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The Problem

Dynamic Light Scattering Measuring Platelet Quality and Bacterial Contamination Elisabeth Maurer, Ph.D. Canadian Blood Services, R&D Vancouver UBC, Department of Pathology and Laboratory Medicine UBC Centre for Blood Research. Shortages - addressed by increasing donor recruitment. The Problem.

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The Problem

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  1. Dynamic Light ScatteringMeasuring Platelet Quality and Bacterial ContaminationElisabeth Maurer, Ph.D.Canadian Blood Services, R&D VancouverUBC, Department of Pathology and Laboratory MedicineUBC Centre for Blood Research

  2. Shortages - addressed by increasing donor recruitment The Problem • Platelet transfusions used to treat and/or prevent bleeding • Number of platelet transfusions produced per year: • Canada: 300,000 • United States: 2,000,000 • Europe: 2,500,000 • Platelets are sensitive to stress (e.g., cold damage) • Activated platelets do not help patients. • Storage at 22ºC to prevent cold damage • Increased risk for bacterial growth

  3. Outline • The Problem Clinical Situation • Solving the problemNovel Approach • Data Acquisition • DLS-PM score • The Invention Technology Background The DLS-PM Accomplishments • Clinical Results • SummaryOther Technology Accuracy, Sensitivity

  4. The Problem: Clinical Situation • No non-invasive in vitro test available • Tested inventory cannot be transfused • Platelet quality / bacterial testing cannot be mandated Transfusion outcome serves as retrospective platelet quality indicator. Good outcome  Assumption: good platelets Bad outcome  Assumption: bad platelets

  5. The Problem: Summary • at least 20% discard rate • Additional 10% discarded after testing (invasive technology) • Unknown quality of transfused platelets • $1,000 / transfusion •  Worldwide loss of at least 1 billion dollars per year In summary: • Unknown platelet quality is a safety issue • Discarded platelet transfusions are a financial burden

  6. Solving the Problem: Novel Approach • Multi-dimensional quality measurement • DLS-PM detects • discoid platelets • activated platelets • microparticles • bacteria • at the same time

  7. 500 nm 1200 nm 50-100 nm Solving the Problem: Data Acquisition BACTERIA (if present) 500 +/- 60 nm 10% Microparticles 54 +/- 7 nm 88% Platelets 1179 +/- 173 nm Transfus Med Rev 2007; 21(4):295

  8. Solving the Problem: DLS-PM Score Most fresh platelet transfusions Temperature Response  High DLS-PM score Mostplatelet transfusions until day 7 - 12 of storage Medium DLS-PM score  Platelet Size Microparticles Low DLS-PM score

  9. The Invention:The Dynamic Light Scattering Platelet Monitor (DLS-PM) • Non-invasive • Small sample volume • Fast • Inexpensive Phys Med Biol 2006; 51:3747

  10. Proof of principle First prototype First generation instrument Validation Latex beads Platelets Bacteria Proteins Nanoparticles First clinical pilot study Nov 2003 April 2005 Sept 2005 2006 May - Aug 2007 The Invention: Accomplishments

  11. The Invention: Clinical Results • Correlation of DLS-PM results with in vivo transfusion outcome • 49 patients enrolled, 160 transfusions • Location: Vancouver General Hospital • Data collected: • DLS-PM scores • 1h and 24h patient platelet counts  transfusion merit DLS-PM score vs. transfusion merit

  12. The Invention: CoDIVO Results 104/160 transfusions65 % Transfusion merit correlates with DLS-PM score

  13. BacT/Alert bioMérieux Other Technology: Platelet Counting • INVASIVE • No single instrument can determine platelet quality and function in multiple dimensions • Impedance • Optical • Immunofluorescence • Hematology analyzers cannot assess bacterial contamination  BacT/Alert required Sysmex XE-2100 Kobe Advia 120 Siemens FacsCanto II BD

  14. Without beads With beads Other Technology: Accuracy Sysmex XE2100 Optical platelet count + 1-micron beads Beads

  15. Other Technology: Sensitivity Optical methods - Low sensitivity Especially for platelet counts < 15,000 / L Segal et al. BrJ Haematol 2005; 128:520.

  16. Summary DLS-PM: The only technology for noninvasive bacterial detection and platelet quality testing at the same time • Mandated technology for hospitals / blood banks • 10,000 hospitals / blood banks in North America • Extended shelf life - reduced outdate-discard rate • Patient safety • Monitor manufacturing processes

  17. Audrey Cheryl Nobu Keddie Thank You! Keddie Brown, iCapture Audrey Labrie, CBS Dr. Mark Scott, CBS Dr. Kate Chipperfield, VGH Cheryl Pittendreigh, CBS Nobu Kitamura, CBS CBS Intellectual Property, Intramural and Bridge Funding

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