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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood culture | Subjects have had a blood culture ordered, per routine standard of care |
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| Measure | Description | Time Frame |
|---|---|---|
| Specificity | Estimated specificity of the T2Candida test will be examined by comparing T2Candida test results from prospectively collected T2 clinical specimens to blood culture results from specimens that are culture negative for Candida and which have been collected at the same time and from the same anatomical location as the T2 specimens. | Up to 19 hours post blood collection |
| Sensitivity | Estimated sensitivity of the T2Candida test will be examined by comparing T2Candida test results 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 blood culture results from specimens that are culture positive for Candida and which have been collected at the same time and from the same anatomical location as the T2 specimens. | Up to 19 hours post blood collection |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients who have had a blood culture ordered, per routine standard of care
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| Name | Affiliation | Role |
|---|---|---|
| Peter Pappas, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-0006 | United States | ||
| Georgia Regents University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25586686 | Derived | Mylonakis E, Clancy CJ, Ostrosky-Zeichner L, Garey KW, Alangaden GJ, Vazquez JA, Groeger JS, Judson MA, Vinagre YM, Heard SO, Zervou FN, Zacharioudakis IM, Kontoyiannis DP, Pappas PG. T2 magnetic resonance assay for the rapid diagnosis of candidemia in whole blood: a clinical trial. Clin Infect Dis. 2015 Mar 15;60(6):892-9. doi: 10.1093/cid/ciu959. Epub 2015 Jan 12. |
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| ID | Term |
|---|---|
| D058387 | Candidemia |
| C536972 | Torulopsis |
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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Whole blood specimens
| Augusta |
| Georgia |
| 30912 |
| United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Houston College of Pharmacy | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center | Houston | Texas | 77030 | United States |
| D007239 |
| Infections |
| D000072742 | Invasive Fungal Infections |
| D016469 | Fungemia |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |