Conditions

Bacteremia Blood Stream Infection Blood Stream Infections Fungemia Sepsis

Keywords

Bloodstream infectionBlood cultureMolecular diagnosticsMolecular diagnostic testingWhole bloodPathogen detectionAntimicrobial resistance markersRapid diagnostic testingSepsis diagnosisDirect-from-blood testingMultiplex polymerase chain reactionUllCORE BSI Test

Outcome Measures

Primary Outcomes (1)

Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test Assessed by Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
Clinical performance of the UllCORE Bloodstream Infection (BSI) Test will be assessed using positive percent agreement (PPA) and negative percent agreement (NPA) compared with standard-of-care microbiological methods, as applicable. Performance will be evaluated for the microorganisms and antimicrobial resistance markers included in the test panel.
From specimen collection through completion of investigational and comparator testing, up to 365 days after specimen collection.

Study Arms (1)

Participants with Suspected Bloodstream Infection or Sepsis

Participants with suspected bloodstream infection or sepsis whose prospectively collected whole-blood specimens are either tested fresh using the investigational UllCORE Bloodstream Infection (BSI) Test or stored frozen before subsequent testing. UllCORE BSI Test results will be compared with standard-of-care microbiology results and will not be used for clinical decision-making.

Diagnostic Test: UllCORE BSI Test

Interventions

UllCORE BSI TestDiagnostic test

The UllCORE Bloodstream Infection (BSI) Test is an investigational molecular diagnostic test designed to detect microorganisms and selected antimicrobial resistance markers directly from whole blood. In this study, prospectively collected whole blood specimens will be tested either fresh or after frozen storage, according to the study protocol. UllCORE BSI Test results will be compared with standard-of-care microbiology results and will not be used for clinical decision-making.

Participants with Suspected Bloodstream Infection or Sepsis

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

The study population will consist of patients with suspected bloodstream infection (BSI) or sepsis who are undergoing standard-of-care blood culture testing. Participants will be recruited from Emergency Departments and Intensive Care Units. Eligible patients will be identified based on clinical signs and symptoms consistent with suspected BSI or sepsis, such as fever, elevated inflammatory markers, hypotension, or other clinical findings prompting blood culture collection. Participants meeting the eligibility criteria will be enrolled prospectively and consecutively, without preference for specific demographic or clinical characteristics.

You may qualify if:

Sponsors & Collaborators

Deepull Diagnostics S.L.
Industrylead

Study Sites (20)

University of California at Irvine Medical Center

Orange, California, 92868, United States

NOT_YET_RECRUITING

Tampa General Hospital

Tampa, Florida, 33606, United States

NOT_YET_RECRUITING

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

NOT_YET_RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood specimens collected prospectively in K2 ethylenediaminetetraacetic acid (EDTA) tubes will be tested either fresh or after frozen storage, according to the study protocol. Frozen specimens will be stored at -65°C or below and may be retained for subsequent investigational, discrepant, or confirmatory testing.

MeSH Terms

Conditions

SepsisFungemiaBacteremia

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsInvasive Fungal InfectionsMycosesBacterial Infections and MycosesBacterial Infections

Central Study Contacts

Roger Canton

CONTACT

936553530 rcanton@deepull.com

Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Participants with Suspected Bloodstream Infection or Sepsis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (20)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Participants with Suspected Bloodstream Infection or Sepsis

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (20)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations