Prospective, multi-center, observational, blinded study, enrolling pediatric and adult subjects. Eligible ED\\Urgent care and hospital admitted patients with symptoms consistent with acute bacterial or viral infection and healthy subjects will be recruited according to the eligibility criteria. Each participant will undergo a thorough investigation upon recruitment that includes documenting clinical, radiological, laboratory and microbiological information for determining their health status. Follow-up data will be collected via a phone call. Diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection will be assessed using an expert adjudication comparator method. The study will be run in a blinded fashion: site personnel will be blinded to the comparator method outcomes, and the expert panel will be blinded to the results of the index test. Results of the index test will not be revealed to the attending clinician and so will not influence patient management.
Study Type
OBSERVATIONAL
Enrollment
1,384
The MeMed BV™ Test is an immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples. The test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The test is indicated for use in patients presenting to the ED, urgent care center and inpatients with suspected acute bacterial or viral infection. The MeMed BV™ Test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection. The MeMed BV™ test is intended for in vitro diagnostic use only.
Johns Hopkins
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Maimonides Medical Center
New York, New York, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
American Family Care Urgent Care
Easley, South Carolina, United States
American Family Care Urgent Care
Powdersville, South Carolina, United States
American Family Care Urgent Care
Chattanooga, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
University of Texas Health Science Center
Houston, Texas, United States
Hillel Yaffe Medical Center
Hadera, Israel
...and 1 more locations
Establish the diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection using expert adjudication comparator method.
Establish the diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection using expert adjudication comparator method.
Time frame: Through study completion, an average of 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.