Candidemia Clinical Trial
Official title:
Prospective Collection and Testing of Un-Spiked and Candida-Spiked Fresh Whole Blood Specimens From Patients Who Have Been Referred For a Diagnostic Blood Culture
The purpose of this study is to validate clinical performance (i.e. estimated sensitivity and specificity) of the T2 Candida test on the T2 DX Instrument compared to blood culture results and/or known Candida positive status of prospectively collected and contrived (i.e. Candida-spiked) clinical specimens.
This study will prospectively collect and analyze whole blood T2 clinical research specimens
and concomitant blood culture specimens from patients who have been referred for a blood
culture per routine standard of care. Additional analysis of blinded, contrived (i.e.
Candida spiked and un-spiked whole blood) specimens will be completed by study sites to
augment the analysis of Candida positive blood specimens prospectively obtained from the
study population.
The clinical performance of the T2 Candida test on the T2 Dx Instrument will be evaluated by
calculating the:
- Estimated clinical specificity of the T2Candida test results compared to Candida
negative blood culture results in prospectively collected specimens, and the
- Estimated sensitivity of the T2 Candida test results compared to the known Candida
positive status or Candida positive blood culture status of contrived specimens that
have been spiked at clinically relevant concentrations of the target organisms and,
where detected, to Candida positive blood culture results in prospectively collected
clinical specimens.
;
Observational Model: Case-Only, Time Perspective: Prospective
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