Atellica® Solution Precision Studies Job Aid Version 1.25 and Below

SIEMENS Healthineers Atellica® Solution Precision Studies Job Aid Template Effective Date: 27-MAY-2019 | HOOD05162003010284 Effective Date: 27-JUL-2020 | HOOD05162003111933 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Healthineers Precision Studies 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. Dilution Probe Understanding the system behavior for aspirations can help you understand how to design your precision study. System CH behavior for aspirations Sample Probe • The system minimizes amount of dilution cuvettes used within an SID order • For example, if 10 ALT tests were ordered, this only requires one Dilution Cuvettes 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 testing of the sample probe Reaction Cuvettes • To make 10 separate dilutions, you need 10 separate primary sample tubes. This would allow testing of the dilution probe 2 Effective Date: 27-JUL-2020 | HOOD05162003111933 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Precision Studies 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. In this training document, we are using 10 replicates of ALT as an example for testing precision on the CH analyzer and 10 replicates of FSH as an example for the IM analyzer. For information on how to determine sample volume requirements, refer to the Sample Volume Specifications topic in Online Help, and the sample volume information in the assay Instructions for Use (IFU). 3 Effective Date: 27-JUL-2020 | HOOD05162003111933 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Precision Studies Methods for creating precision study test orders: • Importing a Worklist • Useful when you need to study multiple assays or analyzers or samples • Manually Creating Orders (Create Patient Orders or Create Batch Orders) • A simple way to create orders for a single assay or analyzer or sample 4 Effective Date: 27-JUL-2020 | HOOD05162003111933 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Precision Studies Manually Creating Orders for a Repeatability Study on the Create Patient Orders * Create Batch Order by Rack ID Create Batch Orders by SID Edit Multiple Orders View Batch Orders Atellica IM Analyzer: Sample Information Test Selections Enter test names, separated by commas. Sample ID FSH123 Module Type IM Select Tests Within run – order 10 replicates or order the test 10 times Rack ID Orders Specimen Serum Dilution Replicates / for one sample (replicates are not available for some IM X | Test System Test Options Manual Dilution + X FSH [x1(Undiluted) 1 Edit Test Options assays, such as HBc IgM) For Study 9 Priority Routine 10 • The system positions the sample once and will use a STAT 11 new sample tip for every aspiration, regardless of how it ASAP 12 13 OOO is ordered 14 Patient Demographics 15 • Use Case Example: To evaluate imprecision contributed 16 by the IM sample probe hardware and movements This shows an example of ordering replicates for a within run repeatability study on the IM Analyzer Between run – order the same test on 10 samples NOTE: Select the For Study checkbox to prevent • The system positions 10 tubes for one aspiration each test results from transferring to the LIS. • Use Case Example: To evaluate imprecision contributed NOTE: The examples in this training content use n=10. For laboratory studies, by the hardware sample tube alignment and positioning the n value should be based on the lab’s standard operator procedures. as well as the sample probe hardware 5 Effective Date: 27-JUL-2020 | HOOD05162003111933 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Precision Studies Manually Creating Orders for a Repeatability Study on the Create Patient Orders Create Batch Order by Rack Create Batch Orders by SID ID Edit Multiple Orders View Batch Orders Range of Orders Test Selections Enter test names, separated by commas. Atellica CH Analyzer: Sample ID PR101 Module Type CH Select Tests Specify Range By Number of Samples Orders *Replicates are not available for CH tests Number of Samples 10 X Test Dilution Replicates System Test Options Print Barcode + X ALT x1(Undiluted) DEdt Test Options Sample Information Within run – order the test 10 times for one sample Specimen Serum Manual Dilution The dilution probe makes one dilution from the primary For Study • Priority Routine tube and the sample probe delivers that diluted sample STAT ASAP to 10 different reaction cuvettes OO • Use Case Example: To evaluate imprecision contributed by the CH sample probe hardware and movements Between run – order the same test on 10 samples Save Clear This shows an example of ordering the same test for 10 samples for a between run repeatability • The system positions 10 tubes for one aspiration each. study using the Create Batch Order by SID screen. This screen includes an option to print barcodes The dilution probe makes 10 dilutions in the dilution to correspond with the Sample ID. tray • Use Case Example: To evaluate imprecision contributed by the CH dilution probe and sample probe hardware 6 and movements Effective Date: 27-JUL-2020 | HOOD05162003111933 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Precision Studies Importing a Worklist Import Worklist X For information on how to create a worklist import file and Worklist Type • Import worklist O mport Carryover Study Worklist import the worklist file, refer to these resources: Import File File Browse o Online Help: About Importing Worklists Print Barcodes o PEPconnect: Importing a Worklist on the Atellica® Solution Sample ID Rack Number Tube Position Test Replicates Reagent Lot Dilution Specimen Module Serial Number Job Aid ? Import Worklist Close 7 Effective Date: 27-JUL-2020 | HOOD05162003111933 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Precision Studies Results Report Selection x Statistics Type Statistics Viewing Precision Results Report Filter Sample ID 04142020 Last Sample ID The statistics for the data can be exported from the Worklist Overview Number of Samples screen by using the Statistics button: 4 Tests 5 Date Time Range From 1. Navigate to Worklist > Worklist Overview H L CL K 4/13/2020 15 3 :49 PM - NA 6AM AAG AAT Acet To 2. Filter and/or sort the worklist as applicable 4/14/2020 15 3 :49 PM aHBcM Alb AlbP Aldo ALP_2c 3. Select Statistics at the bottom of the screen ALT ALTPL Amik Amm Amp1K 4. Filter by Sample ID, Number of Samples, and/or Tests File Name F:\UserRoot\Exports\ResultsStatistics_2020_04_14_15_49_18.txt Browse .. 6 5. Select the appropriate date range ? 7 Save Cancel 6. Browse to report location ResultsStatistics_2020_04_14_15_45_48.txt - Notepad - X O 7. Select Save File Edit Format View Help Statistics **** Date Time Range : 4/13/2020 3:45:48 PM - 4/14/2020 3:45:48 PM System Type: Immunoassay, Serial Number: P-P2-18 The individual results will transmit to the LIS as the result values. Test T3 Sample Count 1 Avg. Max Min Diff. SD CV% Concentration 1.775 1.88 1.68 0.2 0.06364 3.58533 RLU 219931.6 227201.00 212484.00 14717.00 4758.38129 2.16357 Example of Statistics export 8 Effective Date: 27-JUL-2020 | HOOD05162003111933 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Precision Studies 1 Worklist Overview Monitoring Lab Metrics Viewing Repeatability Results Filter 2 Sort By Order Date Time Additionally, if the study was performed by using Order Date All SID Name Test Result Interpretation Flags replicates (only available on the IM analyzer), the Sample Type All FSH123 ****** FSH 7.83 m/U/ml x Test Details screen will display the mean and CV for 3 Analyzer All the data set. Sample Test Custom To access: 0 Ordered 1. Navigate to Worklist > Worklist Overview FSH Test Details x FSH Result Active Interpretation Module Result Date Time 2. Filter and/or sort the worklist as applicable SID FSH123 Priority Routine 7.83 mlU/ml <1(Undiluted) X IA-26 Tuesday, April 14, 2020 1:57 PM Rack ID 3. Select the Test for the replicate order Specimen Serum Manual Dilution Order Date 4/14/2020 1:38 PM Replicate Data Test Data 4. View the results for each replicate and the DOB ****** Data Mean Replicate1 Replicate2 Replicate3 Patient Location ****** statistics for the data set Patient Status ****** RLUIABS 21024 19937 19581 20864 Patient Sex ****** 4 Concentration 7.83 7.36 7.20 7.76 LIS Code FSH Sample Comments Data Value Reagent Data Lot Pack SD 0.5356 Primary FSH 233 P03323319007110 The mean will transmit to the LIS as the result value. Calculated CV 6.84 Ancillary 1 Acceptable %CV 0.00 Ancillary 2 ? QC Statistics Curves ... Set as Active Result Close 9 9 Effective Date: 27-JUL-2020 | HOOD05162003111933 Unrestricted © Siemens Healthineers, 2020 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's Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. 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 may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability. Copyright © Siemens Healthcare GmbH 2020 Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen, Germany Telephone: +49 9131 84-0 siemens.com/healthineers 10 Effective Date: 27-JUL-2020 | HOOD05162003111933 Unrestricted © Siemens Healthineers, 2020