The T2Candida Panel DirecT2 Pivotal Clinical Trial was a multi-center study that enrolled and collected blood specimens from 1,801 hospitalized patients between the ages of 18 and 95 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 of blood spiked with Candida. Results from the pivotal trial were published in Clinical Infectious Diseases (CID).
In this study, the T2Candida Panel and T2Dx Instrument demonstrated:
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!—than blood culture.
Detecting complex cases
In one case described in Clinical Infectious Diseases, the T2Candida Panel detected a Candida infection that blood culture missed in 12 successive tests. Seven days after the T2Candida Panel result, physicians performed an invasive procedure to gather tissue to culture, which proved that the T2Candida Panel result accurately identified a case of intra-abdominal candidiasis.1
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 12 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, [the T2Candida Panel] has the potential to positively impact the practice of medicine for these patients."
Continuing to identify infections missed by blood culture
Now in routine clinical practice, T2 users continue to see evidence that the T2Candida Panel is detecting infections that blood culture misses. A meta-analysis published in Future Microbiology combines the preclinical, clinical and economic studies focused on the impact of the T2Candida Panel on the diagnosis of Candidemia in patients with sepsis.2 It found that the T2Candida Panel:
Was able to detect proven invasive candidiasis in 12 cases and probable or suspected invasive candidasis in an additional 10 cases in which the results of the blood culture were negative.2
Demonstrated an overall sensitivity of 96.4%.2
Projected a potential cost savings of $5,858,448 for a hospital admitting 5,100 high-risk patients.2
Additional data from other investigators in the U.S. and Europe indicate that the T2Candida Panel is detecting invasive candidiasis that was missed by blood culture. In these cases, confirmation of deep-seated infection came in the form of urine, bronchial or wound cultures.