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Becton, Dickinson And — AACC National Meeting 2017
54 slides from Becton, Dickinson And's conference presentation, 2017
Slide 1: Improving quality and turnaround time of clinical chemistry plasma specimens with a mechanical separator
Improving quality and turnaround time of clinical chemistry plasma specimens with a mechanical separator AACC National Meeting, 2017 Speakers: Leonard Dunikoski, PhD, DABCC Becton Dickinson Denise Uettwiller-Geiger, PhD DLM(ASCP) John T Mather Memorial Hospital Joshua Hayden, PhD, DABCC, FACB Weill
Slide 2: Serum vs Plasma
Serum vs Plasma Chemistry Clot activator Lithium Heparin 30 min clot time Mix and spin Centrifuge Centrifuge 1,100 - 1,300g 1,100 - 1,300g 10 min 10 min Serum Plasma 2 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 3: Fibrin – Instrument Operation
Fibrin – Instrument Operation Location Event Type of Potential Result Interference Sampling Aspiration of fibrin Physical Sampling problem, Probe causing probe insufficient quantity aspirated obstruction Erroneous results Reaction Aspiration of Physical, chemical Gradual deposition of fibrin
Slide 4: How to Reduce TAT?
How to Reduce TAT? Fast Analytical Phase Speed Up Sample Transport Reduce Preanalytical Handling & Processing Use Plasma 4 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 5: Ideal Plasma Specimen
Ideal Plasma Specimen • Ideal plasma specimen would be one which is cell/platelet free and in which the anticoagulant functions to inhibit clotting and fibrin formation for extended periods of time • Often not attained with heparin plasma specimens 5 © 2017 BD. BD, the BD Logo and all other trademar
Slide 6: BD Vacutainer Barricor
BD Vacutainer Barricor – Elastomer top • Diameter larger than tube in resting position • Stretches under centrifugation, diameter shrinks • Diameter returns to original shape after centrifugation – High-density base • Ensures proper orientation of separator during centrifugation 6 © 2017 BD. BD, the
Slide 7: How it works
How it works 7 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 8: Less Cellular Contamination vs PST
Less Cellular Contamination vs PST Source data available in BD white paper #VS9280. Download from http://paswhitepapers.bd.com 8 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 9: What if you could look into the centrifuge?
What if you could look into the centrifuge? 9 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 10: Improved analyte stability
Improved analyte stability Source data available in BD white paper #VS9354. Download from http://paswhitepapers.bd.com 10 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 11: Barricor performance for TDMs
Barricor performance for TDMs Initial BD Barricor data, data on file see BD White Paper VS9355, Comparison of the BD Vacutainer® Barricor™ Tube with the BD Vacutainer® PST™ Tube and BD Vacutainer® Serum Tube for Selected Therapeutic Drugs, 2016 11 © 2017 BD. BD, the BD Logo and all other trademarks
Slide 12: BD Barricor: New Blood Collection Technology is a Game Changer for Cardiac Testing and Therapeutic Drug Monitoring
BD Barricor™: New Blood Collection Technology is a Game Changer for Cardiac Testing and Therapeutic Drug Monitoring Denise Uettwiller-Geiger, Ph.D., DLM(ASCP) Clinical Chemist and Director of Clinical Trials John T Mather Memorial Hospital Port Jefferson, New York USA 1177 dgeiger@matherhospital.org
Slide 13: Objectives
Objectives • Describe how new and innovative blood collection technology can be a game changer • Enumerate the advantages of new blood collection technology in terms of process modification and performance • Examine how leveraging new blood collection technology can lead to better patient management
Slide 14: John T Mather Hospital
John T Mather Hospital Our Mission is to be the Best Community Hospital in New York State • 248 Bed Community Hospital • U.S. News & World Report’s Best established in 1929 Hospital 2016 Rankings Ranked #19 in New York State • Located North Shore on Long Island in Suffolk County • Leapfrog Patient S
Slide 15: John T Mather Laboratory Who Are We?
John T Mather Laboratory Who Are We? • JCAHO Accredited • JCAHO Gold Seal • 2.4 million tests/year • Automated Lab since 2001 • 1800 sq. feet of space • 72 FTEs • MT Median Age- 42 • HR Cost- 33% • Average TAT- <30 minutes 15 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton
Slide 16: © 2017 BD. BD, the BD Logo and all other trademarks are property of
16 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 17: Key Questions to Consider
Key Questions to Consider Will BD Barricor™ improve quality and reliability of laboratory testing? Are the results obtained with BD Barricor™ clinically equivalent to those obtained with a plasma gel and/or serum tube? Can patient safety, outcomes and provider satisfaction levels be improved? Are th
Slide 18: © 2017 BD. BD, the BD Logo and all other trademarks are property of
18 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 19: Cardiac Troponin Testing Challenges
Cardiac Troponin Testing Challenges • Testing turnaround time is sensitive • Requirement for accurate diagnostic testing • Avoid and/or minimize spurious, non-reproducible results and false elevation results 19 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and
Slide 20: Troponin Retesting Algorithm with Lithium Heparin Gel Tube
Troponin Retesting Algorithm with Lithium Heparin Gel Tube Troponin is ≥ 0.06 ng/mL Reflexed to automatic re-run If Troponin exceeds 10% Result must be within 10% of limit, aliquot sample, re- NO the original result spin, pipette into sample cup YES Retest Troponin in duplicate Report Troponin resul
Slide 21: Troponin Testing Algorithm with Barricor Lithium Heparin Tube
Troponin Testing Algorithm with Barricor™ Lithium Heparin Tube Troponin is ≥ 0.06 ng/mL Report Troponin result 21 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 22: Cardiac Troponin Testing at Mather
Cardiac Troponin Testing at Mather • Jan – Jun 2017 Troponin volume- 13,476 tests • Troponin repeats ≥ 0.06ng/mL- 2,607 tests • Troponin cost/test- $3.38 • Cost difference of Barricor vs. Plasma gel- $0.10 22 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and C
Slide 23: Testing Cost Reduction
Testing Cost Reduction 2,607 fewer TnI tests for 6 months x $3.38/test = $8,811 Blood collection tube additional cost- $260.70 Total Savings- $8,550.30 23 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 24: Why is this New Blood Collection Tube a Game Changer
Why is this New Blood Collection Tube a Game Changer Enhanced quality, improved diagnostic accuracy and test reliability……………………. PRICELESS 24 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 25: Clinical Impact and Financial Metrics
Clinical Impact and Financial Metrics • Implementation of Barricor™ new blood collection technology • Elimination of Repeat TnI testing • Improved turn-around time (TAT) Decreased Repeat Decreased Testing Testing TAT Decreased Testing Cost -50% -19% -19% 25 © 2017 BD. BD, the BD Logo and all other t
Slide 26: © 2017 BD. BD, the BD Logo and all other trademarks are property of
26 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 27: Therapeutic Drug Compatibility Study Design
Therapeutic Drug Compatibility Study Design • Blood collection tubes - BD Barricor™ - BD Serum Tube • Sample size and population - 705 subjects - Additional prepared samples to cover analytical range for each analyte • Clotting & centrifugation conditions - BD Barricor™ (no clotting required) 4000 g
Slide 28: Therapeutic Drug Compatibility Study Design
Therapeutic Drug Compatibility Study Design • Analytes and Instrumentation: – Siemens Dimension Vista® 1500, Abbott ARCHITECT® Four Classes of Drugs: - Analgesic: Acetaminophen, Aspirin - Anti-epileptics: Carbamazepine, Phenytoin, Valporic Acid - Anti-arrhythmic: Digoxin - Antibiotic: Vancomycin • T
Slide 29: Therapeutic Drug Compatibility Data Analysis
Therapeutic Drug Compatibility Data Analysis • Summary statistics included: - sample size - mean - standard deviation (SD) - range obtained (minimum value to maximum value) • The mean bias and 95% limits for between-tube comparison for each therapeutic drug was calculated at several medical decision
Slide 30: Therapeutic Drug Compatibility Data Analysis
Therapeutic Drug Compatibility Data Analysis • The Medical Decision Levels included values representing: - Reference Range (RR)- low and high limits as determined by the instrument manufacturer - Critical Values (CV) for some analytes, as determined by medical reference materials • The mean bias and
Slide 31: Therapeutic Drug Compatibility Results (T<4 hrs)
Therapeutic Drug Compatibility Results (T<4 hrs) Biases and Confidence Limits- Abbott ARCHITECT® Medically BD Barricor™ vs. BD Serum Drug CAL N Pairs Relevant Source Systematic Bias (Two 1 Sided Points 95% CL) 109 10.00 CV -0.4% (-1.2, 0.4) 109 30.00 RR -0.6% (-1.3, 0.0) ACET 10% 109 43.04 AV -0.7%
Slide 32: Therapeutic Drug Compatibility Results (T<4 hrs)
Therapeutic Drug Compatibility Results (T<4 hrs) Biases and Confidence Limits Siemens Dimension Vista® Medically BD Barricor™ vs. BD Serum Drug CAL N Pairs Source Relevant Points Systematic Bias (Two Sided 95% CL) ACET 71 9.20 AV -0.95 ug/mL (-1.19, -0.71) Instances in 1.5 <20 ug/mL 71 10.00 RR -0.9
Slide 33: Therapeutic Drug Compatibility Results (T<4 hrs)
Therapeutic Drug Compatibility Results(T<4 hrs) Summary Statistics Siemens Dimension Vista® Reference Critical Drug/Unit Tube N MEAN SD Min - Max Range Values* VANCO BD Barricor™ 107 25.52 23.62 0.9 - 129.9 5.0, 40.0 30 ug/mL BD Serum 107 24.24 23.90 1.0 - 129.7 • Differences: for Vancomycin (VANCO)
Slide 34: Therapeutic Drug Compatibility Stability Results
Therapeutic Drug Compatibility Stability Results With in - Tube Comparisons Abbott ARCHITECT Complete Set Drug CAL Tube for Stability Time Difference CI Barricor™ 52 48 hrs vs. initial -1.1% -2.9%, 0.8% ACET 10% Barricor™ 52 7 day vs. initial -0.4% -2.4%, 1.7% Barricor™ 44 48 hrs vs. initial 2.4% 0.
Slide 35: © 2017 BD. BD, the BD Logo and all other trademarks are property of
35 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 36: BD Barricor Plasma Benefits
BD Barricor™ Plasma Benefits • Improves sample quality • Significantly reduces centrifugation time • Improves reliability of cardiac Troponin testing • Exhibits excellent TDM stability • Eliminates gel-related failures - Instrument probe clogging - Test interferences due to gel adsorption 36 © 2017
Slide 37: Achieved Outcomes from Leveraging New Barricor Blood Collection Technology
Achieved Outcomes from Leveraging New Barricor™ Blood Collection Technology • Improved efficiency • Increased productivity • Decreased TAT • Reduced costs • Enhanced service levels • Improved patient safety • Reduced errors • Enhanced quality 37 © 2017 BD. BD, the BD Logo and all other trademarks ar
Slide 38: Key Questions to Consider
Key Questions to Consider Will BD Barricor™ improve quality and reliability of YES laboratory testing? Are the results obtained with BD Barricor™ clinically equivalent to those obtained with a plasma gel and/or YES serum tube? Can patient safety, outcomes and satisfaction levels YES be improved? Are
Slide 39: BD Barricor for LC-MS/MS analysis of testosterone: cell separation without isobaric interferences
BD Barricor™ for LC-MS/MS analysis of testosterone: cell separation without isobaric interferences Joshua Hayden, PhD Assistant Professor, Pathology and Laboratory Medicine Director, Toxicology and Therapeutic Drug Monitoring Assistant Director, Central Laboratory Weill Cornell Medicine jah9108@med.
Slide 40: Weill Cornell / New York Presbyterian Hospital
Weill Cornell / New York Presbyterian Hospital • 862 bed hospital • NYHL Outreach • 16+ million tests/year • CAP and NYS accredited • Fully automated chemistry and hematology line • Advanced diagnostics including tandem mass spectrometry "There are no words to explain how I feel about the treatment
Slide 41: 48 pints = 22 Liters = 6 gallons
48 pints = 22 Liters = 6 gallons 41 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 42: Additional annual blood draw for LCMS testosterone analysis
48 pints = 22 Liters = 6 gallons = Additional annual blood draw for LCMS testosterone analysis at WCMC/NYPH Comprehensive Testosterone by metabolic LCMS panel http://www.laboratoryalliance.com/assets/Uploads/specimentub http://www.capitolscientific.com/BD-367820-zm.jpg es/gold_cap_tube.jpg 42 © 2017
Slide 43: Isobaric interference in testosterone analysis of samples from gel tubes
Isobaric interference in testosterone analysis of samples from gel tubes m/z 289.3 97.0 Gel interference Gel interference Deborah French (2013). Development and validation of a serum total testosterone liquid chromatography–tandem mass spectrometry (LC–MS/MS) assay calibrated to NIST SRM 971, Clin
Slide 44: LC-MS/MS testosterone assay
LC-MS/MS testosterone assay Liquid-liquid Extraction Agilent 1290 Infinity II LC Agilent 6495 QQQ testosterone- 100 mcL [2,3,4-13C3] (positive mode) Plasma (Isosciences, or Cat#6066) Re-suspend Serum + mobile phase 300 mcL MTBE (concentrate 3X) Column Poroshell 120 EC-C18 2.1x50mm, 2.7μm Temp 50°C Q
Slide 45: Isobaric interferences in testosterone from gel tubes
Isobaric interferences in testosterone from gel tubes 103 28997 45 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 46: Barricor allows for separation of cells and plasma without isobaric interference
Barricor allows for separation of cells and plasma without isobaric interference 102 28997 ? http://barricor.bd.com/us/barricor-product-overview.xml 46 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 47: Barricor allows for separation of cells from plasma without introducing interference in LCMS testosterone analysis
Barricor allows for separation of cells from plasma without introducing interference in LCMS testosterone analysis 47 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 48: Chronic Lymphoid Leukemia (CLL)
Chronic Lymphoid Leukemia (CLL) Venetoclax/ Venclexta™ 48 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company. http://drfarrahcancercenter.com/wp-content/uploads/2016/01/Chronic-Lymphocytic-Leukemia-1024x769.jpg
Slide 49: Chronic Lymphoid Leukemia (CLL)
Chronic Lymphoid Leukemia (CLL) Uric acid PO43- K+ Venetoclax/ Venclexta™ K >5.5 K >6.5 K >8 http://drfarrahcancercenter.com/wp-content/uploads/2016/01/Chronic-Lymphocytic-Leukemia-1024x769.jpg 49 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 50: Chronic Lymphoid Leukemia (CLL)
Chronic Lymphoid Leukemia (CLL) Uric acid PO43- K+ Venetoclax/ Venclexta™ Draw sample Administer Analysis venetoclax Adjust dose (?) http://drfarrahcancercenter.com/wp-content/uploads/2016/01/Chronic-Lymphocytic-Leukemia-1024x769.jpg 50 © 2017 BD. BD, the BD Logo and all other trademarks are propert
Slide 51: Chronic Lymphoid Leukemia (CLL)
Chronic Lymphoid Leukemia (CLL) Uric acid PO43- K+ Venetoclax/ Venclexta™ What we need: Fast, accurate potassiums in the setting of Draw sample drastically elevated white blood cells Administer Analysis venetoclax Adjust dose (?) http://drfarrahcancercenter.com/wp-content/uploads/2016/01/Chronic-Lym
Slide 52: Collection Tube Evolution
Collection Tube Evolution Plasma versus BD Vacutainer® Barricor™ PST • Shorter TAT; can be centrifuged immediately • Increase supernatant yield 15-20% > serum • Reduced variability for some analytes e.g. potassium Barricor • Reduces centrifugation to as low as 3 minutes • Reduces contamination from
Slide 53: Less Cellular Contamination vs PST
Less Cellular Contamination vs PST Source data available in BD white paper #VS9280. Download from http://paswhitepapers.bd.com 53 © 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.
Slide 54: THANK YOU!
THANK YOU! Improving quality and turnaround time of clinical chemistry plasma specimens with a mechanical separator AACC National Meeting, 2017 Speakers: Leonard Dunikoski, PhD, DABCC Becton Dickinson Denise Uettwiller-Geiger, PhD DLM(ASCP) John T Mather Memorial Hospital Joshua Hayden, PhD, DABCC,
Becton, Dickinson and Company — AACC National Meeting 2017 on 6ix