NCT07859852 · Deepull Diagnostics S.L.
Evaluation of Diagnostic Accuracy and Clinical Performance of the UIICORE BSI Test
(B-RAPID)
What this study is about
This study is designed to evaluate the clinical performance of the UllCORE BSI Test, an experimental molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance markers directly from whole blood in patients with suspected bloodstream infection or sepsis.
View original scientific description
This study is designed to evaluate the clinical performance of the UllCORE BSI Test, an investigational molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance markers directly from whole blood in patients with suspected bloodstream infection or sepsis. Participants enrolled in the study will have blood collected at the same time as blood samples obtained for standard-of-care blood culture testing. Study blood samples will be tested using the UllCORE BSI Test either as fresh samples or after frozen storage, according to the study protocol. The results of the UllCORE BSI Test will be compared with standard-of-care microbiology results and, when applicable, additional testing methods to assess the diagnostic performance of the investigational test. The UllCORE BSI Test results will not be used to guide patient care and will not be provided to treating healthcare professionals for clinical decision-making. Participation in the study will therefore not change the standard medical care received by participants.
Interventions
DIAGNOSTIC_TEST
UllCORE BSI Test
The UllCORE 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.
Primary outcome measures
Clinical Performance of the UllCORE ID BSI Test Assessed by Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)
Time frame: From specimen collection through completion of investigational and comparator testing, up to 365 days after specimen collection.
Clinical performance of the UllCORE ID 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Any age (where the remaining criteria can be safely fulfilled)
- Ability to provide consent/assent in accordance with IRB/EC determinations
- The patient is presenting with signs and symptoms of suspected bloodstream infection (BSI) or fulfils the criteria for the hospital sepsis protocol.
- Planned blood culture collection and laboratory analysis as per SOC.
- Patient is able and an appropriate candidate to be able to collect 2 K2 EDTA tubes of whole blood.
Exclusion criteria
- Unable to collect UllCORE BSI Test samples from same venipuncture as BC samples
- Patient was previously enrolled in the study
Where
- Orange, California
- Tampa, Florida
- Baltimore, Maryland
- Boston, Massachusetts
- Novi, Michigan
- St Louis, Missouri
- Cleveland, Ohio
- Danville, Pennsylvania
- Nashville, Tennessee
- Temple, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 6, 2026 · Source of record for eligibility and locations