Product Manual

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Sofia SARS Antigen FIA Page 2 of 22
The Sofia SARS Antigen FIA should be used with Sofia or Sofia 2.
SUMMARY AND EXPLANATION
SARS-CoV-2, also known as the COVID-19 virus, was first identified in Wuhan, Hubei Province, China December
2019. This virus, as with the novel coronavirus SARS-1 and MERS, is thought to have originated in bats,
however the SARS-CoV-2 may have had an intermediary host such as pangolins, pigs or civets.
1
The WHO
declared that COVID-19 was a pandemic on March 11, 2020, and human infection has spread globally, with
hundreds of thousands of confirmed infections and deaths.
2
The median incubation time is estimated to be 5.1 days with symptoms expected to be present within 12 days
of infection.
3
The symptoms of COVID-19 are similar to other viral respiratory diseases and include fever,
cough and shortness of breath.
4
PRINCIPLE OF THE TEST
The Sofia SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with
Sofia and Sofia 2 to detect nucleocapsid protein from SARS-CoV and SARS-CoV-2 in respiratory specimens
taken from patients with signs and symptoms who are suspected of COVID-19, or taken from asymptomatic
individuals being tested serially, as described in the authorized intended use. This test allows for the detection
of SARS-CoV and SARS-CoV-2. The test detects, but does not differentiate, between the two viruses.
The patient sample is placed in the Reagent Tube, during which time the virus particles in the sample are
disrupted, exposing internal viral nucleoproteins. After disruption, the sample is dispensed into the Test
Cassette sample well. From the sample well, the sample migrates through a test strip containing various
unique chemical environments. If SARS-CoV or SARS-CoV-2 viral antigen is present, they will be trapped in a
specific location.
NOTE: Depending upon the user’s choice, the Test Cassette is placed inside Sofia or Sofia 2 for automatically
timed development (WALK AWAY Mode) or placed on the counter or bench top for a manually timed
development and then placed into Sofia or Sofia 2 to be scanned (READ NOW Mode).
Sofia and Sofia 2 will scan the test strip and measure the fluorescent signal by processing the results using
method-specific algorithms. Sofia and Sofia 2 will display the test results (Positive, Negative, or Invalid) on the
screen.
REAGENTS AND MATERIALS SUPPLIED
25-Test Kit:
◼ Individually Packaged Test Cassettes (25): Monoclonal anti-SARS antibodies
◼ Reagent Tubes (25): Lyophilized buffer with detergents and reducing agents
◼ Reagent Solution (25): Ampoules with salt solution
◼ Sterile Nasal Swabs (Kits #20374) (25)
◼ Small, Clear 120 µL Fixed Volume Pipettes (25)
◼ SARS Positive Control Swab (1): Swab is coated with non-infectious recombinant SARS antigens
◼ Negative Control Swab (1): Swab is coated with heat-inactivated, non-infectious Streptococcus C antigen
◼ Package Insert (1)
◼ Quick Reference Instructions (1)
◼ QC Card (located on kit box)
MATERIALS NOT SUPPLIED IN KIT
◼ Timer or watch