Serological and PCR Testing for SARS-CoV-2. A Prospective Study Assessing Infection, Immunity, and Asymptomatic Carriage of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 2
- 主要终点
- Identification of carriers of SARS-CoV-2
研究概览
简要总结
Richmond Research Institute (RRI) is applying existing and new COVID-19 PCR and antibody tests to help develop methodologies which provide fast and accurate results. Infection with coronavirus (SARS-CoV-2) is currently a worldwide pandemic and reliable testing for COVID-19 is crucial to understand who is infected and therefore a risk to others by spreading the infection. RRI are currently carrying out the following tests:
A. Using a membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens helps to assess whether an individual has previously had the virus and is potentially immune
B. Polymerase Chain Reaction (PCR) testing using an established method to check for active SARS-CoV-2 infections.
C. Quantification of anti-SARS-CoV-2 IgG and IgM antibodies in whole blood samples.
The above tests are being used by RRI to follow infections (PCR) and immunity (IgG) in their workforce, as well as their families (including children) and visitors to their site.
Collecting this data allows the gathering of epidemiological data on SARS-CoV-2 including incidence, prevalence, information on asymptomatic carriers and efficacy of vaccination. Furthermore, identifying individuals that are infected with SARS-CoV-2 has great potential to improve health outcomes by allowing infected individuals to seek the correct medical treatment as well as self-isolate and reduce transmission.
详细描述
This is a screening study to measure symptomatic and asymptomatic carriage of SARS-CoV-2 in trial participants to help facilitate early detection of a second wave of SARS-CoV-2 infections. Specifically, this study aims to determine ; to assess the duration of immunity by assessing the number and speed at which trial participants were infected and cleared the virus with or without symptoms; and to determine the length of symptom onset in those with an active infection; levels of IgG antibodies by demographics (sex, age, ethnicity, and intensity of symptoms). Longitudinal assessment of antibody levels will additionally allow for assessment of the efficacy of any vaccines adminstered. This study also seeks to explore how many people are asymptomatic carriers. In addition, this study aims to help facilitate the development a quantitative laboratory reference test for antibodies (IgG).
By using multiple different tests, it can be determined if a person is currently infected with SARS-CoV-2 or whether they previously have been infected. This allows for the scanning of people with asymptomatic carriage of the virus, which is important to help reduce the spread of SARS-CoV-2 through contact with people unaware of infection.
Polymerase Chain Reaction (PCR) testing is routinely used to check for active SARS-CoV-2 infections. It measures whether viral RNA is present in an individual's system. All in-house PCR tests are verified by an independent laboratory to check for false positives.
Using a membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens helps to assess whether an individual has previously had the virus and is potentially immune. IgG and IgM detection components are separate allowing for differential detection of each antibody.
To this date, 20904 PCR tests and 6848 antibody tests have been carried out in 2328 individuals, providing some interim data. Of the 20904 PCR tests, 17635 (84%) were negative and 132 (1%) were negative. Of the 6848 antibody tests, 706 (10%) were positive for IgG only, 64 (1%) were positive for IgM only, and 351 (5%) were positive for both IgG and IgM. 5710 (83%) tests were negative.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 5 to 70 years.
- •An understanding, ability, and willingness to fully comply with the project procedures and restrictions.
排除标准
- •Not applicable.
结局指标
主要结局
Identification of carriers of SARS-CoV-2
时间窗: Through study completion, estimated 12 weeks
To identify trial participants who are symptomatic or asymptomatic carriers of SARS-CoV-2 by comparing the results of a blood finger stick test and reference laboratory tests to PCR testing for acute infection
次要结局
- Exploration of SARS-CoV-2 epidemiology(Through study completion, estimated 12 weeks)
- Determination of the duration of immunity to SARS-CoV-2(Through study completion, estimated 12 weeks)
- Development of a quantitative laboratory reference test for the measurement of SARS-CoV-2(Through study completion, estimated 12 weeks)