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T2Candida® 1.1 Panel and T2Dx® Instrument is a qualitative T2 Magnetic Resonance (T2MR®) assy 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 - Candida glabrata and/or Candida krusei 3. 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 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 positive and negative External Controls (T2Candida QCheck Positive Kit and the T2Dx QCheck Negative Kit) 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 and T2Dx Instrument is comprised of the T2Candida 1.1 Panel performed on the T2Dx Instrument. The T2Candida 1.1 Panel is a qualitative molecular diagnostic assay that employs a whole blood compatible PCR amplification followed by T2 magnetic resonance (T2MR) detection. The T2Candida 1.1 Panel is performed on the T2Dx Instrument which executes all steps after specimen loading. A K₂EDTA whole blood specimen is loaded onto the T2Candida 1.1 Sample Inlet, which is then placed on the T2Candida 1.1 Cartridge along with the T2Candida 1.1 Reagent Tray. The Reagent Tray contains the internal control, amplification reagent, enzyme and the probe-coupled superparamagnetic particles for each Candida target. Two milliliters of the blood specimen is transferred to the T2Dx Instrument where lysis of the red blood cells, concentration and lysis of the Candida cells and amplification of the Candida DNA takes place. Amplification products are detected by T2MR detection using species-specific probes which are attached to the superparamagnetic particles. The assay identifies Candida albicans and/or Candida tropicalis, Candida parapsilosis, and Candida glabrata and/or Candida krusei. The test does not distinguish between C. albicans and C. tropicalis. The test does not distinguish between C. glabrata and C. krusei

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.

The T2Candida Panel and 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 species groups: 1. Candida albicans and/or Candida tropicalis, 2. Candida parapsilosis 3. Candida glabrata and/or Candida krusei The T2Candida Panel does not distinguish between C. albicans and C. tropicalis. The T2Candida 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 and negative External Controls are intended to be used as quality control samples with the T2Candida Panel when run on the T2Dx® instrument system. These controls are not intended for use with other assays or systems.

The T2Candida panel and T2Dx® Instrument is comprised of the T2Candida Panel performed on the T2Dx® Instrument. The T2Candida Panel is a qualitative molecular diagnostic assay that employs a whole blood compatible PCR amplification followed by T2 magnetic resonance (T2MR) detection. The T2Candida Panel is performed on the T2Dx Instrument which executes all steps after specimen loading. A K2 EDTA whole blood specimen is loaded onto the T2Candida Sample Inlet, which is then placed on the T2Candida Base along with the T2Candida Reagent Pack. The Reagent Pack contains the internal control, amplification reagent, enzyme and the probe-coupled superparamagnetic particles for each Candida target. Three milliliters of the blood specimen is transferred to the T2Dx® Instrument where lysis of the red blood cells, concentration and lysis of the Candida cells and amplification of the Candida DNA takes place. Amplification products are detected by T2MR detection using species-specific probes which are attached to the superparamagnetic particles. At the end of each assay, the T2Dx® Instrument uses a bleach solution to neutralize all liquids on the cartridge to mitigate the risk of amplicon contamination. The assay provides an identification of Candida albicans and/or Candida tropicalis, Candida parapsilosis, and Candida glabrata and/or Candida krusei. The test does not distinguish between C. albicans and C. tropicalis. The test does not distinguish between C. glabrata and C. krusei.