Rapid Detection of Bacterial Contamination in Platelets

快速检测血小板中的细菌污染

基本信息

批准号：
7685922
负责人：
Ronald J Rieder
金额：
$ 6.06万
依托单位：
BIOSENSE TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-04-01 至 2010-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7685922
关键词：
Aerobic Anaerobic Bacteria Animal Model Applications Grants Attention Bacteria Behavior Biological Assay Biosensing Techniques Biosensor Blood Blood Platelets Businesses Cell Count Cell Survival Cells Compatible Condition Cytolysis Detection Development Devices Diagnostic Dimensions Distress Electric Capacitance Electrodes Electronics Elements Ensure Goals Growth Heat-Shock Response Housing Investigation Laboratories Leukocytes Life Longevity Measurement Measures Medicine Metabolic Methods Monitor Numbers Operative Surgical Procedures Optics Patients Performance Phase Physician Executives Platelet Transfusion Preparation Procedures Process Production Proteins Protocols documentation Reaction Reading Records Recovery Research Rhode Island Sampling Sepsis Shock Side Sodium Azide Speed Staging Standards of Weights and Measures Stream Stress Stress Tests Suspension substance Suspensions Techniques Technology Testing Time Transfusion Triton X100 United States United States Food and Drug Administration Work base biological adaptation to stress concept cost data acquisition day design design and construction dielectric property electric impedance innovation instrument instrumentation laptop microorganism millimeter novel novel strategies pathogenic bacteria patient safety programs prototype rapid detection rapid technique research study response sample collection septic size

项目摘要

DESCRIPTION (provided by applicant): A new approach for detecting pathogenic bacteria in platelet concentrates rapidly is proposed. Technically, the approach is based on an unconventional implementation of impedance sensing to monitor cellular metabolic responses with exceptional sensitivity and stability. This enables the detection of small numbers of viable aerobic and anaerobic microorganisms in near-real time without the need for grown cultures significantly reducing the time from sample collection to detection results by several days compared to currently in use methods. Feasibility of the approach was successfully demonstrated as part of the Phase I investigation with representative Gram-negative and Gram-positive species commonly implicated in platelet- associated bacterial sepsis. In addition, the ability to make decisive measurements in short time enables the bacterial testing of platelets just prior to transfusion ensuring the safety of the patient and potentially extending platelets shelf life. The proposed Phase II effort focuses on the development of a prototype instrument and testing of contaminated platelets in a realistic setting. The described approach may also be applicable to the detection of bacteria in other blood products. Bacterial contamination is detected in approximately one of every 2000 units of platelets and is implicated as the cause of severe or fatal sepsis in an estimated 150 patients per year in the United States. The proposed rapid test will enable the detection of viable contaminant bacteria in platelet supplies in near-real time both insuring their safe use and extending their useable life-span.

描述（申请人提供）：提出了一种快速检测浓缩血小板中致病菌的新方法。从技术上讲，该方法基于阻抗传感的非常规实施，以异常的灵敏度和稳定性监测细胞代谢反应。这使得能够近乎实时地检测少量活的需氧和厌氧微生物，而不需要生长培养物，与目前使用的方法相比，显着缩短了从样品采集到检测结果的时间几天。作为第一阶段研究的一部分，该方法的可行性得到了成功证明，该研究针对通常与血小板相关的细菌性败血症有关的代表性革兰氏阴性和革兰氏阳性物种。此外，能够在短时间内进行决定性测量，使得能够在输血前对血小板进行细菌检测，确保患者的安全并有可能延长血小板的保质期。拟议的第二阶段工作重点是开发原型仪器并在现实环境中测试受污染的血小板。所述方法也可适用于其他血液制品中细菌的检测。大约每 2000 个单位的血小板中就有一个检测到细菌污染，并且是美国每年估计 150 名患者严重或致命败血症的原因。拟议的快速测试将能够近乎实时地检测血小板供应中的活污染细菌，既确保其安全使用，又延长其使用寿命。