Atellica® Solution Reagent Comparison Job Aid

Atellica® Solution SIEMENS Healthineers Reagent Comparison Job Aid Reagent comparisons are performed by the laboratory to compare the results of a set of patient samples using variables of analyzer, lot or reagent pack. It may be to meet accreditation requirements or to troubleshoot assay issues. Other examples are: • Before using a new reagent lot with patient samples • To determine the % difference in results between reagent, packs or lots • To determine the % difference in results across analyzers within a system The laboratory selects a number of samples with concentrations spanning the measuring interval to use in the study. When the study completes, the operator reviews the Reagent Comparison report, evaluates the data, and accepts or rejects the study according to their laboratory's acceptance criteria. The acceptance criteria is part of the laboratory standard operating procedures. 1 Template Effective Date: 10 Aug 2021 | HILS 2223 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Atellica® Solution SIEMENS Healthineers Reagent Comparison Job Aid Setup > Test Definition > IM Test Definition 8 SH1-SCI1 LabManager To perform a reagent comparison (quantitative Select Tests assay type): ThCG (ng/mL) Assay Identification Advanced Test Name / ID Display Name * Replicates Acceptable CV % Definition* ThCG ThCG Test Type Patlent 0 0 Calculation Multicomponent Print Name ThCG 1. Confirm the test definition for both reagents O Calibration Test Version THEG Control o O is available on the system IM Status O Reagents IM CI Investigational Measuring Interval Lots 1.0 1.1 CI Status nvestigational Measuring Interval Low Measuring Interval High Regional Limit Low (USA) Regional Limit Low (International) For the Atellica® CH Analyzers, the test 1.2 14.5 1.2 • Ranges LOINC definitions are loaded automatically with Repeat Overdilution Point Compatibility Code Enter Slope new software updates. Specimen Type Minimum SW Version Enter Intercept General Serum;Plasma 0 Add Result M Region Result Review Mode International; USA O SMT • For Atellica® IM Analyzers, scan the MC None CI Region International; USA Recalibrate After Update TDEF 2D barcode for the new reagent lot. Reuse Result for Ratio Centerfuge Before Repeating Manual Dilution For more information, refer to these Result Time Limit (hours) 99 Control-Bracketed Test Range Window Levels Bracket Timeout (hours) Reminder (hours) Analyte Stability (minutes) 4 24 O resources: 0 o Online Help: Scanning IM Master Curves and Assay Test Definitions 2D Import BLOB Copy Test Import TDefs Export TDefs Scan Barcode Restore Defaults Save Cancel Barcodes o PEPconnect: Scanning MC TDEF Barcodes on the Atellica® IM Analyzer Video 2 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Atellica® Solution SIEMENS Healthineers Reagent Comparison Job Aid 2. Load and calibrate the 2 reagents > Reagent Overview SH1-SCI1 abManager • If you are calibrating a new lot, consider how you 7 All No Filters Reagent Details Tx will configure the system to ensure that patient O Analyzer Reagent nventory OBS Sequence al Status Cal Exp Cal Type In Use QC Status Lot Cal Eligibility O CH-01 Alb 1655 13 d 7 h 00744 13 d 7 h Lot 201116 Lot & Pack Filters samples will not be run on the new lot during the KI 0 CH-01 Chol_2 2066 7 d 21 h 01304 13d7h Pack 01304 Lot & Pack evaluation. Options for this include: CH-01 Dgn 305 2 d 19 h 01212 / 01184 13 d7 h Pack 100123 Lot & Pack CH-01 GluH_3 1429 29 d 17 03959 / 06470 9 d 22h Pack 201137 Lot & Pack o Disable the new lot until you’re ready to do the O CH-01 Mg 178 od 19 h 08717 / 06660 2 d 18h Pack 202247 Lot & Pack comparison study: Reagent Overview > Select O CH-01 RPC1 409 46 d 18 04690 / 04145 100104 Disable Reagent Lot CH-01 RPC1 401 46 d 18 h 04709 / 04167 100104 CH-01 RPC2 157 3 d 16 h 03187 / 03190 100108 Put the assay into troubleshooting mode. This CH-01 RPC2 418 Oh 03188 / 03189 100108 o O CH-01 RPC2 418 03190 / 03187 100108 allows you to run studies but the system will not O CH-01 RPC4 221 04643 10147 run patients on the assay: Assay List > Select O CH-01 RPC4 442 04647 10147 appropriate assay > Select Troubleshooting from CH-01 RPC4 449 04790 10147 Lot & Pack CH-01 TP 1737 62 d 20 h 07162 / 06762 V 3 d 17 h Lot 201265 Lot & Pack drop-down menu Group by Reagent Disable Reagent Pack Disable Reagent Lot Unload Take the whole analyzer off line after running Related Reagent Needs Reagent Loading o the study calibrations: System Status bar > Select analyzer > Uncheck Patient Sample Processing 3 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Atellica® Solution SIEMENS Healthineers Reagent Comparison Job Aid SIEMENS Healthineers Atellica Solution 8 SH1-SC11 abManager 2 Troubleshooting System SH-01 SH-02 CH-01 CH-02 IM-01 CI-01 Others Shortcuts 3. Navigate to Reagent Comparison Lab Evaluation Reagent Loading A. Navigate to Lab Evaluations Reagent Overview B. Select Reagent Comparison Lab Evaluations 8 SH1-SCI1 LabManager Create Evaluation A Lab Evaluations C. Select Next Comparison Evaluations Measuring Interval Verification Evaluation Precision Evaluations O QC Parallel Automatic Measuring Interval Verification O Simple Precision This evaluation allows the laboratory to analyze a new lot of QC This evaluation assesses the measuring intervals of assay reagents This evaluation tests precision of up to 3 samples and provides mean, material for each assay in parallel with the lot of QC material in use using serial dilutions of a high concentrated sample. Compare the SD and CV for each sample measured values to the dilution predicted values after plotting the data on a graph. High level calibrators are appropriate for use B Reagent Comparison 1 Manual Measuring Interval Verification This evaluation offers a comparison of results between two reagent This evaluation assesses the measuring intervals of three or more packs of the same assay samples with concentrations spanning the measurement intervals. Enter individual targets and intervals as appropriate C Next Cancel 4 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Atellica® Solution SIEMENS Healthineers Reagent Comparison Job Aid 4. Configure the Parameters: Lab Evaluation 8 SH1-SCI LabManager Create Evaluation Lab Evaluations A. In Evaluation Name, leave the default name Create New Comparison Study - Reagent Comparison or enter the operator-defined name for the 1 2 3 Parameters Samples Summary study. The Study ID automatically populates. B. In Assay, select the appropriate Assay from A B C D Evaluation Name Assay Candidate Reagent Current Reagent the drop-down menu. The Specimen Type Study Name * Assay * Candidate Analyzer Current Analyzer Reagent Comparison_0001 TSH CH-01 CH-01 automatically populates based on TDEF Study ID 0001 Specimen Type " Candidate Reagent Lot * Current Reagent Lot * Serum 120 configuration. Candidate Reagent Pack " 987654321 Current Reagent Pack ID . 123456789 C. In Candidate Reagent, select the Candidate Analyzer, Candidate Reagent Lot, and Candidate Reagent Pack ID from the drop- down menu. This would be the one you are evaluating for patient testing. D. In Current Reagent, select the Current E Back Next Save Cancel Analyzer, Current Reagent Lot, and Current ? Q EE ), Reagent Pack ID from the drop-down menu. This is the one that is already acceptable for patient testing. E. Select Next 5 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Atellica® Solution SIEMENS Healthineers Reagent Comparison Job Aid 5. Configure the Samples Lab Evaluation SH1-SCI1 abManager Create Evaluation Lab Evaluations A. To create new SIDs, select New SIDs then enter First SID and select Number of Create New Comparison Study - Reagent Comparison 1 2 3 Samples Parametes Samples Summary Reagent Comparison Summary Study Name B. To use Existing SIDs, enter or scan the Reagent Comparison_0001 B Samples Study Id Sample ID 0001 A O New SIDs O Use Existing SIDs TSH First Sample ID Specimen Type C. Select Add 654321 Sample ID Range Serum Candidate Analyzer Number of Samples 40 CH-01 D. Select Next 3 - 100 Samples Candidate Reagent Lot Add C Candidate Reagent Pack ID 987654321 Candidate Analyzer CH-01 Current Reagent Lot 120 Candidate Reagent Pack ID 123456789 D Back Print Barcodes Next Save Cancel 6 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Atellica® Solution SIEMENS Healthineers Reagent Comparison Job Aid 6. Review the Summary ‹ Â Lab Evaluation 5H1-SCI1 abManager Create Evaluation Lab Evaluations A. Review the configuration of the study then select Place Order Create New Comparison Study - Reagent Comparison 1 2 3 Parametes Samples Summary B. To print barcodes for study, select Print Barcodes Reagent Comparison Summary C. Load study samples. Study Name Sample Selection Reagent Comparison_0001 Candidate Analyzer CH-01 New SIDs Study ID Candidate Reagent First Sample ID 0001 120 654321 D. Wait for the analyzer to complete Assay TSH Candidate Pack ID Number of Samples 987654321 40 processing of all samples. Specimen Type Sample ID Range Serum 654321 - 65436 Current Analyzer CH-01 Current Reagent Lot 120 Current Reagen 123456789 A Back Place Order Save Cancel 7 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Atellica® Solution SIEMENS Healthineers Reagent Comparison Job Aid < n Lab Evaluation 8 SH1-SCI1 abManager A 7. Review the results Create Evaluation Lab Evaluations Filters Yx Clear Filters: Analyzer: All X Assay: All X Study Type: All X Status: All X Date Range: 05/19/2022 - 04/19/2022 X A. In Lab Evaluations, select Lab Evaluations Study Type Study Name Study Id Start End Analyzer Assay Status C Analyzer All O QC Parallel QC Parallel_0001 0001 4/22/2022 6:18 AM 4/30/2022 11:51 PM CH-01 Multipl Accepted Detalls B. Select the appropriate study Assay B All Reagent Comparison Reagent Comparison_0001 0001 5/17/2022 5:51 AM 5/18/2022 5:59 AM CH-01 TSH In Progress Print Barcode Study Type C. Select Details to view study results All O Export Manual MIV Manual MIV_0001 0001 5/15/2022 8:02 AM CH-01 Chol In Progress Status Repeat All Automatic MIV Automatic MIV_0001 0001 5/3/2022 6:42 PM CH-01 Cho In Progress Delete By Date Range Automatic MIV Automatic MIV_0002 0002 4/21/2022 1:25 PM 3/12/2021 3:30 PM CH-01 Chol Accepted From 05/19/2022 O Simple Precision Simple Precision_0001 0001 5/18/2022 7:18 PM 5/19/2022 6:06 AM IM-01 AS Rejected To 04/19/2022 0 Within Lab Precision Within Lab Precision_0001 0001 5/8/2022 11:55 AM IM-01 K Awaiting Acceptance O Manual MIV Manual MIV_0002 0002 4/21/2022 1:25 AM CH-01 T4 Not Ordered NOTE: Reagent Comparison can be exported from this screen. 8 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 Atellica® Solution SIEMENS Healthineers Reagent Comparison Job Aid < n Lab Evaluation 8 SH1-SCI1 LabManager 7. Review the results, continued Details ? AX Filters D. In Statistical Tool, select the appropriate tool Reagent Comparison Summary Progress Summary for TSH (mg/dL) Reagent Comparison_0001 Candidate Analyzer CH-01 CALH CH3 Samples Lot Lot 2 Difference % from the drop-down menu Analyzer All Study ID 0001 Candidate Reagent Lot 120 QC Routine CALH CH31 Valid Valid Assay All Assay Candidate Reagent Pack ID 40931 TSH Sample Selection 5.2 5.3 0.10 987654321 New SID E. Select Refresh to update current results Study Type All Specimen Type Current Analyzer 40932 Sample IDs 10.01 10.23 15 Status Serum CH-01 654321 - 654361 All 40933 8.23 8.25 .64 Current Reagent Lot F. Select Reject or Approve, then OK V By Date 654321 9.6 11.1 1.8 Current Reagent Pack ID From 05/19/20 123456789 654322 9.4 9.9 5.31 D To 04/19 /202 Statistical Tool Passing-Bablok Statistics for TSH (mg/dL) NOTE: Statistical Tool dropdown allows for: Deming Slope (95%CI) Lot 1 8 Range of Results 1.01 (+00.004%) 9.5 9.4 - 9.7 Regression, Least Squares Regression, Passing-Bablok Intercept (95%CI) Lot 2 X Average Difference (%) 0.99 (+00.0023%) 3.45 Regression, Weighted Deming Regression, and Correlation Coefficient Measuring Interva 0.01 7.1 - 10.9 Weighted Least Squares Regression analysis Total Number of Tests 25 of 40 Current Method Concentration (ngmi) TT TT| TT TT TTT Candidate Method Concentration (1pm) Lot 2 E F efresh ReJect Approve Close NOTE: Wait until all samples are complete before selecting Approve. NOTE: Progress Summary cells lit in red identify results outside of the measuring interval. 9 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023 SIEMENS Healthineers Please note that the learning material is for training purposes only. For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Please note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. Atellica, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. or its affiliates. All other trademarks and brands are the property of their respective owners. Product availability varies by country and is subject to varying regulatory requirements. Please contact your local representative for availability. © Siemens Healthcare GmbH 2023 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Telephone: +49 9131 84-0 siemens-healthineers.com 10 Effective Date:18-MAY-2023| HOOD05162003352821 Unrestricted © Siemens Healthineers, 2023