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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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Arm | |||
| Contrived Arm |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | The primary endpoint of estimated sensitivity will be determined by comparing positive blood culture results with the concomitantly collected T2Bacteria Panel results from the prospective clinical specimens. PPA will estimated based on the positive T2Bacteria detections of contrived clinical samples. | Up to 19 hours post blood collection |
| Specificity | The primary endpoint of estimated specificity will be determined by comparing the negative blood culture results with the concomitantly collected T2Bacteria Panel results from the prospective clinical specimens. NPA will be estimated based on the negative contrived clinical samples. | Up to 19 hours post blood collection |
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Inclusion Criteria:
Exclusion Criteria:
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Candidates participating in the prospective arm of the study will come from the hospital population who have had a blood culture ordered per routine standard of care. The contrived arm of the study is open to any participants that meet the study enrollment criteria. The study population for both arms is defined as all subjects who meet the study eligibility criteria, provide informed consent, and provide the clinical specimens under this protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States | ||
| University of Pittsburgh Medical Center |
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| ID | Term |
|---|---|
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
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| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| D018746 |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |