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Rapid Identification of Pathogenic Bacteria in Blood causing Sepsis

快速鉴定血液中引起败血症的病原菌

基本信息

批准号：
9141453
负责人：
Ray Anthony Martino
金额：
$ 65.5万
依托单位：
ISENSE, LLC
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-03-15 至 2016-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9141453
关键词：
Address Blood Blood specimen Cause of Death Cessation of life Clinical Clinical Research Clinical Trials Detection Development Device or Instrument Development Diagnosis Documentation Fingerprint Funding Goals Gram&apos s stain Grant Healthcare Systems Hospital Costs Hospitals Human Infection Institutional Review Boards Laboratories Libraries Marketing Medical Molecular Probes Patient-Focused Outcomes Performance Phase Preparation Printing Procedures Process Protocols documentation Quality Control Sales Sampling Sensory Sepsis Specimen Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization Staining method Stains Stream System Systems Development Time Training Work base clinical research site cost effective therapy experience improved instrument meetings new technology pathogenic bacteria public health relevance quality assurance routine Bacterial stain sensor software systems verification and validation

项目摘要

DESCRIPTION (provided by applicant): Sepsis is the leading cause of deaths in US hospitals contributing to or causing 52% of all US hospital deaths and is the most expensive condition treated in US hospitals, costing more than $17 billion annually. More than 300 million blood culture bottles are produced annually, with a market size greater than $1.2B in the US and EU alone. The two-year phase II period spanned February 2013 to February 2015 (5 R44 AI094781-03). The developments, funded in part by this grant, have created a new paradigm to diagnose blood stream infection causing sepsis. The work of this grant has assisted in creating the SpecID blood culture system, which the company is now commercializing. The SpecID solution replaces the present 3-step process for characterization of blood samples, currently divided into 1) detection of infection; 2) an obligatory Gram stain for all positive cultures performed on the bench by trained technician; and then 3) species ID by MALDI-TOF, (again requiring skilled sample preparation), The SpecID solution combines faster detection, more accurate Gram status determination than the benchtop stain, and ID more accurate than MALDI, in a single fully automated step which reduces the time to ID, streamlines lab workflow, and saves significant cost. The result is improved patient outcomes and improved lab operating performance. Phase IIB aims address application to clinical human specimens along with development of instruments and media appropriate for commercial use. The objectives of this proposal reflect the major goals required to achieve commercial entry of the SpecID smart culture system into commercial, high volume laboratories including development of the SpecID blood culture instrument, blood culture bottle sensor attachment, and the clinical and analytical studies to prove performance, gain regulatory approval and make first sales.