MYCOBACTERIUM TUBERCULOSIS (MTB) QUALITY ASSESSMENT PROGRAM (TBQA)

结核分枝杆菌 (Mtb) 质量评估计划 (TBQA) 的目的是提供新的资源来评估位于美国 (U.S.) 和国外 (非美国) 的实验室准确可靠地进行 Mtb 检测以诊断活动性和潜伏性 Mtb 感染、监测疾病进展以及评估治疗反应和疫苗功效的能力，从而直接支持临床试验。 随着新测试/方法的开发，TBQA 计划将在纳入 NIAID 支持的临床研究之前促进其适应、标准化和质量评估。 TBQA 计划将为 NIAID 赞助和合作的临床试验网络和队列以及在美国境内外进行研究的个人受资助者提供服务。 NIAID 赞助的网络的例子包括成人艾滋病临床试验组 (ACTG)、国际孕产妇儿科和青少年艾滋病临床试验组 (IMPAACT) 和 HIV 疫苗试验网络 (HVTN)。 NIAID 赞助的队列示例包括印度和巴西区域结核病前瞻性观察研究 (RePORT)。合作用户组的例子包括疾病预防控制中心、全球结核病药物开发联盟和美国军方艾滋病毒研究计划。 TBQA 合同将负责监控实验室准确可靠地执行研究指定的 Mtb 测试的能力（例如下一代细菌 DNA 和 RNA 测序、固体培养基上的连续痰菌落计数、液体培养中的阳性时间、最低抑菌浓度评估和基于宿主的测定）。这将包括准备能力验证小组（或从商业和非商业来源获取）、分发给参与实验室、从实验室获得的测试结果的捕获和统计分析、性能可接受性的确定以及实验室特定性能报告的生成。 当实验室的测试表现不可接受时，TBQA 将提供纠正措施方面的帮助、指导和培训。

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.