Evaluation of Diagnostic Accuracy and Clinical Performance of the UIICORE BSI Test

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Clinical Performance of the UllCORE ID BSI Test Assessed by Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) — 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.

Trial sites (20)

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