Covid19, SARS-CoV Infection
Conditions
Keywords
Electronic nose, Volatile organic compounds, Diagnosis, Serology, Antibodies
Brief summary
Corona Virus Disease (COVID-19), spread worldwide and has become an emergency of major international concern. In March 2020, the WHO declared the COVID-19 outbreak a global pandemic. Accurate and fast diagnosis is crucial in managing the pandemic. Current diagnostic approaches raise several difficulties: they are time-consuming, expensive, invasive, and most important lacking high sensitivity. The gold standard diagnostic test for COVID-19, reverse transcription polymerase chain reaction (RT-PCR), is highly dependent on adequate deep sampling of the swab in the naso- and oropharynx. A new diagnostic test that can correctly and rapidly identify infected patients and asymptomatic carriers is urgently required to prevent further virus transmission and thus reduce mortality rates. Aim: This proof-of-principle study aims to investigate if an electronic nose (Aeonose) can distinguish individuals with antibodies from individuals without antibodies against COVID-19 based on analysis of volatile organic compounds (VOCs). Methods: between April and July 2020, persons undergoing RT-PCR and a serology test for COVID-19 were recruited at Maastricht UMC+ for breath analysis. All participants had to breathe through the Aeonose for five consecutive minutes. The VOC pattern in their exhaled breath was then linked to the matching RT-PCR and serological test results.
Interventions
DEVICEAeonose
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. A nose clip was placed on the nose of each participant to avoid entry of non-filtered air in the device. Before measuring, the Aeonose was flushed with room air, guided through a carbon filter as well. During each measurement, a video was displayed to distract the participant and to reduce the chance of hyperventilation. Failed breath tests were excluded from analysis; the reason for failure was documented. Four similar Aeonose devices were used for breath analysis. A full-measurement procedure required sixteen minutes.
Sponsors
Maastricht University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants of whom an oropharyngeal and nasopharyngeal swab was collected for RT-PCR and on whom serology testing for the detection of antibodies was performed.
Exclusion criteria
* Participants who where experiencing dyspnea or needed supplemental oxygen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 antibodies vs COVID-19 negative | 3 months | Ability of the electronic nose (Aeonose) to distinguish individuals with antibodies from individuals without antibodies against COVID-19 based on analysis of volatile organic compounds (VOCs). |
Countries
Netherlands
Outcome results
None listed