Introduction - 13
1.4 Principles of Operation
The Instrument automatically processes the Test Strip including sample movement,
reagent mixing, thermal control and fluorescent reading of the reaction product
and provides a calibrated, quantitative or qualitative result. Each Lot of Test
Strips requires a LumiraDx Lot Calibration File, which provides the Instrument with
the information required to process the test. The Lot Calibration File is installed
by placing the RFID tag in the Test Strip Carton against the RFID reader in the
Instrument.
1.4.1 Quality Assurance
The LumiraDx Instrument ensures the quality of test results obtained through the
following features:
• Automated checks of the correct functioning of the Instrument at power on
and during operation.
• This includes electrical component operation, heater operation,
battery charge state, mechanical actuators and sensors and optical
system performance.
• Monitoring of Test Strip performance and controls during test runtime.
• Onboard Quality Control (OBC) assay for some tests (see Product Insert).
• Ability to perform Quality Control Tests using LumiraDx Quality Controls to
meet regulatory compliance requirements.
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