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Ida C. Shum 
Business Development Executive 
LLNL-PRES-502794
Point-of-Care Testing 
 Assay for infectious 
disease 
 Foot & Mouth Disease 
 Methicillin Resistant 
Staphylococcus Aureus
Point-of-Care Device 
 Device 
 Sample Acquisition 
 Preparation 
 Nucleic Acid 
Amplification 
 Detection
Time Series of Images
Advantages 
 Sample preparation and nucleic acid 
amplification in a disposable device 
 Simplified one-tube reaction vessel 
 No detection instrumentation required 
 Colorimetric detection capable of being read 
by eye 
 Inexpensive reagents and device
Questions/Comments 
Contact 
Ida Shum 
shum3@llnl.gov 
925.423.9724

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Point-of-Care Testing for Infectious Diseases

  • 1. Ida C. Shum Business Development Executive LLNL-PRES-502794
  • 2. Point-of-Care Testing  Assay for infectious disease  Foot & Mouth Disease  Methicillin Resistant Staphylococcus Aureus
  • 3.
  • 4. Point-of-Care Device  Device  Sample Acquisition  Preparation  Nucleic Acid Amplification  Detection
  • 5. Time Series of Images
  • 6. Advantages  Sample preparation and nucleic acid amplification in a disposable device  Simplified one-tube reaction vessel  No detection instrumentation required  Colorimetric detection capable of being read by eye  Inexpensive reagents and device
  • 7. Questions/Comments Contact Ida Shum shum3@llnl.gov 925.423.9724

Editor's Notes

  1. Hello, my name is Ida Shum and I am the Business Development Executive who will be speaking to you about the Disposable Point of Care Device developed at Lawrence Livermore National Laboratory. A Point of Care Device is performed near the patient without the need of a clinical lab. The idea is to consume little reagents, sample and while in an effective and accurate device. The most well-known point of care device is a pregnancy test.   The LLNL Disposable Point of Care Device has been used to detect two infectious pathogens. Point-of-Care (POC) testing is an emerging market that promises giant leaps for medical diagnostics. Currently, many tests for disease diagnosis are performed at centralized laboratories and utilize expensive instrumentation. The time and expense of transporting samples and purchasing large instruments for testing create a market need for devices and tests that can provide diagnoses in the clinic or even at the home of the patient.
  2. Foot and Mouth Disease is the most highly infectious animal disease known that strikes clove-hoofed animals (cattle, sheep, goats, and pigs). Nearly 100% of animals exposed to virus become infected. Outbreak in the US could have dire economic consequences. Total livestock sales $140B in 2007, with $13B of being export markets. 2001 outbreak of FMD in the United Kingdom devastated the nation’s livestock industry and other sectors of the economy 2007 outbreak of FMD from a UK lab southwest of London again devastated the livestock industry S. Aureus is a gram-positive bacterium that causes serious community and hospital acquired infections. MRSA is one of several difficult-to-treat infections in humans and is especially troublesome in hospitals where patients with open wounds, invasive devices and weakened immune systems are at greater risk of infection than the general public. In developed countries, MRSA constitutes up to 60% of isolated S. aureus infections.
  3. Early detection of infectious diseases impacting public health and veterinary medicine requires cost-effective, robust and specific assays. These assays have traditionally been conducted in centralized laboratories offering a large footprint, fragile and/or expensive equipment (centrifuges, vortexers, thermocyclers, microscopes, incubators and external power supplies) along with highly trained technicians. LLNL has designed and tested a simplified POC testing system by amplifying and detecting methicillin resistant staphylococcus aureus (MRSA) as well as foot and mouth disease virus (FMDV).
  4. The platform Use a swab to collect sample from surfaces (oral, nasal, lesions) and transfer it to a binding paper (nitrocellulose paper) Place the disc in the containment tube with a loading port Reagents are added to the tube via syringe Waste materials pipette out via a septum Reagents isothermally heated to 63C for an hour on a heated rack Amplification occurs, you see a visible color change of purple to blue