BioFire 424062 SHIELD Control Kit COVID-19 Test Owner’s Manual

BioFire 424062 SHIELD Control Kit COVID-19 Test Owner’s

Materials required but not provided

NOTE: FilmArray® Instrument should be powered on and ready for use prior to pouch preparation.
NOTE: Use clean gloves and other Personal Protective Equipment (PPE) when performing this procedure.

STEP 1: Prepare Pouch
Refer to the BioFire® COVID-19 Test Upper Respiratory Quick Guide STEP 1: Prepare Pouch

STEP 2: Hydrate Pouch
Refer to the BioFire® COVID-19 Test Upper Respiratory Quick Guide STEP 2: Hydrate Pouch

1. To prepare a Positive External Control, proceed to STEP
2. To prepare a Negative External Control, proceed to STEP STEP 3a: Prepare COVID-19 Positive External Control

• a. Use the Transfer Pipette to draw the Transport Medium, PBS or Saline to the third line. Add to the Sample Injection Vial.

• b. Remove rubber cap from Positive External Control Vial and place on a clean surface (a paper towel may be used).

• c. Add Sample Buffer to Positive External Control Vial
  1. Hold the Sample Buffer Tube with the tip facing up and firmly pinch at the textured plastic tab on the side of the tube until seal snaps.
  NOTE: Do not touch tube tip.
  2. Dispense Sample Buffer into Positive External Control Vial using a slow, forceful squeeze, followed by a second squeeze.
  NOTE: Avoid generating excessive foam.

• d. Recap Positive External Control Vial and invert it 3 times to mix.

• e. Pour mixture of Sample Buffer and Control into the Sample Injection Vial.

• f. Dispose of Positive External Control Vial and change gloves.

• g. Tightly close lid of Sample Injection Vial and invert it 3 times, return it to the red well of Pouch Loading Station.
  WARNING: Sample Buffer is harmful if swallowed and can cause serious eye damage and/or skin irritation.

• L Proceed to STEP 4: Load Control Mix.

STEP 4: Load Control Mix
Refer to the BioFire® COVID-19 Test Upper Respiratory Quick Guide STEP 4: Load Sample Mix

STEP 5: Run Pouch
Refer to the BioFire® COVID-19 Test Upper Respiratory Quick Guide STEP 5: Run Pouch
NOTE: Select either Positive External Control v3.2 or Negative External Control v3.2.

STEP 6: Review Results
Run Information – Displays information about the pouch, protocol, run status, operator, serial number, instrument and lot number

Internal Controls:

• If ‘Passed’, results are valid.
• If ‘Failed’ or ‘Invalid’, RETEST CONTROL once.

Run Status

• If ‘Completed’, run is complete.
• If ‘Aborted’, or any other error message, RETEST CONTROL once.

External Control Results

• If ‘Passed’, results are valid.
• If ‘Failed’,
• Positive External Control: RETEST EXTERNAL CONTROL once.
• Negative External Control: Decontaminate the area; and RETEST EXTERNAL CONTROL once.
• If ‘Invalid’, RETEST EXTERNAL CONTROL once.

NOTE: Refer to Instructions for Use for reporting information. If repeated error messages are obtained, contact BioFire Defense Technical Support.

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