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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.

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: 1. Bacillus anthracis (plasmids pXO1 and pXO2) 2. Francisella tularensis 3. Burkholderia spp. (B. mallei/B. pseudomallei) 4. Yersinia pestis 5. Rickettsia prowazekii 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.

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.

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 five species of bacteria: Enterococcus faecium, 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 the sole basis for diagnosis, treatment management decisions in patients with suspected bacteremia.

The T2Bacteria Panel detects and identifies five 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 centrifugation. 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 targetspecific conjugated particles for 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 time 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.

T2Candida 1.1 Panel and T2Dx Instrument is a qualitative T2 Magnetic Resonance (T2MR) assay for the direct detection of Candida species in K2EDTA human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. The T2Candida 1.1 Panel identifies five species of Candida and categorizes them into the following three species groups: 1. Candida albicans and/or Candida tropicalis 2. Candida parapsilosis 3. Candida glabrata and/or Candida krusei The T2Candida 1.1 Panel is indicated for the presumptive diagnosis of candidemia. The T2Candida 1.1 Panel is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification. The T2Candida QCheck Positive and T2Dx QCheck Negative External Controls are intended to be used as quality control samples with the T2Candida 1.1 Panel when run on the T2Dx Instrument. These controls are not intended for use with other assays or systems.

The T2Candida 1.1 Panel run on the T2Dx® Instrument is a qualitative T2 Magnetic Resonance (T2MR®) assay for the direct detection of Candida species in EDTA human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. The T2Candida Panel identifies five species of Candida and categorizes them into the following three groups: - 1. Candida albicans and/or Candida tropicalis, - 2. Candida parapsilosis - 3. Candida qlabrata and/or Candida krusei The T2Candida 1.1 Panel does not distinguish between C. albicans and C. tropicalis. The T2Candida 1.1 Panel does not distinguish between C. glabrata and C. krusei. The T2Candida Panel is indicated for the presumptive diagnosis of candidemia. The T2Candida Panel is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification. The T2Candida positive (T2Candida QCheck) and negative External Controls (T2Dx QCheck) are intended to be used as quality control samples with the T2Candida 1.1 Panel when run on the T2Dx Instrument. These controls are not intended for use with other assays or systems. The T2Candida 1.1 Panel utilizes magnetic resonance-based detection (T2®MR technology) to qualitatively detect the same five species of Candida direct from K2EDTA-treated human whole blood. The T2Candida 1.1 Panel, run on the T2Dx instrument, performs sample concentration and Candida target DNA amplification for direct detection of species-specific amplicon. The test incorporates an Internal Control (IC) for monitoring test performance. The workflow for T2Candida 1.1 Panel is the same as the original cleared test and can only be performed on the T2Dx instrument, a bench-top, automated sample-to-result system, which performs all steps in the test after specimen loading. A design change was made to remove two foil-sealed tubes containing calcium hypochlorite ("bleach tubes") from the T2Candida Cartridge configuration and modify the software to remove the bleach transfer steps from the T2Dx workflow.