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Life sciences · Observational Study
ClinicalTrials.gov · October 8, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Observational Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06531031). This is a study registration, not published results. Lead sponsor: Microbio Co Ltd. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 1500 participants (ESTIMATED). Conditions: Bloodstream Infection, Sepsis, Septic Shock. Interventions: DIAGNOSTIC_TEST: InfectID-BSI (Bloodstream Infection) qPCR Assay. Primary outcome measures: Determine the sensitivity and specificity of InfectID-BSI versus blood culture. , Through study completion, an average of 1 year; Determine the efficacy of detection and identification of the 26-pathogen panel in the InfectID-BSI assay versus standard of care blood culture. Using qPCR - a new molecular technology to identify the top 20 bacterial and 6 yeast sepsis causing species. , Through study completion, an average of 1 year. Brief summary: The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care methods from blood culture. The objective of this study is to determine the sensitivity and specificity of the Microbio InfectID-BSI qPCR kit by the evaluation of clinical blood samples versus standard of care methods from blood culture.