Utility of smartDNA with Sputum Smears

smartDNA 在痰涂片检查中的应用

• 批准号: 7612204
• 负责人: Heather Koshinsky
• 金额: $ 14.49万
• 依托单位: INVESTIGEN, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7612204
• 关键词: Accident and Emergency department; Acid Fast Bacillae Staining Method; Alleles; Bacillus (bacterium); Biological Assay; Biological Products; Businesses; Cells; Characteristics; Clinic; Color; Commit; Country; Coupled; DNA; Detection; Development; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic tests; Drug Resistant Tuberculosis; Drug resistance; Evaluation; Extreme drug resistant tuberculosis; Genotype; Goals; Government; Immigration; International; Lead; Life; Link; Methods; Microscope; Microscopy; Multidrug-Resistant Tuberculosis; Mutation; Mycobacterium tuberculosis; Nucleic Acids; Patients; Persons; Pharmaceutical Preparations; Process; Public Health; Reader; Research; Resources; Rifampicin resistance; Sample Size; Sampling; Screening procedure; Sensitivity and Specificity; Slide; Solutions; Specificity; Sputum; Staining method; Stains; System; Technology; Temperature; Travel; Tuberculosis; United States; United States National Institutes of Health; United States Public Health Service; Visual; Work; base; emergency service responder; innovation; mutant; public health relevance; resistance allele; success; transmission process

DESCRIPTION (provided by applicant): The diagnosis of tuberculosis (TB) is a major weak link in global TB control. Drug resistant TB compounds diagnosis and treatment challenges. The most widely used diagnostic test. Sputum smear microscopy, cannot detect multi drug or extensively drug resistant TB (MDR/XDR-TB) and sputum culture is costly, and depending on the method used, takes 4-8 weeks to obtain a result and up to 16 weeks to detect MDR/XDR- TB. Consequently, there is an urgent need for a simple, rapid diagnostic test to identify the presence of Mycobacterium tuberculosis (MTB) and make a first line assessment of common drug resistance status that could be performed at the public health clinic while the patient waits. Investigen's long term objective is to develop rapid, sensitive, easy to use, POC diagnostic assays (smartDNA" based assays). Investigen's "smartDNATM technology" enables DNA detection to occur rapidly at room temperature in a homogeneous solution with colorimetric readout. There are two specific aims of this proposal. (1) Determine the feasibility of using material from a stained sputum smear slide in smartDNA assays, and (2) Determine the feasibility of discriminating a mutant drug resistance allele from a wild-type allele in post sputum smear samples with the smartDNA activator/reader. Success on this project could provide a diagnostic method and solve a critical barrier in TB control. PUBLIC HEALTH RELEVANCE: While the United States has been largely successful in detecting, treating and controlling TB, in many countries TB, MDR-TB and XDR-TB are a serious and growing public health issue; international travel and immigration have increased TB transmission. The research to be completed by this project is anticipated to lead to the development of a TB, MDR-TB and XDR-TB screening system that will provide results while the patient waits and can be used in resource constrained settings throughout the world, in clinics and emergency rooms in the United States and potentially even at US borders - greatly aiding public health services in the detection, treatment and control of TB, MDR-TB and XDR-TB.

描述（申请人提供）：结核病（TB）的诊断是全球结核病控制的主要薄弱环节。耐药结核病化合物的诊断和治疗挑战。使用最广泛的诊断测试。痰涂片显微镜检查不能检测多药或广泛耐药TB（MDR/XDR-TB），并且痰培养是昂贵的，并且取决于所使用的方法，需要4-8周获得结果，并且长达16周检测MDR/XDR-TB。因此，迫切需要一种简单、快速的诊断测试来识别结核分枝杆菌（MTB）的存在，并对常见的耐药性状态进行一线评估，该测试可以在患者等待时在公共卫生诊所进行。Investigen的长期目标是开发快速，灵敏，易于使用的POC诊断检测（基于smartDNA的检测）。Investigen的“smartDNATM技术”使DNA检测能够在室温下在具有比色读数的均匀溶液中快速发生。这项建议有两个具体目标。(1)确定在smartDNA测定中使用来自染色痰涂片载玻片的材料的可行性，以及（2）确定使用smartDNA激活剂/读取器在痰涂片后样本中区分突变耐药等位基因与野生型等位基因的可行性。该项目的成功可以提供一种诊断方法，并解决结核病控制中的一个关键障碍。公共卫生关系：虽然美国在检测、治疗和控制结核病方面取得了很大成功，但在许多国家，结核病、耐多药结核病和广泛耐药结核病是一个严重的、日益严重的公共卫生问题;国际旅行和移民增加了结核病的传播。该项目即将完成的研究预计将导致结核病、耐多药结核病和广泛耐药结核病筛查系统的开发，该系统将在患者等待时提供结果，并可用于世界各地资源有限的环境，美国的诊所和急诊室，甚至可能在美国边境使用-极大地帮助公共卫生服务部门检测、治疗和控制结核病，耐多药结核和广泛耐药结核。