9/29/2015. Describe the technologies available on the XN-Series and the reason(s) for selection

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1 XN-Series Technology What s Inside the Box? OBJECTIVES Describe the technologies available on the XN-Series and the reason(s) for selection Utilize example case studies to illustrate the new capabilities of PLT-F technology used on the XN-Series Describe the advanced reagent technology of the RU-20 BUT FIRST - DEFINITIONS 1

2 BUT FIRST - DEFINITIONS Is the collection of techniques, methods or processes used in the production of goods or services or in the accomplishment of objectives, such as scientific investigation. Technology can be the knowledge of techniques, processes, etc. or it can be embedded in machines, computers, devices and factories, which can be operated by individuals without detailed knowledge of the workings of such things. Wikipedia Is the use of various control systems for operating equipment. with minimal or reduced human intervention. The biggest benefit of automation is that it saves labor Wikipedia 2

3 Is the discipline of adjusting a process so as to optimize some specified set of parameters without violating some constraint. The most common goals are minimizing cost, maximizing throughput, and/or efficiency. When optimizing a process, the goal is to maximize one or more of the process specifications, while keeping all others within their constraints. Wikipedia 3

4 Accuracy BEYOND TECHNOLOGY BEYOND EXPECTATIONS Dependability Quality NEXT GENERATION DIAGNOSTICS greater accuracy, specificity, productivity ADVANCED TOOLS & TECHNOLOGIES superior insight and control, enhancing speed to treatment HARMONIZED SUPPORT driving improvement, supporting your staff, helping you plan for the future PROCESS OPTIMIZATION automatically balances work-flow and routine tasks NEXT GENERATION DIAGNOSTICS greater accuracy, specificity, productivity ADVANCED TOOLS & TECHNOLOGIES superior insight and control, enhancing speed to treatment PROCESS OPTIMIZATION automatically balances work-flow and routine tasks 4

5 THE MOST ADVANCED HEMATOLOGY DIAGNOSTICS ON THE MARKET Advanced Clinical Parameters Body Fluid Differentials Rerun/Reflex Testing Fluorescent Platelet XN-SERIES Same Analytical Module Up to 100 /hr /module Common Software System Common Reagent System Common QC System XN-1000 SA-01 XN-1000 XN-2000 XN-3000 XN

6 SINGLE MODULE FULLY LOADED Every XN Configuration can include: All the parameters All the features All the capabilities PROCESS OPTIMIZATION EXCEPTIONS TO THE RULE: DIFFERENT XN-1000 SAMPLERS Simple Sampler SA-01 Reflex Sampler SA-10 PROCESS OPTIMIZATION DIFFERENT XN-1000 SAMPLERS Smart Start Reflex/Rerun capabilities Rack bar code read capability MAP tubes in rack mode Simple Sampler SA 01 Reflex Sampler SA 10 MAP tubes in manual mode 6

7 PROCESS OPTIMIZATION XN WITH SIMPLE SAMPLER OPTIONS XN-Series Technology Analytical Technologies SYSMEX XE VS. XN TECHNOLOGY RBC, PLT, Hgb WBC / BASO NRBC DIFF RET / PLT O RBC, PLT, Hgb WNR WDF RET PLT F NEW NEW NEW 7

8 SYSMEX FOUNDATIONAL TECHNOLOGY RBC & Platelet DC Detection / Hydrodynamic Focusing Hemoglobin Absorbance / Sulfolyser RBC & PLATELET Reportable Parameters RBC Platelets Reagents CELLPACK DCL CELLPACK DST* *Used with RU-20 FLUORESCENT FLOW CYTOMETRY Side Fluorescent Light DNA/RNA information Dichroic Mirror Side Scattered Light Cell inside structure information Laser Beam wavelength=633nm Forward Scattered Light Cell size information 8

9 FLUORESCENT FLOW CYTOMETRY WNR channel WDF channel PLT-F channel RET channel WNR Channel White Cells, NRBCs WNR CHANNEL BASO LYMPH MONO Granulocyte NRBC RBC Polymethine Dye 9

10 WNR CHANNEL FSC NRBCs with EVERY CBC BASO NRBC Debris SFL WBC ADVANTAGE OF FLUOROCELL WNR FSC SFL SFL NRBC CORRELATION DATA Correlation Coefficient (R) = N = 171 Correlation Coefficient (R) = N = 171 Data from the University of Iowa / Dec

11 MEGAKARYOCYTES MEGAKARYOCYTES WNR CHANNEL FSC NRBC BASO Granulocyte MONO LYMPH Maximized efficiency NRBC with every CBC No additional steps or reagents Accurate WBC counts in the presence of NRBCs Virtually eliminates interferences from Lyse resistant RBCs Lipids Megakaryocytes Improves turn around times RBC Debris SFL 11

12 WDF Channel WBC Differentials by Fluorescence WDF CHANNEL LYMPH MONO NEUT EO Atypical LYMPH Immature WBC Polymethine Dye WDF CHANNEL SFL MONO IG LYMPH NEUT+BASO Debris SSC EO 12

13 IG XN DIFF ABSTRACT IG: ELEVATED WHEN OTHER MARKERS ARE NOT IG can elevate in infection even when WBC, ANC, and other markers are normal Briggs, C. et al (2003). Laboratory Hematology; Doc. No CFL, Rev 1, June 2014 POTENTIAL OF IG ENUMERATION IG (Immature Granulocytes) A direct cellular measure of leukopoiesis Increased IG count indicates the presence of immature cells in peripheral blood With other clinical information, IG may aid physicians in identification of patients with infection sooner 13

14 ENHANCED FLAGGING ALGORITHMS SAFLAS method (Sysmex Adaptive Flagging Algorithm based on Shape-recognition) Detects abnormal cells - (with high sensitivity) LDA (Linear Discriminant Analysis) WDF SAFLAS METHOD Normal Abnormal (Blasts?) Abnormal (Abn Lympho?) LOW WBC ANALYSIS MODE WB (Whole Blood) mode LW (Low WBC) mode Dilution Rate : x 61.1 Analysis Volume : 58.2µL Whole Counts *2 : 9,530 Dilution Rate : x 61.1 Analysis Volume : 174.6µL Whole Counts *2 : 28,600 Analysis Time extended to 3 times the Whole Blood WBC count time 14

15 LOW WBC ANALYSIS MODE Analysis time extended to 3 times WB WBC count time Better accuracy and precision on counts < 0.50 x 10 3 No Vote Outs Differential results on all counts Increased reportable differentials WDF CHANNEL SFL Atypical LYMPH LYMPH MONO Immature WBC EO Improved efficiency More reportable automated differentials 6-part differential with reportable IG% Rapid TAT Decreased manual interventions Enhanced Flagging Auto-correction of lymphs when NRBC are present NEUT SSC Body Fluid Analysis Using RBC/PLT & WDF Channels 15

16 BODY FLUID ANALYSIS Body fluid mode (target species) HF-BF Cerebrospinal fluid (CSF) MN Pleural fluid Peritoneal fluid MO-BF LY-BF NE-BF PMN EO-BF Synovial fluid WDF Scattergram BODY FLUID ANALYSIS No pre-analysis preparation No additional reagents Automated background counts Rapid analysis PLT-F Channel PLaTelets by Fluorescence 16

17 WHY A SECOND PLATELET CHANNEL? Impedance platelet analysis (size) has limitations Identification and discrimination of platelets from interfering particles with the same size INTERFERENCES IN IMPEDANCE PLATELET COUNTING False Increases RBC fragments False Decreases Giant platelets Microcytes Platelet clumps Bacteria Immune complexes WBC fragments PLT-F CHANNEL RBC PLT IPF Oxazine Dye 17

18 PLT-F CHANNEL FSC RBC IPF PLT-F SFL SEPARATING PLATELETS FROM RBC FRAGMENTS Platelet RBC Fragment CD41/CD61 positive = Platelets Staining by PLT F dedicated reagent Platelets Strong, especially within the cell RBC fragments Weak, only cell membrane Transmitted light CD61/PLT-F GIANT PLATELETS & PLT-F 18

19 DxH 800 Platelet 114 Manual plt estimate 200 DxH 800 Platelet 114 Manual plt estimate 200 INTERFERENCE WITH ROUTINE IMPEDANCE COUNT ß-Thalassemia Major with numerous fragmented red cells PLT-I XE: PLT-I Microcytic RBC XE: PLT-O Microcytic RBC XN: PLT-F Microcytic RBC XE PLT-I = 477*10 9 /L PLT-0 = 111*10 9 /L PLT-CD61 =152.2*10 9 /L IPF% = 13.9% XN PLT-I = 514*10 9 /L PLT-F = 140.8*10 9 /L PLT-CD61 = 152.2*10 9 /L IPF%= 12.9% 19

20 IMPROVED PERFORMANCE OF PLT-F Acute Promyelocytic Leukemia / chemo: white blood cell fragments XE: PLT- O XN: PLT-F WBC cytoplasm fragments WBC cytoplasm fragments IPF XE PLT-I = 25*10 9 /L PLT-0 = 181*10 9 /L PLT-CD61 = 24.2*10 9 /L IPF% = 41.2% IPF# = 74.6*10 9 /L PLT-F XN PLT-I = 28*10 9 /L PLT-F = 24.2*10 9 /L PLT-CD61 = 24.2*10 9 /L IPF% = 1.1% IPF# = 0.3*10 9 /L PLT MEASUREMENT OVER TIME IN A SEVERE BURN INJURY PATIENT The feature: Huge micro-spherical FRCs appeared because of heat shock. PLT COUNT OVER TIME IN A SEVERE BURN INJURY PATIENT Day 1 PLT (x10^3/ul) PLT-I 1118 PLT-F PLT-I PLT-F 228 CD Day 2 PLT (x10^3/ul) PLT-I 795 PLT-F PLT-I PLT-F 161 CD

21 PLT COUNT OVER TIME IN A SEVERE BURN INJURY PATIENT Day 3 PLT (x10^3/ul) PLT-I 632 PLT-F PLT-I PLT-F 116 CD Day 4 PLT (x10^3/ul) PLT-I 201 PLT-F PLT-I PLT-F 54 CD61 51 POSSIBLE MECHANISMS OF THROMBOCYTOPENIA Production Disorders Myeloablative Therapy Bone Marrow Transplant Acute Myeloid Leukemia (AML) Destruction Disorders Immune Thrombocytopenic Purpura (ITP) Thrombotic Thrombocytopenic Purpura (TTP) Infections (HIV, Hepatitis C, CMV) Disseminated Intravascular Hemolysis (DIC) Autoimmune Disease Bacteremia Heparin Induced Thrombocytopenia (HIT) Sepsis Pregnancy Drug-Induced Thrombocytopenia (DIT) Stasi, R. How to approach thrombocytopenia. Hematology :191; /asheducation DIFFERENTIATE PHYSIOLOGICAL MECHANISMS Low PLT + Low/Normal IPF Consistent with production disorder Normal Low PLT+ High IPF Consistent with destruction mechanism (ITP, TTP, DIC, autoimmune) 21

22 IMMATURE PLATELET FRACTION TO ASSESS BONE MARROW RECOVERY Study objective: How well can IPF help the clinician predict bone marrow recovery following peripheral blood HPC transplantation? A persistently low IPF in this setting would suggest failure of thrombopoietic recovery. Zucker M., Murphy CA, Rachel JM, Martinez GA, Abhyankar S, McGuirk JP. Immature Platelet Fraction as a Predictor of Platelet Recovery following Hematopoietic Progenitor Cell Transplantation. Laboratory Hematology, : PLT-F CHANNEL Second method of platelet Fluorescent Dye specific for platelet organelle Extended count time (6 times) for accurate platelet enumeration, especially in low platelet counts Good comparison with CD41/CD61 Minimizes interference from RBC fragments, microcytic RBC s and WBC fragments Automated reflex with on board rules BPR systems only RET Channel RETiculocytes, IRF, RET-He 22

23 RET CHANNEL WBC RET RBC PLT Polymethine Dye RET CHANNEL RET RBC LFR MFR HFR IRF PLT RETICULOCYTE PARAMETERS Reticulocytes # and % of immature RBC s Immature Reticulocyte Fraction Newly released from the marrow, a direct cellular measurement of erythropoiesis Reticulocyte Hemoglobin Direct cellular measure of iron availability 23

24 CLINICAL APPLICATIONS OF RETICULOCYTE HEMOGLOBIN Wellness Pediatrics - Iron deficiency and Iron Deficiency Anemia Prevention Surgical patients pre and post surgical assessments Chronic Disease Management End Stage Renal Disease - anemia management Monitoring response to therapy with ESA and/or iron Cancer- anemia status IRON DEFICIENCY PREVALENCE IN INFANTS AND TODDLERS Adverse consequences in pediatric patients: Increased lead absorption Impaired immunity Anemia Impaired neurocognitive development % of infants and toddlers in the US have iron deficiency anemia; 10% have iron deficiency without anemia. Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). National Health and Nutrition Examination Survey Data. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention. RETICULOCYTE CHANNEL Clinical Utility Monitor RBC development at the cellular level IRF for Retic production RET-He for effectiveness of hematopoiesis Clinically relevant information for the management of anemia in conjunction with other available clinical information Operational Efficiency Reduced Interference From: WBCs Howell Jolley Bodies Parasites Sickle cells Quick and automatic 24

25 Analytical Technology Summary FLUORESCENT FLOW CYTOMETRY BASO LYMPH MONO Granulocyte NRBC RBC W N R W D F LYMPH MONO NEUT EO Atypical LYMPH Immature WBC R E T P L T WBC RET RBC PLT RBC PLT IPF XN TECHNOLOGY SUMMARY WNR Channel Maximized efficiency NRBC the first time all the time Accurate WBC Counts in the presence of NRBCs WDF Channel Enhanced Flagging 6-part differential (including IG) Improved Sensitivity and Specificity 25

26 XN TECHNOLOGY SUMMARY Low WBC Better accuracy and precision on counts < 0.50 x 10 3 No Vote Outs Differential results on all counts Increased Reportable differentials PLT-F Fluorescent Dye specific for platelet organelle Extended count time (6 times) for accurate low platelet enumeration Good comparison with CD41/CD61 Automated reflex with on board rules THE SO WHAT? WNR Channel NRBCs on every CBC No WBC Correction WDF Channel 6 Part Diff Diffs on low WBC IG % & # Highly capable technology with a singular goal: Reduce bottlenecks to Improve TAT while Adding clinical value RET Channel RET, IRF & RET He Production View Functional View PLT F Channel Robust 2 o Method Reflexive, with IPF No operator interaction necessary XN Technology Reagents RU-20 26

27 ADVANCED TOOLS & TECHNOLOGIES SMART REAGENT MANAGEMENT SYSTEM RU-20 Reagent Management System 25x concentrate Reduces reagent changes and instrument idle time Increases free space in the lab. CELLPACK DCL compared with RU-20 and CELLPACK DST ADVANCED TOOLS & TECHNOLOGIES WHY IT MATTERS 1 cube of diluent weighs ~48lbs At 300 samples/day you move about 156 cubes/year RU-20 = 1 cube/50 days ~7.2 cubes/year Model that over 5 years With an average of 3 physical moves of each cube ADVANCED TOOLS & TECHNOLOGIES Why it matters 27

28 XN Technology Automation & Process Optimization PROCESS OPTIMIZATION THE SYSMEX XN-SERIES brings greater accuracy and efficiency throughout the entire testing chain XN-1000 XN-2000 XN-3000 SYSMEX XN-SERIES PROCESS OPTIMIZATION XN-SERIES ON-BOARD RULES Enhanced Walk-Away Capabilities Automated Reflex or Rerun testing No Need To Search For Tube 28

29 PROCESS OPTIMIZATION CO-PRIMARY SYSTEM Fully Automated Workload Balancing Automatic re-run/reflex testing XN-2000 and XN-3000 PROCESS OPTIMIZATION AUTOMATED SLIDE MAKING 4th generation system Fully integrated Fully reflexive slide preparation PROCESS OPTIMIZATION SLIDEMAKER / STAINER Improves smear TAT Rules to define specific slide types Non-batch staining Consistent smear quality Re-cycling reagent system Provides positive patient ID: 3 slide print options available Low sample volume requirements: Micro-sample port Blood aspirated and slide made when indicated 29

30 PROCESS OPTIMIZATION SYSMEX DI-60 Integrated to XN-3000 Compact Automation System Integrated Slide Processing Standalone Cell Imaging * Integrated to XN-9000 Scalable Automation System *: In development PROCESS OPTIMIZATION THE SYSMEX XN-SERIES brings greater accuracy and efficiency throughout the entire testing chain XN-9000 SYSMEX XN-SERIES Now You Know What s Inside the Box Thank You 30