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This is a single-site prospective study to evaluate the diagnostic performance of the investigational SeptiScan System for patients presenting to the Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases.
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Inclusion criteria
Subjects meeting the following criteria may be eligible for participation in the study:
≥ 18 years old or older
The first vital sign (any one of: blood pressure, temperature, pulse or respiratory rate) has been recorded in the medical record
A complete blood count has been ordered for which a blood sample has been collected within 4.5 hours since the first vital sign was recorded
Signs or suspicion of a respiratory infection, defined as:
Exclusion criteria
Subjects are excluded from study participation if they meet any of the following criteria:
a. Blood sample volume is < 300 ul; insufficient quantity for SeptiScan testing.
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Data sourced from clinicaltrials.gov
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