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 START Testing Now

  • 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 Molecular & Serology Test

When fast action and trusted information matter more than ever, we are committed to aiding in the response. SARS-CoV-2 RNA (COVID-19), Qualitative NAAT, Test Code 39448 The RNA test is a qualitative multi-target molecular diagnostics test that aids in the detection of COVID19. This test is intended to be performed on respiratory specimens collected from individuals who meet the Centers for Disease Control and Prevention (CDC) clinical and/or epidemiological criteria for COVID19 testing. For details visit: https://www.cdc.gov/coronavirus/2019-ncov/hcp/index.html

Clinical Significance

SARS-CoV-2 RNA (COVID-19), Qualitative NAAT - The SARS-CoV-2 RNA (COVID-19), Nucleicacid Amplification Test (NAAT) is a qualitative multi-target molecular diagnostics test that aids in the detection of COVID-19. This test is intended to be performed on respiratory specimens collected
from individuals who meet the Centers for Diseases Control and Prevention (CDC) clinical and/or Epidemiological criteria for COVID-19 testing.

For details visit: https://www.cdc.gov/coronavirus/2019-ncov/hcp/index.html

SARS-CoV-2 RNA, Qualitative NAAT, Test

$279.99 START Testing Now

  • Methodology: Nucleic Acid Amplification Test (NAAT) includes PCR or TMA

  • Assay Category: This test has been authorized by the FDA under an Emergency Use Authorization (EUA) for use by authorized laboratories.

  • Reference Range(s): Not detected

  • Alternative Name(s): Novel Coronavirus, COVID19, nCOV, Wuhan, Coronavirus

  • Turn Around T/A: Test results are typically available 3-4 days from the time of specimen pickup and may be impacted by high demand.

  • Insurance CPT Code(s): 87635 (HCPCS:U0003)



Patient Fact Sheet


COVID-19 Lab Based TEST (Antibody Immunoassay)

The COVID-19 Antibody Immunoassay is a blood test that is designed to detect the human antibodies lgG & lgM.
Upon infection with the SARS-CoV-2 virus, the patient's immune system fights the virus by producing specialized immune cells known as antibodies. The two major types of antibodies employed in the fight against viruses of this type are IgM and IgG.

• lgM is a class of antibody that appears early after an infection (as early as 3-5 days). lgM is the body's first line of defense against a foreign invader.
• lgG is another class of antibody that appears later and gradually replaces the lgM antibodies. Typically, lgG antibodies appear in the blood circulation within 2-4 weeks after initial infection.

The presence of SARS-CoV-2-specific lgM and/or lgG antibodies is a strong indication that the patient has been infected with the SARS-CoV-2 virus and may suggest non-susceptibility in the future/functional immunity

Antibody IgG Test

$169.98 START Testing Now

  • Test Name: COVID-19 Antibody IgG Test

  • Specimen: Serum

  • Temperature: Ambient

  • Turn Around T/A: 48 Hours to 72 hours

  • Method: Chemiluminescence Immunoassay

  • Detection of Antibodies: IgG

  • Test Type: SARS-CoV-2 Serology LAB BASED

  • Insurance CPT Code: 86769

Antibody IgG and IgM Test

$198.94 START Testing Now

  • Test Name: COVID-19 Antibody IgG and IgM Test

  • Specimen: Serum

  • Temperature: Ambient

  • Turn Around T/A: 48 Hours to 72 hours

  • Method: Chemiluminescence Immunoassay

  • Detection of Antibodies: IgG and IgM

  • Test Type: SARS-CoV-2 Serology LAB BASED

  • Insurance CPT Code: 86769

COVID-19 ANTIBODY TEST, IgG & IgM by BLOOD Chemiluminescence Immunoassay

FAQ for COVID-19 Antibodies Lab Based TEST

What is an lgM and what is an lgG?
Upon infection with the SARS-CoV-2 virus, the patient's immune system tries to fight the virus by producing blood­ circulating molecules known as antibodies. lgM is a class of antibodies that appears early after an infection
(as early as 3-5 days).

lgM is the body's first line of defense against a foreign antigen. lgG is another class of antibodies that appears later and gradually replaces the lgM antibodies.

Usually, lgG antibodies appear in the blood circulation within 3-4 weeks after initial infection. The presence of SARS-CoV-2-specific lgM and/or lgG antibodies in the blood of a patient is a strong indication that the patient has been infected with the SARS-CoV-2 virus.
How long does it take to develop the lgG & lgM antibodies after exposure to the Coronavirus?
lgM as early as 3-5 days. lgG as early as 3-4 weeks post infection.
What does a positive lgG result mean?
Most likely the individual was exposed at least 3 - 4 weeks prior to testing.
What does a positive lgM result mean?
lgM is the body's first line of defense against a foreign antigen, so the individual was recently exposed to an infection (as early as 3-5 days)
If neither are positive, does this mean the patient was never exposed?
No, only the Real Time RT-PCR,DNA, swab test is a current indicator searching for the presence of SARS-CoV-2.
If a patient shows the presence of the antibodies, does this mean they cannot become infected with the virus in the future?
If the lgG is positive, there is a good chance the individuals body built a defense against the virus.
How long will it take to receive results?
Within 24hrs
Who can order this test?
Physicians or Patients that will have their blood drawn by a healthcare professional.
How do I order COVID-19 lgG & lgM antibody testing?
Log into your online account, create a new requisition on your patient and use order code #Cl 9P. Ship the blood to us using our transport boxes.
Can I send my patients toa draw site to be collected for this test?
Yes
Can a mobile phlebotomist be sent to my patients for this test?
Yes
What are the accepted specimen requirements, stability, shipping protocols?
Serum in an SSTtube. Spin tube after 15min of draw. Ship ambient and it is stable for 48hrs.
What is the test methodology for COVID-19 lgG & lgM AntibodyTesting?
Chemiluminescense lmmunoAssay
How is your test different from other rapid at-home antibody tests?
This is not an"at home test''. This test is performed at a CUA certified lab that is CAP accredited.
What is the clinical specificity of this test?
97.50%
What is the clinical sensitivity of this test?
89.89%
Is the testing method authorized by the FDA?
Our instrumentation is listed on the FDAs list of authorized instrumentation online and we follow their guidance
Does Access accept insurance for this testing?
No
Is this an at home test?
No, this requires a venipuncture by a healthcare professional and will be tested in our CUA certified High Complexity Lab

FAQ for COVID-19 Molecular and Serology Test

What is COVID-19? COVID-19 is caused by the SARS-CoV-2 virus?
The virus, which can cause mild to severe respiratory illness, was first identified in Wuhan, China, and has now spread globally, including the United States. There is limited information available to characterize the spectrum of clinical illness associated with COVID-19 but it likely spreads to others when a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.).
What is the Panther® SARS-CoV-2 Assay?
The test is designed to detect the virus that causes COVID-19 in respiratory specimens, for example nasal or oral swabs.
Why was my sample tested?
You were tested because your healthcare provider believes you may have been exposed to the virus that causes COVID-19 based on your signs and symptoms (e.g., fever, cough, difficulty breathing), and/or because:

• You live in or have recently traveled to a place where transmission of COVID-19 is known to occur, and/or
• You have been in close contact with an individual suspected of or confirmed to have COVID19. Testing of the samples will help find out if you may have COVID-19.
What are the known and potential risks and benefits of the test?
Potential risks include:

• Possible discomfort or other complications that can happen during sample collection.
• Possible incorrect test result (see below for more information). Potential benefits include:
• The results, along with other information, can help your healthcare provider make informed recommendations about your care.
• The results of this test may help limit the spread of COVID-19 to your family and others in your community
What does it mean if I have a positive test result?
If you have a positive test result, it is very likely that you have COVID-19. Therefore, it is also likely that you may be placed in isolation to avoid spreading the virus to others. There is a very small chance that this test can give a positive result that is wrong (a false positive result). Your healthcare provider will work with you to determine how best to care for you based on the test results along with medical history, and your symptoms.
What does it mean if I have a negative test result?
A negative test result means that the virus that causes COVID-19 was not found in your sample. For COVID-19, a negative test result for a sample collected while a person has symptoms usually means that COVID-19 did not cause your recent illness. However, it is possible for this test to give a negative result that is incorrect (false negative) in some people with COVID-19. This means that you could possibly still have COVID-19 even though the test is negative. If this is the case, your healthcare provider will consider the test result together with all other aspects of your medical history (such as symptoms, possible exposures, and geographical location of places you have recently traveled) in deciding how to care for you. It is important that you work with your healthcare provider to help you understand the next steps you should take.
Is this test FDA-approved or cleared?
No. This test is not yet approved or cleared by the United States FDA.

This assay is currently under review by the FDA and is pending EUA. The test was developed, and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Where can I go for updates and more information?
The most up-to-date information on COVID-19 is available at the CDC General webpage: https://www.cdc.gov/COVID19 In addition, please also contact your healthcare provider with any questions/concerns.

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.

Request Information

Fill out the form below to speak with a COVID-19 ANTIBODY BLOOD TEST EXPERT

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

Keep your employees and community safe

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

Accurate. Reliable. Confidential Testing

Learn More About Our Testing Services

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