Clinical data demonstrates superior accuracy & speed
The T2 Biosystems direcT2 pivotal clinical trial was a multi-center study that enrolled and collected blood specimens from 1,801 hospitalized patients between ages 18 and 95 years old who had a blood culture ordered as part of routine care. There were two patient arms: a prospective arm with 1,501 samples from patients with a possible infection and a seeded arm with 300 samples, also from patients with a possible infection. Results from the pivotal trial were published in the journal Clinical Infectious Diseases (CID).
In this publication, the T2Candida Panel and T2Dx Instrument demonstrated:
- 91.1% Sensitivity1
- 99.4% Specificity1
- Limits of detection as low as 1 CFU/mL1
Stop waiting days for blood culture results
The average time to species-specific results with the T2Candida Panel is significantly faster (over 25 times faster!) when compared to blood culture.
In one case described in the Clinical Infectious Diseases publication, the T2Candida Panel detected a Candida infection that blood culture missed in 12 successive tests. Seven days after the T2Candida Panel result was obtained, physicians performed an invasive procedure to obtain a tissue culture, which proved that the T2Candida Panel result accurately identified a case of intra-abdominal candidiasis.
Cornelius J. Clancy, an investigator in the study who presented this case at IDWeek 2014, stated, "Blood culture, the current standard of care for the diagnosis of Candida infections, is known to have poor sensitivity overall and has 38% sensitivity in proven and probable cases of invasive candidiasis. In our case, the T2Candida Panel has shown that it can rapidly identify intra-abdominal candidiasis where twelve serial blood culture results were negative. In many patients at risk for candidiasis, the collection of tissue samples for diagnosis is not possible due to their underlying medical conditions. Achieving the level of sensitivity demonstrated in this case, without requiring an intra-abdominal sample, has the potential to positively impact the practice of medicine for these patients."
1. Mylonakis, E., Clancy, C.J., Ostrosky-Zeichner, et. al. (2015). T2 Magnetic Resonance Assay for the Rapid Diagnosis of Candidemia in Whole Blood: A Clinical Trial. Clinical infectious diseases, ciu959.
2. Pappas, P. G., Kauffman, C. A., Andes, D. R., et. al. (2015). Clinical practice guideline for the management of candidiasis: 2016 update by the Infectious Diseases Society of America. Clinical infectious diseases, civ933.