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SARS-CoV-2 (COVID-19) Detection Using the Breath Analizer TeraSystem

Withdrawn
Conditions
COVID19
Interventions
Diagnostic Test: Breath sample
Registration Number
NCT04497610
Lead Sponsor
Instituto Costarricense de Investigaciones Clínicas ICIC
Brief Summary

The purpose of the study is to verify the sensibility and accuracy of a rapid detection test for SARS-CoV-2 in breath samples analyzed by the breath detector analyzer TeraSystem, comparing with PCR tests.

Detailed Description

BioSafety Technologies has developed a rapid detection test to clear people of COVID-19.

A person can undergo an easy non-invasive test, to determine if they are: COVID-19 Clear (Negative) or Infected (Positive). The user-friendly process does not involve medically trained personnel.

The study will compare TeraSystem test results against PCR test results. Persons participating will be persons having a PCR test as part of the Health System and consenting to participate.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Older than 7 years odf age Able to provide informed consent Able to take the breath test

Exclusion Criteria

Younger than 7 years of age Unable to provide informed consent Unable to take the breath test

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Positive TeraSystem testBreath samplePatients having positive PCR tests will undergo TeraSystem test
Negative TeraSystem testBreath samplePatients having negative PCR tests will undergo TeraSystem test
Primary Outcome Measures
NameTimeMethod
Presence of disease1 minute

Established diagnosis

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Instituto Costarricense de Investigaciones Clínicas

🇨🇷

San José, Costa Rica

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