COVID Antibodies (SARS-CoV-2 IgG Assay)

This test measures human SARS-CoV-2 IgG antibodies (referred to as “COVID antibodies” for simplicity) that are generated as part of the adaptive immune response to the virus.

SARS-CoV-2 IgG assay, developed by Abbott Laboratories, Inc, is authorized for the detection of IgG antibodies to SARS-CoV-2. The Bio-Center Laboratory at the Riordan Clinic has been authorized to draw the lab specimens and process the results under Abbott Laboratories’ direction. Any questions regarding the test should be directed to Abbott Laboratories.

This test is not designed nor intended to diagnose COVID-19.
You must be symptom-free for at least 14 days before having the test drawn in order to have an accurate result.

If you believe you are or may have been infected with the COVID-19 virus, please call your primary healthcare provider or your local health department to obtain access to the appropriate test or services. This test will not detect active COVID-19 virus cells. Please do not visit any of the Riordan Clinic locations if you think you may be infected with COVID-19, with or without symptoms.

 


 

Test Details and FAQ:

 

What is the cost of the COVID-19 Antibodies test?

The cost of this test is $79 per person. The Riordan Clinic accepts cash, check, or credit card. Because this is a self-referred test, most insurances will likely not cover the cost of the test. We can provide you with more information when calling to schedule.

We can provide a discount for group testing of 12 or more individuals (ie, for your staff or organization). Please call for more details!

How is the test performed?

This is a blood test. No nasal swab will be required. We will draw the blood specimen via a vein in your arm or hand, as appropriate. Drink plenty of water the day before and the morning of your appointment to help make the blood draw as efficient as possible.

How do I schedule?

Call our Bio-Center Laboratory staff at 800-447-7276 x1385 to schedule. If you would like to be drawn in Hays or Overland Park, you can call them directly as well. Hays: 785-628-3215 Overland Park: 913-745-4757

Where do I go to have the test drawn?

After scheduling, you will visit one of our three clinic sites to have your blood drawn at your appointment time. We are not allowed to meet you at your car to draw the specimen so we will need you to come into the office for the lab draw. We are following all recommended safety and PPE precautions. We are asking guests to wear a mask while visiting and have masks available if you need one. If you have additional questions regarding safety or protocol, please give us a call. 800-447-7276

  • Wichita: 3100 N Hillside Street
  • Hays: 1010 E 17th Street
  • Overland Park: 6300 W 143rd Street, Suite #205

Who can participate?

This test is open to the public. You do not need to be an established patient of the Riordan Clinic and it does not require a doctor’s referral or order. The test is performed via a traditional blood draw. Children and adults, as long as they are able to successfully complete the blood draw, are welcome to participate.

This test is for those people who want to know if they have developed the COVID Antibodies. This test is NOT to determine if you have COVID. If you think you have come into contact with someone who has COVID, if you have tested positive for COVID within the last 28 days, or you are experiencing any COVID like symptoms, we ask that you please disclose this when scheduling and we will help you schedule appropriately in the future so that it is both safe for you to visit the clinic and to ensure that you have given your body the appropriate time to develop the antibodies if you have been exposed. Questions? Give us a call – we’re happy to help!

How do I get the results?

Results are sent to you by mail in about ten business days.

Please note that per CDC guidelines we are required to report all COVID Antibodies results to KDHE within 24-hours. This information includes the person’s name, address, phone number, and date of birth as well as their results. If you have any questions on this requirement, please give us a call at 316-684-7784.

What if I have the antibodies? What does that mean?

A positive test result with the SARS-CoV-2 IgG assay indicates that antibodies to SARS-CoV-2 were detected, and the individual has potentially been exposed to COVID-19. Please see the full explanation from Abbott Laboratories listed below.

 


 

FAQ by Abbott Laboratories:

 

What are the symptoms of COVID-19?

Many individuals with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). However, limited information is currently available to characterize the full spectrum of clinical illness associated with COVID-19. Based on what is known about the virus that causes COVID-19, signs and symptoms may appear any time from 2 to 14 days after exposure to the virus. Based on preliminary data, the median incubation period is approximately 5 days, but may range 2-14 days.
Public health officials have identified cases of COVID-19 infection throughout the world, including the United States, which poses risks to public health. Please check the CDC webpage for the most up to date information.

What do I need to know about COVID-19 testing?

Current information on COVID-19 for healthcare providers is available at CDC’s webpage, Information for Healthcare Professionals.

  • SARS-CoV-2 IgG assay can be used to test human serum and plasma specimens.
  • SARS-CoV-2 IgG assay can be ordered by a healthcare provider to detect if there has been an adaptive immune response to COVID-19, indicating a recent or prior infection.
  • SARS-CoV-2 IgG assay is only authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests. The Bio-Center Laboratory at the Riordan Clinic is an authorized lab to perform this test.

Specimens will be collected with appropriate infection control precautions.

We will use appropriate personal protective equipment when collecting and handling specimens from individuals suspected of having COVID-19 as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19).

What does it mean if the specimen tests positive for IgG antibodies against virus that causes COVID-19?

A positive test result with the SARS-CoV-2 IgG assay indicates that antibodies to SARS-CoV-2 were detected, and the individual has potentially been exposed to COVID-19.

IgG antibodies are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.

When IgG antibodies are present it often indicates a past infection but does not exclude recently infected individuals who are still contagious. It is unknown how long IgG antibodies to SARS-CoV-2 will remain present in the body after infection and if they confer immunity to infection.

A positive result for IgG may not mean that an individual’s current or past symptoms were due to COVID-19 infection. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making a final diagnosis and patient management decisions.

The SARS-CoV-2 IgG assay has been designed to minimize the likelihood of false-positive test results. However, in the event of a false-positive result, risks to individuals could include the following: risk of infection by exposure to persons with active COVID-19. If a recent infection is suspected a false positive result may lead to a recommendation for isolation of the individual, monitoring of household or other close contacts for symptoms, isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19-infected individuals, limits in the ability to work, or other unintended adverse effects.

All laboratories using this test must follow standard confirmatory testing and reporting guidelines according to their appropriate public health authorities.

What does it mean if the specimen tests negative for IgG antibodies against virus that causes COVID-19?

A negative test result with this test means that SARSCoV-2 specific antibodies were not present in the specimen above the limit of detection. However, a negative result does not rule out COVID-19 and should not be used as the sole basis for treatment, patient management decisions, or to rule out active infection.

Individuals tested early after infection may not have detectable IgG antibody despite active infection; in addition, not all individuals will develop a detectable IgG response to SARSCoV-2 infection. The absolute sensitivity of the SARS-CoV-2 IgG assay is unknown.

When testing is negative, the possibility of a false negative result should be considered in the context of an individual’s recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. The possibility of a false negative result should especially be considered if the individual’s recent exposure or clinical presentation indicate that COVID- 19 is likely and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. Direct testing for virus (e.g., PCR testing) should always be performed in any individual suspected of COVID-19, regardless of the SARS-CoV-2 IgG assay result.

Risks to an individual of a false negative result include: restriction of activities deemed acceptable for individuals with evidence of an IgG response to SARS-CoV-2, or other unintended adverse events.

What is an EUA?

The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.
An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective in the detection of IgG antibodies to the virus that causes COVID-19.

The EUA for this test is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).

Contact Information for Abbott Laboratories, Inc:

corelaboratory.abbott/us/en/offerings/segments/infectious-disease/sars-cov-2
Phone: 1-877-4ABBOTT

 


 

About Bio-Center Laboratory:

Bio-Center Laboratory at Riordan Clinic is certified by CENTERS for MEDICARE & MEDICAID SERVICES and by CLINICAL LABORATORY IMPROVEMENT AMENDMENTS

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Licensure | Certification

  • CLIA certified (Federal certification) License Number: 17D0648333
  • Medicare: 008052
  • Federal ID: 48-0840415

Contact Information for Bio-Center Laboratory:

  • Call: 316-684-7784
  • Fax: 316-682-2062
  • Email: information@biocenterlab.org

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