Atellica® Solution Measuring Interval Verification Job Aid Version 1.25 and Below

SIEMENS Healthineers Atellica® Solution Measuring Interval Verification Job Aid Template Effective Date: 27-MAY-2019 | HOOD05162003010284 Effective Date: 05-JUL-2020 | HOOD05162003104500 Unrestricted © Siemens Healthcare GmbH, 2020 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification 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 serial 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. 2 Effective Date: 05-JUL-2020 | HOOD05162003104500 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification - Automated Automated Measuring Interval Verification • Available on the CH analyzer only • The system makes serial dilutions from a sample with high concentration to evaluate the linearity of the assay o The sample is defined in the system as a calibrator o Any material with a high enough concentration can be used. For example: ➢ Calibrator material (if the concentration is high enough) ➢ Patient sample 3 Effective Date: 05-JUL-2020 | HOOD05162003104500 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification - Automated Automated Measuring Interval Verification – Ensuring SIEMENS Healthineers Atellica Solution Version 1.14.0.2951003 P-P1-03 K Calibrator Definition Exists System Samples Inventory Calibration Oc Patient Orders Worklist Maintenance Setup Calibration Overview Create Calibration Orders Calibration Results Calibrator Definitions IMT Calibration Filters Assays Material Name Lot ID Material ID Expiration Date Assays Add New 1. The assay needs to be enabled and calibrated Status ENZ1 7CD069 69 3/1/2018 11:59 PM LDLP, GGT Edit Expired HDULDL 412577 77 3/1/2018 11:59 PM D_HDL, DLDL Delete 2. Ensure that a calibrator definition exists for the material that will be Active Tox Cal 7290999 TO 5/31/2018 11:59 PM Acet Print Barcode used Inactive Drug Cal 780053 53 9/1/2019 11:59 PM Theo OOO CALUL C1022 4/4/2018 11:59 PM Tnl_UL If the calibration definition needed is not listed in the Calibration Definition Emit Cal K1 9A 5/31/2018 11:59 PM Pcp25 screen, refer to these resources for the procedures to add the calibration Drug Cal II 7KM019 DC 10/31/2018 11:59 PM Tob, Gent, Carb, Vanc. VPA ALHBsII C3930 10/2/2018 11:59 PM Conf, HBsll, RgtA2, RgtB2 definition: CALC CC53 1/4/2019 11:59 PM Fer, VB12 TOX Cal 72909627 TO 2/28/2019 11:59 PM Acet, Sal • Online Help: About Installing Calibrator Definitions Chem Cal 36C 807936C CH 2/28/2019 11:59 PM Alb, Ca, Crea_2, DBil_2, GluH_3, IP, TBil_2, TP, Trig. UA, UN_C ENZ2 7BD056 56 4/30/2018 11:59 PM ALT, AS • PEPconnect: Installing Calibrator Definitions on the Atellica® Solution CALUL C1029 7/29/2018 11:59 PM Tnl_UL Video TOX Cal 72909627 TO 2/28/2019 11:59 PM Acet, Sal ? PER LabManager 500 Thursday, May 10, 2018 8:30 AM * This procedure is continued on the next slide 4 Effective Date: 05-JUL-2020 | HOOD05162003104500 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification - Automated Automated Measuring Interval Verification – Creating the Order Calibration Overview Create Calibration Orders Calibration Results Calibrator Definitions IMT Calibration Select Assays Calibrator Material 3. Confirm the system is in one of the following states: Ready, Standby, B Analyzer CH Cal Name Cal ID Cal Lot +jCal Lot Exp Assays Search or Processing CO2_C Coc150 Coc300 Cop Crea_2 CRP_2 4. Prepare the measuring interval verification material sample Cu CYSC D_HDL ALIGN DBil 2 Dgn 5. Create a measuring interval verification order DLDL DMIX DRINSE Orders eCKMB ECre_2 ETOH X Cal Name Reagent Lot Tests Remaining + Analyzer Identifier Assay Cal Lot Pack ID Edit Cal Order A. Navigate to Calibration > Create Calibration Orders E Fen FLCK FLCL ChemCal 110000 1517 CH : (CC) GluH_3 234565 Edit Cal Order X Fruc Gent GGT B. In Select Assays, select the analyzer C GluH_3 GluO Hapt hsCRP IgA_2 lgG_2 C. Select an assay IgM_2 IP Lac LDLP LEV Li D. In the Calibrator Material area, select + for the material that Place Order Clear will be used for the study E. In the Orders area, select Edit Cal Order 5 * This procedure is continued on the next slide Effective Date: 05-JUL-2020 | HOOD05162003104500 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification - Automated Automated Measuring Interval Verification – Creating the Order Edit Calibration Order CH, GluH_3, 110000 X F. In Edit Calibration Order, select or enter information: 1 Assay and Lot GluH_3 234565 1) Select an assay reagent lot from the Assay and Lot dropdown menu Pack OBS Cal Exp Tests Cal Type 2) Select Automatic Measuring Interval Verification 110000-11113 99 d 23 h 8/22/2020 1517 Autoselect Measuring Interval Verification 3) Select a reagent pack and well from the Pack ID dropdown menu 4) Edit the number of replicates in Number of Replicates (must be equal to or greater than the minimum required to calibrate the assay) Autoselect Cal Type Automatic Measuring Interval 5) 2 Select Save Lot Calibration Verification O Pack Calibration Manual Measuring Interval Verification OOO O G. Select Place Order to create the order Pack ID 110000-11113:Well 1 3 6. If needed, print the sample barcode and load the sample on the system Replicates 3 4 Perform QC with Calibration ? 5 Save Cancel Close * This procedure is continued on the next slide 6 Effective Date: 05-JUL-2020 | HOOD05162003104500 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification - Automated Automated Measuring Interval Verification – Reviewing Results Calibration Results Details for TBil_2 on C-P1-01 x Information Data Comments Activity Autoselect Measuring Interval Verification 1 (L) 2 (H) 3. Assay TBil 2 Review the measuring interval results by navigating to the Units mg/dl 7. Replicate Include Analyte Signal + Flag Include Analyte Signal + Flag Include Calculation Type Linear Ordered Date 1/4/2019 3:00:00 PM Calibration Results Details screen 4.97 mAU 1.18 mg/dl -9.80 mAU Completed Date Replicate 1 v 0.01 mg/dl V VM Accepted By Analyzer Name C-P1-01 Replicate 2 0.00 mg/dL 5.13 mAU 1.18 mg/dL -9.81 mAU M K Analyzer Serial Number C-P1-01 0.00 mg/dl 1.20 mg/dL 10.01 mAU • This screen can be accessed from either the Worklist Reagent Lot 170188 Replicate 3 5.05 mAU Edit Pack/Well 00326:Well 1 Overview (Edit/View) or the Calibration Results (Details) Ancillary 1 Ancillary 1 Lot/Pack Graph Ancillary 2 Mean 0.00 5.05 1.19 -9.87 A screen Ancillary 2 Lot/Pack B Calibrator Name CHEM CALX Median 0.00 5.05 1.18 -9.81 Calibrator Lot 123456 Cal Status Awaiting Acceptance SD 0.01 0.08 0.01 0.12 A. A graph will display with the 5 automatically created Acceptance Criteria OK Acceptance Mode Observed %CV 173.21 1.58 0.97 -1.20 Observed Analyse concentration levels Trigger Mode Operator Initiated Cal Expiration 3/5/2019 3:00:25 PM QC Performed with Calibration Acceptance Criteria The calibration status will be Awaiting Acceptance QC QC Limits New Old B. Observed Observed Criteria Result Value Expected Observed Curve Shapa Coefficients 45,1 -58.58 45,4 -14.10 45.4/85.1 0.24 Co 5.11 Statistics • The lab evaluates the results according to their C1 - 63.19 Slope Intercept Corr. Coefficient Standard Operating Procedures Enlarge ? Print Accept Reject Close C. Select Accept or Reject to change the cal status D C D. Select Print to print the information on this screen NOTE: There is an option to define acceptance criteria in the Setup screens. If defined, the acceptance criteria will display on the Calibration Results Details screen. The status for measuring interval verification results will still be “awaiting acceptance”. The operator can use 7 Effective Date: 05-JUL-2020 | HOOD05162003104500 the displayed acceptance criteria to help in their evaluation of the results. Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification - Manual 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 The materials must be defined on the Calibrator Definition screen as Measuring Interval REF 10995474 Verification Material LOT 92773 o Examples of materials that could be used: 2021-10-12 ➢ Siemens MCM (Master Curve Material) siemens,comidocument-library ➢ AUDIT Microcontrols, Maine Standards Validate, etc 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 MCM 4 1,376 1,032 - 1,720 MCM 5 4.322 > 3.242 10997641 Rev.04 A Linsi B C D m --- 8 Effective Date: 05-JUL-2020 | HOOD05162003104500 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification - Manual D Manual Measuring Interval Verification – Add Calibrator Definition X C Calibrator Material Assay Type Material Name Material ID Lot ID Expiration Date Revision Measuring Interval Verification Material IM THCG MCM 54338 6/4/2021 1 Creating the Definition Active OO Specimen Type for Measuring Interval Verification Number of Levels for Measuring Interval Verification Search Serum 9 Select Tests Assigned Values 1. The assay needs to be enabled and calibrated E AFP aHAVM aHBcM Cal Code Assay Level 1 Level 2 Level 3 Level Level 5 Level 6 Level 7 Level 8 Level 9 Units aHBcT aHBs2 aHCV 29 ThCG 4.94 23 6 49.2 94.3 243 497 729 1470 miU/mL O X 2. Create measuring interval verification material definitions aTG aTPO BNP F BR CA125 CA15_3 A. Navigate to Calibration > Calibrator Definition CA19_9 CEA CHIV B. Select Add New CKMB CPLR100 Cps CPSA Dgtn Dig C. Select Measuring Interval Verification Material EHIV ELF Fer Fol FSH FT3 D. Enter the following information: Assay Type, FT4 H2n HA Material Name, Material ID (ID from the value HAVT HCY IRI G sheet), Lot ID, Expiration Date, Revision (from the ? Add Assay by Cal Code Print Save Cancel value sheet), Specimen Type, Number of Levels (from 2-9) E. Select a test F. Enter the concentration values for each level G. Select Save * This procedure is continued on the next slide 9 Effective Date: 05-JUL-2020 | HOOD05162003104500 Unrestricted © Siemens Healthineers, 2020 Atellica® Solution SIEMENS Healthineers Measuring Interval Verification - Manual Manual Measuring Interval Verification – Creating the Orders Calibration Overview Create Calibration Orders Calibration Results Calibrator Definitions IMT Calibration Select Assays Calibrator Material 3. Confirm the system is in one of the following states: Ready, Standby, B Analyzer IA-26 + Cal Name Cal ID Cal Lot Cal Lot Exp Assays Search or Processing + CALB CB93 12/28/2020 11:59 PM 31, FSH, LH, ThCG D aHBCM CPLR100 FSH 4. Prepare the measuring interval verification material samples C LH PrimeAB PrimeAB_A PrimeH20 PrimeH20_A PrimeRP1 5. Create a measuring interval verification order PrimeRP2 PrimeRP PrimeW PrimeW1_A RP1WWash RP2WWash Orders A. Navigate to Calibration > Create Calibration Orders RP3WWash T3 ThCG X Cal Name Reagent Lot Tests Remaining - Analyzer Identifier Assay Cal Lot Pack ID Edit Cal Order B. In Select Assays, select the analyzer E TSH3U VB12 xABFIsh X THCG MCM 315 84 IA-26 : (IA) ThCG 08112020 Edit Cal Order xABFish1 xCAPILR xCAP1SP C. Select an assay xCAPIT xCAP2LR xCAP2SP