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

Withdrawn

• Conditions: COVID19

• 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.

Study Timeline

• Study First Submitted: 2020-08-02
• Study First Submitted QC: 2020-08-02
• Study First Posted: 2020-08-04
• Status Verified: 2022-11
• Study Start: 2022-11
• Primary Completion: 2022-11
• Study Completion: 2022-11
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-29

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• Status: WITHDRAWN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

Primary Outcome Measures

Name	Time	Method
Presence of disease	1 minute	Established diagnosis

Trial Locations

Locations (1)

Instituto Costarricense de Investigaciones Clínicas; 🇨🇷 San José, Costa Rica