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

Not Applicable

• Conditions: COVID-19
• Interventions: Diagnostic Test: Breath Sample analysis

• Registration Number: NCT05094674
• Lead Sponsor: Tera Group

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2021-10
• Study Start: 2021-10-22
• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-10-24
• Last Update Submitted: 2021-10-24
• Study First Posted: 2021-10-26
• Last Update Posted: 2021-10-26
• Primary Completion: 2022-06-22
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants who require a diagnostic or screening COVID-19 RT-PCR test	Breath Sample analysis	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

Primary Outcome Measures

Name	Time	Method
Rate of positive and negative cases in collected breath samples using breath analyser test.	The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample

Trial Locations

Locations (1)

Tameside and Glossop Integrated Care NHS; 🇬🇧 Ashton Under Lyne, Lancashire, United Kingdom