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.
Inclusion Criteria:
Subjects meeting the following criteria may be eligible for participation in the study:
1. ≥ 18 years old or older
2. The first vital sign (any one of: blood pressure, temperature, pulse or respiratory
rate) has been recorded in the medical record
3. 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
4. Signs or suspicion of a respiratory infection, defined as:
1. Subject designated for evaluation in the ED respiratory or pulmonary pod or
similar location. OR
2. An order placed for a respiratory viral panel. OR
3. An order placed for a SARS-CoV-2 test. OR
4. A subject self-reported as having tested positive for the SARS-CoV-2 test within
the previous 7 days and returning with a related complaint.
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.
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
Hollis R O'Neal, Jr., MD, MSc, Principal Investigator
Pulmonary & Critical Care LSUHSC, Baton Rouge