Diagnostic Efficacy of the SARS-CoV2 Antigen Detection Test for the COVID-19 Contact Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 3,000
- 主要终点
- Sensitivity of the antigen detection test used in the study of contacts of COVID-19 patients.
研究概览
简要总结
Stopping the SARS-CoV2 spread is essential to control the pandemic cause by this virus.
A great effort is being made to carry out surveillance, case detection and contact control protocols in order to detect and isolate those contagious subjects.
Since both symptomatic and asymptomatic subjects can be contagious, a surveillance system based on the presence of symptoms is not enough, requiring to perform diagnostic tests in a large number of subjects, such as asymptomatic contacts or high-prevalence populations, and repeatedly. Moreover, the speed in obtaining results is crucial in order not to delay the isolations of positive subjects.
The polymerase chain reaction (PCR) is an expensive test which requires specialized equipment and personnel with a delay in results of 24-48 hours. In addition, its high sensitivity can mean that subjects without infective capacity have a positive result.
In contrast, antigen detection tests (ADTs) are cheap and easy to perform, having a result in few minutes. They have shown high sensitivity and specificity in symptomatic subjects, specially in the first week of symptoms when the viral load is high. This could be very useful for the study of asymptomatic contacts to detect those with potential contagiousness quick, easily and cheaply. However, there is no evidence to support the use of ADTs in this group of subjects.
For this reason, the investigators propose to carry out a study to compare the diagnostic efficacy of ADTs versus PCR in the group of subjects considered to be close contacts of SARS-Cov2 positive patients in the health area of Cáceres.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects considered close contacts of COVID-19 patients according to the definition of the Ministry of Health of Spain at the time of inclusion.
排除标准
- •Subjects who do not obtain their informed consent for the study.
- •Symptomatic subject at the time of inclusion.
研究组 & 干预措施
SARS-CoV2 contacts
Subjects considered close contacts of COVID-19 patients according to the definition of the Ministry of Health in the health area of Cáceres.
干预措施: Antigen detection test (Diagnostic Test)
结局指标
主要结局
Sensitivity of the antigen detection test used in the study of contacts of COVID-19 patients.
时间窗: 2 days
The investigators will analyze the probability of a positive antigen detection test result in a COVID-19 patient contact with a positive polymerase chain reaction test.
Specificity of the antigen detection test used in the study of contacts of COVID-19 patients.
时间窗: 2 days
The investigators will analyze the probability of a negative antigen detection test result in a COVID-19 patient contact with a negative polymerase chain reaction test.
次要结局
- Negative predictive value of the antigen detection test used in the study of contacts of COVID-19 patients.(2 days)
- Positive likelihood ratio of the antigen detection test used in the study of contacts of COVID-19 patients.(2 days)
- Negative likelihood ratio of the antigen detection test used in the study of contacts of COVID-19 patients.(2 days)
- Cut-off point of the cycle threshold of the polymerase chain reaction test that discriminates infectivity.(2 weeks)
- Risk of SARS-CoV2 infection in close contacts of COVID-19 patients with a positive polymerase chain reaction test depending on whether the antigen detection test is positive or negative.(2 weeks)
- Positive predictive value of the antigen detection test used in the study of contacts of COVID-19 patients.(2 days)
- Change in the pretest probability when the antigen detection test result is positive in a COVID-19 patient contact.(2 days)
- Change in the pretest probability when the antigen detection test result is negative in a COVID-19 patient contact.(2 days)
- To predict a positive result of the polymerase chain reaction test based on the appearance of symptoms during quarantine(10 days)
- The percentage of COVID-19 patient contacts with symptoms during the quarantine.(10 days)
研究者
Juan Fernando Masa Jiménez
Principal investigator
University of Extremadura