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12
RESULT INTERPRETATION
When the test is complete, the results are clearly displayed on the instrument screen.
Instrument Display
Interpretation of Results and Follow-up Actions
COVID-19 Positive
Positive results do not rule out bacterial infection or co-
infection with other viruses.
COVID-19 Negative
Negative results should be treated as presumptive and, if inconsistent with
clinical signs and symptoms or necessary for patient management, should be
tested with an alternative molecular assay.
A ne gative result does not rule out co-infections with other pathogens.
The presence or absence of COVID-19 Viral RNAs cannot be
determined.
Repeat testing of the sample using new test components. If repeated Invalid
results are obtained, results should be confirmed by another method prior to
reporting the results.
If an Invalid result is received, one additional test may be run using the same Sample Receiver. The
instructions below should be followed:
• Remove the connected Test Base and Transfer Cartridge from the instrument and connect the Test
Base portion to an open, UNUSED Sample Receiver. The connected Test Base and Transfer
Cartridge MUST be attached to a Sample Receiver prior to disposal. The Sample Receiver from a
new Transfer Cartridge package may be used for this.
• Remove the blue Sample Receiver separately and carefully from the instrument. The Sample
Receiver should be retained and kept upright to avoid spilling the liquid contents.
• From the Home Screen, start a new test. Follow the screen prompts; however, when asked to insert
the Sample Receiver, reuse the Sample Receiver and DO NOT re-elute the swab.
LIMITATIONS
• The performance of the ID NOW COVID-19 test was evaluated using the procedures provided in this
product insert only. Modifications to these procedures may alter the performance of the test.
• Negative results should be treated as presumptive and tested with an alternative FDA authorized
molecular assay, if necessary for clinical management, including infection control.
• False negative results may occur if a specimen is improperly collected, transported or handled. False
negative results may also occur if amplification inhibitors are present in the specimen or if inadequate
levels of viruses are present in the specimen. Negative results should be considered in the context of a
patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with
COVID-19.
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