T2Candida® 1.

1 Panel Workflow

Work Area Preparation

Decontaminate prior to the first load each day and after each unload as follows.

PUT ON FRESH GLOVES

1. Fully saturate a lint-free wipe with surface decontaminant solution1 and wipe the
preparation area (benchtop, dead air box, or biosafety cabinet) in a unidirectional motion.
Discard wipe.
2. Dampen a new lint-free wipe with surface decontaminant solution and wipe the following
T2Dx components in a unidirectional motion:
• Touchscreen
• Barcode scanner
3. Fully saturate the lint-free wipe with surface decontaminant solution and wipe the
following work areas in a unidirectional motion:
• Drawer panel and front cover of the T2Dx
• Benchtop around the T2Dx Unidirectional Wiping
4. Discard wipe.
5. Allow surface decontaminant solution to sit for at least 3 minutes.
*Repeat Steps 1 - 5 with 70% isopropyl alcohol.*

Cartridge
T2Candida 1.1 Panel Assembly
Sample
Inlet Reagent
PUT ON FRESH GLOVES Tray

1. Confirm that the T2Dx is operational.

2. Obtain room temperature sample(s) and place them upright next to the prep area.
3. Ensure ≥3 mL of sample volume in each 4 mL K2EDTA or K3EDTA blood collection tube.
4. Obtain the packaged T2Candida 1.1 components and place next to prep area. T2Candida 1.1 Panel Components
5. Open outer packaging without touching inner components.

PUT ON FRESH GLOVES

6. Remove the Panel components from the packaging and place onto prep area.
7. Check the labels and barcodes for integrity.
8. Without touching the foil on top, hold the Reagent Tray lengthwise and shake side to side
until all contents are homogenous. Vortex mixing is optional.
9. Tap the Reagent Tray on the Panel assembly work surface to displace any trapped
air bubbles and visually confirm that all air bubbles are removed and volumes appear
consistent.
10. Insert Reagent Tray onto Cartridge using orientation notch to align components. Reagent Tray Snaps into Cartridge
11. Push down on Reagent Tray at site of barcode until a snap is heard.

*Repeat Steps 8 - 11 for all Cartridges and Reagent Trays to be used*

12. Obtain a 4mL K2EDTA or K3EDTA blood collection tube and mix gently by inverting 8 - 10
times until homogeneous.

DO NOT USE IF SAMPLE IS NOT AT ROOM TEMP OR DOES NOT APPEAR

HOMOGENOUS AFTER RE-SUSPENSION

13. Uncap tube and dispose of cap in biohazard container.

14. Invert Sample Inlet to “re-cap” blood collection tube, using a push and twist motion. It is
critical that a good seal has formed between the blood collection tube and the Sample
Inlet.
Invert Sample Inlet and “Re-cap” Sample
15. Avoiding contact with the foil seal, turn the Sample Inlet assembly right-side up and place
on prep area.

*If preparing multiple Panels, repeat Steps 12 - 15 for each sample to be tested.*

16. Ensure that the sample level in each blood collection tube drops and the Sample Inlet
wells fill.

If the sample level does not drop after one minute, gently tap the Sample Inlet
module against the benchtop several times.
17. Hold the back sides of a Sample Inlet assembly and push it down onto a Cartridge until
an audible snap is heard.

*The Panel set-up is complete. Repeat for all Sample Inlet assemblies and Cartridges.*
1. Prediluted solutions of 10% bleach (Bleach-Rite or equivalent) or sodium dichlorolsocyanurate (NaDCC; BruTab Snapping Sample Inlet onto Cartridge
6S or equivalent) consisting of >4,306ppm chlorine may be used for surface decontamination.
Loading a T2Candida 1.1 Panel
1. Carry the Panel from assembly workspace to the T2Dx.
2. Press LOAD.
3. When prompted, scan barcodes on:
• Sample
• Reagent Tray
• Cartridge
4. The T2Dx will open an available drawer. Place the Panel in the drawer, ensure the Panel is Location Pins and Locking Mechanism
loaded onto the locator pins, and press NEXT.
5. When prompted “Tear off Label” hold the Panel with one hand for stability and remove
Cartridge label.

ENSURE ALL COMPONENTS ARE PRESENT 5 small tubes 1 large tube

with cap with cap
6. Press NEXT.
7. Scan/enter Operator ID.
8. Press CONFIRM, the locking mechanism will engage to hold the Panel in place and the 10 pipette
drawer will close.

*Repeat Steps 1 - 8 for all Panels assembled.*

Cartridge Components
Data Retrieval
PUT ON FRESH GLOVES

Press RESULTS on the touchscreen. There are two options to visually confirm results:
Option 1: Press the sample ID line item on the touchscreen twice. A pop-up window with the
results will open.
Option 2: Check the square box to the left of the date and press PRINT. A document with
the results and related items such as date/time, sample ID, results, lot numbers,
etc. will open. Multiple boxes can be checked off to print more than one result.
Each valid Panel will yield three reportable results (positive or target not detected) for:
1. C. albicans/ tropicalis Results Touchscreen
2. C. parapsilosis
3. C. krusei/ glabrata
In addition, an Internal Control (IC) result will be reported as Valid or Invalid.

Unloading a T2Candida 1.1 Panel

PUT ON FRESH GLOVES

1. Press UNLOAD, then NEXT to open T2Dx drawer.

2. Visually confirm all Cartridge components are present.
3. Using a biohazard waste bag as a glove over your gloved hand, remove
Panel from drawer. T2Candida 1.1 Panel Results
4. Use your other hand to close the biohazard waste bag over the used Panel.
5. Immediately close and secure with a twist tie.
6. Discard the used panel into a biohazard waste container.
7. Press NEXT twice on T2Dx touchscreen to close drawer.
8. Repeat for all drawers displaying “Complete” for each completed T2Candida 1.1 Panel.

PUT ON FRESH GLOVES

*Repeat Work Area Preparation steps to decontaminate the T2Dx.*

R
 efer to the T2Candida 1.1 Panel Instructions for Use for additional detail on the
procedure. This Workflow Guide is intended to serve as an aid for the trained operator.

Removing the Panel

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T2 Biosystems®, the T2Biosystems, Inc. logo, T2Candida®, T2Dx®, are either registered trademarks or trademarks of T2 Biosystems, Inc.
in the United States and/or other countries. ©2019 T2 Biosystems. All rights reserved. T2_805 DES_00543 R01 05/19