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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 The Problem • Platelet transfusions used to treat and/or prevent bleeding • Number of platelet transfusions produced per year: Canada: United States: Europe: 300,000 2,000,000 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 Shortages - addressed by increasing donor recruitment 2 of 17 Outline • The Problem Clinical Situation • Solving the problem Novel Approach Data Acquisition DLS-PM score • The Invention Technology Background The DLS-PM Accomplishments Clinical Results • Summary 3 of 17 Other Technology Accuracy, Sensitivity 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 4 of 17 Bad outcome Assumption: bad platelets 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 5 of 17 Solving the Problem: Novel Approach Multi-dimensional quality measurement DLS-PM detects • discoid platelets • activated platelets • microparticles • bacteria at the same time 6 of 17 Solving the Problem: Data Acquisition BACTERIA (if present) 500 +/- 60 nm 500 nm 1200 nm 50-100 nm Transfus Med Rev 2007; 21(4):295 7 of 17 10% Microparticles 54 +/- 7 nm 88% Platelets 1179 +/- 173 nm Solving the Problem: DLS-PM Score Temperature Response High DLS-PM score Medium DLS-PM score Platelet Size Low DLS-PM score 8 of 17 Most fresh platelet transfusions Most platelet transfusions until day 7 - 12 of storage The Invention: The Dynamic Light Scattering Platelet Monitor (DLS-PM) • Non-invasive • Small sample volume • Fast • Inexpensive Phys Med Biol 2006; 51:3747 9 of 17 The Invention: Accomplishments Proof of principle Nov 2003 10 of 17 First prototype April 2005 First generation instrument Sept 2005 Validation Latex beads Platelets Bacteria Proteins Nanoparticles 2006 First clinical pilot study May - Aug 2007 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 11 of 17 The Invention: CoDIVO Results 104/160 transfusions 65 % Transfusion merit correlates with DLS-PM score 12 of 17 Other Technology: Platelet Counting • INVASIVE Sysmex XE-2100 Kobe Advia 120 Siemens FacsCanto II BD • No single instrument can determine platelet quality and function in multiple dimensions • Impedance • Optical • Immunofluorescence • Hematology analyzers cannot assess bacterial contamination BacT/Alert required BacT/Alert bioMérieux 13 of 17 Other Technology: Accuracy Sysmex XE2100 Optical platelet count + 1-micron beads 200 180 160 140 120 Without beads 100 With beads 80 60 Beads 40 20 0 1 14 of 17 2 3 4 Other Technology: Sensitivity Optical methods - Low sensitivity Especially for platelet counts < 15,000 / L Segal et al. BrJ Haematol 2005; 128:520. 15 of 17 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 16 of 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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