Antibody Test FAQs

Coronavirus Antibody Testing at ARCpoint Labs

New information is coming out every day, regarding COVID-19 and antibody testing. We are doing our best to stay on top of it, interpret it, and get it back out to you in a meaningful way. Please be sure to check back in for the most up-to-date information.

Our antibody testing is available at select locations.

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Who is the COVID-19 antibody test for?

This test is best for people who believe they’ve been exposed to COVID-19 or had symptoms in the past (fever, cough, shortness of breath, etc.). You must be free of symptoms for at least 7 days before receiving the test. The test is intended to indicate the presence of COVID-19 antibodies, in order to better inform an individual’s personal decisions about returning to work in a high-risk or customer-facing profession.

Does the antibody test diagnose the COVID-19 RNA virus?

NO! This test screens for antibodies, which are a specialized type of immune cell your body produces in response to COVID-19. 

 

What is a COVID-19 antibody test?

The COVID-19 Antibody Test (COVID-19 IgG/IgM) is a blood test that is designed to detect immune proteins called antibodies, which may indicate that your body has been exposed to COVID-19 (also known as coronavirus or SARS-CoV-2).

How are antibodies developed and what is their purpose?

When a virus or foreign antigen enters your body, your immune system responds by producing specific proteins called antibodies to help fight off the virus. Antibodies can remain in your body for a period of time, potentially protecting you from reinfection in the future. Because the SARS-CoV-2 virus is so new, it is unclear how strong the immune response might be, or how long the antibodies may last in your body.

 

What’s the point of this test?

The results of this test may help identify people who have had an immune response to COVID-19. The testing data will be shared with the health department and CDC, in an effort to assist experts in determining the best response to the pandemic, as well as how to continue protecting the public’s health. 

What is the process for getting a COVID-19 lab-based antibody test?

  1. Find an ARCpoint Labs location that is offering COVID-19 antibody testing at www.arcpointlabs.com
  2. Schedule your appointment 
  3. Come in to have your blood drawn at the ARCpoint Labs location
  4. ARCpoint Labs will collect the specimen and send it to one of our trusted third-party lab partners
  5. That third-party lab partner will process your test in their high complex facility, following all necessary protocols
  6. You should receive your results in 3-5 business days (wait times might be slightly longer due to high demand)
  7. Consult with your primary care physician or other licensed medical professional for guidance on how to interpret your results

Can this test be performed if I have COVID-19 symptoms?

No.  You must be asymptomatic for at least seven days before taking an antibody test.  Symptomatic individuals may run the risk of test error.

How long will I have to wait for my results?

Most lab-based antibody test results will be securely emailed within 3-5 business days after our blood draw. Due to increased demand, turnaround times may vary. We recommend consulting your Primary Care Physician (PCP) or other licensed medical professional to interpret your results.

What are the potential risks of the test?

  • Possible discomfort or other complications that can happen during sample collection. 
  • Possible incorrect test result (see below for more information). 

What are the potential benefits of the test?

  • 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. 

If I test positive, what does that mean?

If you have a positive test result, it is likely you have been exposed to COVID-19 and that you have developed an antibody response to the virus. Your healthcare provider will work with you to determine how best to care for you based on the test results, along with other factors of your medical history, including (but not limited to) any previous symptoms, possible exposure to COVID-19, and the location of places you have recently traveled. There is a chance this test can give a false positive result. It is important that you work with your healthcare provider to help you understand the next steps you should take.

 

What does it mean if I have a negative test result?

A negative test result means antibodies for the virus that causes COVID-19 were not found in your sample. However, it is possible for this test to give a false negative in some people with COVID-19 infection. A negative result may occur if you are tested early in your illness and your body hasn’t had time to produce antibodies to infection. 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 antibody test FDA-approved?

No. This test has not been reviewed or approved by the FDA.

ARCpoint Labs does the phlebotomy pull (or blood draw), then sends the sample off to a high-complexity lab for testing and review by a physician. We are providing these tests based upon the FDA’s, Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)

 

Does the FDA require test providers to give any disclaimers for this test?

Yes. The FDA currently requires the following instructions for use:

  • This test has not been reviewed by the FDA.
  • Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
  • Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

What is the clinical sensitivity and specificity for this test?

ARCpoint Labs partners with several test manufacturers and high complexity labs to provide these antibody tests to the consumer. Please contact your ARCpoint Labs location for specific information about the test they are offering.

Do I need to see my doctor for a referral before I get this test done?

No. You can make an appointment for this test without a referral from your doctor.

Will my insurance cover this test?

We currently do not accept insurance.  We are able to provide you with the CPT code and receipt for the antibody test to submit to your insurance company for reimbursement. All insurance companies vary, and you will need to reach out to them about your potential reimbursement. We are able to accept major credit cards, debit cards, cash, Health Savings Accounts (HSAs) and Flexible Spending accounts (FSAs).

Is this the test where they insert a swab up my nose?

No. This test uses a venipuncture (blood draw) to help find out if you have antibodies to the virus that causes COVID-19. This is NOT a test for the presence of the COVID-19 virus.

Is fasting required for this test?

No, fasting is not required for this test.

Are there any medications or conditions that could impact the results of this test?

If you are severely immunocompromised, on immune suppressing prescription medication, or taking long-term inhaled corticosteroids, you may not be able to form antibodies in a predictable way, making the results of this test less reliable.

According to the FDA’s web site, “Those who use an antibody test need to understand its limitations and use test results as just one piece of data to inform decision making. All tests can provide at least some false results. Even a high-performing antibody test when used on individuals in a population that does not have many cases of COVID-19 infection – a population with low prevalence – may produce as many or more false results as true results because the likelihood of finding someone who has been infected is very small. This doesn’t mean the test is bad, but rather recognizes the inherent limitations of these kinds of tests. Therefore, it may be necessary for some individuals to have two serology tests performed to generate reliable results. That is why antibody tests should only be used as part of a well-conceived testing plan and why the results should always be interpreted by appropriate experts.”

Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy (Updated May 4)

 

Our COVID-19 antibody testing is  offered at select locations. We are closely following recommendations from the CDC to ensure the safety of all customers and staff. You MUST be symptom-free for at least seven (7) days prior to antibody testing. If you have had a fever, cough, shortness of breath or any other COVID-19 symptoms in the past 7 days, you are not eligible for this testing at this time. Please schedule your appointment once you are symptom-free for at least 7 days.

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The COVID-19 Antibody Tests currently being offered at select ARCpoint Labs locations are not FDA approved. The are available under the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019.

FDA page capture

According to the FDA, while antibody tests are of limited value in the immediate diagnosis of a patient where COVID-19 infection is suspected, this type of test may help the medical community better understand how the immune response against the SARS-CoV-2 virus develops in patients over time and how many people may have been infected. For that reason, ARCpoint Labs de-identifies all of its data and shares it with the health department and the CDC, so it can be used by doctors, scientists and researchers who are working to create treatments and vaccines for COVID-19.

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