Study Stopped
Lack of financing. Furthermore, antigen tests were incorporated into contact detection, so the study lost interest.
COVID-19 Contact Study by Antigen Detection Test
DETAC
Diagnostic Efficacy of the SARS-CoV2 Antigen Detection Test for the COVID-19 Contact Study
1 other identifier
observational
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2021
CompletedFirst Posted
Study publicly available on registry
February 9, 2021
CompletedStudy Start
First participant enrolled
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedApril 29, 2026
April 1, 2026
2 months
February 4, 2021
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Sensitivity of the antigen detection test used in the study of contacts of COVID-19 patients.
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.
2 days
Specificity of the antigen detection test used in the study of contacts of COVID-19 patients.
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.
2 days
Secondary Outcomes (10)
Positive predictive value of the antigen detection test used in the study of contacts of COVID-19 patients.
2 days
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
Change in the pretest probability when the antigen detection test result is positive in a COVID-19 patient contact.
2 days
- +5 more secondary outcomes
Study Arms (1)
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.
Interventions
To compare the results of the antigen detection test against the polymerase chain reaction in the study of contacts of COVID-19 patients during quarantine.
Eligibility Criteria
All subjects considered close contacts of COVID-19 patients according to the definition of the Ministry of Health of Spain in the health area of Cáceres
You may not qualify if:
- Subjects who do not obtain their informed consent for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 4, 2021
First Posted
February 9, 2021
Study Start
February 15, 2021
Primary Completion
April 30, 2021
Study Completion
June 30, 2021
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Additional related documents such as study protocol, statistical analysis plan and informed consent form will be available upon request from the project principal investigator. (Dr. Juan Fernando Masa Jiménez). De-identified patients´data can be requested by researchers for use in independent scientific research and will provided following review and approval of the research proposal (including statistical analysis plan) and completion of a data sharing agreement with the Project Publications Committee. Investigator Data requests can be made anytime from 1 to 2 years after the publication of this trial. Requests should be sent to the corresponding author (Dr. Juan Fernando Masa Jiménez- fmasa@separ.es)