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Device Development for Microbial Surface Sampling, Field Extraction and Collection


Phase I SBIR proposals will be accepted. Fast-Track proposals will not be accepted. Phase I clinical trials will be accepted. Number of anticipated awards: 1-2 Budget (total costs): Phase I: up to $150,000 for up to 6 months PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Background Sampling surfaces to investigate disease transmission is a common practice. Surfaces touched by patients and healthcare workers, such as bedrails, tables, and medical equipment and toilet sites, are not often cleaned properly and can contribute to the spread of organisms such as Clostridioides difficile, Acinetobacter baumannii, methicillin-resistant Staphylococcus aureus (MRSA) and other antibiotic resistant organisms. When infections repeatedly occur in healthcare settings, epidemiologists and hospital staff typically investigate and search for a potential source of the infection by sampling with swabs (for small surfaces; 4in2) and wipes or sponges (for larger surfaces; 100 – 200 in2), sending them to a laboratory to extract the organisms from the sampling device, and for detection of the organisms by culture or by a direct molecular detection assay such as polymerase chain reaction (PCR) or whole genome sequencing. Laboratory extraction methods are often labor intensive and require expensive equipment and time. With the advent of rapid detection instruments such as the MinION for metagenomics sequencing, microfluidic devices, and “Lab on a Chip” portable detection instruments, the detection of microbes in the field will soon be routinely possible. However, direct detection of target organisms in the field is challenged by low bioburden environmental samples, thus requiring the need for samples to be tested in the laboratory using culture-dependent methods. Novel strategies are needed that can elute and concentrate samples from the environmental sampling tool for direct detection of target organisms while at the field location. All manipulations need to be completed while maintaining integrity of the sample, i.e., aseptically and without cross-contamination of samples. Responders investigating the potential release of a bio threat agent also face the same concerns and, in a bio-terrorism event, rapid detection guides decisions to protect public health and safety. This research topic aims at development of a novel device for environmental sampling of a large area and direct elution and concentration in the field for detection of target organisms and/or broader delineation of microbial populations with either molecular assays or culture assays. Project Goals The goal of this project is to develop a novel sampling device that is able to efficiently collect microorganisms from a solid surface and to extract and concentrate the organisms from the device and into a vial or tube in the field. The extracted sample will be used to detect organisms with both culture and culture-free assays. Since organisms in healthcare settings are typically found in low numbers, the sampling devices must be efficient at recovering vegetative cells and spores from surfaces and able to sample a large surface area (100 in2 to 200 in2 or greater) without drying out. Wipes or sponges that are pre-moistened with a wetting agent containing a surfactant or disinfectant neutralizer recover organisms better than if dry, therefore the device should be made available pre-moistened and able to maintain stability and shelf life for at least 1 year or, be available dry and able to be pre-moistened easily prior to sampling on-site. The criteria for a successful device are: 1) Easy to use. 2) Packaged as sterile and pre-moistened OR be easily pre-moistened aseptically at the sampling site. 3) Sterile gloves are not required by the person using the device to collect organisms from a surface. 4) After sampling, the device can be sealed aseptically to prevent contamination. 5) Able to easily extract the collected organisms from the sampling device without need for a laboratory (i.e., at the sampling site) into a vial or tube for storage until detection is available. 6) The final extraction volume must not exceed 2-3 mL. If the sample can be concentrated to a smaller volume without losing sensitivity, this would be optimum. 7) Effective at collecting and eluting organisms, recovering the same log10 level of organisms known to be present on a surface. 8) Low cost (<$15 for each device). Phase I Activities and Expected Deliverables The expected deliverables are: 1) Develop prototype sampling, elution and concentration device. 2) Test efficiency of recovery by placing known quantities of Staphylococcus aureus, and Acinetobacter baumannii cells and Clostridioides difficile spores (or Bacillus spp. Spores, if anaerobe chamber is not available) onto surfaces, then use the device to recover the cells and spores. Efficiency will be determined by a quantitative microbial culture and qPCR, and then compared to number of cells and spores placed on surface. Impact A successful novel sampling and extracting device will enable rapid response during a public health investigation resulting from transmission of infections due to contaminated environmental surfaces, whether from drug resistant bacteria in a healthcare facility or as the result of an intentional release of a bio-threat agent. This device, coupled with a field deployable rapid detection device, will eliminate the need to ship samples to a laboratory for analysis, thereby allowing for detection of target organisms in hours rather than days. Reduced sample analysis time will enable faster public health decisions, saving lives. Commercialization Potential The commercialization potential is high. A successful device may be used for detection of multiple organisms in a variety of field settings, whether in a healthcare setting, a bio threat public health scenario, or a pharmaceutical manufacturing facility requiring environmental monitoring. A successful device could be used for traditional culture detection, as well as for next generation molecular detection. The device would save money and time for rapid detection of organisms by enabling field detection or readying and optimizing samples for laboratory detection methods.
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