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引起的严重肺炎爆发，严重急性呼吸道 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程度的理解 快速测试策略迫切需要填补这一空白。 对UCSD合作HIV临床试验部（CTU）的行政补充，以筛选所有患者 - 面对研究人员和一部分研究参与者直接响应PA-18-591和Nosi Ai-ai- 20-031可能可以在我们的三个美国临床研究网站（CRSS）安全恢复关键的研究服务 （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），为患有艾滋病毒（PWH）的人服务，他们可能面临更高的风险 新冠肺炎。与护理协调的研究的连续性在结束HIV流行有关的过程中至关重要 在研究环境中，员工和参与者不受与参与者有危险的风险。没有其他本地 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选方法，以确定SARS- 无症状的研究人员的COV-2与PWH直接接触，并看到研究参与者 为了进行研究访问，请确定新事件感染，并有可能防止无症状的载体传播 SARS-COV-2到PWH。该建议在概念上具有创新性，因为它应用了核酸测试（NAT）合并 节省测试用品，个人防护设备和金钱以满足即时需求的技术 用于增加测试。由于没有技术障碍，因此可以立即开始测试。 我们将在UCSD（n = 40）的3天/周筛选（1）直接护理研究人员，每周在USC（n = 8）和 无症状SARS-COV-2和（2）每个站点的10个研究参与者的Uch（n = 20） 测试日。自我收集的鼻拭子样品将使用NAT池平台（UCSD AVRC CRS）进行测试 或基于RT-PCR的单个商业SARS-COV-2测试（USC和UCH CRSS）。 我们的理由是，通过利用我们的CTU专业知识，以汇总NAT，这三个基础设施能力 CRSS和圣地亚哥艾滋病研究中心（CFAR），我们将实施和评估成本效益 筛选方法以确定SARS-COV-2感染和SARS-COV-2免疫反应的患病率 （即血清阳性）在直接护理研究人员和返回研究参与者中（目标1）和 与单个基于RT-PCR相比，确定合并测试的测试特征（UCSD AVRC） 商业SARS-COV-2测试（USC和UCH CRSS，AIM 2）。一旦验证，可以部署此方法 在其他环境中，以帮助确保安全恢复工作程序或在诸如医护人员之类的高风险环境中 在癌症或艾滋病毒诊所或疗养院中。