To assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Bacteremia Assay.
This protocol is intended for use by external sites collecting clinical research specimens for T2 Biosystems' use in developing the T2Bacterial Assay. Specimens and information on patients' medical history, blood properties, medications, and blood culture history/results are required from the T2Bacterial Assay's target patient population (i.e., candidates for blood culture). Ideally, clinical specimens for use in developing the T2Bacterial Assay will be collected from negative blood culture, positive non-bacteria blood culture and positive bacteria blood culture patients.
Study Type
OBSERVATIONAL
Enrollment
156
Cooper Medical School
Camden, New Jersey, United States
Number of bacteremia positive patients
Number of bacteria positive patients based on concordant, sequential blood culture results and a positive T2 signal
Time frame: 3-5 days post blood culture
Number of bacteremia negative patients
Number of negative bacteremia samples based on concordant, sequential blood culture results and a negative T2 signal
Time frame: 3-5 Days post blood culture
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