Methods: An IRB-approved, prospective, observational study was implemented at a Safety-Net, Level One Trauma Center in Denver, Colorado. Patients were enrolled who received an order for a blood culture from the ED or SICU. Patients who had blood drawn for cultures had a concurrent draw for testing with a T2Bacteria Panel RUO.
Results: 66 patients are included in the present interim analysis. Mean patient age was 51 years old (19-84), 36% were female, 86% Caucasian (34% Hispanic/Latino), and 74% of patients were enrolled upon presentation to the ED, 13% from the SICU, and 15% from the wards. 90% of blood sampling (culture and T2Bacteria) was done from peripheral stick while 7% were from the initial stick of a peripheral IV and 2% obtained from an indwelling catheter.
85% of blood cultures were negative. Of the 56 patients with negative blood culture, 53 had concordant negative T2Bacteria results, providing a specificity of 94.6%. 10 patients had positive blood cultures (15%) for T2Bacteria Panel RUO targets. Interestingly, only 5 of these (50%) had concordant positive T2Bacteria testing. Examining the discordant samples, all (5) blood culture positive, T2Bacteria negative were found to have clinically false positive blood cultures. T2Bacteria positive samples were distributed as follows: 2 E.coli, 1 S. aureus, 1 K. pneumoniae, and 1 P. aeruginosa. No detections were made for E. faecium or A. baumannii.
Conclusion: In this interim analysis, T2Bacteria Panel RUO provides feasible rapid diagnostics for ED and surgical ICU settings with a high specificity and much shorter time to result when compared to gold standard blood cultures.
Research Coordinator for funded study from T2 Biosystems
A. Sauaia, None
M. Cohen, T2 Biosystems: PI on study being funded by T2 Biosystems, not paying for any part of salary , Research support .