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COVID-19 Antibody Testing

We are excited to offer antibody testing to COVID-19 (SARS-CoV-2). According to public health experts this testing will be critical to getting America back to work. We are currently offering a rapid in house test with results in 15 minutes and a serum test with results in 3-4 days. If you are an individual, business or organization looking to test yourself or your employees to safely return to work give our office a call at (850) 877-6790. Testing can be arranged at our office or at your place of business.

Rapid Testing: This test is done using a finger prick and requires only one drop of blood. These tests are also called "lateral flow" tests due to style of testing similar to a pregnancy test. These tests will test for IgM (current infection) and IgG (previous infection and immunity) and results are final in 10-15 minutes. An example of this testing is seen in the video below.

Accuracy: These tests were sourced from Confirm Biosciences and report an overall accuracy of 96.8% for IgM and 95% for IgG.

Price: $95

Serum Testing: Serum testing is a complete blood draw that tests for antibodies using chemiluminesence and processed at the University of Washington Laboratory Medicine Virology Division. These tests were manufactured by Abbott Labs and independently verified by the University of Washington lab. This test is only for IgG antibodies (previous infection and immunity) and does not test for current infection. It is the most accurate test we have available and results are reported within 3-4 days.

Accuracy: The Abbott product insert reports 91% sensitivity before 14 days after symptom onset and 100% sensitivity more than 14 days after symptom onset. UW Lab independent data from 126 patients recovered 100% sensitivity at 17 days after symptom onset and 13 days after PCR positivity. The sensitivity of the test in subjects with asymptomatic infection is unclear, and the duration of positive results is unknown. The product insert of the assay reports a specificity of 99.6%. UW lab internal testing in pre-COVID-19 sera has detected 1 false positive in 1,020 specimens for a specificity of 99.90%.

Price: $145

Testing Disclaimer: These tests have not been reviewed by the FDA and have been made available as part of the U.S. Food and Drug Administration’s notification without an Emergency Use Authorization (EUA) pathway that was outlined for COVID-19 diagnostic tests during the public health emergency. The results of antibody tests should not be the sole basis to diagnosis SARS-CoV-2 or to inform on infection status.

FAQs

What does a positive or negative result mean?

  • The results are either “positive” or “negative” based on the manufacturer-indicated cutoff.
  • A negative result indicates that either a person has not been infected with SARS-CoV-2 or there is not a detectable level of antibody present. Explanations for this may include a very recent exposure such that not enough time has elapsed to generate an immune response, or the immune response has decreased below the detectable level. A negative result does not rule out current or past infection with SARS-CoV-2.
  • A positive result indicates previous or current infection. Recent studies examining serial plasma samples in hospitalized patients with SARS-CoV-2 infection suggest that the median time to seroconversion is about 10 days in moderately ill patients, and 14 days in severely ill patients. It is important to note that a positive serology test cannot distinguish between active or past COVID-19. If there is concern for active infection, molecular testing (PCR) with a nasopharyngeal swab is recommended.
  • At this time, it is not known whether the presence of antibodies confers protection from reinfection with SARS-CoV-2, how long the antibody response lasts, or the association between antibody response and clinical outcomes of individuals with COVID-19.

How accurate are these tests? What is the difference between sensitivity and specificity?

  • Specificity is how likely a test will NOT result in a false positive. So if a test is 99% specefic, there is only a 1% chance of a false positive.
  • Sensitivity is how likely a test will NOT result in a false negative. So if a test is 99% sensitive, there is only a 1% chance of a false negative.
  • Specificity and Sensitivity are listed for each test under the descriptions above.

What are the limitations of the test?

  • This is not intended for acute diagnosis early in the course of disease. As stated above, negative results do not rule out a SARS-CoV-2 infection. For patients in which there is a high clinical suspicion for COVID-19 is high, PCR-based testing is recommended to evaluate infection. Antibody testing should not be used alone to diagnose COVID-19.
  • False-positive results rarely may occur as the result of infection with non-COVID-19 human coronaviruses.
  • Immunocompromised patients with COVID-19 may not have detectable levels of antibodies, or have a delayed antibody response.

Is testing covered by insurance?

  • In general, antibody testing for COVID-19 is not considered "diagnositic" and no antibody tests approved by the FDA, only cleared for use under the FDA's Emergency Use Authorization. For this reason we do not believe these tests to be covered.
  • The University of Washington Lab for the Abbott test does not bill out of state samples to insurance at this time.
  • We can provide you a "super bill" which can be submitted to your insurnace for potential reimbursment.

What if I haven't had symptoms but was exposed to someone with COVID-19, will I have antibodies?

  • Maybe. While you do have to get infected with COVID-19 to produce anitbodies, many people are asymptomatic during infection. So while they would not show symptoms or have mild symptoms, they would still produce antibodies.

Where is the testing done?

  • Testing can be done in our office or at your place of business. If you need alternative arragnements please call our office at (850) 877-6790.

Other COVID-19 Resources

COVID-19 and Immune Optimization Strategies Webinar

Immune Optimization Protocol:

Suggestions mentioned in the presentation are available from the link below. This protocol is NOT intended to treat COVID-19 as this is a new virus with no proven treatment options. This protocol is based off current literature that shows immune optimization and benefits against similar known viruses. Before starting this protocol, please consult with Dr. Zaideman or your primary care physician to make sure there is no contraindications with current prescription medications. If you have specific questions on what will be the best protocol for you, we recommend making a no charge consultation with Dr. Zaideman. These consultations are available via phone or video chat to ensure appropriate social distancing.

To access these recommendations, simply click the image below, register for an account, and within 24 hours you will be sent a specific recommendation.

https://www.healthytallahassee.com/index.php?p=522881

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