Atellica® Solution Precision Studies Job Aid

Atellica® Solution SIEMENS Healthineers Precision Studies Job Aid Precision studies are often used for troubleshooting assay or hardware issues on a clinical laboratory instrument. Repeatability is a way to define and measure precision. This study tests within-run precision or repeatability of the system. The Assay must be ready to use, and the reagent must be onboard and calibrated. Dilution Probe Understanding the system behavior for aspirations can help you understand how to design your precision study. Sample Probe System CH behavior for aspirations • The system minimizes amount of dilution cuvettes used within an SID order Dilution Cuvettes • For example, if 10 ALT tests were ordered, this only requires one aspiration from the primary sample tube to make one aliquot into a dilution cuvette. Then the sample probe will transfer 10 aliquots of diluted sample from the dilution cuvette to the reaction cuvettes. This allows for Reaction Cuvettes testing of the sample probe Template Effective Date: 10 Aug 2021 | HILS 2223 1 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Precision Studies Job Aid System IM behavior for aspirations • The system uses a new tip and aspirates from the primary sample for every test within an order. If 10 FSH are ordered, the sample probe uses 10 tips and aspirates from the same tube 10 times For both IM and CH: Note that the tube may be shuffled/repositioned between aspirations if other samples are being processed in the queue at the same time (according to above described behavior). If the positioning of the primary sample tube needs to be tested, the study should be run separately from other sample processing. For information on how to determine sample volume requirements, refer to the Sample Specifications topics in Online Help, and the sample volume information in the assay Instructions for Use (IFU). 2 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Precision Studies Job Aid SIEMENS . Healthineers" ... Atellica Solution SH1-SCI LabManage 2 Troubleshooting System SH-01 SH-02 CH-01 CH-02 IM-01 CI-01 1. Create a simple precision study Athare Shortcuts Lab Evaluation Reagent Loading A. Navigate to Lab Evaluations B. Select Simple Precision Orders Reagent Overview Lab Evaluations SH1-SCI1 abManager C. Select Next A Create Evaluation Lab Evaluations Comparison Evaluations Measuring Interval Verification Evaluation Precision Evaluations O QC Parallel i O Automatic Measuring Interval Verification i B 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 C Reagent Comparison O 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 ? Q E ) 503 3 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Precision Studies Job Aid 2. Configure the Parameters, Samples & Pack: ‹ Â Lab Evaluation 8 SH1-SCI1 LabManager Create Evaluation Lab Evaluations A. Create an Evaluation Name or use the name the system provides. Create New Simple Precision Study 1 2 Parameters, Summary B. Select an Analyzer and Assay Samples & Pack C. Enter the Number of Replicates Parameters Samples D Reagent Pack A Study Name O Sample ID Cal QC Inventory D. Enter or scan the SID and select Add, or Simple Precision_0010 Number of tests needed Enter or scan Sample ID Samples Replicated x # samples select Cal-QC Inventory to use a tube 0010 Sample ID * SID that is in the Cal-QC inventory B Select Pack ID* Analyzer SID123457 CH-02 1 - 3 Samples E ack ID Onboard Stability Inventory Assay * Chol Add 4545528980 2 days, 3 hours 200 O E. Select the Pack ID Number of Replicates C 10 O 2154789878 10 days, 6 hours 150 3 - 30 Samples F. Select Next O 2154511321 5 days, 23 hours 80 O 8752135852 3 days, 8 hours 25 Note: Cal-QC tubes that are used as F samples will no longer be used for Cal-QC Back Next Save Cancel after study. do Note: For IM precision studies, select a reagent pack based on inventory. The system will not roll over into another pack within an order. For CH precision studies, chose one reagent pack or cross-pack replicates for the replicates. 4 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Precision Studies Job Aid 3. Review the Summary: ‹ n Lab Evaluation H1-SCI1 abManager Create Evaluation Lab Evaluations A. Verify information and select Create New Simple Precision Study Place Order 1 2 Parameters, Summary Samples & Pack B. If appropriate, print barcodes C. Select OK on the pop-up Simple Precision Summary window Study Name Simple Precision_0010 SID Study ID Ongo SID12345 Analyzer 042940941T_0010 CH-02 SID 1234! Assay Number of Replicates 10 Reagent Pack ID 4545528980 A Back Print Barcodes Place Order Save Cancel 5 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Precision Studies Job Aid Lab Evaluation SH1-SCI1 LabManager 4. Review the precision statistics by Cre Details ? AX navigating to the Details screen. Lab Filters Simple Precision Summary Statistics for Chol (mg/dL) Evaluations > select Lab Evaluations > Study Name Material Replicate CHEMCAL 2 CHEMCAL 3 MULTIQUAL 2 Analyzer Simple Precision_0001 All Select appropriate evaluation > Select Study ID CHEMCAL 2 1 136.2 125.3 126.3 Assay 0010 de All Analyzer CHEMCAL 3 2 124.8 136.5 126.8 Details to view study results Study Type CH-02 All Assay Cho MULTIQUAL 2 125.3 128.0 125.3 Status The status will be Awaiting All Number of Replicates 136.5 10 Error No Result A. By Date Reagent Pack ID 5 128.0 136.2 128.0 2154789878 Acceptance From 06/01/2022 6 Error 124.8 Error To 05/02/2022 136.2 136.2 124.8 • The lab evaluates the results Result CHEMCAL 2 HEMCAL 3 MULTIQUAL 2 124.8 124.8 125.3 according to their Standard 150 125.3 125.3 136.2 Operating Procedures 145 10 136.5 136.5 124.8 140 129.2 132.8 131.5 B. To refresh the summary, select CV 0.9 0.8 0.8 135 Refresh Measuring Interval 130 125.0 - 148.5 1 2 3 5 6 7 10 C. Select Approve or Reject B C Refresh ReJect Approve Close D. Data can be exported as .txt or DB printed from the Lab Evaluations screen Note: Cells with values that fall outside of the Measuring Interval are highlighted in red. Values that are reported as < or > are excluded from the statistics. 6 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 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 2022 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Telephone: +49 9131 84-0 siemens-healthineers.com 7 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022