T2Bacteria Panel Pivotal Study

Status:	Completed
Conditions:	Infectious Disease, Hematology
Therapuetic Areas:	Hematology, Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - 95
Updated:	8/19/2018
Start Date:	December 2015
End Date:	June 2016

The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria
Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of
the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status
of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole
blood "clinical samples".

Inclusion Criteria:

- Subject or subject's legally authorized representative (LAR) must be able to
understand, read and sign the study specific informed consent form after the nature of
the study has been fully explained to them.

- Subject has had a diagnostic blood culture ordered, per routine standard of care
(prospective arm only).

- Subject is between 18-95 years of age.

Exclusion Criteria:

- Subject has other co-morbid condition(s) that, in the opinion of the Investigator,
could limit the subject's ability to participate in the study or impact the scientific
integrity of the study.

- Subject has had previous specimens tested by the T2Bacteria Panel with valid results.

- Treatment of subject with any investigational novel drug compound within 30 days prior
to the collection of T2 specimens.

We found this trial at

sites

University of Pittsburgh Medical Center

200 Lothrop St
Pittsburgh, Pennsylvania 15213