COVID-19 Contact Study by Antigen Detection Test (DETAC)

Juan Fernando Masa Jiménez

Status: Unknown

Conditions: SARS-CoV Infection

Treatments: Diagnostic Test: Antigen detection test

Study type: Observational

Funder types: Other

Identifiers

NCT04745533

12/2020

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects considered close contacts of COVID-19 patients according to the definition of the Ministry of Health of Spain at the time of inclusion.

Exclusion criteria

• Subjects who do not obtain their informed consent for the study.
• Symptomatic subject at the time of inclusion.

Trial design

3,000 participants in 1 patient group

SARS-CoV2 contacts

Description:

Subjects considered close contacts of COVID-19 patients according to the definition of the Ministry of Health in the health area of Cáceres.

Treatment:

Diagnostic Test: Antigen detection test