Product Manual

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Sofia SARS Antigen FIA Page 14 of 22
Negative Results:
Invalid Results:
LIMITATIONS
◼ Use of viral transport media may result in decreased test sensitivity, and directly testing specimens is
recommended.
◼ Remel® M4 and M4RT® should not be used in with the Sofia SARS Antigen FIA Assay in either the Sofia or
Sofia 2. Some lots of M4 and M4RT have been shown to cause false positive results when used with the
Sofia SARS Antigen FIA Assay.
◼ The contents of this kit are to be used for the qualitative detection of SARS antigens from direct anterior
nasal swabs only.
◼ This test detects both viable (live) and non-viable, SARS-CoV, and SARS-CoV-2. Test performance depends
on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results
performed on the same sample.
◼ A negative test result may occur if the level of antigen in a sample is below the detection limit of the test
or if the sample was collected or transported improperly.
For example: This display shows a valid
negative result for SARS.
NOTE: Negative results should be treated as
presumptive and confirmation with a
molecular assay, if necessary, for patient
management, may be performed. For serial
testing programs, additional confirmatory
testing with a molecular test for negative
results may be necessary after second
negative result for asymptomatic patients, if
there is a high likelihood of SARS-CoV-2
infection, such in an individual with as a
close contract with COVID-19 or with
suspected exposure to COVID-19 or in
communities with high prevalence of
infection. Additional confirmatory testing
with a molecular test for positive results
may also be necessary, if there is a low
likelihood of SARS-CoV-2 infection, such as
in individuals without known exposures to
SARS-CoV-2 or residing in communities with
low prevalence of infection.
For example: This display shows an invalid
result.
Invalid Result: If the test is invalid, a new test
should be performed with a new patient
sample and a new Test Cassette.