Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Recruiting Locations

More Details

NCT ID
NCT04372472
Status
Unknown status
Sponsor
Cytovale, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.