Atellica® Solution Measuring Interval Verification Job Aid

Atellica® Solution SIEMENS Healthineers Measuring Interval Verification Job Aid Laboratories use measuring interval verifications to verify the claimed measuring interval in the IFU of quantitative assays. The materials used will have varying known concentrations of the assay spanning the measuring interval. • Calibrator, patients, or commercial products The measuring interval verification feature can be used in 2 ways: calibration verification (manual) and linearity (automated) Manual/Automated Analyzer Notes Manual Available for both IM and CH analyzers Standalone materials are used to evaluate the recovery of each level Automated CH analyzer only The system makes dilutions (0, 25, 50, 75, and 100% with the onboard CH diluent) from a sample with high concentration to evaluate the linearity of the assay NOTE: IMT and A1c_E measuring interval verifications are not available. Template Effective Date: 10 Aug 2021 | HILS 2223 1 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification Job Aid Automated Measuring Interval Verification • Available on the CH analyzer only • The CH system makes dilutions from a sample with high concentration. It calculates the relationship of the dilutions to evaluate the linearity of the assay o Any material with a high enough concentration can be used. For example: ➢ Calibrator material ➢ Patient sample ➢ Remnant external QC or proficiency sample 2 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification Job Aid SIEMENS .. Healthineers' Atellica Solution SH1-SCI1 abManage 2 Troubleshooting 1. Confirm the system is in one of the following System SH-01 SH-02 CH-01 CH-02 M-01 CI-01 states: Ready, Standby, or Processing Others Shortcuts Lab Evaluation Reagent Loading 2. Prepare the measuring interval verification material sample Orders Reagent Overview Lab Evaluations SH1-SCI LabManage 3. Create a measuring interval verification order A Create Evaluation ab Evaluations A. Navigate to Lab Evaluations B. Select Automatic MIV Comparison Evaluations Measuring Interval Verification Evaluation Precision Evaluations O QC Parallel B 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, C. Select Next 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 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 3 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification Job Aid 4. Configure the Parameters: Lab Evaluation 8 SH1-SCI1 LabManager Create Evaluation Lab Evaluations A. Create an Evaluation Name or accept the Create New Measuring Interval Verification Study - Automatic MIV automatically generated Evaluation Name. 1 2 3 Parametes Samples Summary The system creates a Study ID. B. In Parameters, select the appropriate Evaluation Name Parameters analyzer, assay, and reagent lot (not A Study Name . Automativ MIV_0001 B Analyzer CH-01 mandatory). Study ID Assay . 0003 Choi Measuring Interval for Chol 25- 618 C. Select Next Unit mg/dl Reagent Lot 837376 C Back Next Save Cancel 4 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification Job Aid Lab Evaluation 8 SH1-SCI1 LabManager 5. Configure the Samples: Create Evaluation Lab Evaluations Create New Measuring Interval Verification Study - Automatic MIV A. In High Concentration Samples, select 2 3 - Defined Calibrator, if you are using a Parametes Samples Summary Automatic MIV Summary calibrator that is already on the system is Study Name Automatic MIV_0001 using, or New Sample for any other kind of High Concentration Samples Replicates Study Id 0001 A O Defined Calibrator New Sample B Number of Replicates * Analyze sample. Enter sample information. For CH-01 1 - 5 Replicates Assay Defined Calibrator, select a Calibrator and Calibrator ThemCal (298873D) Chol Measuring Interval for Chol verify the Material Name, Material ID, Lot ID, Material Name 25-618 ChemCal Unit Material ID mg/dL and Expiration Date. For Other Sample, enter ECLevel2 Reagent Lot Lot ID 837326 2988730 a Sample ID. Expiration Date Material 11/15/2020 Automatic Onboard B. In Replicates, from the dropdown, select the number of replicates, if appropriate. C. Print barcodes C D Back Print Barcodes Next Save Cancel D. Select Next 5 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification Job Aid Lab Evaluation 8 SH1-SCI1 LabManager 6. Review the Summary: Create Evaluation Lab Evaluations Create New Measuring Interval Verification Study - Automatic MIV A. Review the information in 1 2 3 Parametes Samples Summary summary then select Place Order. B. Print barcodes. You can not come Automatic MIV Summary back to reprint barcodes. Study Name Automativ MIV_0001 Calibrator ChemCal (298873D) Dilution ID CH Diluent ECLevel2 Replicates Study ID Material Name 100% ChemCal 0% C. Select OK 0001 Analyzer Material ID 2 75% 25% ECLevel2 Assay 3 50% 50% Lot ID Chol 298873D 4 Expiration Date 25% 75% Measuring Interval for Chol 5 25-618 11/15/2020 5 0 % 100% 5 Units Number of Replicates mg/dl 5 Total Tests 25 Reagent Lot Total Number of Tests 837326 25 Material Automatic Onboard A Back Place Order Save Cancel O ? Q SE 6 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification Job Aid 7. Review the measuring interval results. Lab Evaluation 8 SH1-SCI LabManager Lab Evaluations > Lab Evaluations > Details ? HX Select appropriate study > Select Details Filters Automatic MIV Summary Progress Summary for Chol (mg/dL) to view study results Analyzer MaterialID Replicates Analyzer CH-01 25878931 Dilution ID 2 3 5 All Assay Chol LOT ID 031 3.1 2.5 6.2 4.5 2.1 3.68 A. A graph will display with the Measuring Interval for Chol Expiration Date 25 - 618 11/15/2020 2 Allpe 269.4 240.1 223.6 Error 250.4 251.8 Units automatically created Number of Replicates Status mg/d 3 557.2 559.9 524.4 No Result 518.3 So. a8 All Reagent Lo Total Number of Tests 720.6 775.8 770.2 275.2 780.5 767.54 concentration levels By Date Material 5 998.7 1011.6 990.2 1012.7 From 05/25/2022 Automatic Onboard 1022.5 1040.5 B. The status will be Awaiting To 04/25/2022 Measuring Interval Range Verification Statistics for Chol (mg/dL) Slope (95%CI) Level N Predicted Target XI Acceptance 0.910 (+00.004%) Intercept (95%CI) 0.0 4.0 2 (+00.0002%) 3 14 .0 152.7 • The lab evaluates the results Correlation Cooefficent 0.9998 3 3 244.0 234.0 Measuring Interval for Chol according to their Standard 25 - 618 3 527.0 523.3 Operating Procedures 3 1,117.0 1,022.0 500 2.000 C. To refresh the summary, select C D Refresh Reject Approve Close Refresh ? Q = E 06 D. Select Approve or Reject 7 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification Job Aid SIEMENS Manual Measuring Interval Verification Healthineers Atellica® IM MCM • Available for both CH and IM analyzers BNP • Standalone materials (with known target and range) are used to evaluate the recovery of each level MCM |LOT VAL o Examples of materials that could be used: REF 10995474 ➢ Siemens MCM (Master Curve Material) LOT 92773 ➢ Audit MicroControls, Maine Standards Validate, etc 2021-10-12 siemens,comidocument-library pg/mL pg/mL UNITS C -I- MCM 1 0.000 V 6.00 MCM 2 62.9 44.0 - 81.8 MCM 3 131 98.3 - 164 A Lise MCM 4 Line B Lisos D E 1,376 1,032 - 1,720 - Line MCM 5 4.322 3.242 -- -- > 10997641 Rev.04 8 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification Job Aid SIEMENS Healthineers Atellica Solution 8 SHI-SCH Lab Manager 2 Troubleshooting Manual Measuring Interval Verification System SH-01 SH-02 CH-01 CH-02 IM-01 C1-01 Others Shortcuts Lab Evaluation Reagent Loading 1. Create a measuring interval verification study Orders Reagent Overview A. Navigate to Lab Evaluations ‹ n Lab Evaluations 8 SH1-SCI1 LabManager A Create Evaluation ab Evaluations B. Select Manual MIV 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 O Reagent Comparison i Manual Measuring Interval Verification i 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 9 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification Job Aid 2. Configure the Parameters: Lab Evaluation SH1-SCI1 LabManager Create Evaluation Lab Evaluations A. Create an Evaluation Name and Study ID. Create New Measuring Interval Verification Study - Manual MIV 1 2 3) B. In Parameters, select the appropriate analyzer, Parameters Samples Summary assay, and Reagent lot. C. Select Next Study Name Parameters A B Study Name . Manual MIV 0001 Analyzer CH-01 Measuring Interval for T4 25- 618 Unit mg/dl Reagent Lot 345678 C Back Next Save Cancel O ? Q = E ) 10 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification Job Aid 3. Configure the Samples: < n Lab Evaluation 8 SH1 - SCI1 abManager Create Evaluation Lab Evaluations A. Enter the Material Lot, Expiration Create New Measuring Interval Verification Study - Manual MIV 1 2 3 Date, and SID prefix. Parameters Samples Summary Manual MIV Summary Study Name B. Select the number of levels. The SID Manual MIV_0001 Material Targets and Ranges Replicates Study I for each level is auto-populated. The 0001 A Material Lot Expiration Date C Analyzer Target, Low, and High fields are 11/27/2021 SID Prefix . Number of Replicates * CH-01 3 - 10 Replicate optional. Level SID Target Measuring Interval for Chol Low High 25-618 123451 0.000 NIA 0.700 Unit C. Select the Number of Replicates, if mg/d appropriate B 2 123452 3.00 4.72 9.88 3 123453 4.72 4.01 5.43 D. Select Next + D Back Print Barcodes Next Save Cancel 11 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification Job Aid Lab Evaluation 8 SHI-SCI LabManager 4. Review the Summary: Create Evaluation Lab Evaluations Create New Measuring Interval Verification Study - Manual MIV A. Verify the information in Manual 1 2 3 Parameters Samples Summary Measuring Interval Verification Summary Manual MIV Summary B. Note the total tests you are ordering A Study Name Material Lot Level SID Target LOW High teplicates Manual MIV_0001 A6847-0 123451 0.000 NIA 0.700 C. Select Place Order Study ID 0001 Expiration Date 11/27/2021 2 123452 3.00 4.72 9.88 Analyzer Number of Replicates CH-01 123453 4.72 4.01 5.43 5 D. Print barcodes 74 Total Tests 15 E. Select OK C Back Place Order Save Cancel 12 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification Job Aid 5. Review the measuring interval results by navigating Lab Evaluation 8 SH1-SCI7 LabManager to the Details screen. Lab Evaluations > select Lab Cre Details x Evaluations > Select appropriate evaluation > Select Filters Manual MIV Summary Progress Summary for T4 (mg/dL) Details to view study results Material Lo Replicate Manual MIV_0001 SID 1 3 A6847-0 x Assay Study ID Expiration Date MCM1 2 6.2 4.5 2.1 3.68 All 0001 3.1 11/27/2019 A. A graph will display with the automatically de Study Type Analyzer Number of Replicates MCM2 269.4 240.1 223.6 Error 250.4 251.8 All created concentration levels Status Assay Total Number of Tests MCM3 557.2 559.9 524.4 No Result 543.98 All T4 25 Reagent Lot MCM4 720.6 775.8 770.2 275.2 780.5 767.54 By Date 345678 MCM5 1022.5 998.7 1011.6 1040.5 990.2 1012.7 B. The status will be Awaiting Acceptance From 05/25/2022 04 /25 /2022 Measuring Interval Range Verification Statistics for T4 (mg/dL) • The lab evaluates the results according Slope (95%CI) Level N Target Range 0.910 (+00.004%) to their Standard Operating Procedures Intercept (95%CI) 3 4.0 0.0 3 -17 -2 (+00.0002%) 2 152.7 141.0 0.0000 Correlation Cooefficent 0.9998 C. To refresh the summary, select Refresh 3 3 234.0 244.0 0.0000 Measuring Interval for T4 25 - 618 3 523.3 527.0 0.0000 D. Select Approve or Reject 1,022.0 1,117.0 0.0000 C D Refresh ReJect Approve Close 13 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 14 Effective Date: 08-SEP-2022 | HOOD05162003300252 Unrestricted © Siemens Healthineers, 2022