T2Cauris Panel

Direct detection of emerging superbug in patient skin and blood samples

*This product is available for research use only (RUO) and is not cleared for diagnostic use.

The T2Cauris™ Panel provides direct detection of the emerging superbug Candida auris in patient skin, patient blood, and hospital environmental samples and is now available for research use. The Centers for Disease Control and Prevention (CDC) validated the T2Cauris™ Panel swab test on patient skin samples and published their findings in Mycoses.1 

A serious global threatCandida auris is a multidrug-resistant pathogen recognized by the CDC as a serious global health threat because it can be resistant to all three major classes of antifungal drugs and difficult to identify. The CDC has also reported that more than 1 in 3 patients with C. auris infections has died.2 Unlike most other species of CandidaC. auris can spread quickly in a hospital, making rapid identification and hospital environment surveillance a critical component of containing outbreaks. Reported cases of C. auris have surged internationally, and the CDC has reported a significant increase in infected patients in the United States. Because C. auris can be resistant to most treatment options, hospital outbreaks have been difficult to contain by even the most enhanced control measures.

Existing diagnostics suffer from extended detection times and low accuracy: Existing laboratory methods that detect C. auris, including blood culture, suffer from prolonged detection times and low accuracy, which exacerbates the challenge in the fight to contain the superbug. The CDC utilizes culture-based methods that require 14 days for results. 

A new rapid diagnostic assay: The T2Cauris Panel demonstrated significant superiority in time advantages (<5 hours) compared to culture methods that took 14 days and inability to detect low levels of C. auris. The T2Cauris Panel can detect levels as low as which is < 5 CFUs/mL which is greater than a 100-fold increase in sensitivity compared to other molecular diagnostic tests for C. auris.1,3,4,5 Additional data was presented by T2 Biosystems in a poster on the T2Candida auris assay at IDWeek 2017.6    

T2 Biosystems has demonstrated the following performance in the detection of C. auris:

  • Detection in blood and environmental and skin swab elution buffer at ≤5 CFU/mL
  • Detection in skin swab and whole blood specimens from patients known to be infected with C. auris
  • Lack of cross-reactivity with Candida species commonly misidentified as C. auris
  • Detection of all four known clades of C. auris

 

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1. Sexton DJ, et al. Mycoses, 2018
2. Centers for Disease Control and Prevention, 2017
3. Sexton DJ, et al. Journal of Clinical Microbiology, 2018
4. Kordalewska M, et al. Journal of Clinical Microbiology, 2017
5. Leach L, et al. Journal of Clinical Microbiology, 2018
6. Manning B, et al. Poster Presentation, IDWeek, 2017

T2CAURIS PANEL RUO

>89% Sensitivity1,* | 98% Specificity1,*

— C. auris
— C. duobushaemulonii
— C. haemulonii

Method validated by CDC for patient swabs

Demonstrated performance in whole blood

 

Research Use Only (RUO)