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The T2Bacteria Panel run on the T2Dx Instrument is a qualitative T2 Magnetic Resonance (T2MR) test for the direct detection of bacterial species in K2EDTA human whole blood specimens with suspected bacteremia. The T2Bacteria Panel identifies six species of bacter baumannii, Enterococus faccium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa and Staphylococcus aureus.

The T2Bacteria Panel is indicated as an aid in the diagnosis of bacteremia and results should be used in conjunction with other clinical and laboratory data. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification and for organisms not detected by the T2Bacteria Panel.

Results from the T2Bacteria Panel are not intended to be used as for diagnosis, treatment, or other patient management decisions in patients with suspected bacteremia.

The T2Bacteria Panel detects and identifies six bacterial target species directly from whole blood specimens and independent of blood culture using nucleic acid amplification and proprietary T2MR detection technology. The assay is performed on the proprietary T2Dx platform. The whole blood specimen, drawn into a blood collection tube containing K₂EDTA is used for the test. The blood collection tube containing a minimum of 3 mL of blood is loaded directly onto the T2Dx instrument as part of the assembled Cartridge, a single use self-contained unit that contains all of the reagents and disposables required to run a single test. Fully automated on the T2Dx, the blood specimen is mixed with the Lysis Reagent to lyse the red blood cells and the bacterial cells are concentrated by centrifygation. The Internal Control is added to the concentrated bacterial cells, which then undergo a bead beating step to lyse the bacteria cells. The supernatant containing the DNA from the lysed bacterial cells and the Internal Control are amplified with the target and Internal Control specific primers. The generated amplicon is then aliquoted into individual tubes containing target specific conjugated particles for Acinetobacter baumannii, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus, and the Internal Control. These individual tubes are read in the MR reader and a signal is generated.

Up to seven specimens can be loaded onto the T2Dx Instrument in parallel. When running a single specimen, the first result is reported in 3.5 hours from the specimen is loaded onto the instrument. The results are interpreted using the T2Dx applications software as valid or invalid, and if valid, target specific results are reported as Positive or Target not Detected. For one target, the Escherichia coli channel, results are reported as Positive, Indeterminate, or Target not Detected. An Indeterminate result is a valid result, but the presence or absence of Escherichia coli cannot be definitively assessed, and the indeterminate status applies only to the Escherichia coli channel. Results are displayed on the T2Dx touchscreen and can be printed. Raw T2MR data are not available to the end user.

Here's a summary of the acceptance criteria and study details for the T2Bacteria Panel, specifically concerning the addition of Acinetobacter baumannii detection:

Acceptance Criteria and Device Performance for Acinetobacter baumannii

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