Pooled and conventional nucleic acid testing strategies for SARS-CoV-2 to screen direct care research staff and protect HIV patients

SARS-CoV-2 的汇总和常规核酸检测策略，用于筛选直接护理研究人员并保护 HIV 患者

• 批准号: 10166377
• 负责人: CONSTANCE ANN BENSON
• 金额: $ 84.56万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-23 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10166377
• 关键词: 2019-nCoV; AIDS prevention; Acquired Immunodeficiency Syndrome; Address; Administrative Supplement; Affect; Antibodies; Antiviral Agents; Biological; Biological Assay; Blood Donations; COVID-19; COVID-19 pandemic; California; Caring; Characteristics; China; Clinic; Clinical Trials Unit; Colorado; Complement; Disease; Disease Outbreaks; Ensure; Environment; Enzyme-Linked Immunosorbent Assay; Epidemic; Equipment; FDA approved; Goals; Grant; HIV; Health Personnel; Health system; Hospitals; Human Resources; Immune response; Immunoglobulin G; Individual; Infection; Infrastructure; Local Government; Location; Malignant Neoplasms; Measures; Methods; Monitor; Nose; Nucleic Acid Amplification Tests; Nursing Homes; Outcome; Participant; Patients; Persons; Pneumonia; Polymerase Chain Reaction; Population; Prevalence; Procedures; Public Health; Reagent; Research; Research Activity; Research Personnel; Risk; SARS coronavirus; Sampling; Secure; Seroprevalences; Service provision; Services; Site; Specimen; Swab; Techniques; Testing; Universities; Visit; Vulnerable Populations; Work; Workplace; base; clinical center; clinical research site; cost; cost effective; cost efficient; high risk; innovation; novel; pandemic disease; parent grant; pathogenic virus; prevent; prevention service; professional atmosphere; programs; response; screening; testing services; transmission process; treatment research; treatment services

ABSTRACT An outbreak of serious pneumonia caused by a previously unknown viral pathogen, severe acute respiratory syndrome coronavirus (SARS-CoV-2), emerged in Wuhan, China in December 2019. Inadequate access to testing has limited our understanding of the extent of this new epidemic in the U.S. A cost effective accurate and rapid testing strategy is urgent to fill this gap. This administrative supplement to the UCSD Collaborative HIV Clinical Trials Unit (CTU) to screen all patient- facing research staff and a proportion of research participants is directly responsive to PA-18-591 and NOSI AI- 20-031 as it may allow safe resumption of key research services at our three U.S. Clinical Research Sites (CRSs) (UCSD Antiviral Research Center [AVRC] CRS, the University of Southern California [USC] CRS and the University of Colorado Hospital [UCH] CRS), serving persons with HIV (PWH) who may be at higher risk for COVID-19. Continuity of research coordinated with care is critical in progress toward ending the HIV epidemic without putting staff and participants at risk for COVID-19 acquisition in the research setting. No other local government or health systems are undertaking this approach. Our goal is to implement and evaluate a cost-effective screening approach to determine the prevalence of SARS- CoV-2 in asymptomatic research staff who are in direct contact with PWH and research participants being seen for study visits, identify new incident infections and potentially prevent asymptomatic carrier transmission of SARS-CoV-2 to PWH. This proposal is conceptually innovative in that it applies nucleic acid test (NAT) pooling techniques to save testing supplies, personal protective equipment and money to address an immediate need for increased testing. As there are no technical barriers, testing can start immediately. We will screen (1) direct care research personnel 3 days/week at UCSD (n=40) and weekly at USC (n=8) and UCH (n=20) for asymptomatic SARS-CoV-2 and (2) a subset of 10 research participants at each site every testing day. Self-collected nasal swab samples will be tested using a NAT pooling platform (UCSD AVRC CRS) or individual RT-PCR based commercial SARS-CoV-2 testing (USC and UCH CRSs). Our rationale is that by leveraging our CTU expertise in pooled NAT, the infrastructure capacity of the three CRSs and the San Diego Center for AIDS Research (CFAR), we will implement and evaluate a cost-effective screening approach to determine the prevalence of SARS-CoV-2 infection and SARS-CoV-2 immune response (i.e. seroprevalence) among direct care research staff and returning research participants (Aim 1) and to determine the test characteristics of pooled testing (UCSD AVRC) compared to individual RT-PCR based commercial SARS-CoV-2 testing (USC and UCH CRSs, Aim 2). Once validated, this approach can be deployed in other settings to help ensure safe return to work procedures or in high-risk settings such as healthcare workers in cancer or HIV clinics or nursing homes.

抽象的 由以前未知的病毒病原体、严重急性呼吸道疾病引起的严重肺炎的暴发 综合症冠状病毒（SARS-CoV-2）于 2019 年 12 月在中国武汉出现。 测试限制了我们对美国这种新流行病严重程度的了解。 快速检测策略迫切需要填补这一空白。 加州大学圣地亚哥分校艾滋病毒临床试验协作组 (CTU) 的行政补充，用于筛查所有患者 面向研究人员和一部分研究参与者直接响应 PA-18-591 和 NOSI AI- 20-031，因为它可能允许安全恢复我们三个美国临床研究中心 (CRS) 的关键研究服务 （UCSD 抗病毒研究中心 [AVRC] CRS、南加州大学 [USC] CRS 和 科罗拉多大学医院 [UCH] CRS），为可能面临较高感染风险的艾滋病毒感染者 (PWH) 提供服务 新冠肺炎。与护理相协调的连续性研究对于结束艾滋病毒流行的进展至关重要 不会让工作人员和参与者在研究环境中面临感染 COVID-19 的风险。没有其他当地的 政府或卫生系统正在采取这种方法。 我们的目标是实施和评估一种具有成本效益的筛查方法，以确定 SARS 的流行情况 与 PWH 直接接触的无症状研究人员和正在就诊的研究参与者中存在 CoV-2 对于研究访问，识别新的事件感染并可能防止无症状携带者传播 SARS-CoV-2 至 PWH。该提案在概念上具有创新性，因为它应用了核酸检测（NAT）池 节省测试用品、个人防护设备和资金以满足紧急需求的技术 以增加测试。由于不存在技术障碍，测试可以立即开始。 我们将在 UCSD 每周 3 天 (n=40) 筛查 (1) 直接护理研究人员，在 USC 每周筛查 (n=8) UCH (n=20) 针对无症状 SARS-CoV-2 和 (2) 每个地点每年有 10 名研究参与者的子集 测试日。自行采集的鼻拭子样本将使用 NAT 池平台（UCSD AVRC CRS）进行测试 或基于个体 RT-PCR 的商业 SARS-CoV-2 检测（USC 和 UCH CRS）。 我们的理由是，通过利用我们的 CTU 在池化 NAT 方面的专业知识，三个网络的基础设施容量 CRS 和圣地亚哥艾滋病研究中心 (CFAR)，我们将实施并评估具有成本效益的 确定 SARS-CoV-2 感染流行率和 SARS-CoV-2 免疫反应的筛查方法 （即血清阳性率）在直接护理研究人员和返回的研究参与者中（目标 1） 确定与基于个体 RT-PCR 相比的汇总测试 (UCSD AVRC) 的测试特征 商业 SARS-CoV-2 测试（USC 和 UCH CRS，目标 2）。一旦经过验证，就可以部署该方法 在其他环境中，以帮助确保安全返回工作程序或在高风险环境中，例如医护人员 在癌症或艾滋病毒诊所或疗养院。