DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY
A diagnostic prospective single-site study, with no anticipated risks or constraints. Primary objective- To validate the value of a set of breath VOC biomarkers that enable us to distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison to the gold-standard testing methodology.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
2,558
Analysis of a single breath Biopsy
Shamir Medical Center
Be’er Ya‘aqov, Israel
Presence of Volatile Organic Compounds indicating carriers of COVID-19.
Comparison of Volatile Organic Compounds found among COVID-19 carriers and Healthy controls.
Time frame: Through the study completion, up to 3 months.
Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.).
Correlation level between exhaled biomarkers and participants' demographic characteristics.
Time frame: Through the study completion, up to 3 months.
sensitivity level of biomarkers' algorithm.
comparison of algorithm's sensitivity level to the sensitivity of COVID-19 swab TEST.
Time frame: Through the study completion, up to 3 months.
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