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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

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.

Trial locations and contacts

20 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Blood Stream Infection, Blood Stream Infections, Sepsis, Fungemia, Bacteremia

Being tested

UllCORE BSI Test

Keywords

Bloodstream infection, Blood culture, Molecular diagnostics, Molecular diagnostic testing, Whole blood, Pathogen detection, Antimicrobial resistance markers, Rapid diagnostic testing, Sepsis diagnosis, Direct-from-blood testing, Multiplex polymerase chain reaction, UllCORE BSI Test

Medical subject headings

Sepsis, Fungemia, Bacteremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: From specimen collection through completion of investigational and comparator testing, up to 365 days after specimen collection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Oct 2026
2. Study start21 Sep 2026
3. Primary completionApr 2027 (estimated)
4. Study completionOct 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Blood Stream InfectionStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.