Can the Electronic Nose Smell COVID-19?

Not Applicable

Completed

• Conditions: Covid19; SARS-CoV Infection
• Interventions: Device: Aeonose

• Registration Number: NCT04475562
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

Infection with SARS-CoV-2 causes Corona Virus Disease (COVID-19). The most standard diagnostic method is reverse transcription-polymerase chain reaction (RT-PCR) on a nasopharyngeal and/or an oropharyngeal swab. The high occurrence of false-negative results due to the non-presence of SARS-CoV-2 in the oropharyngeal environment renders this sampling method not ideal. Therefore, a new sampling device is desirable. This proof-of-principle study investigates the possibility to train machine-learning classifiers with an electronic nose (Aeonose) to differentiate between COVID-19 positive- and negative persons based on volatile organic compounds (VOCs) analysis.

Methods: between April and June 2020, participants were invited for breath analysis when a swab for RT-PCR was collected. If the RT-PCR resulted negative, presence of SARS-CoV-2 specific antibodies was checked to confirm the negative result. All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine-learning and used for pattern recognition. The result is a value between -1 and +1, indicating the infection probability.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-06
• Primary Completion: 2020-05-06
• Status Verified: 2020-07
• Study Completion: 2020-07-01
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-16
• Last Update Submitted: 2020-07-16
• Study First Posted: 2020-07-17
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

• Participants of whom an oropharyngeal or nasopharyngeal swab was collected to perform RT-PCR on.

Exclusion Criteria

• Participants who were experiencing dyspnea or needed supplemental oxygen.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COVID-19 suspected	Aeonose	Participants were recruited at the outpatient clinic for MUMC+ employees with COVID-19 symptoms or at the nursing unit where a SARS-CoV-2 patient was admitted.

Primary Outcome Measures

Name	Time	Method
COVID 19 positive vs negative	3 months	Ability of the eNose to distinguish COVID-19 positive from COVID-19 negative persons based on VOC patterns.

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands