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The T2Biothreat Panel will not distinguish between detection of Burkholderia mallei and Burkholderia pseudomallei but will present valid detections as a positive detection of Burkholderia species.

The T2Biothreat Panel is intended to test individuals with signs and symptoms of infection from biothreat agents and/or individuals who are at risk for exposure or may have been exposed to these agents. The T2Biothreat Panel is indicated as an aid in the diagnosis of anthrax, tularemia, melioidosis, glanders, typhus fever and plague in response to suspected or confirmed bioterrorism events or outbreaks. Diagnosis of infection must be made in conjunction with clinical, epidemiologic and other laboratory data. Results are for the presumptive identification of Bacillus anthracis, Francisella tularensis, Burkholderia spp. (B. mallei), Yersinia pestis and Rickettsia prowazekii. Results are meant to be used in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidel by the relevant public health authorities. The definitive identification of Bacillus anthracis, Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei, Yersinia pestis or Rickettsia prowazekii requires additional testing and confirmation procedures in consultation with the appropriate public health authorities for whom reports may be required. Positive results do not rule out co-infections with pathogens not included on the T2Biothreat Panel. Negative results do not preclude infection with the biothreat microbial agents targeted by the device and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

The T2Biothreat Panel is indicated for use in laboratories that have the appropriate biosafety equipment, personal protective equipment (PPE), containment facilities, and personnel trained in the safe handling of clinical specimens potentially containing biothreat organisms.

The T2Biothreat Panel is indicated for use in laboratories that follow public health guidelines that address appropriate biosafety conditions, interpretation of test results, and coordination of findings with public health authorities.

This assay is not FDA-cleared or approved for testing blood or plasma donors.

Device Description

The T2Biothreat Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the T2Dx Instrument. The T2Biothreat Panel detects nucleic acids from the following organisms directly from K2EDTA whole blood samples: Bacillus anthracis (plasmids pXO1 and pXO2), Francisella tularensis, Burkholderia spp. (B. mallei/B. pseudomallei), Yersinia pestis, and Rickettsia prowazekii. The T2Biothreat Panel is run on the T2Dx, a fully automated, benchtop instrument. During processing on the T2Dx, intact pathogen cells are concentrated directly in whole blood, then lysed to release the target DNA. After amplification, target amplicon is hybridized with superparamagnetic particles and then detected by T2MR. The Internal Control on the T2Biothreat Panel monitors performance for each sample. The T2Biothreat Panel is a qualitative molecular diagnostic assay that employs whole blood compatible PCR amplification followed by T2 Magnetic Resonance (T2MR) detection. The T2Biothreat Panel is performed on the T2Dx Instrument, which executes all steps after specimen loading, with the capability of loading up to seven blood specimens at the same time. Individually, a KeEDTA whole blood specimen containing a minimum of 3 mL is loaded directly onto the T2Biothreat Sample Inlet, which is then placed on the T2Biothreat Cartridge along with the T2Biothreat Reagent Tray. The Cartidge and Reagent Tray contain the lysis reagent, internal control, primers, enzyme, buffer and probe-coupled superparamagnetic particles for each detected tarqet. After loading into the T2Dx. the blood specimen is mixed with the red blood cell lysing reagent and the bacterial cells and human cellular debris are concentrated by centrifygation. The internal control is added to the concentrated pellet and a bead-beating process lyses the bacterial cells. The supernatant containing the DNA from the lysed bacterial cells and the internal control is amplified using the target and internal control-specific primers. The generated amplified product is aliquoted into individual tubes containing target-specific probe conjugated particles for each detected target and the internal control. The amplified to target-specific probes attached to superparamagnetic particles causing clustering of the particles. The hybridization occurring in individual tubes is analyzed in the T2MR reader and a signal for each target is generated, which indicates the presence of the target organism(s). This automated process is the same process followed by the FDA cleared T2Candida and T2Bacteria Panels performed on the T2Dx Instrument system. When running a single specimens simultaneously, the first specimen will be reported in approximately 4 hours from the specimen is loaded onto the instrument. The results are interpreted by the device software as valid or invalid (based on the result of the internal control or target detections), and if valid, results are reported as "Positive" or "Target not Detected" for each specific target.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the T2Biothreat Panel, based on the provided text:

Acceptance Criteria and Device Performance

Parameter	Acceptance Criteria (Implicit)	Reported Device Performance
Limit of Detection (LoD)	95% positivity rate at minimum bacterial concentration	Ranges from 2-17 CFU/mL or 9 CAGe/mL
Analytical Reactivity	100% inclusivity for target sequences	All tested strains successfully detected, except Y. pestis strains lacking pPCP plasmid.
Analytical Specificity	No cross-reactivity with common bloodstream infection organisms or genetically similar pathogens	No cross-reactivity observed at 1,000 CFU/mL (or IU/mL) for 30 out of 31 tested strains. One Bacillus cereus strain (G-9241) with a pXO1-like plasmid showed cross-reactivity with the BaPXO1 channel, but the device differentiates this from fully virulent B. anthracis. No cross-reactivity at higher concentrations (1x10^5 copies/mL) for exclusivity strains.
Reproducibility	High agreement with expected positive and negative results across sites, operators, lots, and instruments.	Overall agreement of 98.4% for expected positive results; 100% for expected negative results.
Interfering Substances	No interference with detection of targets or sample validity by specified endogenous and exogenous substances.	None of the tested substances (excluding Feraheme, Magnevist, and Ablavar which are known interferents at high concentrations from previous studies) demonstrated interference.
Competitive Inhibition	No competitive effects impacting positive detection in co-infection scenarios.	No competitive effects observed for any combination of Panel members or non-Panel members.
Clinical Sensitivity (PPA)	High Positive Percent Agreement (PPA) for target analytes.	Ranged from 94.3% to 100% for analyte concentrations at 1-3x LoD.
Clinical Specificity (NPA)	High Negative Percent Agreement (NPA) for all analytes.	100% for all analytes.

Study Information

The provided document describes standalone performance studies for the T2Biothreat Panel. It does not mention any multi-reader multi-case (MRMC) comparative effectiveness study.

2. Sample Sizes and Data Provenance

Test Set (Clinical Performance):
- Negative Arm: Undisclosed number of K2EDTA whole blood samples from healthy donors (no signs/symptoms of infection) and febrile donors (fever ≥ 100.4 °F).
- Positive Arm: Sequence-verified clinical bacterial strains spiked into whole blood collected from febrile donors. The sample sizes for the positive arm are listed as:
  - B. anthracis (pXO1 & pXO2): 6 (

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