Clinical Validation of Breath Analyser Tests for Diagnosis of COVID-19.

Tera Group

Status: Unknown

Conditions: COVID-19

Treatments: Diagnostic Test: Breath Sample analysis

Study type: Interventional

Funder types: Industry

Identifiers

NCT05094674

BREATHE

Details and patient eligibility

About

The Sponsor has developed a rapid screening tool intended to determine if the subject tested is COVID-19-free (Negative to COVID-19).

Full description

Within this proposed project, the NHS will collect two diagnostic or screening tests per participant. One sample will be used by NHS and be run through regular diagnostics. The second, will be breath sample which will be tested using the BioSafety Technologies Ltd, rapid screening tool. This will use a pre-defined protocol. These tests would then be compared to assess the diagnostic efficacy including sensitivity and specificities. We will be aiming to achieve a significant comparison to ensure certainty and to exploit the information for proposing a novel diagnostic system to enhance capabilities to scale up the testing of patients. The proposed activity involves clinical validation of BioSafety Testing, to enhance the performance of detection along with clinicians.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Requiring a diagnostic or screening RT-PCR test for COVID-19

Exclusion criteria

• Subjects under general anaesthesia
• The inability to personally sign the consent form.
• The inability to exhale breath

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Participants who require a diagnostic or screening COVID-19 RT-PCR test

Other group

Description:

Participants who require a diagnostic or screening COVID-19 RT-PCR test, presenting at Tameside and Glossop Integrated Care NHS Foundation Trust aged 18 years or over

Treatment:

Diagnostic Test: Breath Sample analysis