Item Brochure

Reader Display
Interpretation
SARS:
Procedural Control:
Positive Test for SARS
(SARS antigen present)
SARS:
Procedural Control:
Negative Test for SARS
(no SARS antigen detected)
SARS:
Procedural Control:
Result Invalid
From the main menu,
select Run QC.
Follow the prompts on the screen. Scan the QC Card (located on the kit box).
Sofia 2 prompts the user to select the desired mode (WALK AWAY or READ NOW).
Run the External Control Swabs.
Follow the Swab Test procedure of this Quick Reference Instructions. First test the
Positive Swab, followed by the Negative Swab.
After both the Positive and Negative Swabs have been run, the results will be displayed as
or .
INTENDED USE
The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia, Sofia instrument intended for the qualitative detection of the nucleocapsid protein antigen from
SARS-CoV-2 in direct anterior nasal (NS) swab specimens from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms, or from
individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests. Testing is
limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests.
This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The Sofia SARS Antigen FIA does not differentiate between SARS-CoV and SARS-CoV-2.
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the
presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-
infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public
health authorities.
Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection, and should not be used as the sole basis for treatment or patient management decisions, including infection control
decisions. 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, and confirmed with a
molecular assay, if necessary, for patient management. For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of
SARS-CoV-2 infection, such in an individual with as a close contact 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..
Sofia 2 Interpretation of Results
Sofia 2 External Quality Control (External Positive and Negative Swabs are supplied in the kit)
When the test is complete, the results will be displayed on the Sofia 2 screen. Test Lines will not
be visible to the naked eye.
Results: The Sofia 2 screen will display results for the procedural control as being or . If the
control is , retest with a new patient sample and new Test Cassette. If used on asymptomatic
individuals for serial testing, a second test should be obtained with at least 24 hours (and no
more than 36 hours) between tests.
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