Atellica Calibrations

[Audio] Good morning everyone. Today's presentation will cover the importance of Atellica's calibrations, the process for evaluating post calibration QC, and the understanding of patient correlations. We aim to give you a greater understanding of how these elements interact. Let's get started..

[Audio] Calibrations are essential for the reliability of laboratory results. In the preceding part of this presentation, we examined calibrations for Atellica 1 and Atellica 2 analyzers. The CH Analyzer supports Lot, Pack, and CO Adjust calibrations, and the IM Analyzer supports Lot and Pack Calibrations. In addition, calibrations on both Atellicas have to be done at 11 pm and 3 pm each day. Any new reagent lot calibrations must be performed by the first shift on both Atellicas. The upcoming part of this presentation will pinpoint Green vs. Red Calibration Due Tile and the Sample Interventions Tile, which are critical tools for keeping Atellica calibrations. I am looking forward to detailing how they can be utilized..

[Audio] When deciding on whether to accept a calibration, it is essential to examine if all acceptance criteria have been satisfied. Furthermore, replicates should be analyzed to confirm accuracy. Precision is a measurement to evaluate how closely various measures of the same quantity match each other. If the answer to either of these queries is negative, then the assay must be recalibrated..

[Audio] Presenting a slide on Atellica calibration, part two, we must evaluate the post calibration quality control results to consider if the results are acceptable in the Atellica Diagnostics Monitoring system. Acceptability is determined by the QC results being within two standard deviations from the mean. If a sample is no more than three, but more than two standard deviations away from the mean, then we have two options. First, rerun the same vial of QC one time, or rerun with a fresh vial. If the results are still outside of two standard deviations, patient correlations are required. If the sample is more than three standard deviations away from the mean, then the calibration is unacceptable..

[Audio] Patient correlations can be used to diagnose and solve hardware issues, reagent issues or the QC Matrix Effect. Data can be compared to previous patient samples, run on a valid calibration, and those with the new calibration. CAP samples that have been previously assessed can also be utilized for patient correlations; they are essential in pinpointing hardware faults and guaranteeing results are accurate..

[Audio] Atellica puts a great emphasis on accuracy and reliability when calibrating tests. It is necessary to consider the Analytical Measurement Range (AMR) to ensure proper calibration. To validate accuracy, patient samples must cover the full AMR range. For instance, when calibrating Glucose, a low, medium, and high sample spanning the 4-700 mg/dL range, with no dilutions, should be included. Correlations should also be made for specimen types such as serum/plasma, urine, and cerebrospinal fluid. Atellica's thorough approach makes sure that calibrated tests are reliable and accurate..

[Audio] Atellica offers high-accuracy calibrations in the healthcare sector. Our revolutionary patient correlations program ensures patient results are compatible with CAP Survey Assays, ClinLabScans, CAP Evaluations for 2022 and 2023, as well as the table of results in the slide. Our meticulous review helps to guarantee healthcare practitioners receive the most precise readings for their patients..

[Audio] In part two of our presentation, we discuss patient correlation acceptability criteria. If all values are within the total allowable error for the assay, the patient results are fit for use. The allowable total error limits for chemistry are specified in the document GEN.ATEL.005B. If any of the patient correlation values fail, the assay must be recalibrated. All calibrations that require patient correlations must be reviewed by a technical specialist or LTIII, and the form GEN.ATEL.005A must be filled out to keep a record..

[Audio] Calibrations are necessary to guarantee correct results when operating with Atellica devices, and there are now two distinct types of calibrations. To implement new reagent lot calibrations or troubleshooting calibrations, GEN.ATEL.005A form must be printed and completed. Likewise, all pack or lot calibrations must be stored as a PDF inside the analyzer. Moreover, all calibrations must be inspected on a regular basis by a LTIII and Tech Specialist to ensure accuracy..

[Audio] To ensure accuracy and validity of the results, post-calibration quality control must be documented in the appropriate database with coded comments. Troubleshooting must also be documented during calibration, such as repeating a control with the same control vial, running quality control with a fresh vial, replacing a reagent pack, or performing patient correlations for calibration. It is important to note that a 1-2S rule cannot be used during calibration..