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

Diagnostic Efficacy of the SARS-CoV2 Antigen Detection Test for the COVID-19 Contact Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: SARS-CoV Infection
• Intervention / Treatment: Diagnostic test: Antigen detection test

• Study Type: Observational
• Enrollment (Anticipated): 3000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Antigen detection test; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value of the antigen detection test used in the study of contacts of COVID-19 patients.	The investigators will analyze the probability that a subject considered COVID-19 patient contact with a positive antigen detection test result has a positive polymerase chain reaction test.	2 days
Negative predictive value of the antigen detection test used in the study of contacts of COVID-19 patients.	The investigators will analyze the probability that a subject considered COVID-19 patient contact with a negative antigen detection test result has a negative polymerase chain reaction test.	2 days
Positive likelihood ratio of the antigen detection test used in the study of contacts of COVID-19 patients.	The investigators will analyze how much the probability of having a positive polymerase chain reaction test increases when a subject considered a COVID-19 patient contact has a positive antigen detection test.	2 days
Negative likelihood ratio of the antigen detection test used in the study of contacts of COVID-19 patients.	The investigators will analyze how much the probability of having a positive polymerase chain reaction test decreases when a subject considered a COVID-19 patient contact has a negative antigen detection test.	2 days
Change in the pretest probability when the antigen detection test result is positive in a COVID-19 patient contact.	The investigators will analyze the change that occurs in the probability that a subject considered a COVID-19 contact has a positive polymerase chain reaction test before and after performing an antigen detection test with a positive result	2 days
Change in the pretest probability when the antigen detection test result is negative in a COVID-19 patient contact.	The investigators will analyze the change that occurs in the probability that a subject considered a COVID-19 contact has a positive polymerase chain reaction test before and after performing an antigen detection test with a negative result	2 days
Cut-off point of the cycle threshold of the polymerase chain reaction test that discriminates infectivity.	The investigators will analyze the cut-off point of polymerase chain reaction test (PCR) cycle threshold that maximizes discrimination of patients with at least one close contact with positive PCR (infectivity in the first circle of contacts).	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.	The investigators will compare the number of infected subjects by COVID-19 patient contacts with a positive polymerase chain reaction test, depending on whether the antigen detection test is positive or negative	2 weeks
To predict a positive result of the polymerase chain reaction test based on the appearance of symptoms during quarantine	Researchers will analyze the appearance of symptoms during quarantine in the contacts of COVID-19 patients and whether or not they have a positive polymerase chain reaction test.	10 days
The percentage of COVID-19 patient contacts with symptoms during the quarantine.	The investigators analyze the percentage of contacts of COVID-19 patients who develop symptoms during the quarantine.	10 days

Collaborators and Investigators

• Sponsor: Juan Fernando Masa Jiménez

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2021
• Primary Completion (Anticipated): April 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Antigen detection tests; Diagnostic efficacy; Contact study; Asymptomatic contacts
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Severe Acute Respiratory Syndrome
• Other Study ID Numbers: 12/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No