Validation of TERA Bio Station T101 of COVID-19 Tested Population.

Launched by TERA GROUP · Oct 21, 2021

Keywords

ClinConnect Summary

The goal of the pilot is to perform a localized validation to the TERA Bio Tests by TERA Bio Station(s). Success Criteria: Clearing at least 80% of the healthy population.

Pilot duration: approx. 6-10 work weeks long.

Research Population Requirements:

Male and Female, age ≥ 18 years old, whose COVID-19 virus infection status is known and verified for at least the last 24 hours (prior to the TERA.Bio test).

The study will include a minimum of 300 tested Positive individuals and a minimum of 700 Negative individuals, tested during the 24 hours prior to the TERA.Bio test.

Additional PCR t...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years old (under 18 years old - only if it is allowed under local regulations and with legal guardian's approval and consent if needed.
• • 2. COVID-19 virus infection status is known and verified 24 hours prior to a TERA.Bio test by RT-PCR and if required, a repeated PCR test based on symptomatic status and or / the CT value of the tested individual.
• • 3. Signed Informed consent form.
• Exclusion Criteria:
• • 1. Discrepancies to inclusion criteria
• • 2. Individuals under general anaesthesia
• • 3. Individuals lacking the capability to personally sign the consent form.
• • 4. Individuals lacking the capability to exhale breath.

Trial Officials