The Sponsor has developed a rapid screening tool intended to determine if the subject tested has COVID-19.
According to recent scientific literature, the virus infection occurs mainly through the nasal cavity, and therefore, samples of nasal and pharyngeal fluids are expected to be high viral load samples. The proposed clinical trial is to test the mentioned for potential dominant virus particles absorbance frequencies according to which, it will be possible to perform a statistical analysis of spectral data of infected subjects' samples compared to healthy ones and to examine whether a statistical significance between 'Infected' and 'Healthy' can be demonstrated in terms spectroscopic measurements. Indication for Use: Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples. The study is aimed to collect data in order to assess whether a patient's COVID -19 status can be identified by a unique spectrophotometric pattern.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
500
Rapid detection of the novel SARS-CoV-2 (COVID-19) virus in breath samples.
Primary Outcome Measure
Rate of positive and negative cases in collected breath samples using breath analyzer test compare to PCR results.
Time frame: The collection of an additional samples requiring COVID 19 diagnostic evaluation will take approximately 1 minute from initial collection of the sample
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