MYCOBACTERIUM TUBERCULOSIS (MTB) QUALITY ASSESSMENT PROGRAM (TBQA)

结核分枝杆菌 (MTB) 质量评估计划 (TBQA)

基本信息

批准号：
9915563
负责人：
JEANETTE COFFIN
金额：
$ 142.23万
依托单位：
MIDWEST RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-01-01 至 2019-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9915563
关键词：
AIDS clinical trial group Adult Bacterial DNA Bedside Testings Biological Assay Blood Brazil Centers for Disease Control and Prevention (U.S.)Childhood Clinical Clinical Trials Clinical Trials Network Collection Contracts DNA sequencing Diagnosis Disease Progression Drug-sensitive Evaluation Evaluation Studies Generations Genetic Variation Geography HIV HIV Infections HIV Vaccine Trials Network India Individual International Maternal Pediatric Adolescent AIDS Clinical Trials Group Laboratories Liquid substance Lung Methodology Methods Military Personnel Monitor Mycobacterium tuberculosis National Institute of Allergy and Infectious Disease Non-Commercial Sources Observational Study Performance Preparation Procedures Quality Control Reagent Reporting Research Resources Saliva Sampling Shipping Solid Source Specific qualifier value Sputum Standardization Statistical Data Interpretation Test Result Testing Time Training Tuberculosis United States Urine base clinical investigation cohort design drug development next generation novel performance tests programs prospective resistant strain sample collection therapeutic vaccine transcriptome sequencing treatment response tuberculosis drugs vaccine efficacy

项目摘要

The purpose of the Mycobacterium Tuberculosis (Mtb) Quality Assessment Program (TBQA) is to provide a new resource to assess the ability of laboratories located both in the United States (U.S.) and outside (non-U.S.) to accurately and reliably perform Mtb testing to diagnose active and latent Mtb infection, monitor disease progression, and assess treatment response and vaccine efficacy in direct support of clinical trials. As new tests/methodologies are developed, the TBQA program will facilitate their adaptation, standardization and quality assessment prior to inclusion in NIAID-supported clinical investigations. The TBQA program will serve NIAID-sponsored and collaborating clinical trials networks and cohorts as well as individual grantees conducting research in and outside the United States. Examples of NIAID-sponsored Networks include the Adult AIDS Clinical Trials Group (ACTG), the International Maternal Pediatric and Adolescent AIDS Clinical Trials Group (IMPAACT) and the HIV Vaccine Trials Network (HVTN). Examples of NIAID-sponsored cohorts include the India and Brazil Regional Prospective Observational Research for Tuberculosis (RePORT). Examples of collaborating User Groups include the CDC, the Global Alliance for TB Drug Development, and the US Military HIV Research Program. The TBQA contract will be responsible for monitoring Labs’ ability to perform accurately and reliably study-specified Mtb tests (e.g. next-generation bacterial DNA and RNA sequencing, serial sputum colony count on solid media, time to positivity in liquid culture, minimal inhibitory concentration assessment, and host-based assays). This will include preparation of proficiency testing panels (or acquisition from commercial and non-commercial sources), distribution to participating laboratories, capture and statistical analysis of test results obtained from Labs, determination of performance acceptability, and generation of Lab-specific performance reports. The TBQA will provide assistance, guidance and training in corrective action when Labs’ test performance is unacceptable.

结核病（MTB）质量评估计划（TBQA）的目的是提供新的资源MTB感染，监测疾病的进度和治疗反应和直接支持的疫苗功效。。）援助赞助的人群和巴西的结核病前瞻性观察研究（报告）。 TBQA合同将负责监测实验室的Actorial DNA和RNA测序，固体培养基上的串行痰菌落计数，液体培养的阳性时间，最小的抑制对照评估以及基于宿主的分布）。实验室，捕获和统计分析从实验室获得的测试结果以及特定于实验室的性能报告的生成。