COVID-19 Sofia SARS Antigen FIA

The Sofia SARS Antigen Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2. The Sofia SARS Antigen FIA, with the Sofia 2 and Sofia analyzers, provides automated and objective results in 15 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.

  • An antigen is a molecule or structure present on the outside of a pathogen.
  • Antigen tests are typically used for early identification of an active infection in symptomatic patients.
  • These tests identify the virus through detection of nucleoproteins, similar to influenza tests.
  • Viral antigens can often be detected in samples taken from nasal passages and from the throat.
  • The Centers for Disease Control and Prevention recommends using a test that detects the SARS-CoV-2 virus, such as one that checks respiratory samples, to test for active infection.

Sofia SARS Antigen FIA (COVID-19)

$200 Make Appointment

  • Time to Results: 15 minutes

  • Sample Type: Direct or VTM: Nasal swab, nasopharyngeal swab.

  • Controls: Positive and negative

  • PPA: 93.8%

  • NPA: 100%



Patient Fact Sheet


SARS Antigen FAQ


Safety Data Sheet (SDS)


COVID-19 Sofia SARS Antigen FIA

SARS Antigen Frequently Asked Questions

How does the assay work?
The test employs immunofluorescence technology used with Sofia and Sofia 2 to detect nucleocapsid protein from SARS-CoV and SARS-CoV-2 virus in nasopharyngeal (NPS) and nasal swab (NS) specimens.
Does the test come with nasal swabs?
Yes, the test includes nasal swabs.
Where is the test performed?
Testing is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity/high complexity tests, or at the Point of Care (POC) in patient care settings operating under a CLIA Certificate of Waiver
Where is the test made?
The test was designed and is manufactured in San Diego, California.
How fast is the test?
The test includes approximately 1 minute of extraction with a 15-minute run time.
Where can patients get a test?
Anyone with symptoms consistent with COVID-19 should contact a medical professional for evaluation. The test can be ordered by a medical professional if the patient meets the criteria for COVID-19 testing.
Medical professionals may order these tests through their select distributor representative.
What is the sensitivity of the assay?
We have met the sensitivity hurdle required by the FDA for Emergency Use Authorization on a small number of clinical samples. Over the next few weeks we will be conducting further studies with clinical specimens collected using nasal swabs to better understand the performance of the Sofia SARS Antigen FIA.
Can viral transport media (VTM) be used with this assay?
Yes, VTM may be used with this assay in accordance with the package insert, however, we recommend running direct swabs for the best performance
What viral transport medias (VTM) are allowed with the assay?
Internal validation of all medias is ongoing. The data in the package insert supports use with Universal Transport Media (UTM) and internal validation supports use of CDC’s Formulation Media. Remel M4 and M4RT should not be used as some lots have been demonstrated to generate false positive results.

Antigen vs. Antibody Testing: What does each method offer?

Antigen Tests

An antigen is a molecule or structure present on the outside of a pathogen.
Antigen tests are typically used for early identification of an active infection in symptomatic patients.
These tests identify the virus through detection of nucleoproteins, similar to influenza tests
Viral antigens can often be detected in samples taken from nasal passages and from the throat.
The Centers for Disease Control and Prevention recommends using a test that detects the SARS-CoV-2 virus, such as one that checks respiratory samples, to test for active infection.1

Antibody Tests

Antibodies are proteins that the body’s white blood cells produce to fight infection, which may remain in the blood long after the infection clears.
Antibody tests identify active (IgM) or past (IgG) infections by looking for antibodies against the specific virus.
Antibody tests look for exposure to a pathogen resulting in the generation of an immune response, e.g. increase in IgG/IgM antibodies. The immune response may take days or weeks to show up in a serology assay post-exposure.
Antibodies are typically detected in blood samples; either whole blood or serum/plasma.
Antibody tests typically cannot diagnose the disease immediately after exposure, as antibodies may take 1-3 weeks to develop.1
A positive antibody test indicates that a person had an immune response to SARS-CoV-2 regardless of the presence of symptoms.2 Whether antibodies may indicate immunity to further infection is still being investigated by the healthcare community.

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Should I be Tested?

If you believe you have been exposed to COVID-19 or you have had symptoms in the past, this is the test for you. You must be asymptomatic (free of symptoms) for at least seven (7) days prior to testing.

Workplace Testing

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ARCpoint Labs of Tampa Coronavirus Antibody Test can help you make informed decisions regarding your staff’s return to work or safe interaction with others. This is especially important with essential employees such as first responders, medical professionals, or other essential staff.

If you are interested in testing your employees, we're here for you! With onsite testing available, we're able to work within your schedule to test your employees so everyone can work safely.

Step 1

Schedule your appointment

Step 2

Come to your ARC Point Labs and get your sample collected

Step 3

Get results via a secure email in about 48 hours

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