bac kit challenge O.Gutierrez

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Full Description:
For over 30 years clinicians have struggled with finding a technique that is accurate and fast to
diagnose blood stream infections (BSIs) or sepsis ,which is still a major cause of morbidity and
mortality. Sepsis and other aggressive bacterial infections associated with BSIs are often times
managed within intensive care units with associated high costs, which impose significant
healthcare, economic and social burdens. The extremely high mortality of blood infections is
due, in part, to the inability to rapidly detect, and accurately identify and thus treat bacteria
with appropriate antibiotics in the early stages of infection, thus people often die before they
can be diagnosed and treated. It is widely recognized that if there were a method for fast
effective detection of BSI at an early-stage it would have a profound effect on survival rates.
However, the present gold standard to detect a BSI is blood culture, which unfortunately can
take days to get a definitive result. Recent amplification-based molecular diagnosis methods
including polymerase chain reaction (PCR) can reduce the assay time to hours but are often not
sensitive enough to detect bacteria that occur at low concentrations in blood or to detect the
vast species of bacteria that could be present. Microscopic analysis and biochemical procedures
are time-consuming and require specialist equipment and trained users, thus they are also
expensive and prohibitive due to the extensive training needed.
We require a rapid point of care for accurate diagnosis of sepsis. Novel approaches to prevent,
and diagnose sepsis remain major clinical needs that may only be adequately addressed by
employing novel technologies or significantly improving present technologies.
The Challenge
The Seeker specifically wishes to identify a robust method that:
1. Minimizes the time for diagnosis from several days to several hours.
2. Measures blood, urine, sputum or other bodily fluid or cells/tissue (but minimally invasive).
3. Easy to use and cost effective and can be done at point of care or reference lab by a
technician or nurse.
4. Freedom to practice: no IP, however licensing opportunities will be considered.
5. Can measure multiple samples at once, although does not necessarily have to be high though
put but can be.
6. Has a limit of detection 1-10 CFU/mL or less and is specific enough to detect several
serotypes of bacteria.
In Scope
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Protocols describing assays that include procedural steps with reagents and instuments.
Scientifc explanations and reasonings for the recommended techniques.
Reference papers or clinical trials supporting the techniques.
Out of Scope
The Seeker is not interested in a solution that:
• Consists of a literature survey
• Requires excessively expensive reagents or supplies
• Has many or time-consuming steps
• Is not amenable to rapid analysis of many samples
• Is primarily theoretical and would be difficult to assess efficacy in a practical manner
• Has negative health and safety issues or environmental impact
Criteria that must be met:
Solutions that permit sensitive, quick and specific diagnosis of sepsis will be evaluated by the
Seeker based on the:
1. Extent of evidence provided to demonstrate the efficacy of the test.
2. Level of detail provided for the proposed protocol such as reagents, solution formulations,
consumables, equipment.
3. Accessibility and cost of the technological solution, i.e., does not require development of an
entirely new technology.
4. Ease of method for use and/or efficacy in diagnosing sepsis.
5. Time the test takes to attain a result and the number of samples that can be measured.
6. The limit of detection should be between 1-10 CFU/mL or less.
7. A number of bacterial serotypes should be detected and differentiated by the test.
Project Deliverables
Challenge solutions should provide:
1. A detailed description and explanation of the proposed solution or solutions;
2. Persuasive scientific rationale, references and, ideally, experimental or clinical data, to justify
the solution; and,
3. Full disclosure of any third party intellectual property used in the solution.
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