1 / 14

Innovations for a Secure and Healthy World

Innovations for a Secure and Healthy World. Core Technologies. Core technologies in multiple industries. Cheese & Dairy. Water & Beverages. 1999. 2006.

khuyen
Download Presentation

Innovations for a Secure and Healthy World

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Innovations for a Secure and Healthy World

  2. Core Technologies Core technologies in multiple industries Cheese & Dairy Water & Beverages 1999 2006 GenPrime TechnologiesRapid Microbe Detection (Broad Patent Protection) Founded 1997 Fermentation Blood Products 2000 2005 Homeland Security 2002

  3. Platelet Contamination Bacterial Contamination of Platelets is a Major Concern to the Medical Community AABB Standard 5.1.5.1 requires bacterial testing on every platelet unit (100% QC)

  4. Industry Requirements Blood Banks & Hospitals Need Robust Bacterial Assay • Rapid • Sensitive • Cost-effective • User-friendly • Computer interface capability Of the current methods, the rapid assays are not sensitive and the sensitive assays are not rapid.

  5. Current Methods Bacterial Detection in Platelets • Method Sensitivity • Staining/microscopy 106 cfu/ml • Dipsticks: pH & glucose 107 cfu/ml • Swirling 107 cfu/ml • O2 consumption: Pall eBDS <102 cfu/ml • CO2 generation: BacT/ALERT <102 cfu/ml Rapid (No Culture required) Slow (Culture required) Additional methods are under development

  6. GenPrime's Approach GenPrime Expanded its Antibody Technology to Develop a Rapid Bacterial Test - BacSTAT • Broad-spectrum antibody-based lateral flow device for detection of bacteria in apheresis or whole blood derived platelets • Unique lateral-flow scanning system • Pass/Fail software system

  7. GenPrime’s Technology Broad-Spectrum Antibody Detection of Bacteria Unique Bar Code Control Line (pos) A single lateral-flow antibody strip detects all 14 contaminating organisms. (neg)

  8. Platelet Bacteria Target Organisms Target Sensitivity S. epidermidis S. aureus B. cereus B. subtilis Ps. aeruginosa Streptococcus viridans/mitis Streptococcus pyogenes E. coli Klebsiella oxytoca Serratia marcescens Enterobacter cloacae Corynebacterium xerosis Propionibacterium acnes Clostridium perfringens   103 cfu/ml

  9. Bacterial Detection Preliminary Data with BacSTAT Current sensitivity for detection of E. coli in platelets is 104 cfu/ml. 107 106 105 104 103

  10. Assay Method The Assay is Simple and Rapid Total Test Time is Less Than 20 Minutes Run Lateral-Flow Strip 1 ml Platelet Sample Scan and Log Data Sample Prep (< 1 min) (3 min) (15 min) (< I min) Multiple tests can be carried out simultaneously.

  11. BacStat BacSTAT Detects Bacteria with Objective Results Rapid Lateral-Flow Scanner The BacSTAT employs pass/fail threshold software to determine if platelets are contaminated. Antibody Strips

  12. Validation for FDA Validation Plan for BacSTAT as QC Indication • Sensitivity • Spiking studies in platelets • Test all 14 bacteria (aerobic and anaerobic) • Evaluate 10 samples for each concentration (10/10 = detection limit) • Compare to Predicate Device • Spike platelets at 1 cfu/ml and collect samples at 24 hour intervals • Test each sample with BacSTAT, plate count and either BacT/ALERT or eBDS • Potential issues: Low spiking level and some bacteria may not grow in platelets

  13. Conclusion BacSTAT is a robust bacterial detection test for the QC of whole blood and apheresis platelets prior to transfusion. • Simple - Dipstick format • Rapid - Total time less than 20 minutes • Sensitive - 103 cfu/ml • Automated Data Tracking

  14. Jim Fleming Chief Technology Officer jfleming@genprime.com 866-624-9855

More Related