Product Manual

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Sofia SARS Antigen FIA Page 15 of 22
◼ Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test
result.
◼ Test results must be evaluated in conjunction with other clinical data available to the physician.
◼ Positive test results do not rule out co-infections with other pathogens.
◼ Positive test results do not differentiate between SARS-CoV and SARS-CoV-2.
◼ Negative test results are not intended to rule in other non-SARS viral or bacterial infections.
◼ Negative results should be treated as presumptive and confirmation with an FDA authorized molecular
assay, if necessary for patient management, may be performed.
◼ If the differentiation of specific SARS viruses and strains is needed, additional testing, in consultation with
state or local public health departments, is required.
◼ The performance of this test for SARS-CoV-2 was established based on the evaluation of a limited number
of clinical specimens collected between April 2020 and June 2020. The clinical performance has not been
established in all circulating variants but is anticipated to be reflective of the prevalent variants in
circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary
depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their
prevalence, which change over time.
◼ The performance of this test has not yet been clinically validated for use in patients without signs and
symptoms of respiratory infection, or for serial screening applications and performance may differ in these
populations.
CONDITIONS OF AUTHORIZATION FOR THE LABORATORY
The Sofia SARS Antigen FIA Letter of Authorization, along with the authorized Fact Sheet for Healthcare
Providers, the authorized Fact Sheet for Patients, and authorized labeling are available on the FDA website:
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-
medical-devices/in-vitro-diagnostics-euas.
However, to assist clinical laboratories using the Sofia SARS Antigen FIA (“your product” in the conditions
below), the relevant Conditions of Authorization are listed below:
◼ Authorized laboratories
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using your product must include with test result reports, all authorized Fact
Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may
be used, which may include mass media.
◼ Authorized laboratories using your product must use your product as outlined in the authorized labeling.
Deviations from the authorized procedures, including the authorized instruments, authorized clinical
specimen types, authorized control materials, authorized other ancillary reagents and authorized materials
required to use your product are not permitted.
◼ Authorized laboratories that receive your product must notify the relevant public health authorities of
their intent to run your product prior to initiating testing.
◼ Authorized laboratories using your product must have a process in place for reporting test results to
healthcare providers and relevant public health authorities, as appropriate.
◼ Authorized laboratories must collect information on the performance of your product and report to
DMD/OHT7-OIR/OPEQ/CDRH (via email: [e-mail]) and Quidel (via email:
[e-mail], or via phone by contacting Quidel Customer Support Services at
800.874.1517 (in the U.S.) or 858.552.1100) any suspected occurrence of false positive or false negative
results and significant deviations from the established performance characteristics of your product of
which they become aware.
◼ All operators using your product must be appropriately trained in performing and interpreting the results
of your product, use appropriate personal protective equipment when handling this kit, and use your
product in accordance with the authorized labeling.
◼ Quidel Corporation, authorized distributors, and authorized laboratories using your product must ensure
that any records associated with this EUA are maintained until otherwise notified by FDA. Such records
will be made available to FDA for inspection upon request.