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

This study is designed to evaluate the clinical performance of the UllCORE Bloodstream Infection (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.

Inclusion Criteria: * Any age (where the remaining criteria can be safely fulfilled) * Ability to provide consent/assent in accordance with Institutional Review Board (IRB)/Ethics Committee (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 standard of care (SOC). • Patient is able and an appropriate candidate to be able to collect 2 K2 ethylenediaminetetraacetic acid (EDTA) tubes of whole blood. Exclusion Criteria: * Unable to collect UllCORE BSI Test samples from the same venipuncture as blood culture (BC) samples * Patient was previously enrolled in the study