     Select the play arrow to begin the video. Select each checkbox to learn more about loading kit components.  Select Position to LoadHTML After the appropriate carousel is in pause mode you can use the carousels status screen to select a position to load the reagent wedge or bead pack.  When a position is selected the carousel rotates so that position is accessible.   Loading a Reagent WedgeHTML     Select the play arrow to begin the video.  Loading a Bead PackHTML     Select the play arrow to begin the video.     When complete, select the X in the upper-right corner to close the window and continue.   Before using a new kit lot, an adjustment must be run. This corrects for any variations in performance between your system and the manufacturer's system. Kits must also be readjusted periodically. The adjustment frequency for a kit is indicated in the IFU. The reagent and bead screens indicate if an adjustment is due. Note:  Proper preparation, storage and handling of adjustor material is critical to achieving accurate results. Refer to the IFU for information about each assay.   Sample Tube Sizes and Dead Volumes Learn More about sample tube sizes and dead volumes. The following primary and secondary round bottom tube sizes may be used by the system:   12 x 75 mm 13 x 75 mm 16 x 75 mm 12 x 100 mm 13 x 100 mm 16 x 100 mm The sample volume required varies with the assay to be run and the number of replicates requested on that sample. The exact sample volume required for each test can be found in the corresponding instructions for use. An additional 250 µl of sample is required for proper instrument operation. For adjustors, the total required sample volume would be four times the sample volume (since the adjustors are always run in replicates of four) plus 250 µl dead volume.   When complete, select the X in the upper-right corner to close the window and continue. Single Adjustor Assays Learn More about single adjustor assays. In qualitative assays, the results are classified as non-reactive or reactive, or possibly indeterminate. The results in these assays are calculated by comparing the signal obtained for a patient sample to a cut-off signal. When complete, select the X in the upper-right corner to close the window and continue.    Load Adjustor Tubes Learn how to load adjustors.   Select the play arrow to begin the video.  When complete, select the X in the upper-right corner to close the window and continue.    Running Adjustors Learn how to run adjustors. Instructions:If media does not automatically start, select the play arrow to begin.Flash File:/content/generator/Course_90003558/sim_IMMXPi_RunningAdjustors_9/sim_IMMXPi_RunningAdjustors_9.swfHTML5 File:/content/generator/Course_90003558/sim_IMMXPi_RunningAdjustors_9/index.htmlPDF File: Running adjustors is part of the calibration process on the IMMULITE 2000 XPi System.  The system uses the results from the adjustors to calculate patient results. Adjustment and Calibration Process Learn about the adjustment and calibration process. Slide NumberText BlocksCalloutsAudio ScriptImage File1Calibration on the IMMULITE 2000 XPi System is a two step process: Master Curve Established by the manufacturer Encoded in the kit barcode Concentration vs Signal Adjustment  The result of running the low and high adjustors Master Curve CPS vs Customer CPS  Select Next to continue.Note: If audio does not automatically start, select the play arrow in the top left to begin.Calibration on the IMMULITE 2000 XPi System is a two step process. In the first step, a master curve is created. The master curve is a calibration curve generated by the manufacturer for every kit lot. A series of calibrators is run in many replicates on a master instrument at the Siemens site. Through the master curve, the relationship between concentration and signal is established. The information for the master curve is encoded in the kit barcode that is scanned into the customer’s instrument with each new kit lot. The master curve cannot be used on its own to calculate patient results because the master curve was generated on a different instrument than the one being run in the customer lab. There are subtle differences in the signal measurement from instrument to instrument. To compensate for these differences, an adjustment is performed, which is the second step of the calibration process. During an adjustment, the low and high adjustors are run on the instrument. The CPS, or counts per second, results of these adjustors are compared with the master curve adjustor CPS values from the kit barcode, and a relationship between master curve CPS and the instrument CPS is established. Select next to continue.2 The adjustment and master curve are used together to calculate results from CPS values generated by the instrument. The results from adjustors are used to create the relationship between master curve CPS and the customer’s instrument CPS. This relationship can be described by a straight line, which has a slope and an intercept. When an unknown patient sample is run on the customer’s instrument, the instrument measures a CPS value from that sample.  The adjustment relationship is used to convert that customer CPS into a master curve CPS value.  In other words, the instrument determines what the CPS value for that unknown patient sample would be if that sample had been run on the master instrument.  Select Next to continue.   Now we’ll look at how the adjustment and master curve are used together to calculate results from CPS values generated by the instrument. As we discussed on the previous slide, the results from adjustors are used to create the relationship between master curve CPS and the customer’s instrument CPS. This relationship can be described by a straight line, which has a slope and an intercept. When an unknown patient sample is run on the customer’s instrument, the instrument measures a CPS value from that sample. The adjustment relationship is used to convert that customer CPS into a master curve CPS value. In other words, the instrument determines what the CPS value for that unknown patient sample would be if that sample had been run on the master instrument. Select next to continue.3 After the master curve CPS for the sample has been calculated from the adjustment relationship, that CPS value is plugged into the master curve in order to obtain the concentration.  By using the adjustment curve to adjust the CPS signal, we are able to use the master curve directly to calculate the concentration result.  Select Next to continue. Once the master curve CPS for the sample has been calculated from the adjustment relationship, that CPS value is plugged into the master curve in order to obtain the concentration. By using the adjustment curve to adjust the CPS signal, we are able to use the master curve directly to calculate the concentration result. Select next to continue.4 In summary, calibration on the IMMULITE 2000 XPi system is a two step process. In order to calculate accurate patient results, the system requires both a master curve and a valid adjustment.  When complete, select the X in the upper-right corner to close the window and continue.In summary, calibration on the IMMULITE 2000 XPi system is a two step process. In order to calculate accurate patient results, the system requires both a master curve and a valid adjustment. After we have a set of adjustment results, we use the adjustment validation guidelines to decide whether or not the adjustment is valid.  The adjustment validation guidelines involve three steps: Evaluating the controls Reviewing the slope Evaluating the intercept Validating Adjustment Results Learn how to validate adjustment results. Slide NumberText BlocksCalloutsAudio ScriptImage File1The first and most important adjustment validation guideline is to evaluate the quality control results: Run QC samples every time adjustors are run. The QC results must be within laboratory expected limits.  Select Next to continue.Note: If audio does not automatically start, select the play arrow in the top left to begin.The first and most important adjustment validation guideline is to evaluate the Quality Control results. Quality control must be run immediately following an adjustment. The results obtained for the control samples should be within acceptable limits as established by the laboratory and should not show a consistent large bias toward either the upper or lower acceptable limits. This is the primary and most important means of validating an adjustment. Select next to continue.2The second guideline that we need follow is to evaluate the slope. The value for the slope can be found in the upper left portion of the Adjustment Report.   Select Next to continue.  The second guideline that we need follow is to evaluate the slope. The value for the slope can be found in the upper left portion of the Adjustment Report. Select next to continue.3For an initial adjustment: Slope reflects matching instrument to master curve instrument Range: should fall within Instrument Slope Range   Select Next to continue.  There are two guidelines for determining if the slope is acceptable, depending on if the adjustment was an initial adjustment or a readjustment. An initial adjustment is the first time that kit lot is ever adjusted. Each instrument has an average slope, which is based on the slopes for all initial adjustments from all tests run on that instrument. The slope of an initial adjustment for any new kit lot should fall within plus or minus twenty percent of the instrument’s average slope. This range is referred to as the Instrument Slope Range, and is displayed on the Adjustment Report. Select next to continue. 4For a readjustment: Slope reflects changes in chemistry over time Range: should fall within +/-10% of the previous slope for that assay  Select Next to continue.  Every assay must periodically be readjusted, as indicated in the kit’s instructions for use, in order to correct for the reagent’s normal loss of activity over time. The slope from a readjustment should fall within plus or minus ten percent of the slope from the last adjustment for that kit lot. This range is referred to as the plus or minus ten percent of previous slope, and is displayed on the Adjustment Report. Select next to continue.5If the slope is just outside of range: Adjustment is likely valid Verify that QC results are as expected Treat slope range as a “reference range”   Select Next to continue.  Now, let’s look at an example of applying the slope range to slope values from an adjustment. Remember, the adjustment validation criteria are called guidelines and not rules. In other words, if the slope is out of range, there might not be a problem, and therefore it doesn’t necessarily mean you should determine that the adjustment is not valid. In this example on an initial adjustment, the instrument slope range on the adjustment report is 0.77 to 1.15. Slope values that fall somewhat outside of this range may still be acceptable as long as the QC results are not biased in the same direction and the current slope is consistent with previous slopes for the same assay. For example, if the slope is 1.2 or 0.75, it is important to verify that the quality control sample results are not biased in the same direction. Treat the slope as a reference range, recognizing that results just outside the reference range do not necessarily mean something is wrong. Select next to continue.6If the slope is slightly worse, adjustment may still be valid: If QC results are close to expected mean  If the assay slope has historically been near the range limits   Select Next to continue.  If the slope is a bit worse, for example 1.4 or 0.6, the adjustment may still be valid depending on several factors. If the quality control results are not consistently biased in the same direction and the slope for the assay has historically been near the same limit of the slope range, the adjustment is likely valid. Select next to continue.7If the slope is less than 0.5 or greater than 1.8: There is a problem Adjustment is not valid, even if the QC results are acceptable Slope will be flagged by software    Select Next to continue.  A slope less than 0.5 or greater than 1.8 indicates a problem and the adjustment is not valid, even if QC is within range. In this case, the slope will be flagged by the software. Select next to continue.8The last adjustment guideline involves evaluating the adjustment intercept. The intercept is located in the top right portion of the Adjustment Report.  Underneath the intercept, the intercept guideline is displayed. The absolute value of the intercept printed on the Adjustment Report should be less than or equal to the intercept guideline.  Select Next to continue.  The last adjustment guideline involves evaluating the adjustment intercept. The intercept is located in the top right portion of the Adjustment Report. Underneath the intercept, the intercept guideline is displayed. The absolute value of the Intercept printed on the Adjustment Report should be less than or equal to the Intercept Guideline. Select next to continue.9Guideline set to give early warning: Can result from normal assay imprecision during adjustment May increase over time due to increased non-specific binding as reagent ages Not necessarily rejection of the current adjustment Intercepts can also signal a problem: Contamination of instrument / water  Problem with reconstitution of adjustor Contaminated adjustor Impact is reflected in QC results: Check QC at low and high decision points For intercept exceeding guideline, final decision on accepting adjustment based on QC  Select Next to continue.  The intercept guideline is indicative of an early warning rather than a pass / fail criteria. Intercepts that exceed the intercept guideline do not necessarily indicate a failed adjustment. High intercepts may occur due to assay imprecision, even though the imprecision is within the assay specifications. In some assays, intercepts may increase over time due to increased non-specific binding as the reagent ages. It is rare for an adjustment to be considered invalid solely due to a high intercept. However, intercepts should always be monitored because an increased intercept can alert operators to other problems, such as contamination or issues with the adjustors. If the absolute value of the intercept exceeds the guideline, the final decision on accepting the adjustment should be based on the QC results. For example, it’s possible for adjustments with large intercepts to still be considered valid if the QC near the low and high decision points are acceptable and do not indicate biased results. Select next to continue.10Two types of immunoassays: Sandwich Assay: direct relationship between concentration and signal Competitive Assay: inverse relationship between concentration and signal To determine whether an assay is a sandwich assay or competitive one, refer to the instructions for use. Large intercepts can affect the results for sandwich and competitive assays differently.   Select Next to continue.  There are two types of immunoassays: sandwich and competitive. To determine whether an assay is a sandwich assay or competitive one, refer to the instructions for use. A sandwich assay has a direct relationship between concentration and signal. In contrast, a competitive assay has an inverse relationship between concentration and signal. Large intercepts can affect the results for sandwich and competitive assays differently. Let’s take a look at some examples on the following slides. Select next to continue.11Sandwich Assays - large intercepts affect the lower range of the assay before the higher end of the range  Select Next to continue.  For a sandwich assay, a large intercept affects the lower range of the assay before it starts to affect the higher end. In this example, the intercept of an adjustment should be less than or equal to 10,570 CPS. The initial adjustment produced an intercept of 5,624 and the QC is within range as indicated on the slide. This intercept is acceptable. When the assay is readjusted, the intercept is equal to the intercept guideline and there is a 7% increase in the low level control. When the assay is adjusted the third time, the intercept increases to 15,855. Notice that there is a 13% increase in the low level control, but the high level control is still not affected. By the fourth adjustment, the intercept increases to 21,140 and now there is a 20% increase in the low level control and the high level control is only minimally affected. If an intercept exceeds the intercept guideline, and the QC bias is clinically significant, the adjustment should not be used, patient results should not be reported, and the problem should be investigated. Select next to continue.12Competitive Assays - large intercepts affect values across the range of the assay, especially those in the very high range of the assay  Select Next to continue.  In a competitive assay, a large intercept can affect values across the entire range of the assay, with the most significant impact at the high end. In this example, the absolute value of the intercept should be less than or equal to 403,239 CPS. For the initial adjustment, the intercept is 18,750 and the QC is within range as indicated on the slide. This intercept is acceptable. When this assay is adjusted again, the absolute value of the intercept is equal to the intercept guideline and now there is a 24% increase in the high level control and a 9.8% increase in the low level control. When the assay is adjusted for a third time, the absolute value of the intercept is 604,859 and there is now a 42% increase in the high level control and a 15.5% increase in the low level control. On the fourth adjustment, the absolute value of the intercept is 806,478 and now there is a 65% increase in the high level control and a 22% increase in the low level control. Again, if the bias noted in the QC is clinically significant, the adjustment should not be used, patient results should not be reported, and the problem should be investigated. Select next to continue.13After we have a set of adjustment results, we use the adjustment validation guidelines to decide whether or not the adjustment is valid.  The adjustment validation guidelines involve three steps:  Evaluating the controls Reviewing the slope Evaluating the intercept    When complete, select the X in the upper-right corner to close the window and continue.Let’s recap the three Adjustment Validation Guidelines. First, QC results obtained after an adjustment should fall within the laboratory expected range and should not show a consistent large bias. Second, the Slope of the adjustment needs to be evaluated. If it is an initial adjustment, the slope should fall within the instrument’s slope range. If it is a re-adjustment, the slope should fall within plus or minus ten percent of the previous slope for that assay. Last, the adjustment Intercept needs to be evaluated. If the absolute value of the intercept exceeds the intercept guideline, QC results should be used to determine if the adjustment is valid.

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